Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3

July 22, 2020

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3

This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here.  Part 2 examined the patentability of diagnostic inventions in Europe and can be found here.   Part 3 will examine the patentability of diagnostic inventions in Canada.

Canada

In Canada, the patentability of medical diagnostic methods is currently in a state of flux.  The issues began with the decision in Amazon.com v. Attorney General (Amazon.com) 97 C.P.R. (4th) 171 (F.C.A).  In Amazon.com, the Federal Court of Appeal identified three important elements for patentability subject matter:  (i) it must not be a disembodied idea but have a method of practical application; (ii) it must be a new and inventive method of applying skill and knowledge; and (iii) it must have a commercially useful result.  Additionally, the Court also ruled that “purposive construction” of patent claims must be performed prior to making a determination of subject matter eligibility, which involves identifying and assessing the essential and non-essential elements of the claims. 

Moreover, in 2015, the Canadian Intellectual Property Office (CIPO) released patentability Examination Guidelines specific to diagnostic methods (Guidelines).  These Guidelines have now been incorporated into the CIPO Manual of Patent Office Practice (MOPOP) and contain the following instructions for Examiners when approaching a claim directed to diagnostic methods:

(a) Identify the problem the inventors set out to solve and the solution provided by the invention, guided by the description and the Examiner’s understanding of the common general knowledge in the relevant art.

(b) Consider that for diagnostic methods, an inventor is generally looking to solve a data acquisition problem and/or a data analysis problem.

(c) Factors that may indicate a data acquisition problem include novel analytes or biomarkers and novel means of identifying or quantifying an analyte (regardless of whether the analyte is new).

(d) Factors that may indicate a data analysis problem include a new correlation between a condition and an analyte that is common general knowledge.

(e) Determine whether elements in the claims are essential (provide a solution to the identified problem) or non-essential (do not provide a solution to the identified problem).

(f) If the essential elements are required solely to solve a “data analysis problem” as opposed to a “data acquisition problem”, the claim will be refused as directed to non-statutory subject matter.

Practically, the Guidelines direct Examiners to reject patent claims where the subject matter of the claim is based only on the identification of new and non-obvious correlation, for example, between a disease state and a known biomarker. While some claims directed to diagnostic inventions have issued since the Guidelines were established, there has been a fair amount inconsistency at CIPO with respect to the application of the Guidelines.  Canadian patent practitioners still determining types of claims which are currently allowable in Canada under CIPO policy, drawing on claim wording strategies similar to those used in the U.S.

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 2

July 21, 2020

This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here.  Part 2 will examine the patentability of diagnostic inventions in Europe.

Europe

Despite the challenges of obtaining patent protection for diagnostic inventions in the U.S., patent protection for diagnostic inventions is available in a number of jurisdictions outside of the U.S.  Europe remains a pro-patentee jurisdiction as far as diagnostic inventions are concerned.  At the European Patent Office (EPO), Article 53(c) of the European Patent Convention (EPC) does state that:  “European patents shall not be granted in respect of … methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body…” (emphasis added).  However, the EPO applies this exclusion narrowly.  To be excluded, the method must be both diagnostic in nature and practiced on the human or animal body. 

In G 1/04, the Enlarged Board stated that because neither the EPC nor the preparatory documents to the EPC provided a definition for the term “diagnostic methods”, according to established jurisprudence of the EPO, a diagnostic method must include at least the following steps: 

(i)   the examination phase involving the collection of data;

(ii)  the comparison of these data with standard values;

(iii) the finding of any significant deviation, i.e., a symptom, during the comparison; and

(iv) the decision phase (attribution of the deviation to a particular clinical picture).

Thus, presenting claims lacking some of steps (i) to (iv) may avoid the exclusion.

Additionally, in G 1/04, the Enlarged Board further stated that for a claimed method to be considered a diagnostic method excluded from patentability under Article 53(c) EPC, the claim must contain the following features:

(a) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as purely intellectual exercise (i.e., decision step (iv), above);

(b) the preceding steps which are constitutive for making that diagnosis (i.e., examination, comparison and finding of significant deviation steps (i) to (iii) above); and

(c) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.

What is meant by feature c) above is that when determining whether or not the method is “practiced on the human or animal body”, only the recited steps that are a) preceding steps necessary for making a diagnosis, and, b) technical in nature, should be considered.   The EPO has a consistent but very broad interpretation of what is meant by the term “practiced on the human or animal body”.  If the performance of the respective step implies any interaction with the human or animal body, then the requirement is met.  The interaction does not need to be invasive, involve any risk to patient safety or require a medical professional to be considered a step “practiced on” the body. Furthermore, a direct physical interaction on the body is not required; it is sufficient that the body is present and an interaction occurs.  Moreover, a diagnostic method claim may be objected to as encompassing steps practiced on the human or animal body even if the practice is not positively recited.  For example, EPO Examiners will consider the content of the description and dependent claims and, if it is considered that a step practiced on the human or animal body is encompassed by the claim, then an objection will likely be raised. 

It is important to note that the exclusion of Article 53(c) EPC does not apply to in vitro diagnostic methods, such as for the testing or processing of samples derived from a subject.  Even simple in vitro diagnostic method claims, straightforwardly based on the discovery of a correlation between a biomarker/ analyte and a disease state/clinical picture, are patent patentable at the EPO.  In this regard, the subject-matter eligibility situation for diagnostics is much more positive at the EPO than at the U.S. Patent and Trademark Office.

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 1

July 20, 2020

This 3-part series will provide a brief overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada.  Part 1 will examine the patentability of diagnostic inventions in the U.S.

United States

As many readers are aware, beginning in 2012, the U.S. Supreme Court issued the first of a series of three decisions over three consecutive years that had a tremendous impact on the patenting of inventions in the life science industry.  These decisions were Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 575 U.S. 208 (2014).  For diagnostic companies, the Mayo decision was particularly problematic.  The patents in Mayo, namely, U.S. Patent Nos. 6,355,623 (the ‘623 patent) and 6,680,302, were directed to methods for optimizing drug dosages for the treatment of autoimmune diseases in humans.  Specifically, the inventions involved the discovery of the relationship between the concentration of a metabolite in the blood following administration of a drug and the likelihood that the dosage administered would be ineffective or cause harmful side effects.  Claim 1 of the ‘623 patent was considered representative and recited:

  1.  A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, and

wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Court in Mayo held that the claims of the ‘623 patent were invalid as directed to a law of nature and thus encompassing patent ineligible subject matter pursuant to 35 U.S.C. § 101 (§ 101).  Additionally, the Court introduced a two-step test or framework for distinguishing patent ineligible concepts from patent-eligible applications of those concepts.  The first step involves determining whether the claims are directed to a judicially recognized exception to patentability, such as a law of nature, natural phenomena or abstract idea. If the answer to the first question is “yes”, the claim is considered to be directed to a judicially recognized exception and the analysis moves to the second question.  The second question involves determining whether the claims “do significantly more than simply describe those natural relations,” when considered separately and in an ordered combination.  If the answer to this question is “no”, then the claims are considered to be directed to ineligible subject matter, and not patentable.

The patents involved in the Myriad decision related to isolated human genes, namely, the BRCA1 and BRCA2 genes and mutations thereof, that were associated with a predisposition to breast and ovarian cancer.  In its decision, the Supreme Court unanimously held that genes (e.g., DNA) and the information they encode (e.g., proteins) were not patent eligible simply because they had been isolated from surrounding genetic material since such DNA and proteins did not exhibit any “markedly different characteristics” than those products found in nature.

The final decision in Alice, which was issued about one year after Myriad, involved a series of patents directed to a computer-implemented scheme for mitigating “settlement risk” (e.g., the risk that only one party to a financial transaction will pay what it owes) by using a third-party intermediary.  In Alice, the Court reaffirmed the Mayo two-step test, applying it to claims directed to a computer-implemented process, a computer system, and computer-readable medium for mitigating the settlement risk.  With respect to the second step of the Mayo test, the Court referred to this step as a “search for an inventive concept – i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounted to significantly more than a patent upon the ineligible concept itself”. 

Since these three decisions, the Mayo/Alice 2-step framework has been used by the U.S. Patent and Trademark Office (USPTO) and courts in determining the patent eligibility of claimed subject matter under § 101. Unfortunately, since the Court’s decisions in Mayo, Myriad, and Alice, the United States Court of Appeals for the Federal Circuit (Federal Circuit) has found all eight cases involving patents claiming diagnostic methods to be invalid as being directed to patent ineligible subject matter. 

Despite the challenges of the Mayo decision as well as the subsequent decisions at the Federal Circuit, it is still possible to obtain claims to diagnostic inventions in the U.S.  While the types of claims currently being granted by the USPTO tend not to be as broad as the claims granted before the Mayo decision, patent protection is still possible.  The ability to obtain patent protection for diagnostic inventions is important, particularly during times of significant public health crisis, such as that currently being experienced with COVID-19, in order to provide an incentive for diagnostic manufacturers to invest the time and resources to pursue the research and commercialization of new diagnostic tests. 

To learn more on the patenting of diagnostic inventions in the U.S., Europe and Canada, please join Lisa Mueller of Casimir Jones, Phillip Price of Dehns, and Noel Courage of Bereskin & Parr LLP for a webinar on July 23, 2020 that will explore in more detail the patentability of diagnostic inventions and provide practical tips on how to overcome objections commonly raised with respect to these inventions in each of these jurisdictions.  You can register for the webinar at the following link:  Link to webinar.

This post was written by Lisa Mueller, Phillip Price of Dehns, and Noel Courage and Ainslie Parsons of Bereskin & Parr LLP.

At last! Brazil is set to approve the Nagoya Protocol!

July 17, 2020

On July 8, 2020, the Brazilian Chamber of the State Representatives unanimously voted on the Bill of Legislative Decree # 324/20 to approve the Nagoya Protocol.  As a result, the text was sent for consideration to the Senate and, once approved, the President should enact a federal Decree allowing the treaty to take effect in the country.

The Nagoya Protocol (Protocol) is a multilateral agreement ancillary to the Convention on Biological Diversity (CBD) and aims to implement the CBD’s objective relating to the sharing of benefits arising from the utilization of genetic resources and/or associated traditional knowledge in a fair and equitable way.  The Protocol entered in force on October 12, 2014.  Currently, 124 countries are signatories to the agreement. 

The Protocol takes into consideration the principle established by the CBD that countries have sovereign rights over the genetic resources within their territory and may demand compliance with the requirements and sharing of any benefits arising from their use by individuals, companies, or government entities whose countries are parties to the Protocol. 

The country providing the genetic resources (i.e., provider country) has the right to establish (or not if it so chooses) specific requirements for access to its genetic resources and/or associated traditional knowledge as an exercise of its own sovereignty. The other parties to the Protocol (i.e., user countries) are required to take appropriate measures to comply with the requirements that have been established by the provider country.  Accordingly, the parties to the Protocol, both as provider and/or user countries, must ensure that access to these genetic resources and/or associated traditional knowledge, as well as the sharing of the benefits arising from their use, comply with their own country’s legislation.

The impact arising from the ratification of the Protocol on the national industry in Brazil will mostly involve the general duty of individuals, companies, and government entities to know and comply with the obligations established by a provider country that supplies any foreign genetic resources and/or any associated traditional knowledge for the development and manufacture of products.  This same duty will also apply to any user country (i.e., foreign individual, company or government entity) that accesses any genetic resources of Brazil’s biodiversity and/or associated traditional knowledge for the development and manufacture of products.  Thus, the Protocol has the potential to eliminate any asymmetries that exist between national and international industries.

Since the enactment of the CBD, Brazil, as a “mega biodiverse” country, has taken a leadership role in several discussions relating to the access and benefit sharing of genetic resources.  As a result, the delay in the approval of the Protocol may have been the result of internal (political) dissent regarding the positive or negative impact of the Protocol on the country’s economy. Despite Brazil’s huge biodiversity, the country relies heavily on foreign genetic resources, such as in the area of agriculture and livestock.

Nonetheless, despite the delay, both the agricultural and environmental caucuses agreed that accession to the Protocol would be important in order for Brazil to have a voting seat in on-going discussions relating to the implementation of the Protocol.   Some of the matters currently under debate by the 124 parties include, for example, the scope of the Protocol (e.g., whether it will be applicable only to the species that entered into the user country after ratification of the Protocol or if new uses of species already in user countries would be encompassed), definition of checkpoints and information to be provided (e.g., would patent offices be included as one of the authorities to be used as a check point?), how to handle genetic resources of biomes in transborder areas, and the use of digital sequence information. 

It is important to note that the Brazilian law on access to the biodiversity, Law #13123, establishes that the sharing of benefits provided for in the Protocol should not apply to the use of species introduced into Brazil as a result of human action relating to agriculture and livestock  activities. In other words, Brazil has limited the Protocol’s scope in its national legislation in order to mitigate its impact in this area. 

Please continue to watch BRICS & Beyond for updates on the Nagoya Protocol in Brazil.

This post was written by Lisa Mueller and Viviane Kunisawa at Licks Attorneys

Israeli Patent Office Clarifies Patent Term Extension (PTE) Requirements

July 8, 2020

Background

Israel has a unique patent term extension (PTE) system.  Patent term extension orders are granted only for patents that claim an active pharmaceutical ingredient (API) once a marketing authorization is issued for the first time by the Israeli Ministry of Health.  A petition for PTE must be submitted within 90 days from “the date of registration of the pharmaceutical preparation” in the Israeli Drug Register. This deadline is non-extendable and late filing will result in the loss of eligibility for PTE. 

In addition, Israel’s PTE system links the entitlement, duration and validity of PTEs to the marketing authorizations and PTE and Supplementary Patent Certificates (SPCs) issued for reference patents in the United States (U.S.) and in the top five European countries (namely, Great Britain, Italy, Germany, France and Spain, collectively referred to as the “EU-5 countries”).  In other words, in Israel, PTE eligibility is subject to a “two-state” requirement.  Specifically, if a marketing authorization for a small molecule or biologic is granted in the U.S. and an EU-5 country, then PTE will only be granted in Israel if a PTE and SPC is granted in both the U.S. and at least one of the EU-5 countries.  Further, in July 2019, the Israeli Patent and Trademark Office (PTO) issued a circular clarifying the reporting requirements imposed on PTE applicants and holders in Israel. This circular affirmed that any change affecting the validity or registrability of a PTE order must be reported to the Israeli PTO.  Additionally, a cancellation, expiry or renewal of a drug registration must also be reported.

Amgen’s PTE Request for Israeli Patent No. 138857

In May 2020, a decision regarding a PTE for Israeli Patent No. 138857 (in the name of Amgen Research (Munich) GmbH), provides further guidance regarding adherence with the above requirements. Specifically, the patent at issue, Israeli Patent No.138857, claims Amgen’s API blinatumomab (BLINCYTO®).  Blinatumomab is a monoclonal antibody used as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia.   Amgen received regulatory approval for blinatumomab from the Israeli Ministry of Health in October 13, 2016 and timely filed a PTE request for blinatumomab with the Israeli PTO.

For 18 months while Amgen’s Israeli PTE was pending, Amgen’s Israeli representative failed to report to the Israeli PTO any PTEs and/or SPCs granted in any corresponding jurisdiction (i.e., U.S. or any EU-5 country) for blinatumomab. It was only after the expiration of IL 138857 that Amgen’s representative continued with the PTE proceedings.  At this point: (1) technically, the PTE proceedings should have been terminated; or (2) Amgen’s representative, should have, at a minimum, filed a request for an extension of time well before the expiration date of the patent.   Not surprising, and in strict accordance with the wording of the law and regulations, the Israeli PTO refused the PTE application. The basis of the rejection was the fact that Amgen failed to inform the PTO of the EU-5 SPCs obtained within 90 days from the date of issuance and, in addition, failed to submit copies of these SPCs to the PTO.  Interestingly, Amgen’s representative took advantage of a minor ambiguity in the law and regulations as well as an inconsistency in the practice of the PTO and appealed the refusal and obtained a reversal of the PTO’s decision.  Thus, as a result, Amgen was able to obtain a PTE of 1463 days until April 23, 2023, subject to completing all requirements specified in the decision.

Key Takeaways from the Amgen Decision

In its decision, the Israeli PTO affirmed that once a PTE and SPC have been granted for a small molecule or biologic in the U.S. and in an EU-5 country, the Patent Owner has a non-extendible, 90-day period from the second granted extension (whether a U.S. PTE or EU-5 SPC) to report the grant of such PTE or SPC to the Israeli PTO.  A “second” granted extension refers to second granted extension in an EU-5 SPC (if the first extension is a U.S. PTE) or a U.S. PTE (i.e., if the first granted extension is in an EU-5 SPC country). In a situation where a first SPC issues in Spain and a second SPC issues in France, the French SPC is not considered to be a “second” granted decision.

Additionally, the Amgen decision stresses that the 90-day deadline to report the first U.S. PTE/EU-5 SPC and second EU-5 SPC/U.S. PTE to the Israeli PTO is non-extendable. Moreover, copies of the PTE/SPCs and any additional information required should be filed within reasonable time, such as, for example, within 90 days, however, this deadline can be extended, even retroactively.

Examples

For example, if a U.S. PTE is granted for small molecule X on June 1, 2020 and a first SPC is granted in France for the same small molecule X on October 1, 2020, the Patent Owner would have a non-extendible period of 90 days beginning from October 1, 2020 to report the grant of the U.S. PTE and a SPC granted in France for small molecule X to the Israeli PTO.   Failure of the Patent Owner to report the PTE and SPC to the Israeli PTO by December 30, 2020 (90 days from October 1, 2020) would result in forfeiture of eligibility for PTE for small molecule X.   Likewise, if a first SPC is granted in Great Britain for biologic Y on October 1, 2020 and a U.S. PTE is granted for biologic Y on January 15, 2021, the Patent Owner would have a non-extendible 90-day period beginning from January 15, 2021 to report the SPC and PTE for biologic Y to the Israeli PTO.  Failure of the Patent Owner to report the SPC and PTE to the Israeli PTO by April 15, 2021 (90 days from January 15, 2021) would result in forfeiture of eligible for PTE for biologic Y in Israel.

In all other circumstances, such as, for example, when a U.S. PTE grants before a EU-5 country SPC, a EU-5 country SPC grants before a U.S. PTE, or if a second EU-5 SPC grants after fulfillment of the “two-state” requirement, then the 90-day deadline is extendible, subject to the discretion of the Israeli PTO. However, it should be noted that a PTE application and the proceedings for obtaining the PTE should be conducted and preferably concluded before the expiration of the Israeli patent. Extensions of time can be obtained in the event that PTE or SPC are still pending in U.S. or Europe.

Given the complexity of the Israeli reporting requirements for PTEs issued in the U.S. and SPCs granted in the EU-5 countries, it is recommended that Patent Owners err on the side of caution and report the granting of such PTEs and SPCs to the Israeli PTO as soon as such PTEs and/or SPCs are granted to avoid running afoul of this complex reporting requirement.  Specifically, using the example recited above, if a U.S. PTE is granted for small molecule X on June 1, 2020 and a SPC granted in France for small molecule X on October 1, 2020, it is recommended that a Patent Owner report the granting of the U.S. PTE within 90 days after the grant of the U.S. PTE (i.e., 90 days after June 1, 2020, namely, August 30, 2020) and within 90 days after the grant of the SPC in France (i.e., 90 days after October 1, 2020, namely, December 30, 2020).

Please continue to watch BRICS & Beyond for updates on PTE requirements in Israel.

This post was written by Lisa Mueller and Yael Saidian of YSDN Patents

Ukraine Adopts a Bolar Exemption

June 5, 2020

On June 2, 2020, the Ukrainian Parliament passed a draft law introducing a legal exemption for patent infringement for actions relating to the development and submission of testing data to a Ukrainian regulator/authority for obtaining marketing authorization for medicinal products. These amendments were introduced to the Ukrainian Intellectual Property law entitled, “On Protection of Rights in Inventions and Utility Models”.  As a result, Ukraine law now contains a “Bolar exemption”.  More specifically, the new law excludes from infringement the importation into “…Ukraine, in accordance with the procedure established by law, of goods manufactured using the invention for the purpose of, and/or using the invention in, studies carried out with a view to prepare and submit  information for marketing approval of a medicinal product (based on the draft law presented for consideration of Ukrainian Parliament” (Please note that as of the date of this post that the final approved text of the law is not yet publicly available).

Previously, Ukrainian legislation and law did not contain a Bolar type exemption. Therefore, the issue of whether the early working (e.g., clinical studies, importation of samples and/or the submission of application for marketing approval) of a patented invention by a generic company could be considered a patent infringement was decided based on existing case law.  Although the practice varied somewhat, the prevailing position of the Ukrainian courts was that the start of any preparation by a generic manufacturer to obtain market entry constituted patent infringement.  Specifically, patent holders were often able to obtain injunctions during the term of a patent (a) when a generic company submitted an application for marketing approval to a Ukrainian regulator/authority (thus blocking or delaying the application at an early stage); or (b) once a marketing authorization was granted.  Despite this, the new law is expected to change this trend, thereby allowing generic companies to apply for marketing approval for a generic product before the expiration of a patent for purposes of commercialization after expiry.

From a formal perspective, the law requires execution by the (Ukraine) President as well as official publication to become effective. Additionally, as has happened previously in other jurisdictions, the breadth and specifics of the Ukrainian Bolar exemption will be further developed by future practice and case law.

Please continue to watch BRICS & Beyond for updates on the Bolar exemption in Ukraine.

This post was written by Lisa Mueller and Viktoriya Podvorchanska of Asters Law.

Non-obviousness of Pharmaceutical Inventions at the Brazilian Patent & Trademark Office

May 27, 2020

The Guidelines for Examination (Guidelines) of the Brazilian Patent & Trademark Office (BRPTO), also known as the National Institute of Industrial Property, establish a three-step test for examining the non-obviousness of a claimed invention.  This three-step test involves: (i) determining the closest prior art; (ii) identifying the distinguishing features of the invention and/or the technical problem actually solved by the invention; and (iii) determining, in view of the technical problem, and considering the closest prior art, whether an invention is obvious to a person skilled in the art (items 5.9 to 5.21 of the Guidelines).

However, a detailed review of recent decisions from the BRPTO indicates that different tests for non-obviousness are being applied by Examiners in the examining division (e.g., first instance) when compared to Examiners handling appeals (e.g., Board of Appeals). This conclusion was obtained based on a review of cases being handled by Examiners in the pharmaceutical unit art divisions.  The results demonstrate that Applicants must be strategic when dealing with an Examiner.  In other words, a one-size-fits all type of approach during patent prosecution may lead to higher denials at first instance.  Nonetheless, understanding the experience and background of the Examiner may result in a better result (e.g., allowance) for an Applicant. 

The cases considered in this analysis had an appeal decision issued in 2020 and were examined (at the first instance) after the issuance of BRPTO’s Rule #169/2016 (i.e., the current Guidelines).  The results show that the BRPTO conducts a much more detailed analysis (based on its Guidelines) during appeals (i.e. appeal stage) than during examination at first instance.  Specifically, while 83% of the analysis carried out by the Examiner during the appeal stage applied the non-obviousness test as defined according to the Guidelines (e.g., BRPTO’s Rule #169/2016), only 20% of the analysis performed by Examiners during first instance applied the test.

In general, we observed that at first instance Examiners failed to: (1) identify the closest prior art; and (2) determine a starting point for a person skilled in the art.  In most of the analysis examined it was not clear whether the closest prior art consisted of a combination of documents.  Moreover, general allegations stating that an invention “would be obvious” over the prior art, without explaining how one skilled in the art would have arrived at such a conclusion, were commonly found to form the basis for rejection.  Some examples of such allegations include:

“Upon analyzing the present application in view of documents D2 to D4, we noted that it is obvious. The methods claimed in claims 1 to 58 have the same goal and the same steps encompassed in the teachings of D2 to D4. The chromatographic techniques employed are non-inventive variations of those presented in said documents”. (PI0709726-3)

“Hence, a person skilled in the art that knew the state of the art at the time [previously described by means of 8 prior art documents] would have been motivated to carry out a similar process for the preparation of 2-oxoindoline products comprised in the state of the art to arrive at the 2-oxoindoline compounds claimed in the present patent application with reasonable expectation of success and obtain the additional beneficial compounds useful in the treatment of rheumatoid arthritis or cancer, for instance”. (BR 11 2015 022431 8)

“Claims 16 to 23, which refer to the lentiviral recombinant vector, are not inventive in view of any of the teachings of D1 or D2. Considering the vectors disclosed therein and that Flavivirus proteins are known from the state of the art, the construction of Ptrip lentiviral recombinant vectors expressing Flavivirus proteins derives in an obvious way for a person skilled in the art”. (PI0510016-0)

“(…) document D4 already disclosed Fe compounds close to the claimed compounds for the same function claims, namely, fighting tuberculosis. Thus, the claimed matter is not inventive”. (PI0300770-7)

“Even though the document cited in table 4 refers to serotoninergic receptor modulators, D1 does not motivate a person skilled in the art to carry out the structural modifications to obtain the compounds of the present application”. (PI0312176-3)

With respect to second medical use claims, we reviewed 37 second medical use inventions examined by the BRPTO during the appeal stage after issuance of BRPTO’s Rule #169/2016.  Surprisingly, we found that the three-part test for obviousness was applied in only 53%[1] of the second medical use inventions examined by the BRPTO (during the appeal stage) compared to 83% overall as discussed above. Moreover, examination at first instance only applied the three-part test in 23% of the cases[2].

In fact, with respect to the patentability of second medical use inventions, the BRPTO relies most frequently on Rule #208/2017, which establishes examination guidelines for chemistry-related applications (Chemistry Guidelines).  Unfortunately, the Chemistry Guidelines take a very strict view regarding the patentability of second medical use inventions.  Specifically, general standards have been established for determining the novelty and non-obviousness of these inventions. For example, if an invention claims a particular dosing regimen or the treatment of a specific patient population, these types of claims are automatically deemed to lack novelty and be obvious. In other words, in most instances, the three-part test defined in the Guidelines is simply not even applied to these types of inventions.   

Because Applicants must submit counter arguments to the BRPTO’s obviousness objections raised in an Office Action, the methodology by which the non-obviousness of a claimed invention is assessed by an Examiner can have a huge impact on the outcome of the examination. Therefore, as illustrated by the above, replying to Office Actions at the BRPTO represents an extra challenge, which can be even greater in the case of second medical use inventions. Thus, when defending the patentability of a claimed invention, Applicants must come up with an argument regarding the non-obviousness of the claimed invention which can often be challenging in view of the harsh conditions pre-defined in the Guidelines.  As illustrated by the above, Applicants for pharmaceutical inventions in Brazil need to have a good understanding of the experience and background of the Examiner handling their case at first instance, and if need, be, at the appeal stage, as well. 

This post was written by Lisa Mueller and by Yasmin Kronemberger, Luiza Cotia and Roberto Rodrigues of Licks Attorneys.

[1] Only the cases which assessed non-obviousness at the appeal stage were considered.

[2] A total of 22 cases were considered. These cases were examined at first instance after the issuance of Rule #169/2016.

Filing a Divisional Application in Pakistan– Part 8

May 21, 2020

This is the eighth 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 seven posts examining divisional practice in Brazil, Mexico, China, India, Argentina, Canada, and Thailand and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina, Divisional Practice – Canada, and Divisional Practice -Thailand.

Time Periods for filing a Divisional Application

Section 13(3) of the Pakistani Patents Ordinance, 2000 (2000 Ordinance) provides that “each application shall relate to one invention only”. Section 13(4) further states that “the Applicant may, before the acceptance of the application, divide it into two or more applications, provided that each divisional shall not go beyond the disclosure in the first application”. By stating that “each application shall relate to one invention only”, Section 13(3) allows an Examiner to require an Applicant who is trying to protect two (or more) inventions in a single (e.g., one) application to restrict its application to a single single invention and make the second (or more) invention(s) the subject of a divisional application (e.g., a compulsory divisional application). Alternatively, section 13(4) gives an Applicant the right to divide its first/parent application into one or more (divisional) applications if the Applicant believes that its claims cover more than one invention (e.g., a voluntary divisional application).

According to section 13(4), the time period for filing a divisional application is “any time until the first/parent application has not proceeded to acceptance”.  Thus, the implication is that once a parent application has been accepted, the opportunity to file a divisional application has expired.

Absent definite period for acceptance, a divisional may be kept pending up to the maximum life of a patent

As mentioned previously, according to section 13(4), an Applicant can file a divisional application “any time before acceptance of the first/parent application”.  However, section 13(4) is silent regarding when (e.g., the time period) an application must be accepted.  Specifically, this section of the 2000 Ordinance does not explicitly require or imply that a divisional application must be placed in order of acceptance at the same time as a parent application.  As a result, an Applicant can keep a divisional application pending in Pakistan for the term of 20 years.

Lack of unity (e.g., non-unity) is not a ground to invalidate a patent post-grant

The question of whether an application claims more than one invention is considered by an Examiner during the substantive examination stage of an application.  Although section 15(4) of the 2000 Ordinance requires that the claim(s) of a complete specification relate to only a single invention, section 13(6) provides that “the fact that a patent has been granted on an application that did not comply with the requirement of unity of invention is not a ground for invalidation of the patent”.  In other words, if an application containing claims to two or more inventions ultimately proceeds to grant, the resulting patent cannot be later challenged as invalid based on a lack of unity.

Additionally, section 44(1) stipulates that “[N]o amendment of specification shall be allowed, except for the purpose of correcting an obvious mistake, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed in the specification before the amendment”.  This section suggests that similar to pre-grant amendments, any post-grant amendments are subject to examination for unity/added matter. However, if after this examination, the Examiner allows the amendment or is convinced by the Patentee’s arguments and withdraws the unity objection, the allowed or approved amendments cannot be called in question after advertisement and expiry of the opposition period except on the ground of fraud. It is for this reason that the grounds of opposition and revocation (e.g., belated opposition) in the 2000 Ordinance do not include a ground based on lack of unity against the original specification.

Divisional applications containing subject matter that exceeds beyond the contents of its parent application are not allowed

The proviso to section 13(4) of the 2000 Ordinance requires that a divisional application be based on the subject matter disclosed in a parent application. This implies that the contents of a divisional application must not exceed the contents of its parent application either as originally filed or amended (e.g., such as for the purpose of correcting an obvious mistake or otherwise subsequent to the filing [Sec. 44(1)]). However, when this proviso is read in conjunction with the provision of section 23(1), it is clear that a divisional application that contains subject matter that exceeds the scope of disclosure of a (complete) specification as originally filed in the parent application, may be the subject of a pre-grant opposition or revocation (e.g., belated opposition).  Therefore, although a lack of unity (e.g., non-unity) is not considered to be a ground of invalidation, either pre-grant or post-acceptance, a divisional application having a claim that is broader in scope than that disclosed in its parent application will not be allowed to proceed unless its specification is amended to exclude the new/added subject matter (section 42(5)).

 Use of “cascading divisionals” to overcome lack of unity (e.g., non-unity) objections

As mentioned previously, section 13(4) of the 2000 Ordinance allows an Applicant to voluntarily divide its application into two or more divisional applications.  It is important to note that each of the two or more divisional applications must originate from the very first parent application filed.  However, because each divisional application is considered to constitute an independent application that is the subject of substantive examination, if a lack of unity (e.g., non-unity) is found to exist in a divisional application, the filing of a subsequent divisional (e.g., a divisional off of a divisional), is permitted.  Thereupon, an Applicant may have a series of divisional applications (e.g., “cascading divisionals”) on its immediate or second parent application.

Right to file further divisionals is prohibited once the first parent application is accepted

According to section 13(4), the right to file two or more divisional applications is permitted up until the acceptance of the parent application. Thus, once the parent application has been accepted, the filing of subsequent divisional applications is no longer permitted.  For example, assume a specification discloses four inventions and the Applicant has decided to pursue three inventions in a single divisional application before acceptance of the parent application.  Once the parent application is accepted, the Applicant may not be able to file a further divisional application.  Therefore, the filing of any divisional applications from a parent application or any divisional application filed from the parent (e.g., a cascading divisional), must be filed before the acceptance of the first parent application.  Failure to file any such divisionals within this time period may result in abandonment/loss of any unclaimed inventions. 

The existence of “technical inter-relationships” among various groups of inventions may avoid the need to file a divisional application

The statutory requirement that “each application shall relate to one invention only” indirectly connotes that two inventions cannot be claimed in a single (e.g., one) application.   However, the question of what constitutes a “single invention” is a question of fact that is typically decided by the Controller of Patents.  For example, in an application relating to a device, a claim to an overall device, and separate claims for parts that constitute its assembly may be considered one invention, but if the parts have other applications or characteristics that provide a solution to another problem which is not envisaged by the former, a lack of unity issue may arise.  Likewise, with respect to chemical inventions a claim to an intermediate (I) together with a claim to compound (A) per se and a process claim for the manufacturing of compound (A) using said intermediate may be retained in a single application provided  that a technical inter-relationship exists between the intermediate and the final product.  Such inter-relationship may be established if the intermediate contributes to the essential structural feature of the final product.

In contrast to applications claiming mechanical inventions, the 2000 Ordinance provides the standard for determining unity for applications claiming chemical products intended for use in agriculture or medicine.  Specifically, the first part of section 15(8) states that “claim or claims in respect of a complete specification of a chemical product intended for use in agriculture or medicine shall be structurally defined and shall relate to a single chemical product only excluding its derivatives and salts, each of which, with a material or a novel improvement in its claim from the main product, shall be filed a separate invention or where applicable, as a divisional application”. Without conceding to the statutory basis excluding derivatives and salts from the scope of claims directed to compounds per se, it is clear according to section 15(8) that any derivatives and salts of a claimed compound that are pursued in a separate or divisional application must show an activity that is substantially improved or enhanced compared to the compound (in free base form).  A voluntary divisional covering derivatives or salts having activity in common with the compound (in free base or in congruity (1:1 ratio) with the compound) run the risk of being rejected or invalidated on the grounds of one or more of lack of subject matter, double patenting, insufficiency of disclosure, etc.

Divisional applications attempted to achieve a post-filing broadening of the claims is not allowed

As discussed previously herein, a divisional application (e.g., voluntary or compulsory) can be filed to protect a second or another invention.  However, a divisional application that seeks to broaden the scope of the claimed invention will likely be refused.  For example, if a parent application discloses a composition comprising a combination of compound A and compound B using water as a solvent, a divisional application covering the same composition (compound A and compound B) claiming the same activity for the composition but using non-aqueous solvent would be considered to be impermissible broadening and would not be allowable.  The caveat to this is provided in section 15(5) which states: “[S]ubject to the foregoing provisions of this section, a complete specification filed after a provisional specification, or filed with a Convention application, may include claims in respect of developments of, or additions to, the invention which was described in the provisional specification or, as the case may be, the invention in respect of which the application for protection was made in a Convention country, being developments or additions in respect of which the applicant would be entitled under the provisions of section 11 to make a separate application for a patent”.  In other words, according to this section, if an Applicant files a priority application claiming an invention and identifies additional improvements relating to the invention during the priority year, the Applicant can include those improvements in its specification when filing its original (e.g., Convention) application in Pakistan (remembering that Pakistan is not a PCT member country).  However, if the Applicant identifies additional improvements after both the priority year and the filing of its application in Pakistan, then those additional improvements cannot be included and/or claimed in the already filed application (i.e., any attempt to add those additional improvements will be rejected if the Applicant tries to add them by way of one or amendments to the original specification).  Under these circumstances, the Applicant will need to consider whether to file for a Patent of Addition.

In summary, a divisional application can be filed in Pakistan when an Examiner raises a lack of unity of invention rejection during examination.  Additionally, a voluntary divisional can be filed by an Applicant at any time prior to grant of a parent application in order to extend prosecution until the commercial value and/or likelihood of success of an innovative product is fully appreciated or realized.  This ability to extend prosecution of such a divisional application is particularly helpful for pharmaceutical and biotechnology inventions where the full commercial value or likelihood of success of such products may not be realized until many years after filing.

This post was written by Lisa Mueller and Naeema Sadaf of PakPat World Intellectual Property Protection Services

Filing a Divisional Application in Thailand – Part 7

May 12, 2020

This is the seventh 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 six posts examining divisional practice in Brazil, Mexico, China, India, Argentina and Canada and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, Divisional Practice – Argentina and Divisional Practice – Canada.

Time Periods for filing a Divisional Application

In Thailand, the filing of a divisional application is governed by Section 26 of the Thai Patent Act B.E. 2522 as amended by the Patent Act (No.3) B.E. 2542 (Act), which states:

Section 26. In examining a patent application, if it appears to the competent official that the patent application involves several inventions which are not so linked as to form a single inventive concept, the competent official shall give a notification to the applicant to divide the application into several divisional applications, each of which relates to a single invention.

            If the applicant files any of the divisional applications according to paragraph one within one hundred and twenty days from the date of receipt of the notification from the competent official, the applicant shall be deemed to have filed such divisional application on the date of filing of his initial application.

            The division of the application shall be in accordance with the rules and procedures prescribed in the Ministerial Regulations.

            In the case where the applicant does not agree with the order of the competent official, the applicant shall appeal to the Director General within one hundred and twenty days.  Once the Director General has made a decision, the decision of the Director General shall be final.

Unlike many other countries, according to Section 26 of the Act, the filing of a voluntary divisional application is not permitted in Thailand.  Instead, a divisional application can only be filed if an Examiner believes that the application claims multiple inventions which are not linked to form a single inventive concept.  In other words, a divisional application can only be filed when an Examiner raises a “lack of unity” rejection.  Typically, what occurs is that during the examination stage, the Examiner simultaneously issues two Office Actions.  The first Office Action contains a lack of unity rejection that requires the Applicant to elect only a single (one) invention for prosecution.  The second (simultaneously issued) Office Action, which is sent together with the first Office Action, requires the Applicant to file one or more divisional application(s) for any non-elected inventions. The Applicant is required to file any such divisional applications within 120 days following the date of receipt of the Examiner’s instructions.  The filing of a divisional application beyond the 120-day time limit is not possible (e.g., any such divisional application filed will be rejected).   In the event the Applicant files one or more divisional applications in response to the Examiner’s instructions, any such divisional applications are deemed to have been filed on the date of filing of the initial parent application.  Because divisional applications are filed in response to a lack of unity rejection, double patenting issues generally do not arise in Thailand.

Requirements for Filing a Divisional Application

The filing of a divisional application is treated as a filing of a new patent application, thus all applicable fees, professional and official, for filing a new application, including any amendment fee, priority fee, etc. are required.  However, new documentation is not required.  In other words, copies of the Power of Attorney, Deed of Assignment and certified priority documents from the initial parent application can be used.  Additionally, divisional applications are examined for both formality and patentability requirements. Thus, during examination, an Examiner applies the same rules regarding lack of unity with respect to an application claiming multiple inventions which are not linked to form a single inventive concept (i.e., regardless of whether the application being examined is a divisional application or an originally filed application). Additionally, the term of any divisional application is calculated based on the term of the original parent application. 

The current Act is silent on whether a divisional application can be filed only off of an original (parent) applications only, or a pending divisional application.  Because the Act does not contain a specific provision prohibiting the filing of a further divisional application off of an already existing divisional application, an Applicant may do so (but, as mentioned previously herein, only upon receipt of instructions from the Examiner).

Future Changes to Divisional Practice

We are pleased to report that changes to the procedures and rules regarding the filing of divisional applications are expected in the next amendment of the Thai Patent Act B.E. 2542.  Under the current draft amendment, voluntary filing of divisional applications will finally become possible.  Additionally, under the draft amendment, the filing of one or more divisional applications in response to an Examiner’s instructions will remain available, however, the time period for filing such a divisional application will be shortened from 120 days under the current law to 90 days.  The draft amendment has undergone a public hearing and is currently being reviewed by the Office of the Council of State.  Unfortunately, we do not have any clear indication when the amendment may pass into law, and the expectation is that it may take some quite time.  Please continue to watch BRICS & Beyond for updates on when the draft patent amendment might pass into law.

This post was written by Lisa Mueller and Prateep Naboriboon of Satyapon & Partners Limited.

Filing a Divisional Application in Canada – Part 6

May 1, 2020

This is the sixth 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 five posts examining divisional practice in Brazil, Mexico, China, India and Argentina and can be found here:  Divisional Practice – Brazil, Divisional Practice – Mexico, Divisional Practice – China, Divisional Practice – India, and Divisional Practice – Argentina.

Time Periods for filing a Divisional Application

In Canada, a divisional application must be filed during pendency of the original application (parent application).   Typically, a divisional will be filed during prosecution of the original application, or at the latest, when paying the issue fee.  The ultimate deadline to file a divisional is the day before issuance.   Additionally, if an original application is refused, a divisional application can be filed before 6 months from the mailing of the refusal or, if there is an appeal, 2 months from when the appeal process ends.  Divisional applications can be filed for any reason (often referred to as “voluntary” divisional applications) or in response to a lack of unity rejection.  Cascading divisionals (meaning a divisional application filed from another divisional application) are permitted.

Requirements for Filing a Divisional Application

When filing a divisional application, a copy of the specification, abstract and drawings from the parent application must be filed.  A set of claims (either the original claims from the parent application or a new claim set) must also be included.  Often an applicant refiles the original claims for continuity of subject matter.   The cost of filing a divisional is comparable to the cost of a new application.  The content of the divisional filing papers are similar to that of the parent application.  The disbursement for a divisional is often significant because of the requirement to pay all the annuity fees accrued since the filing date of the parent application. The term of patent for a divisional application is twenty years from the filing date of the very first parent application. 

Request for Examination

A divisional application gets the same filing date as its parent application.  The deadline for filing request for examination a divisional application will vary depending on the filing date of the parent application from which the divisional application originates.  There is variance because Canada is in a transition period following new Patent Rules that came into effect October 30, 2019 (“transition date”).   Specifically, if a divisional application has a parent filing date before the transition date, then examination must be requested and the examination fee paid within the later of five years from the original filing date and six months from the presentation date of the divisional application.  However, if a divisional application has a parent (i.e. original) filing date on or after the transition date, examination must be requested and the examination fee paid within the later of four years from the original filing date and three months from the presentation date of the divisional application.

Claims of a Divisional Application

A divisional application may be filed with the claims as originally filed in the parent or PCT application.  However, the claims of a divisional application filed with the same claims of a parent or PCT application will need to be amended at some point during prosecution to a non-elected group, if there was a unity objection in the parent.  Otherwise, they will need to be amended in a manner to ensure that the divisional application claims are patentably distinct (meaning novel and non-obvious) from the parent claims. 

Double Patenting

In Canada, much like the United States (U.S.), there is a prohibition against double patenting. Divisional applications following a unity objection are treated differently than voluntary divisionals.  

Divisional Following Unity Objection

If the claims being pursued in a divisional application were previously cancelled in response to a lack of unity rejection in a parent application, then the claims of the divisional application are immune from a double patenting attack based on the parent application.

When prosecuting a divisional application after a unity objection, care should be taken to avoid amendments that might cause the claims to depart significantly from what the Examiner originally considered to be a separate invention group.  Therefore, to ensure validity of both parent and the divisional patents, it is advisable to refer back to the original unity requirement to divide a set of claims so that new issues of double patenting are not created inadvertently.

Voluntary Divisional

Voluntary divisionals are where double patenting concerns arise.  Specifically, in Whirlpool Corp v. Camco In., 2000 SCC 67, the Supreme Court of Canada confirmed that an inventor is only entitled to one patent of each invention.  A patentee who claims successive patents for a single invention by way of obvious variations unlawfully extends the scope of the patent term, such that the second patent is invalid on the basis of double patenting.  Note that a double patenting objection during prosecution of a divisional is not fatal if the applicant can amend claims and/or argue to traverse. 

In Canada, the double patenting prohibition comprises 2 branches:

  1. A “same invention” or “coterminousness” branch; and  
  2. An “obviousness” branch.

The “same invention” or “coterminousness” branch is similar to statutory double patenting in the U.S., where claims of a pending application and an issued patent cannot have the same exact (identical) scope.  An applicant needs to amend pending divisional claims to overcome this objection. 

The “obviousness” branch is similar to “obviousness-type” double patenting in the U.S., and the applicant will have to amend pending claims or argue with the Patent Office. Under this branch, the claims of a pending application (such as a divisional application) must be patentably distinct (meaning novel and nonobvious) over the claims of an issued patent or co-pending application.  In the U.S., in most instances, an obviousness-type double patenting rejection can be obviated by the filing of a terminal disclaimer.  However, Canadian law does not provide for a terminal disclaimer.

Therefore, an Applicant filing a voluntary divisional in Canada must be very careful to make sure that the claims of its divisional application: (1) do not claim the same invention as the parent application; and (2) are patentably distinct over the claims of the parent application.

Similar to the U.S., an issued patent can be invalidated for double patenting in Canada.  Once a patent has issued, it may still be possible in Canada to cure a deficiency by disclaimer or reissuance, if the double patenting arose due to mistake. 

As a matter of practice, the best option in Canada is to file all claims of interest in the parent application, and allow the Examiner to make an assessment of whether there is more than one invention so that a formal unity objection (i.e., requirement for division) is on record before a divisional application is filed.  In effect, voluntarily filed divisional applications should be avoided in Canada where possible.

This post was written by Lisa Mueller and Noel Courage of Bereskin & Parr, LLP.