NIST’s Proposed Changes to Bayh-Dole Would Create Additional Burdens for Tech Transfer Offices

March 26, 2021

On January 4, 2021, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) announced that they are seeking comments on proposed changes to the regulations entitled, “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions” that support the University and Small Business Patent Procedures Act of 1980, commonly known as the “Bayh-Dole Act”.  Comments on the proposed regulations can be submitted via the Federal e-Rulemaking Portal using the docket identification number 201207-0327 and must be received no later than April 5, 2021. NIST held a public webinar on February 25, 2021, on the Notice of Proposed Rulemaking.  The proposed changes are intended to further the Return on Investment (ROI) Initiative for Unleashing American Innovation, which was published in April 2019. 

As provided in the Federal Register, these proposed changes would:

  • make technical corrections;
  • reorganize certain subsections;
  • remove outdated and/or unnecessary sections;
  • institute a reporting requirement on Federal agencies; and
  • provide clarifications on definitions, communications, scope of march-in rights, filing of provisional patent applications, electronic filing, the purpose of royalties on government licenses, and the processes for granting exclusive, co-exclusive and partially exclusive licenses and for appeals.

The proposed changes related to the scope of march-in rights have received the most attention to date, and have been the subject of commentary in trade journals, blog posts, law firm alerts, and from AUTM CEO Stephen Susalka.  Briefly, these proposed changes would clarify 37 CFR § 401.6 to include a provision that march-in rights would not be exercised by an agency exclusively on the basis of business decisions of a contractor regarding the pricing of commercial goods and services arising from the practical application of an invention.

This post, however, will focus on changes related to the filing of provisional patent applications.  The proposed revisions to 37 CFR § 401 will, in part:

  • update the definitions of a patent application and initial patent application in § 401.2(m) and (n) to encompass U.S. provisional and nonprovisional applications, applications filed in a foreign country or international patent office directly, PCT applications, and applications for Plant Variety Protection certificates; and
  • revise § 401.14(c)(3) to clarify the procedures for filing more than one provisional patent application on a disclosed subject invention

More particularly, 37 CFR § 401(m) and (n) would be revised to read as follows (changes from the previous version are shown with additions underlined and deletions in brackets):

(m) The term patent application or ‘‘application for patent’’ [includes a provisional or nonprovisional U.S. national application for patent as defined in 37 CFR 1.9 (a)(2) and (a)(3), respectively,]  may be the following: (1) A United States provisional application as defined in 37 CFR 1.9(a)(2) and filed under 35 U.S.C. 111(b); or (2) A United States nonprovisional application as defined in 37 CFR 1.9(a)(3) and filed under 35 U.S.C. 111(a); or (3) A[n] patent application [for patent] filed in a foreign country or an international patent office; or (4) A patent application filed under the Patent Cooperation Treaty as defined in 37 CFR 1.9(b) which designates the United States; or (5) An application for a Plant Variety Protection certificate.

(n) The term initial patent application means, as to a given subject invention[,]: (1) T[t]he first United States provisional [or non-provisional U.S. national] application as defined in 37 CFR 1.9(a)(2) [and (3), respectively,] and filed under 35 U.S.C. 111(b); or (2) The first United States nonprovisional application as defined in 37 CFR 1.9(a)(3) and filed under 35 U.S.C. 111(a); or (3) The first patent application filed in a foreign country or an international patent office; or (4) The first [international] patent application filed under the Patent Cooperation Treaty as defined in 37 CFR 1.9(b) which designates the United States[;], or (5) The first application for a Plant Variety Protection certificate [, as applicable].

The changes to 37 CFR § 401.14, however, would have the most potential impact on operating procedures for technology transfer offices and in-house and outside counsel.  The revisions to 37 CFR § 401.14(3) include (changes from the previous version are shown with additions underlined and deletions in brackets):

(i) The contractor will file its initial patent application on a subject invention to which it elects to retain title within one year after election of title or, if earlier, prior to the end of any statutory period wherein valid patent protection can be obtained in the United States after a publication, on sale, or public use. Subject to the grant of an extension by an agency under paragraph (c)(5) of this clause, if the contractor files a provisional application as its initial patent application, it shall file a non-provisional application within 10 months of the filing of the provisional application.   (ii) Each provisional application filed following the initial patent application must contain additional written description of the subject invention not previously disclosed in a patent application. The contractor shall file or notify the government that they do not intend to file a non-provisional application within 10 months of the last filed provisional application that is consistent with this section. (iii) The contractor will file patent applications in additional countries or international patent offices within either ten months of the first filed patent application or six months from the date permission is granted by the Commissioner of Patents to file foreign patent applications where such filing has been prohibited by a Secrecy Order. (iv) If required by the Federal agency, the contractor will provide the filing date, patent application number and title; a copy of the patent application; and patent number and issue date for any subject invention in any country in which the contractor has applied for a patent.

Of particular concern are the proposed revisions under 37 CFR § 401.14(3)(ii), which provide that “each provisional application filed following the initial patent application must contain additional written description of the subject invention not previously disclosed in a patent application.” (emphasis added).  The proposed revision does not define what is meant by “additional written description” or what, at a minimum ,would be sufficient to satisfy this requirement.  Does “additional written description” require inclusion of additional features and/or embodiments not previously disclosed in the initial patent application or would merely revising a paragraph disclosed in the initial patent application to add further clarifications or discussion about the invention be sufficient?

In practice, it is not uncommon to abandon a first filed provisional application, either expressly or naturally by not filing a non-provisional application on or before the one-year anniversary of the priority date.  This strategy often is adopted when sufficient progress has not been made on the invention to merit the filing of a non-provisional application and no public disclosure has occurred or to delay the expense of preparing and filing a non-provisional application or the start of potential patent term.  In these circumstances, the first filed provisional application is often refiled “as is” one day after abandonment.    

Under the proposed changes, however, any provisional applications filed after the initial patent application would need to contain additional written description of the invention that was not contained in the previously filed application.  In practice, however, this is often not the case and would create additional burdens on technology transfer offices and their counsel regarding what would be sufficient to constitute “additional written description.”   For example, if sufficient progress has not been made on an invention during the provisional filing year, the inventor, technology transfer office and their counsel will need to spend precious time and resources determining what additional written description would or could be needed to be added to the application.  This begs the question of whether the time and resources being expended on trying to find additional (and sufficient) written description for refiling a provisional might be better spent on assisting an inventor on making progress with his or her invention and developing a patent filing strategy consistent with the current state of the research and potential licensing opportunities.  

Also of concern is the provision under 37 CFR § 401.14(3)(ii) that “[t]he contractor shall file or notify the government that they do not intend to file a non-provisional application within 10 months of the last filed provisional application that is consistent with this section.” (emphasis added).  This provision seems to be inconsistent with 37 CFR § 401.14(3)(i), which provides that “if the contractor files a provisional application as its initial patent application, it shall file a non-provisional application within 10 months of the filing of the provisional application.”

In practice, it is not uncommon to file more than one provisional application during the one-year pendency of the initial patent application, e.g., the first filed provisional application.  This strategy often is referred to as “rolling provisionals,” or “serial provisionals” in which new data, additional description, and potentially new claims, are added to the first filed provisional application as the inventor(s) generate new experimental results.  Under this strategy, a non-provisional application is filed on or before the one-year anniversary of the filing date of the first filed provisional application, including all of the subject matter included in any subsequently filed provisional application in this series. 

Under the proposed changes, however, the contractor would need to file a non-provisional application or notify the government that they do not intend to file a non-provisional application within 10 months of the last filed provisional application.  In practice, this most likely would never be the case as the decision to file a non-provisional application is based on the filing date of the first filed provisional application not the last.  Further, filing a non-provisional application based on the filing date of the last provisional application would run counter to the definition of the “first application” as provided Article 4(c)(4) of the Paris Convention.  This inconsistency should be addressed by the rulemaking body.

Finally, in the public webinar conducted by NIST, slide 21 provides that revisions to 37 CFR § 401.14(c)(3) include that “the filing of serial provisional applications on the same subject invention – must be approved by agency, ….”  (emphasis added).  This language, however, is not mentioned in the materials published in the Federal Register.  To our knowledge, agency approval to file a patent application has not been required by previous regulations and the filing of a patent application has been at the discretion of the contractor, e.g., the tech transfer office.  If adopted, this language would place additional burdens on technology transfer offices and would be impractical as provisional filings typically must be made in a timely manner, for example, prior to a public disclosure.  It is unlikely that approval from the funding agency could be received before the provisional application would need to be filed prior to such disclosure, which could result in the forfeiture of foreign patent rights and negatively impact the commercial value of the invention.  This approach would run counter to the express goals of the Bayh-Dole Act.

Please continue to watch BRICS & Beyond for updates on the proposed changes to the Bayh-Doyle Act.

This post was written by Lisa Mueller & Jeff Childers.

Impossible™ Foods:  Protecting Plant-Based Meat Substitutes having the Aroma and Flavor of Meat

March 20, 2021

In 2011, Impossible™ Foods (Impossible) was founded with the aim of providing meat products with the taste and nutritional benefits of meat but without the negative health and environmental impacts.  In 2016, Impossible™ launched its first product, the Impossible™ burger, which is available in restaurants (e.g., Burger King®) and grocery stores.  The four main ingredients in the Impossible™ burger are protein (soy and potato proteins), fat (coconut and sunflower oils), binders (methylcelluloses) and flavor (a heme, specifically, soy leghemoglobin).  As discussed in more detail below, Impossible™ discovered that heme is the key ingredient that provides meat with its aroma and flavor.

Impossible™ discovered that certain characteristics of meaty flavors (e.g., beef, bacon, umami, savory, blood, etc.) produced during the cooking process were the result of a chemical reaction between flavor precursor molecules and iron complexes.  As a result of this discovery, Impossible™ combined flavor precursor molecules and iron complexes to produce consumable food products having a range of savory and meaty aromas and tastes.

The flavor precursor molecules that can be used in these products can be sugars, sugar alcohols, sugar acids, sugar derivatives (e.g., glucose, fructose, ribose, sucrose, etc.), oils (e.g., coconut oil, mango oil, sunflower oil, cottonseed oil, etc.), free fatty acids (e.g., caprylic acid, capric acid, lauric acid, myristic acid, oleic acid, etc.), amino acids and derivatives thereof (e.g., cysteine, cystine, methionine, isoleucine, leucine, lysine, etc.), nucleosides and nucleotides (e.g., inosine, guanosine, adenosine, etc.), vitamins (e.g., vitamin D, vitamin B6, vitamin E), acids (e.g., acetic acid, alpha hydroxy acids, tricarboxylic acids, dicarboxylic acids, etc.), peptides and protein hydrolysates (e.g., glutathione, vegetable protein hydrolysates, etc.), or extracts (e.g., malt extracts, yeast extract, etc.).

The iron complexes that can be used can be a heme moiety or other highly conjugated heterocyclic ring complexed to an iron ion.  Specifically, the heme moiety can be a heme cofactor, such as a heme-containing protein.  Heme-containing proteins include globins, such as soy leghemoglobin, which is currently used in the Impossible™ burger.

It is not surprising that Impossible™ filed for patent protection covering food products containing these iron complexes having the flavor and aroma of meat.  This post examines one patent family owned by Impossible™ covering these food products.  Specifically, this post compares the issued claims granted in Australia, Europe, Japan, Russia, and the United States (U.S.).

Australia

Australia Patent No.  2014205114B2

1.  A ground beef-like food product, comprising:

a) 1% – 5% by weight of a heme-containing protein;

b) a compound selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphate, maltose, and galactose, and mixtures of two or more thereof;

c) at least 1.5 mM of a compound selected from cysteine, cystine, thiamine, methionine, and mixtures of two or more thereof; and

d) one or more plant proteins;

wherein the ground beef-like food product contains no animal product;

wherein cooking the ground beef-like food product results in the production of at least two volatile compounds which have a beef-associated aroma.

Australia Patent No. 2018200969B2 (Divisional of Australia Patent No. 2014205114B2)

1. A meat substitute comprising:

a) a porphyrin or a chlorin complexed to an iron ion; and

b) one or more flavor precursor molecules selected from the group consisting of glucose, fructose, ribose, arabinose, glucose-6-phosphate, fructose 6-phosphate, fructose 1,6-diphosphate, maltose, galactose, lactose, xylose, sucrose, maltodextrin, thiamine, cysteine, cystine, a cysteine sulfoxide, allicin, selenocysteine, methionine, isoleucine, leucine, lysine, phenylalanine, threonine, tryptophan, 5-hydroxytryptophan, valine, arginine, histidine, alanine, asparagine, aspartate, glutamate, glutamine, glycine, proline, serine and tyrosine;

wherein cooking imparts a taste and smell of meat to the meat substitute; and

wherein said porphyrin or a chlorin complexed to an iron ion is ferrous chlorin.

Europe

EP Patent No. 2943072B1

1. A meat substitute comprising:

a) a heme-containing protein; and

b) at least two flavor precursor molecules selected from the group consisting of glucose, fructose, ribose, arabinose, glucose-6-phosphate, fructose 6-phosphate, fructose 1,6-diphosphate, maltose, galactose, lactose, xylose, sucrose, maltodextrin, thiamine, cysteine, cystine, a cysteine sulfoxide, allicin, selenocysteine, methionine, isoleucine, leucine, lysine, phenylalanine, threonine, tryptophan, 5-hydroxytryptophan, valine, arginine, histidine, alanine, asparagine, aspartate, glutamate, glutamine, glycine, proline, serine and tyrosine;

wherein a taste and smell of meat is given to the meat substitute during the cooking process.

Note:  claim 1 as shown above is the claim as granted.  EP Patent No. 2943072B1 is currently subject of an opposition, the claims as granted may change as a result of the opposition procedure.

Japan

Japanese Patent No. 6553516B2

1. A food product which, when cooked, reproduces the taste of meat products, comprising:

a) 1% to 1% (w/v) of a heme-containing protein;

b)  sugars, sugar alcohols, sugar acids or sugar derivatives selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphoric acid, maltose, galactose, and mixtures of two or more of these;

c)  a compound selected from cysteine, cystine, selenocysteine, thiamine, and mixtures of 2 or more of these; and

d)  one or more plant proteins.

Russia

Russian Patent No. 2701852C2

1. A meat analog containing:

a) a highly conjugated heterocyclic ring complexed with an iron ion; and

b) one or more taste precursor molecules selected from the group consisting of: glucose, fructose, ribose, arabinose, glucose-6-phosphate, fructose-6-phosphate, fructose-1,6-diphosphate, inositol, maltose, sucrose, maltodextrin, glycogen, nucleotide bound sugars, molasses, lecithin, inosine, inosine monophosphate (IMP), guanosine monophosphate (HMP), pyrazine, adenosine monophosphate (AMP), lactic acid, succinic acid, glycolic acid, thiamine , creatine, pyrophosphate, algae oil, safflower oil, linseed oil, rice oil, cottonseed oil, coconut oil, mango oil, cysteine, methionine, isoleucine, leucine, lysine, phenylalanine, threonine, tryptophan, valine, arginine, histidine, alanine, asparagine, aspartate, glutamate, glutamine, glycine, proline, serine, tyrosine, glutathione, an amino acid derivative, protein hydrolysate, malt extract, yeast extract, and peptone.

United States

U.S. Patent No. 9,700,067B2

1. A ground beef-like food product comprising:

a) 1%-5% by weight of a heme-containing protein comprising an amino acid sequence having at least 80% sequence identity to the polypeptide set forth in SEQ ID NO:4;

b) a compound selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphate, maltose, and galactose, and mixtures of two or more thereof;

c) at least 10 mM of a compound selected from cysteine, cystine, selenocysteine, thiamine, methionine, and mixtures of two or more thereof; and

d) 10% or more by weight of one or more plant proteins;

wherein the ground beef-like food product contains no animal products; and

wherein cooking the ground beef-like food product results in the production of at least two volatile compounds which have a beef-associated aroma.

U.S. Patent No. 9,808,029B2 (Continuation of U.S. Patent No. 9,943,096B2)

1. A ground beef-like food product, comprising:

a) 01%-5% by weight of a heme-containing protein;

b) a compound selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphate, maltose, and galactose, and mixtures of two or more thereof;

c)  at least 1.5 mM of a compound selected from cysteine, cystine, thiamine, methionine, and mixtures of two or more thereof, and

d) one or more plant proteins;

wherein the ground beef-like food product contains no animal product; and

wherein cooking the ground beef-like food product results in the production of at least two volatile compounds which have a beef-associated aroma.

U.S. Patent No. 9,826,772B2 (Continuation of U.S. Patent No. 9,943,096B2)

1. A ground beef-like food product, comprising:

a) 1%-5% by weight of a heme-containing protein;

b) a compound selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphate, maltose, and galactose, and mixtures of two or more thereof;

c) at least 10 mM of a compound selected from cysteine, cystine, thiamine, methionine, and mixtures of two or more thereof; and

d) one or more plant proteins;

wherein the ground beef-like food product contains no animal product; and

wherein cooking the ground beef-like food product results in the production of at least two volatile compounds which have a beef-associated aroma.

U.S. Patent No. 9,943,096B2 (continuation of U.S. Patent No. 9,700,067B2)

1. A food flavor additive composition comprising:

a) an isolated heme-containing protein;

b) a compound selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphate, maltose, maltodextrin, and galactose, and mixtures of two or more thereof; and

c) a compound selected from cysteine, cystine, thiamine, methionine, and mixtures of two or more thereof;

wherein the flavor additive composition contains no animal products; and

wherein cooking the food flavor additive composition results in the production of at least two volatile compounds which have a meat-associated aroma.

U.S. Patent No. 10,314,325B2 (Continuation of U.S. Patent No. 9,943,096B2)

1. A food product, comprising:

a) a heme, wherein the heme is present in an amount equivalent to the amount of heme present in the food product when the food product contains a heme-containing protein in an amount of 0.01% to 5% by weight;

b) a compound selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphate, maltose, and galactose, and mixtures of two or more thereof;

c) at least 1.5 mM of a compound selected from cysteine, cystine, thiamine, methionine, and mixtures of two or more thereof; and

d) one or more plant proteins;

wherein the food product contains no animal product; and

wherein cooking the food product results in the production of at least two volatile compounds selected from the group consisting of (1-ethyl-1-propenyl)-benzene, (E)-2-decenal, (E)-2-heptenal, (E)-2-hexenal, (E)-2-nonenal, (E)-2-octen-1-ol, (E)-2-octenal, (E)-2-tridecen-1-ol, (E)-3-penten-2-one, (E)-4-octene, (E)-5-decene, (E,E)-3,5-octadien-2-one, (Z)-2-decenal, (Z)-2-heptenal, (Z)-3-decen-1-ol, acetate, [(methyl sulfonyl)methyl]-benzene, 1-(ethylthio)-2-(methylthio)-buta-1,3-diene, 1-(methylthio)-propane, 1,1′-(1,2-cyclobutanediyl)bis-cis-benzene, 1,10-undecadiene, 1,3,5-cycloheptatriene, 1,3-bis(1,1-dimethylethyl)-benzene, 1,3-diisopropoxy-1,3-dimethyl-1,3-disilacyclobutane, 1,3-dimethyl-benzene, 1-decen-3-one, 1-heptanol, 1-heptyl-1,2,3,4-tetrahydro-4-methyl-naphthalene, 1-hexanol, 1-hydroxy-2-propanone, 1-nonanol, 1-octanol, 1-octen-3-ol, 1-octen-3-one, 1-octene, 1-pentanol, 1-penten-3-one, 1-undecanol, 2,2,4,6,6-pentamethyl-heptane, 2,3,4-trimethyl-pentane, 2,3-butanedione, 2,3-dihydro-5-methyl-furan, 2,3-dimethyl-pyrazine, 2,4-decadienal, 2,4-dimethyl-1-heptene, 2,5-dimethyl-pyrazine, 2-acetatyl-1-propene, 2-acetyl-propen-2-ol, 2-acetylthiazole, 2-butanone, 2-butenal, 2-butyl-1-decene, 2-decanone, 2-decenal, 2-ethyl-5-methyl-pyrazine, 2-ethylacrolein, 2-ethyl-furan, 2-heptanone, 2-heptenal, 2-hexyl furan, 2-methyl-1(H)-pyrrole, 2-methyl-1-heptene, 2-methyl-1-penten-1-one, 2-methyl-3-(methylthio) furan, 2-methyl-3-furanthiol, 2-methyl-5-(methylthio)-furan, 2-methyl-butanal, 2-methyl-cyclopentanone, 2-methyl-furan, 2-methyl-heptane, 2-methyl-pentanal, 2-methyl-propanal, 2-methyl-thiazole, 2-n-octylfuran, 2-nonanone, 2-nonen-4-one, 2-octanone, 2-octenal, 2-pentanone, 2-pentyl-furan, 2-pentyl-thiophene, 2-phenylpropenal, 2-propenal, 2-propenoic acid, methyl ester, 2-thiophenecarboxaldehyde, 2-tridecen-1-ol, 2-undecanone, 2-undecenal, 3-(methylthio)-propanenitrile, 3-(phenylmethyl)-2,5-piperazinedione, 3,3′-dithiobis-2-methyl-furan, 3,5-bis(1,1-dimethylethyl)-phenol, 3,5-di-tert-butylbenzoic acid, 3-decen-2-one, 3-ethylcyclopentanone, 3-ethyl-pentane, 3-methyl-2-butenal, 3-methyl-2-thiophenecarboxaldehyde, 3-methyl-3-buten-2-one, 3-methyl-butanal, 3-methyl-furan, 3-methylheptyl acetate, 3-methyl-pentanal, 3-pentyl-furan, 3-phenyl-furan, 3-thiophenecarboxaldehyde, 3-thiophenemethanol, 4,7-dimethyl-undecane, 4-chloro-2,6-bis(1,1-dimethylethyl)-phenol, 4-ethoxy-benzoic acid, ethyl ester, 4-ethyl-2-methyl-pyrrole, 4-ethyl-benzaldehyde, 4-methyl-2-heptanone, 4-methyl-5-thiazoleethanol, 4-methylthiazole, 4-nitrophenyl 2-thiophenecarboxylic acid ester, 4-penten-2-one, 4-quinolinecarboxaldehyde, 5-(2-chloroethyl)-4-methylthiazole, 5-ethenyl-4-methyl-thiazole, 5-ethyldihydro-2(3H)-furanone, 5-formyl-4-methylthiazole, 5-methyl-1-undecene, 6-methyl-2-heptanone, 7-methyl-(E)-5-undecene, 9-octadecenal, acetaldehyde, acetic acid, acetone, acetonitrile, acetophenone, acetyl valeryl, aminophenylacetylene, benzaldehyde, benzene, benzoic acid, benzyl alcohol, bis(2-methyl-4,5-dihydro-3-furyl) disulfide, butanal, butanone, butyrolactone, carbon disulfide, decanal, dihydro-3-(2H)-thiophenone, dihydro-5-pentyl-2(3H)-furanone, dimethyl selenone, dimethyl sulfide, dimethyl trisulfide, dodecanal, ethanol, ethyl acetate, formic acid, heptyl ester, furan, furfural, heptanal, hexanoic acid, isopropyl alcohol, isothiazole, isothiocyanato-methane, m-aminophenylacetylene, methacrolein, methanethiol, methional, methyl (methylthio)methyl disulfide, methyl isopropyl disulphide, methyl thiolacetate, methyl vinyl ketone, methyl-pyrazine, methyl-thiirane, nonanal, octanal, octane, oxalic acid, diallyl ester, oxalic acid, isobutyl pentyl ester, p-Cresol, p-dithiane-2,5-diol, pentanal, pentanoic acid, 2,2,4-trimethyl-3-hydroxy-, isobutyl ester, phenol, phenylacetaldehyde, propanal, propyl-cyclopropane, p-xylene, pyrazine, pyrrole, styrene, thiazole, thiocyanic acid, methyl ester, thiophene, toluene, trans-2-(2-pentenyl)furan, trichloromethane, and tridecane.

U.S. Patent No. 10,327,464B2 (Continuation of U.S. Patent No. 9,943,096B2)

1. A food product, comprising:

a) 01%-5% by weight of a heme-containing protein;

b) a compound selected from glucose, ribose, fructose, lactose, xylose, arabinose, glucose-6-phosphate, maltose, and galactose, and mixtures of two or more thereof;

c) at least 1.5 mM of a compound selected from cysteine, cystine, thiamine, methionine, and mixtures of two or more thereof; and

d) one or more plant proteins;

wherein the food product contains no animal products that contain heme; and

wherein cooking the food product results in the production of at least two volatile compounds selected from the group consisting of (1-ethyl-1-propenyl)-benzene, (E)-2-decenal, (E)-2-heptenal, (E)-2-hexenal, (E)-2-nonenal, (E)-2-octen-1-ol, (E)-2-octenal, (E)-2-tridecen-1-ol, (E)-3-penten-2-one, (E)-4-octene, (E)-5-decene, (E,E)-3,5-octadien-2-one, (Z)-2-decenal, (Z)-2-heptenal, (Z)-3-decen-1-ol, acetate, [(methylsulfonyl)methyl]-benzene, 1-(ethylthio)-2-(methylthio)-buta-1,3-diene, 1-(methylthio)-propane, 1,1′-(1,2-cyclobutanediyl)bis-cis-benzene, 1,10-undecadiene, 1,3,5-cycloheptatriene, 1,3-bis(1,1-dimethylethyl)-benzene, 1,3-diisopropoxy-1,3-dimethyl-1,3-disilacyclobutane, 1,3-dimethyl-benzene, 1-decen-3-one, 1-heptanol, 1-heptyl-1,2,3,4-tetrahydro-4-methyl-naphthalene, 1-hexanol, 1-hydroxy-2-propanone, 1-nonanol, 1-octanol, 1-octen-3-ol, 1-octen-3-one, 1-octene, 1-pentanol, 1-penten-3-one, 1-undecanol, 2,2,4,6,6-pentamethyl-heptane, 2,3,4-trimethyl-pentane, 2,3-butanedione, 2,3-dihydro-5-methyl-furan, 2,3-dimethyl-pyrazine, 2,4-decadienal, 2,4-dimethyl-1-heptene, 2,5-dimethyl-pyrazine, 2-acetatyl-1-propene, 2-acetyl-propen-2-ol, 2-acetylthiazole, 2-butanone, 2-butenal, 2-butyl-1-decene, 2-decanone, 2-decenal, 2-ethyl-5-methyl-pyrazine, 2-ethylacrolein, 2-ethyl-furan, 2-heptanone, 2-heptenal, 2-hexyl furan, 2-methyl-1(H)-pyrrole, 2-methyl-1-heptene, 2-methyl-1-penten-1-one, 2-methyl-3-(methylthio) furan, 2-methyl-3-furanthiol, 2-methyl-5-(methylthio)-furan, 2-methyl-butanal, 2-methyl-cyclopentanone, 2-methyl-furan, 2-methyl-heptane, 2-methyl-pentanal, 2-methyl-propanal, 2-methyl-thiazole, 2-n-octylfuran, 2-nonanone, 2-nonen-4-one, 2-octanone, 2-octenal, 2-pentanone, 2-pentyl-furan, 2-pentyl-thiophene, 2-phenylpropenal, 2-propenal, 2-propenoic acid, methyl ester, 2-thiophenecarboxaldehyde, 2-tridecen-1-ol, 2-undecanone, 2-undecenal, 3-(methylthio)-propanenitrile, 3-(phenylmethyl)-2,5-piperazinedione, 3,3′-dithiobis-2-methyl-furan, 3,5-bis(1,1-dimethylethyl)-phenol, 3,5-di-tert-butylbenzoic acid, 3-decen-2-one, 3-ethylcyclopentanone, 3-ethyl-pentane, 3-methyl-2-butenal, 3-methyl-2-thiophenecarboxaldehyde, 3-methyl-3-buten-2-one, 3-methyl-butanal, 3-methyl-furan, 3-methylheptyl acetate, 3-methyl-pentanal, 3-pentyl-furan, 3-phenyl-furan, 3-thiophenecarboxaldehyde, 3-thiophenemethanol, 4,7-dimethyl-undecane, 4-chloro-2,6-bis(1,1-dimethylethyl)-phenol, 4-ethoxy-benzoic acid, ethyl ester, 4-ethyl-2-methyl-pyrrole, 4-ethyl-benzaldehyde, 4-methyl-2-heptanone, 4-methyl-5-thiazoleethanol, 4-methylthiazole, 4-nitrophenyl 2-thiophenecarboxylic acid ester, 4-penten-2-one, 4-quinolinecarboxaldehyde, 5-(2-chloroethyl)-4-methylthiazole, 5-ethenyl-4-methyl-thiazole, 5-ethyldihydro-2(3H)-furanone, 5-formyl-4-methylthiazole, 5-methyl-1-undecene, 6-methyl-2-heptanone, 7-methyl-(E)-5-undecene, 9-octadecenal, acetaldehyde, acetic acid, acetone, acetonitrile, acetophenone, acetyl valeryl, aminophenylacetylene, benzaldehyde, benzene, benzoic acid, benzyl alcohol, bis(2-methyl-4,5-dihydro-3-furyl) disulfide, butanal, butanone, butyrolactone, carbon disulfide, decanal, dihydro-3-(2H)-thiophenone, dihydro-5-pentyl-2(3H)-furanone, dimethyl selenone, dimethyl sulfide, dimethyl trisulfide, dodecanal, ethanol, ethyl acetate, formic acid, heptyl ester, furan, furfural, heptanal, hexanoic acid, isopropyl alcohol, isothiazole, isothiocyanato-methane, m-aminophenylacetylene, methacrolein, methanethiol, methional, methyl (methylthio)methyl disulfide, methyl isopropyl disulphide, methyl thiolacetate, methyl vinyl ketone, methyl-pyrazine, methyl-thiirane, nonanal, octanal, octane, oxalic acid, diallyl ester, oxalic acid, isobutyl pentyl ester, p-Cresol, p-dithiane-2,5-diol, pentanal, pentanoic acid, 2,2,4-trimethyl-3-hydroxy-, isobutyl ester, phenol, phenylacetaldehyde, propanal, propyl-cyclopropane, p-xylene, pyrazine, pyrrole, styrene, thiazole, thiocyanic acid, methyl ester, thiophene, toluene, trans-2-(2-pentenyl)furan, trichloromethane, and tridecane.

This post was written by Lisa Mueller.

 

 

 

Update on the Constitutional Challenges to the 10-Year Patent Term in Brazil

March 15, 2021

This is an update to our post on March 10, 2021.  On Thursday, March 11th, Reporting Justice Dias Toffoli requested that the Brazilian Patent and Trademark Office (BRPTO) respond to 13 questions considered relevant by the Brazilian Supreme Court in deciding the constitutional challenge involving Article 40 of the Brazilian Intellectual Property (IP) Statute (ADI 5529).  The 13 questions address the backlog and patent application pendency before the BRPTO.  In our opinion, the fact that Justice Toffoli has asked for input from the BRPTO indicates that the Brazilian Supreme Court is struggling with how to decide this case.

The Brazilian Supreme Court is scheduled to hear ADI 5529 on April 7, 2021.  Given that the hearing is less than a month away, Justice Toffoli’s request is quite unusual. Typically, requests such as this by the Supreme Court are made when a case is not yet ripe for a hearing.

The BRPTO has five working days (e.g., until March 18, 2021) to respond to Justice Toffoli’s questions.  The question posed by Justice Toffoli are:

  1. What is the current backlog of pending patent applications awaiting a grant or rejection decision based on Article 37 of the Brazilian IP Statute? The BRPTO should provide the total number and number by technical section (technological area).
  2. How many of the backlog patent applications awaiting decision (Article 37 of the Brazilian IP Statute) have been pending for more than ten years? The BRPTO should provide the total number and number by technical section (technological area).
  3. How many of the backlog patent applications awaiting decision (Article 37 of the Brazilian IP Statute) in the health sector (e.g., drugs, hospital equipment, etc.) have a potential indication related to COVID-19?
  4. What was the average time elapsed between the filing of a patent application and the BRPTO’s decision to grant or reject an application (Article 37 of the Brazilian IP Statute) in the last ten, five and one year(s)?  The BRPTO should publish the total number and number by technical section (technological area).
  5. Which technical sections (technological area) have applications with the longest average time between the application’s filing date and the BRPTO’s decision to grant or reject (Article 37 of Brazilian IP Statute) the application?
  6. By July 2021, is it expected that the BRPTO will be able to reduce the number of pending patent applications awaiting decision by 80% as estimated in the Plan to Combat Patent Backlog? So far, how much has this stock of patent applications have been reduced?
  7. Among the patents currently in force, how many (in total and by percentage) have been in force for more than 20 years from their filing date, in the case of utility patents, and 15 years, in the case of utility model patents (Article 40 of the Brazilian IP Statute)?  The BRPTO should publish the total number and number by technical section (technological area).
  8. Among the patents currently in force for more than 20 years, in the case of utility patents, and 15 years, in the case of utility model patents, how many (in total and by percentage) are held by public entities (including universities)? The BRPTO should publish the total number and number by technical section (technological area).
  9. Among the patents currently in force for more than 20 years, in the case of utility patents, and 15 years, in the case of utility model patents, how many have a potential indication related to COVID-19?
  10. How many examiners conduct patent examination? What is the average number of applications awaiting analysis per examiner? Based on the statistics produced by the World Intellectual Property Organization (WIPO), are there any international comparative performance indicators/parameters in this regard?
  11. Do the number of examiners correspond to the total number of vacancies for positions in the BRPTO? If there are open vacancies, how many are there? What are the reasons for those vacancies, and how long have they been open? When was the last public tender to fill vacancies at the BRPTO?
  12. Considering the Federal Court of Accounts decision in the Audit Process TC #015.369 / 2019-6 recognized that at that time the BRPTO lacked a technological solution in its operations that allowed it to manage the entire flow of patent applications, has the BRPTO, since this decision, adopted any measures aimed to implement a technological solution? Are there any ongoing administrative actions to develop a tool in this regard?
  13. Considering the Federal Court of Accounts decision in the Audit Process TC #015.369 / 2019-6, has the BRPTO provided, or is it providing, any standardization of patent examination procedures?

This post was written by Lisa Mueller and Rob Rodrigues from Licks Attorneys

Introducing Future Foods Friday

March 12, 2021

Welcome to Future Foods Friday!  In this new Friday series, we will focus on patent, regulatory and other issues associated with “future food technologies” such as non-animal derived food products, cellular agriculture, and gene editing techniques.  As many readers are aware, these innovative technologies have the potential to provide sustainable, affordable, and secure nutrition for the growing global population.  In this first post, we provide some background on a few of the future food technologies that will be the subject of future posts.

Non-animal derived food products:  Non-animal derived food products involve fashioning analogues of traditional food products such as meat, seafood, and dairy products from non-animal derived sources such as plants (e.g., as pulses (lentils, peas, fava, chickpeas, mung beans), wheat, soy, etc.), insects, bugs, worms, and/or microorganisms (e.g., algae, fungi, etc.).  For example, plant-based food products are generally made by mixing plant proteins with other ingredients such as one or more fats, starches, fibers, binding ingredients, spices and/or colorants (such as from vegetable and fruit dyes) and often extruded to result in the appropriate shape and texture.  One of the challenges with non-animal derived food products is to mimic the texture and flavor of the relevant product, such as meat. Companies have developed innovative ways of addressing these issues.  For example, Impossible Foods has patented technology for producing a soy leghemoglobin protein which imparts a reddish-brown color and beefy flavor in their burgers.  In contrast, Beyond Meat uses beetroot juice to recreate the “ooze” of blood from its burgers.  Other companies use 3D printing to produce their food products (e.g., Redefine Meat).   Still other companies use fermentation (e.g., precision fermentation) to produce their products (e.g., Helaina to make breast milk and Air Protein to make meat-alternatives out of elements in the air).

Cellular agriculture (also known as “cultured” or “clean” meat):  Cellular agricultural borrows well known techniques from the biotech industry which have traditionally been used to produce medicines.  Specifically, cellular agricultural involves taking biopsies from the relevant animal, fish, or crustacean whose meat is to be replicated.  From these biopsies, the “right” cells are identified, isolated, and converted into stable cell lines which proliferate in a bioreactor together with a mix of nutrients and growth factors, buffering solutions, temperature, etc.  After sufficient proliferation, the cells differentiate into muscle fibers that aggregate on a scaffold (e.g., a 3D structural support) to provide a structured equivalent of a food product (e.g., a steak).  If a scaffold is not used, unstructured products (e.g., a burger) can be obtained. There are a plethora of companies working in this area on a variety of products from beef (e.g., Aleph Farms, Future Meat, Meatable, Memphis Meats, Mosa Meat), chicken (e.g., Future Meat, Memphis Meats), duck (e.g., Memphis Meats), lamb (e.g., Future Meat), pork (e.g., Future Meat, Meatable), foie gras (e.g., Integriculture) seafood (e.g., Shiok Meats, BlueNalu, Finless Foods) to breast milk (e.g., Biomilq, Turtletree Labs).

Gene editing techniques:  Gene editing techniques have the potential to allow for important improvements in animals and plants, such as disease and/or pest resistance, drought and cold tolerance, and/or increases in yield.  For example, transcription activator-like effector nucleases (TALEN) have been used by Calyxt to create high-oleic soybeans which have been on the market since 2019.  Tropic Biosciences has developed a proprietary technique, gene editing induced gene silencing (GEiGS), to create coffee with reduced caffeine and increased solubility as well as novel banana varieties that are resistant to Panama disease. Genus PLC is using clustered regularly interspaced short palindromic repeats/Cas9 (CRISPR) to create resistance in pigs to Porcine Reproductive and Respiratory Syndrome Virus (PRRS) which is one of the great scourges of pig production around the world.

As the search continues for more sustainable food sources, there are plenty of opportunities for innovation with future food technologies.  It will be fascinating to watch as the global intellectual property and regulatory frameworks for these products continue to develop and mature over time.

This post was written by Lisa Mueller.

 

 

Brazilian Supreme Court sets an earlier date to decide the fate of the 10-year patent term

March 10, 2021

The constitutional challenge before the Brazilian Supreme Court (ADI 5529) that seeks to invalidate any remaining patent term of approximately 40% of Brazil’s patents and pending applications is scheduled to be decided on April 7, 2021 instead of May 2021.

The lawsuit challenging Article 40 of the Brazilian IP Statute was filed by the Federal Prosecutor’s Office (FPO) in 2016. Article 40 establishes a minimum term for patents of 10 years from the date of grant. Due to the backlog in examination of patent applications at the Brazilian Patent and Trademark Office, Article 40 is critical for many patent owners investing in Brazil affected by the backlog.

The Supreme Court is deciding this case earlier due to a request filed on February 24, 2021 by the FPO seeking a preliminary injunction (PI) to immediately suspend the effect of 10-year patent term.  The basis for the request was the impact of the 10-year patent term on pharmaceutical products and the supply of generic drugs to address the Covid-19 pandemic.

The FPO’s PI request was followed by several amici curiae filings.  On March 4, 2021, without deciding the PI request, Reporting Justice Toffoli requested that Supreme Court Chief Justice Luiz Fux move the oral hearing to a date earlier than May 2021.

As alluded to above, ADI 5529 has the potential to impact about 40% of all patents currently in force in Brazil. Approximately 25,119 utility patents and 1,907 utility model patents could have their term reduced, of which about 2,279 and 456, respectively, would immediately expire. Almost 14,000 pending patent applications are at risk of having with no patent term left when granted (10,049 utility patent applications and 3,631 utility model patent applications).

If the ADI 5529 is successful, the strategic industrial sector of the Brazilian economy will be severely affected. For example, about 88.32% of telecommunications utility patents could have their patent term reduced or invalidated. A similar outcome might result for about 67.66% of biotech patents, about 66.67% of pharmaceutical patents, about 59.94% of electronic patents, etc.

Brazilian patentees will also these effects if ADI 5529 is successful.  Specifically, about 36.52% of Brazilian owned utility and utility model patent currently in force may immediately become expired.  Among the top 15 Brazilian patentees are important research institutions, universities, and public companies such as FAPESP, UNICAMP, EMBRAPA, UFRJ, USP and PETROBRAS. The impact on these institutions could undermine Brazil’s capability to foster innovation.

Licks Attorneys has prepared a special publication with information about the potential impact that ADI 5529 might have, if successful, on the Brazilian patent system, patent owners, investments, manufacturing, and value-added chains that rely on patents in Brazil.  This material is available at Licks’ website.

Please continue to watch BRICS & Beyond for updates on ADI 5529.

This post was written by Lisa Mueller and by Rob Rodrigues, Otto Licks, Ana Calil, and Alysson Farias from Licks Attorneys

 

Filing a Divisional Application in Europe – Part 15

March 2, 2021

This is the fifteenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first fourteen posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan, Malaysia, Singapore, Russia, Saudi Arabia and Vietnam and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand,  Divisional Practice – Pakistan, Divisional Practice – Malaysia, Divisional Practice – Singapore, Divisional Practice in Russia, Divisional Practice in Saudi Arabia, Divisional Practice in Vietnam and Divisional Practice – United States.

Divisional applications in Europe

For European patent applications, a divisional application must be filed while a parent application is pending.  A parent application is no longer pending when it is granted, definitively refused or definitively withdrawn.  In other words, a patent application is considered pending:,

  1. Until the day before the date of publication of the mention of grant of the patent in the European Patent Bulletin;
  2. Until the last day of the period for filing an appeal (even if an appeal is not subsequently filed), when the Examining Division has refused the patent application; and if an appeal is filed, during the subsequent appeal proceedings;
  3. On the day the European Patent Office (EPO) receives a written request to withdraw a patent application; or
  4. Until the last day of a time limit; where non-observance of the time limit results in the application being “deemed withdrawn” with “a loss of rights”; such as, for example, due to: a failure to (a) pay a fee in due time; (b) file a translation of the claims; or (c) respond to a communication from the Examining Division with respect to an application’s deficiencies. However, if the Applicant takes steps to remedy the loss of rights (for example by filing a request for further processing and paying the relevant fees) then the application will be deemed to have been pending throughout the period.   It is important to note that if the parent application is a Europe-PCT (Euro-PCT) application, it must enter the European regional phase either before or together with the divisional application in order to be deemed pending.

Requirements for Filing a Divisional Application

According to Rule 40 of the European Patent Code (EPC), when filing a divisional application, the following must be supplied to the EPO:

  1. A written statement that an European patent is being sought;
  2. Information identifying the Applicant or allowing the Applicant to be contacted; and
  3. A description or reference to a previously filed application (A reference to a previously filed application must state the filing date and the number of the application and the Office in which it was filed.  Such reference must indicate that it replaces the description and any drawings).

When an application contains a reference to a previously filed application, a certified copy of the previously filed application must be filed within 2 months of the filing of a divisional application, unless the reference application was originally filed with the EPO.  If the previously filed application is not in an official language of the EPO (namely, in English, French or German), a translation into one of the official languages will be required within 2 months of the filing of the divisional application.

The filing and search fee for a divisional application must be paid within one month after filing.  The designation fee must be paid within 6 months of the date on which the European Patent Bulletin mentions the publication of the European search report for the divisional application.

Claims of a Divisional Application

A divisional application may be filed with or without any claims.  If a divisional application is filed without any claims, the EPO will set a 2-month period for the Applicant to provide a set of claims.  Alternatively, a divisional application may be filed with the claims as originally filed in the parent or Euro-PCT application.  However, the claims of a divisional application filed with the same claims of a parent or Euro-PCT application will need to be amended at some point during prosecution to ensure that neither the parent or divisional application claim the exact same subject matter from one another.

Double Patenting

The EPC does not explicitly contain any specific provisions prohibiting double patenting (namely, the case of co-pending European patent applications having the same filing date, filed by the same Applicant, and claiming the same subject matter).  However, the Guidelines for Examination in the EPO (Guidelines) in Section G-IV-5.4 state that “it is an accepted principle in most patent systems that two patents cannot be granted to the same application for one invention”.  In fact, the Enlarged Board of Appeal (Board) in decisions G 1/05 and G 1/06 accepted a prohibition on double patenting.  The reasoning the Board gave is that an Applicant does not have a “legitimate” interest in proceedings leading to the grant of a second patent for the same subject matter if the Applicant already possesses a granted patent for that same subject matter.  According to the Board, it is permissible to allow an Applicant to proceed with 2 applications having the same description provided that the claims are distinct in scope and directed to different inventions.

In view thereof, substantial overlap between claims has been permitted by the EPO.  For example, if claims to a narrow genus are obtained in a first application (such as a parent application), the EPO is likely to allow claims to a broader genus that encompasses the species in  a divisional application.   Specifically, the Guidelines in Section G-IV-5.4 state that:

“…in the rare case in which there are two or more European applications from the same applicant definitively designating the same State or States (by confirming the designation through payment of the relevant designation fee) and the claims of those applications have the same filing or priority date and relate to the same invention, the applicant should be told that he must either amend one or more of the applications in such a manner that the subject matter of the claims of the applications is not identical, or choose which one of those applications he wishes to proceed to grant.  If he does not do so, once one of the applications is granted, the other(s) will be refused under Art. 97(2) in conjunction with Art. 125.  If the claims of those applications are merely partially overlapping, no objection should be raised (see T 877/06).  Should two applications of the same effective date be received from two different applicants, each must be allowed to proceed as though the other did not exist” (emphasis added).

Therefore, practically speaking, an Applicant is unlikely to receive a double patenting objection by an Examiner in a divisional application provided that the Applicant can show that the claims in the divisional application do not contain the identical scope of the parent application.

Examination of Divisional Applications

A divisional application is treated as a separate application and is accorded a separate application number, requires separate fees, requires a separate request for examination, will be prosecuted separately from the parent application, and will result in an independent patent from the parent application.  The fees for a divisional application are the same as for any parent application.  The term of patent for a divisional application is twenty years from the filing date of the very first parent application.

Other Important Information Regarding Divisional Applications

Unlike other jurisdictions where divisional applications can only be filed when a lack of unity objection is raised by the relevant Office, European divisional applications can be filed at any time (namely, before receipt of the Search Report or issuance of any communication from the Examining Division).

Furthermore, unlike other jurisdictions where divisional applications can only be filed with claims directed to an invention other than the first invention identified by the relevant Office, European divisional applications can be filed (subject to the above considerations on double patenting) with claims directed to any subject matter, provided that the subject matter is literally supported by both the European divisional application as originally filed and the parent application(s) as originally filed.  In particular, divisional applications can be filed with claims directed to subject matter only disclosed in the description and/or drawings of the parent application even where the claims of the parent application were never directed to such subject matter.

When filing and/or subsequently amending a divisional application, care must be taken to avoid an  “extension of subject matter” beyond that disclosed in both the divisional application as filed and the parent application as filed, as well as the priority application, if its priority is claimed. The Examining Division will apply the so-called ‘gold-standard’ for determining what is disclosed, i.e., only subject matter “which is directly and unambiguously derivable from the disclosure of the invention in the priority and/or parent application (excluding the abstract, but including the drawings), also taking into account any features implicit to a person skilled in the art in what is expressly mentioned (see G 2/98)”.  Applicants are recommended to include all the subject matter disclosed in the parent application in the divisional application, for example, by including the claims of the parent application (in the form of clauses) in the description of the divisional application.

Additionally, Applicants must take care not to definitively delete any subject matter from a parent application (for example due to a unity objection), since this subject matter cannot become part of its divisional application.

This post was written by Lisa Mueller and Verena Simpson, Lars Pallisgaard Olsen and Annette Sorensen of Guardian IP.

Filing a Divisional Application in the United States – Part 14

February 24, 2021

This is the fourteenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first thirteen posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan, Malaysia, Singapore, Russia, Saudi Arabia and Vietnam and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand,  Divisional Practice – Pakistan, Divisional Practice – Malaysia, Divisional Practice – Singapore, Divisional Practice in Russia, Divisional Practice in Saudi Arabia and Divisional Practice in Vietnam.

Divisional Practice in the United States

Continuing Applications

In the U.S., a pending application may serve as the basis for a continuing application.  Three types of continuing applications exist under U.S. practice, namely divisional, continuation, and continuation-in-part applications.  A continuing application may itself serve as the basis for another continuing application.

Time Period for Filing a Continuing Application 

One or more divisional, continuation, and/or continuation-in-part applications may be filed any time prior to grant of a U.S. patent application.

Requirements for Filing a Continuing Application 

When filing a continuing application, the following documents must be submitted:

  1. A copy of the specification, drawings, and abstract;
  2. A set of claims to be pursued;
  3. An oath or declaration (for continuation-in-part applications) or a copy of a previously submitted oath or declaration (for divisional and continuation applications); and
  4. Basic filing, search, and examination fees.

Additional fees will be required for more than three independent claims, more than 20 total claims, and for each additional 50 sheets that exceeds 100 sheets.

Claims of a Continuing Application 

Divisional Application:   U.S. law provides that if an application contains claims directed to two or more independent and distinct inventions, an Applicant may be required to elect a single invention for examination on the merits.  Each non-elected invention may be pursued in what is referred to as a “divisional” application(s).  Because restriction was required in the parent (original) application, the parent application cannot serve as the basis of a double patenting rejection as long as the claims of the divisional application are directed to a non-elected invention.  In another words, in a properly filed divisional application, a double patenting rejection cannot be made.

Continuation Application:   A continuation application contains the originally disclosed subject matter.  A continuation application may be filed with the originally filed claims and/or new claims (provided that there is support for the claims in the specification as originally filed).  The parent application (or another continuation application that claims priority back to the parent application) may serve as the basis of a double patenting rejection during examination of any continuation application. 

Continuation-in-part Application:   A continuation-in-part application contains the originally disclosed subject matter, plus additional, new subject matter.  Accordingly, the claims of a continuation-in-part application may be directed to the originally disclosed subject matter, the newly disclosed subject matter, or a combination thereof.  The parent application (or a continuation application that claims priority back to the parent application) may serve as the basis of a double patenting rejection during examination of a continuation-in-part application.

Double Patenting 

Under U.S. practice, the doctrine of double patenting prevents an Applicant from extending patent exclusivity beyond the term of a patent.  This doctrine assumes that the public will be free to use the claimed invention, plus modifications and variants that would have been obvious to one of ordinary skill in the art upon expiration of a patent.  Double patenting may be raised when an issued patent and one or more pending applications (referred to as “non-provisional” double patenting) or two or more pending applications (referred to as “provisional” double patenting because neither application has yet issued as a patent) meet one of the following requirements: (1) have the same inventors; (2) have at least one common inventor; (3) are commonly assigned or owned; or (4) are non-commonly owned or assigned, but subject to a joint research agreement.

Generally, two types of double patenting exist in U.S. practice: 

  1. Statutory Double Patenting:  Based on 35 U.S.C. § 101, refers to the fact that an Applicant may obtain only a single patent per invention.  Accordingly, if the claims of an application being examined and an issued patent or pending application are directed to the same invention, a statutory double patenting rejection will be issued by the United States Patent and Trademark Office (USPTO).  The phrase “same invention” means identical subject matter.  The test of whether or not the same invention is being claimed twice is whether the claim in an application being examined can be infringed without literally infringing a corresponding claim in a patent or pending application.  An example is provided below.

Example

  • Claim in a pending application undergoing examination:  A compound of Formula I wherein X is chlorine.
  • Claim in issued patent:  A compound of Formula I wherein X is chlorine.
  • Test:  Can the claim in the examined application be infringed without literally infringing the claim in the issued patent?  Answer:  No.  The claim in the application being examined will be rejected by the Examiner for statutory double patenting.
  1. Non-statutory Obviousness-type Double Patenting:  This type of double patenting is the result of a judicially created doctrine.  Non-statutory obviousness-type double patenting intends to prevent an Applicant from extending patent exclusivity by obtaining claims in a second patent that are patentably indistinguishable (in other words, not patentably distinct) from the claims in another patent or pending application.  Accordingly, if the claimed invention in an application that is being examined (such as in a continuation or continuation-in-part application) is an obvious variant or modification of a claimed invention in an issued patent or pending application, a non-statutory obviousness-type double patenting rejection will be issued by the USPTO.  Essentially, a non-statutory obviousness-type double patenting rejection is considered to be “analogous” to a failure to meet the obviousness requirement of 35 U.S.C. Section 103 except the patent or pending application underlining the double patenting rejection does not have to be prior art.

The key inquiry in a non-statutory obviousness-type double patenting rejection is the differences between the inventions defined by the conflicting claims.  The specification can only be used to construe the meaning of the claims (namely, as a dictionary to learn the meaning of the term in the claims).

Overcoming a Double Patenting Rejection 

  1. Statutory Double Patenting: A statutory double patenting rejection may be overcome by:  (a) amending the claims in the application being examined so as not to be coextensive in scope with the claims of the issued patent or pending application that form the basis of the rejection; (b) arguing the rejection; (c) canceling the conflicting claims in the application being examined; (d) if a “provisional” statutory double patenting rejection is the only rejection remaining in both applications, asking the Examiner to withdraw the rejection in the application with the earlier filing date and permitting that application to issue as a patent (if both applications were filed on the same date, Applicant will need to elect which of the two applications is to be allowed); or (e) abandoning the application in which the rejection is raised.  A terminal disclaimer cannot be used to overcome a statutory double patenting rejection.
  2. Non-statutory Obviousness-type Double Patenting: A non-statutory obviousness-type double patenting rejection may be overcome by:  (a) amending the claims in the application being examined to be patentably distinct over the claims of the issued patent or pending application that form the basis of the rejection; (b) arguing the rejection; (c) canceling the claims at issue in the pending application being examined; (d) if a “provisional” non-statutory obviousness-type double patenting rejection is the only rejection remaining in both applications, asking the Examiner to withdraw the rejection in the application with the earlier filing date and permitting that application to issue as a patent (if both applications were filed on the same date, Applicant will need to elect which of the two applications is to be allowed); (e) if the rejection is a “provisional” rejection, abandoning one of the pending applications; or (f) filing a terminal disclaimer.

Terminal Disclaimers 

A terminal disclaimer is a legal document that ensures that the term of a patent granted on an examined application will not extend past the expiration of the term of the conflicting patent or a patent granted on a conflicting application.  A terminal disclaimer is effective only if there is common ownership between the conflicting claims at issue.  If there is no common ownership, a terminal disclaimer cannot be filed.  Additionally, it is important to remember when conducting due diligence that a patent granted in which a terminal disclaimer is filed is enforceable only as long as the patent issuing and the prior patent that formed the basis of the non-statutory obviousness-type double patenting rejection are commonly owned.

A terminal disclaimer must: (1) specify the portion of the term of the patent being disclaimed; (2) state the present extent of Applicant’s or Assignee’s ownership interest in the patent to be granted; and (3) indicate that the terminal disclaimer fee is enclosed (Presently, $170.00 per terminal disclaimer filed for a large, small or micro entity).  The terminal disclaimer may be signed by the Applicant or an attorney or agent of record.

A terminal disclaimer operates with respect to all claims in a patent.  A terminal disclaimer is only effective with respect to the application identified in the disclaimer, unless an Applicant specifically recites that the disclaimer applies to one or more continuation applications.

A certificate of correction cannot be used to remove a terminal disclaimer mistakenly filed during prosecution or which is no longer believed to be necessary.  However, an Applicant can file a petition to withdraw a terminal disclaimer during prosecution before an application issues if grounds are provided explaining why the terminal disclaimer(s) is no longer believed to be necessary.  A reissue proceeding cannot be used to withdraw a terminal disclaimer that is in effect at the time a patent issues.

This post was written by Lisa Mueller.

Ukraine introduces managed entry agreements for innovative pharmaceuticals

February 11, 2021

In January 2021, the Ukrainian Government introduced managed entry agreements (MEA), a market access instrument widely known in the European Union, but brand new to Ukraine. Managed entry agreements are arrangements between pharmaceutical companies and healthcare payors for innovative medicines that provide flexibility in managing the uncertainty around the financial impact or performance of such medicines. The introduction of MEAs in Ukraine should facilitate access to costly innovative health technologies which is needed in view of the budget constraints currently faced in the country.

Managed entry agreement regulations provide new business opportunities for innovative pharmaceutical companies in Ukraine.

Benefits of MEAs  

 Managed entry agreements provide flexibility for Ukrainian public payors when negotiating the terms of purchase for original medicinal products with pharmaceutical companies.  This flexibility provided by MEAs will better allow payors to manage the financial impact of such purchases.  Managed entry agreements may be: (1) purely financial agreements (e.g., agreements that provide discounts, supply of stock at zero cost at the initial stages of treatment etc.); (2) outcome-based (e.g., pay-for-performance); or (iii) a combination of (1) and (2).

The Ministry of Health (MOH) has stated that it intends to pilot MEAs on a more straightforward financial basis.  Most importantly, because MEAs will be deemed to be confidential, sensitive commercial terms (e.g., product pricing) will be protected from public disclosure. Only basic information on the product covered by MEA, its duration and parties will be released to the public.

Mandatory State Health Technology Assessment

The feasibility of a MEA for an original medicinal product must be confirmed by a state health technology assessment (HTA). A health technology assessment is a structured evaluation of the properties, effects and impacts of a health technology that is performed for the purpose of providing input on a health policy decision. State HTAs are intended to provide Ukrainian policymakers with data and evidence to support their decisions on how to efficiently direct limited health budget and select from a range of health technologies available.  The state HTA process may be initiated by the marketing authorization holder (MAH) at its own initiative or, under certain limited circumstances, at the request of the MOH. To participate in a state HTA, the MAH must submit a product HTA dossier to the Ukrainian HTA authority.  The assessment will be conducted by the authority, drawing on clinical, epidemiological, health economic and other information and methodologies.

Decision-making process

Decision-making on a MEA rests with the MOH. A MEA will only be executed following confidential negotiations between the MAH and representatives of the MOH.  The entire process (excluding HTA) to execution of a MEA may take over 1 year.  However, the Ukraine government has instituted statutory time limits for each stage of the decision-making process. For example, negotiations of a MEA should be limited to no more than 120 days, execution of a MEA should be limited to no more than 60 days, etc.

 Contracting parties

Once the key terms have been negotiated and agreed upon, a MEA can be entered into with respect to an original medicinal product and the following parties:

  • From the pharmaceutical company: MAH / its authorized affiliate / authorized distributor; and
  • From the Government: the MOH or State Enterprise “Medical Procurement of Ukraine” (if instructed by the MOH).

Term of a MEA

Managed entry agreements will be valid for a period of up to 1 year.  A MEA can be extended for additional 1-year periods, for a maximum of up to 3 years. Any extension of a MEA is contingent upon the receipt of a positive HTA.

A MEA can be terminated early in the event a generic product or biosimilar with the same INN, dosage form and/or therapeutic indication is authorized for marketing in Ukraine.

Key takeaways

Given the strategic importance of MEAs for innovative pharmaceutical companies, as well as the complexity and timeline of the HTA and MEA processes, it is recommended that pharmaceutical companies that have products that could potentially be subject to a MEA in Ukraine begin preparing for the HTA and MEA processes as soon as possible to minimize any potential for delay.

This post was written by Lisa Mueller and Viktoriya Podvorchanska at Asters

Filing a Divisional Application in Vietnam – Part 13

January 29, 2021

This is the thirteenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order).  Our first twelve posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, Thailand, Pakistan, Malaysia, Singapore, Russia and Saudi Arabia and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, Divisional Practice -Thailand,  Divisional Practice – Pakistan, Divisional Practice – Malaysia, Divisional Practice – Singapore, Divisional Practice in Russia and Divisional Practice in Saudi Arabia.

Divisional Practice in Vietnam

In Vietnam, divisional practice is fairly flexible.  Specifically, one or more divisional applications can be filed: (1) in response to a lack of unity rejection; and/or (2) at any time for any reason (e.g., voluntary divisionals are permitted).   The specification of a divisional application must not go beyond the original specification of the parent application.  In other words, no new matter can be added in a divisional application.

Time Period for Filing a Divisional Application

A divisional application can be filed any time during the pendency of the parent application, namely, before the Intellectual Property Office of Vietnam (IP Vietnam) issues a final decision regarding the grant or refusal of the parent application.  In practice, a divisional application should be filed no later than at the time of paying the grant fees of the parent application.  Vietnam’s Intellectual Property Law (IP Law) does not indicate whether a divisional application can be filed off of a pending divisional application once the parent application has issued.  Currently, IP Vietnam is not rejecting divisional applications filed off of a divisional application.

Requirements for Filing a Divisional Application

According to Vietnam IP Law, the requirements for filing a divisional application are as follows:

  1. Submission of a copy of the specification (including the abstract), claims and drawings of the divisional application as well as an entry form indicating the name, address and nationality of each inventor;
  2. The divisional application cannot include any subject matter not originally disclosed in the parent application; and
  3. The parent application and the divisional application cannot claim the same (e.g., identical) subject matter.

The priority and filing dates of each divisional application will be identical to the priority and filing date of the (original) parent application.

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the parent application or PCT application.  However, the claims of a divisional application filed with the same claims as a parent or PCT application must be amended prior to or during examination to ensure that neither the parent or divisional application claim identical subject matter.  As will be discussed in more detail below, if the claims of two patent applications or a patent and a pending application have identical scope, they the application(s) will be considered to be an identical invention and rejected for double patenting.

Double Patenting

Article 90 of the Vietnam IP Law states that if more than one application has been filed for the same or “equivalent” inventions, then only one patent will be granted for the application having the earliest priority or filing date (i.e., if the application does not claim priority).  Article 24 of the Guidelines for Examination of Patent Applications (Guidelines) provides a series of steps that should be performed in determining whether two sets of claims recite “the same invention”.

According to the Guidelines, the first step involves determining the scope of protection of the invention based on the terms and concepts recited in the two sets of claims (with the description and drawings being used to interpret the scope of protection).  Next, the claims in the first application or patent must be compared with the claims in the second application (The claims of the first application or patent must not be compared with the specification of the second application).  If the scope of protection of a claim in the first application or patent is identical to the scope of protection of a claim in the second application, then the inventions will be deemed to be “identical” inventions.  If the specifications of the first application or patent and the second application are the same, but the scope of protection of the claims in each are different, then the two inventions will be deemed not to be identical.  For example, if the specification of a first application or patent and a second application disclose the same product and process but the claims in the first application or patent are directed to the product and the claims of the second application are directed to the process, then the two inventions will not be deemed to be identical (e.g., there is no double patenting problem).  Likewise, if the scope of protection of the claims of a first patent application or patent and a second application partially overlap, then the two inventions will also be deemed to be identical.  For example, if the claims of a first application or patent recite a pH range of 1.0 to 6.0 and the claims of a second application recite a pH range of 3.0 to 5.0,  then the two inventions will be considered to overlap and will be considered to be identical, since the pH range of 3.0 to 5.0 is encompassed within the broader pH range of 1.0 to 6.0.

Unfortunately, the Guidelines do not provide any information about what is meant by an “equivalent invention”.  However, the issue of “equivalent inventions” often arises when the claims in a first application or patent recite a genus and the claims in a second application recite species encompassed within the scope of a claimed genus.  If the genus claims are patented, then in practice, the second application claiming the species will be rejected for double patenting (as being encompassed within the scope of the patented genus).  However, if the claims of the species are patented, then a second application claiming a genus would be allowable provided that the claims in the second application are amended to include a disclaimer to the species claimed in the patent. However, Applicants should be aware that the requirements for specification support of a disclaimer under Vietnam IP Law are similar those of the European Patent Office.

Examination of Divisional Applications

A divisional application is accorded the same filing date as the parent application but is treated as a new patent filing.  As such, the divisional application:

  1. Is allotted its own (new) application number;
  1. Requires payment of its own filing fees (separate from the filing fees paid in the parent application) and all back annuities;
  1. Requires the filing of a request for examination (separate from the filing of a request for examination in the parent application);
  1. Is prosecuted separately from the parent application; and
  1. Results in a patent that is independent from the parent application.

The fees for a divisional patent application are similar to those for a parent application except that the payment of fees for a priority claim are not required in a divisional application.

The term of a patent issuing off of a divisional application is twenty years from the filing date of the parent application.

This post was written by Lisa Mueller and Thanh Phuong Vu of Tilleke & Gibbins.

Expediting Patent Publication and Examination in China

January 21, 2021

According to Articles 34 and 35 of Chinese Patent Law, an invention patent application (versus a utility model or a design patent application) will be published within 18 months from its filing date (or earliest claimed priority date) after passing preliminary examination by the National Intellectual Property Administration (the “NIPA”). An applicant may apply to NIPA for substantive examination at any time within 3 years from its filing date (or the earliest claimed priority date), and NIPA will perform substantive examination after the application is published. In addition to the above-mentioned general time limit, Chinese Patent Law, the Administrative Measures for Prioritized Patent Examination and other relevant laws and regulations provide four ways to accelerate the grant of patent rights, including Early Publication and Examination, the Patent Prosecution Highway (the “PPH”), Prioritized Patent Examination and Patent Pre-examination.

Early Publication and Examination

According to Article 34 of Chinese Patent Law, an applicant may request NIPA to publish a patent application earlier than 18 months from its filing date (or earliest priority date when priority is claimed).

Under patent examination practice in China, patent applications will normally be published within 4-6 months after the applicant files a request for early publication. If the applicant requests early publication and has applied for substantive examination by the time the application publishes, the application will enter the substantive examination phase immediately after publication, thereby shortening the examination period and facilitating the grant of patent rights.

PPH

The PPH is an accelerated examination approach provided by patent offices in different countries for foreign patent applications. If at least one claim of the application submitted by the applicant with the Office of First Filing (“OFF”) is determined to be patentable, the applicant can request accelerated examination in the Office of Second Filing (“OSF”). At the end of 2011, NIPA launched its first PPH pilot project between China and Japan, and then signed PPH project agreements with several other countries. At present, China has carried out PPH projects with more than 20 countries, including the United States, Japan, the United Kingdom, Russia, etc.

1.  Types of PPH

Applicants can request accelerated examination using one of the following three approaches:

a) Conventional PPH: An applicant files a PPH request to the OSF based on the results of the work of the OFF, which mainly includes the PPH through the Paris Convention and the Patent Cooperation Treaty (PCT).

b) PPH-MOTTAINAI: Based on the conventional PPH, the PPH-MOTTAINAI expands the conditions for the PPH to be accepted, such where an office which is not the OFF finds an application patentable or where the OSF makes the results of the examination available earlier.

c) PCT-PPH: An applicant files a PPH request in the relevant patent office based on the work product produced during the PCT international phase.

2.  Timing of the Request

An applicant can submit a PPH request either at the time of applying for substantive examination with NIPA, or after the patent application begins substantive examination but prior to receipt of the first office action.

3.  Conditions of the Request

According to the IP5 PPH Guidelines and the instructions of NIPA’s official training materials, applications are eligible for PPH if the following three conditions are satisfied:

a) There is connection between the Chinese application and the corresponding foreign application. For example, the Chinese application effectively claims priority to a corresponding foreign application based on the Paris Convention, or has the same priority as the corresponding foreign application, etc.;

b) At least one claim of the foreign corresponding application is patentable; and

c) There is full correspondence of claims. In other words, the scope of claims of the Chinese application is the same as or narrow than that of the claims found to be patentable in the corresponding foreign application. Claims will not meet the requirements of full correspondence if new or different types of claims (e.g., different claim categories) are introduced into the claims of the Chinese application.

4.  Acceleration Effect

Generally, it typically takes at least 20 months for an invention patent application to grant.  In contrast, under the PPH, it takes about 7-12 months from the filing of a PPH request for a patent to grant. In addition, the chance of a successful grant of a patent right is higher using the PPH.

Prioritized Examination

Pursuant to the Administrative Measures on Prioritized Examination of Invention Patent Applications (the “2012 Measure”) released in August 2012, China established a prioritized examination system. After amendments were made to the 2012 Measure, the Administrative Measures for Prioritized Patent Examination (the “2017 Measure”) were released on June 27, 2017, which expanded the scope, refined the conditions of applying prioritized examination, and improved the process of examination. The details are as follows.

1.  Timing of Request

According to the provisions of Article 2 of the 2017 Measure, an application for prioritized examination for an invention patent application must be filed after the application has entered the substantive examination phase.  An application for prioritized examination for a utility model or design patent application can only be filed after the classification number has been determined. There is no fee for filing for prioritized examination for either an invention, utility model or design patent application.

2.  Patent Applications Available for Prioritized Examination

According to Article 2 of the 2017 Measure, prioritized examination is available for the following six types of patent applications.

a) Applications in industries strongly supported by the central government, such as energy saving and environmental protection, newly generated information technology, biology, high-end equipment manufacturing, and new types of energy, materials, energy vehicles, intelligent manufacturing, etc.

b) Applications in industries strongly encouraged by the provincial governments and municipal governments.

c) Applications relating to the Internet, big data, cloud computing and other fields and covering ever-changing technologies or products.

d) Applications where the applicant is preparing or has started to commercialize the invention or where there is evidence demonstrating that others are commercializing the invention.

e) After the application is first filed in China, it is filed in other countries or regions claiming the same subject matter.

f) Other applications which are significant to the national interest or public interest and require prioritized examination.

Article 8.2, Chapter 7, Part V of the Guidelines for Patent Examination (the “Guidelines”) provides that if the same applicant applies for an utility model and invention patent for the same invention on the same day (e.g., have the same filing date only), the invention patent application will not be accepted for prioritized examination.

3.  Time Limits for Response to Office Actions

According to the Chinese Patent Law and the Guidelines, the time limit for responding to a first office action in an ordinary application is 4 months, and 2 months for each office action thereafter (which can be extended for another 2 months). For applications under prioritized examination, the time limit for response is 2 months for all office actions of an invention patent application and 15 days for all office actions for a utility model or design patent application.

4.  Acceleration Effect

According to Article 20 of the 2017 Measures, prioritized examination of invention patent application must be concluded within 1 year from the date that NIPA grants the prioritized examination. Prioritized examination of utility model and design patent applications must be concluded within 2 months from the date NIPA grants the prioritized examination.

Patent Pre-examination

After the release of the Notice for Rapid Collaborative Protection of Intellectual Property Rights on November 23, 2016, many intellectual property protection centers have been successively set up throughout China. These intellectual property protection centers perform patent pre-examination services for patent applications. The pre-examination services mainly include examining applications for formality and obvious substantive defects and examining whether these applications are directed to national security or major national interests (which may further require that a national security application be submitted). Applications that pass pre-examination can quickly enter the examination channel before the NIPA.

1.  Conditions of Application

In order to apply for pre-examination before an intellectual property protection center, an application must satisfy the following four conditions:

a) The applicant should submit the pre-examination application to the proper intellectual property protection center prior to formally submitting the patent application to NIPA;

b) The registered address of the applicant must be in a location where an intellectual property protection center is located;

c) The applicant has been recorded before the intellectual property protection center (For the purposes of recordal, an applicant must provide certain materials required by the relevant intellectual property protection center, which may vary from center to center. However, in general, an applicant must demonstrate that it has established a good foundation for its intellectual property work (e.g., it has a stable intellectual property management team and has established a standardized intellectual property management system) and is in the industry of generating information technology or high-end equipment; and

d) The application submitted must be within the technical field of the intellectual property protection center.

Different intellectual property protection centers provide patent pre-examination services in different technical fields. For example, the Beijing Center mainly focuses on the fields of generating new information technology and high-end equipment manufacturing, the Shanghai Pudong Center focuses mainly on the fields of biomedical and high-end equipment manufacturing, and the Guangdong Center focuses mainly on the fields of new generation of information technology and biological industry, etc.

2.  Applications for which Pre-examination is not Applicable

Pre-examination is not available for the following applications:

a) An invention patent application for which a utility model patent application claiming the same subject matter is filed on the same day (e.g., have the same filing date).

b) A divisional application of an earlier filed invention application.

c) Applications involving major national interests or security (i.e., these applications must be submitted as national security applications).

d) International applications submitted through PCT and applications entering China via the national phase.

3.  Time Limits for Response

A patent application submitted to the NIPA after pre-examination will be converted into an ordinary application under the following circumstances: (1) for an invention patent application, when the applicant fails to submit a response to the first office action within 10 working days and the second office action within 5 working days, or the application cannot be granted after the applicant responds to the second office action; (2) for a utility model patent application, where a patent cannot be granted after the applicant responds to the first office action; or (3) for a design patent application, where the patent office of preliminary examination issues an office notice.

4.  Acceleration Effect

According to an official news release, the time to grant for a patent application submitted to NIPA after passing pre-examination can be shortened to: (1) about 3 months for invention patents; (2) about one month for utility model patents; and (3) less than 10 days for design patents.

However, it should be noted that an applicant can only submit a formal patent application to NIPA after receiving notice that the application has passed pre-examination. Since pre-examination normally takes about 10 days, this will cause a delay in the filing of the formal application (e.g., the filing date of an application requesting pre-examination will be later than an application that does not request pre-examination), which may have adverse consequences for novelty and inventive step.

Special regulations relating to 2019-nCoV

On February 17, 2020, NIPA, the State Administration for Market Regulation and National Medical Products Administration jointly issued the Ten Articles to Support Resumption of Work and Production, which clearly stipulated that prioritized examination can be applied to patent applications relating to prevention and treatment of 2019-nCoV (e.g., COVID-19).

In addition, the Guangdong Intellectual Property Office issued the Notice on Strengthening the Protection of Intellectual Property Rights during the Epidemic Prevention and Control Period for 2019-nCoV, which required the intellectual property protection centers in Guangdong to give a green light to accelerate the pre-examination of applications relating to the prevention and treatment of 2019-nCoV, and the Guangzhou Office of the NIPA to give priority to applications relating to prevention and treatment of 2019-nCoV. Although specific guidelines on applications related to 2019-nCoV have not been issued in other provinces, many intellectual property protection centers have given the green light for such applications to be prioritized and receive accelerated pre-examination. In fact, the time period for pre-examination of such applications has been significantly shortened.  For example, there are cases where a notice of passing pre-examination is issued within 2-3 days and even on the same date that an application has been accepted.

This post was written by Lisa Mueller and Samuel Zhang of Zhong Lun.