BRICS & Beyond

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

Lisa L. Mueller March 15, 2021

This is an update to our post on March 10, 2021. On Thursday, March 11^th, 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:

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).
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).
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?
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).
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?
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?
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).
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).
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?
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?
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?
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?
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

Future Foods Friday

Introducing Future Foods Friday

Lisa L. Mueller 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

Lisa L. Mueller 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

Lisa L. Mueller 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:,

Until the day before the date of publication of the mention of grant of the patent in the European Patent Bulletin;
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;
On the day the European Patent Office (EPO) receives a written request to withdraw a patent application; or
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:

A written statement that an European patent is being sought;
Information identifying the Applicant or allowing the Applicant to be contacted; and
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.

United States

Filing a Divisional Application in the United States – Part 14

Lisa L. Mueller 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:

A copy of the specification, drawings, and abstract;
A set of claims to be pursued;
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
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:

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.

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

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.
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

Lisa L. Mueller 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

Vietnam

Filing a Divisional Application in Vietnam – Part 13

Lisa L. Mueller 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:

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;
The divisional application cannot include any subject matter not originally disclosed in the parent application; and
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:

Is allotted its own (new) application number;

Requires payment of its own filing fees (separate from the filing fees paid in the parent application) and all back annuities;

Requires the filing of a request for examination (separate from the filing of a request for examination in the parent application);

Is prosecuted separately from the parent application; and

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

Lisa L. Mueller 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.

The GCC Patent Office is No Longer Accepting New Patent Application Filings

Lisa L. Mueller January 8, 2021

In 1981, the Gulf Cooperation Council (GCC) was established in Abu Dhabi by six founding members: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. According to Article 4 of the GCC Charter, the basic objectives of the GCC were to effect coordination, integration and interconnection between GCC member states in order to: (1) achieve unity; (2) deepen and strengthen relations, links and areas of cooperation between the peoples in the six founding countries in various fields; (3) formulate similar regulations in various fields including those related to economic and financial affairs, commerce, customs and communications, education and culture; (4) stimulate scientific and technological progress in the fields of industry, mining, agriculture, water and animal resources; (5) establish scientific research; and (6) establish joint ventures and encourage cooperation by the private sector for the good of the people in each of the six founding countries.

In December 1992, the GCC Supreme Council, during its 13^th session, approved the GCC Patent Office Patent Regulation and the Statute of the GCC Patent Office (GCCPO), thereby establishing the GCC Patent Office. As a result, the GCCPO opened in Riyadh, Saudi Arabia, and started receiving patent applications as of October 3, 1998 and has been issuing patents ever since.

On January 6, 2021, following several decisions that were issued by the GCC Supreme Council during its 41^st meeting on January 5, 2021, an amended GCC Patent Law (Regulation) was approved. In a statement made on its official website, the GCCPO announced that as of January 6, 2021, it was no longer accepting new patent application filings. As a result, Applicants wishing to file a patent application in any of the six founding member countries should either: (1) file a patent application via the Paris Convention in each founding member country within 12 months from the earliest filed priority application; or (2) file a Patent Cooperation Treaty (PCT) application and then enter the national phase in each of one or more of the six founding member countries.

The sudden nature of the GCCPO’s announcement raises the question as to what happens to patent applications that are currently pending at GCCPO. Based on our current understanding, we expect that the GCCPO will continue to process these applications. Nonetheless, we are awaiting further information from the GCCPO as to how the processing of pending applications and granted patents will be handled on an ongoing basis in view of this announcement.

Additionally, we are also awaiting updates and guidance from each of the national patent offices as to their capability and capacity to assume the burden of processing, publishing, examining and issuing the anticipated increase in national filings resulting from this decision. Whereas the GCCPO used to issue patents between 5-7 years from filing, some countries, namely Kuwait, have yet to issue their first patent.

Please continue to watch BRICS & Beyond for updates on the processing of pending applications and issued patents in the GCC.

This post was written by Lisa Mueller and Namir Sioufi of Saba IP.

New Patent Application Examination Guidelines for Biotechnology Inventions in Brazil

Lisa L. Mueller January 7, 2021

On December 1^st, 2020, the Instituto Nacional da Propriedade Industrial (INPI; also known as the Brazilian Patent and Trademark Office (BRPTO)) published Normative Instruction #118 (November 12, 2020), revoking the previous guidelines (Rule #144/2015) and establishing new guidelines for the examination of biotechnology inventions.

Summary of Main Changes Between New Guidelines and Previous Guidelines

A summary of the main changes between the new guidelines and the previous ones are provided below:

Regarding enablement, the following will not constitute undue experimentation: (i) standard procedures for carrying out the claimed invention (e.g., obvious or routine experiments, such as standardized optimal conditions for conducting a polymerase chain reaction (PCR)), unless the standard procedures are specifically related to the technical problem that is solved by the claimed invention; and (ii) the determination of degenerate nucleotide sequences of preferred codons in species that were well studied at the time of the invention (e.g., filing date of the application).
Regarding non-statutory matter, medical or surgical techniques and methods of treatment or diagnosis involving human and animal embryos are now explicitly excluded from patentability (article 10 (VIII) of the Brazilian Patent Statute). However, inventions related to products and methods of obtaining and using human embryonic stem cells constitute statutory matter.
With respect to biological sequences (e.g., amino acid and/or polynucleotide sequences), any sequences not disclosed in the application at the time of filing cannot later be added to the application, even if such sequences can be inferred from the disclosure as filed. In fact, any amendments to the application to include such information will be rejected by the BRPTO as constituting new matter. However, if a biological sequence is known in the art and a specific reference (e.g., citation to a publication, database and/or patent) to the sequence is included in the specification, its later inclusion in the application will be allowed.
Claims directed to DNA or RNA must be defined by its sequences of nucleotides (SEQ ID NO), while a protein must be defined by its sequence of amino acids (SEQ ID NO) in order to clearly define the subject matter of protection, provided that such sequences are disclosed in the application as originally filed. According to the new guidelines, it is possible to redraft DNA, RNA and protein claims that were not defined as outlined above, provided that their corresponding SEQ ID NO is disclosed in the application as originally filed. For example, a claim to a DNA encoding a polypeptide having a certain sequence of amino acids (SEQ ID NO) can be redrafted to recite a DNA having a certain nucleotide sequence. Moreover, degenerated sequences of a DNA or RNA defined by a nucleotide sequence through their SEQ ID NO are acceptable provided they generate the same protein and the protein is precisely defined in the specification.

Clarification of the Criteria for Written Description and Unity of Invention for Claims Involving Markush Language

Additionally, the new guidelines clarify the criteria to be used for assessing written description support and unity of invention for claims reciting Markush language for polynucleotides and peptides, as summarized below:

Regarding written description support of alternatives in a claim containing Markush language for amino acid sequences, it is necessary to evaluate: (i) the physical and chemical characteristics of the amino acids claimed at each position in view of what was disclosed in the specification; and (ii) the region in which modifications occur, since in the critical areas involving the function of a polypeptide even conservative modifications can generate different results;
For written description support of claims containing Markush language for nucleotide sequences, it is necessary to evaluate whether the sequence encodes a protein. In the case of coding sequences, alternatives that generate the same protein are acceptable. If the claimed sequence is not a coding sequence, then the evaluation of alternatives must consider the information presented in the specification, i.e., only the sequences disclosed in the specification will be accepted; and
Claims containing Markush language should meet the unity of invention criteria specific to Markush groups as set forth in BRTPO´s Rule #124/2013 which establishes that: (i) all alternatives should have a common property or activity; and (ii) a common structure should be presented, i.e., a significant structural element should be shared by the alternatives.

Clarification of Several Issues Relating to Antibodies

The new guidelines also provide clarification on several issues relating to antibodies, such as:

A better definition of what is considered patentable in connection with antibodies and fragments thereof. For example, if an antibody is obtained from an organism that is naturally exposed to an antigen, the antibody will be considered to be naturally occurring and will not be patentable pursuant to article 10 (IX) of the Brazilian Patent Statute. However, if the antibody can only be obtained through human intervention, such as, for example, by an immunization protocol (e.g., immunization of a mouse), then the antibody will not be deemed to be naturally occurring and will be patentable;
Methods for obtaining polyclonal antibodies will be considered to be patentable, provided that all of the steps of the methods are sufficiently described in the specification and that the methods are neither of natural occurrence nor invasive. Therefore, methods of immunization/vaccination that comprises an invasive step are not eligible for patent protection;
Monoclonal antibodies can be claimed by their complementary determining regions (CDRs); however, the claims must recite the three CDR sequences of the light and heavy chains by their SEQ ID NO; and
Claims directed to chimeric, humanized and human antibodies and methods for obtaining the same must be defined by (i) their CDRs sequences; or (ii) biological sequences to specific regions (e.g., variable region) in order to ensure clarity, precision and support of the claimed subject matter. The new guidelines provide specific examples on how such antibodies can be claimed. Specifically, example 37 provides the following recommendation of how such claims can be worded: (a) A humanized antibody against α-actin characterized by comprising the variable murine region consisting of SEQ ID NO:X and constant regions in the human γ chain; and/or (b) A humanized antibody against α-actin characterized by comprising the complementarity determining murine regions (CDR1; CDR2; CDR3) that consist of SEQ ID NO: X, SEQ ID NO:Y, SEQ ID NO:Z in the light chain and SEQ ID NO:A, SEQ ID NO:B and SEQ ID NO:C in the heavy chain and constant regions in the human γ chain.

Patentability of Genetic Use Restriction Technology

Moreover, according to the new guidelines, the processes for the generation/multiplication of genetically modified plants that involve genetic use restriction technology (GURTs) are excluded from patentability, in particular, those directed to the production of sterile reproductive structures (e.g., those which encompass processes that involve the activation or inactivation of plant fertility genes with external chemical inductors), in compliance with the provisions of article 6^th (VII) of the Biosafety Law (Law #11, 105/2005). However, methods for restoring the fertility of plants that do not involve the use of external chemical inductors are considered to be patentable.

Requirements for Patent Applications Resulting from Access to Brazilian National Genetic Heritage

Finally, under the new guidelines, if any subject matter claimed in a patent application is the result of access to any Brazilian national genetic heritage, it is mandatory that registration before the Genetic Heritage Management Council (CGEN) via the System for Genetic Heritage and Associated Traditional Knowledge Management occur prior to the filing of a patent application.

Please continue to watch BRICS & Beyond for updates on changes to patent examination guidelines in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues, Rafaella Oliveira, Luiza Cotia and Danielle Altomari from Licks Attorneys.