New guidelines in Brazil give more power to ANVISA in the examination of pharmaceutical patent applications

On March 13, 2017, the board of directors of Agencia Nacional De Vigilancia Sanitari’s (ANVISA) announced that they had reached a new agreement with the Brazilian Patent Office, namely, the Instituto Nacional da Propriedade Industrial (INPI), concerning the prior approval provision under Article 229-C of the Brazilian Patent Statute (For more information about the 229-C article, please see our posts here, here, and here).  On April 12, 2017, after an event with several authorities and President Michel Temer, ANVISA and INPI published a written version of the new joint guidelines #1/2017 (translation enclosed here:  INTERAGENCY ORDINANCE). These guidelines describe the new workflow between ANVISA and INPI involving the examination of pharmaceutical patent applications.

Article 4 of the guidelines establishes that ANVISA will analyze whether a patent application is contrary to public health.  According to Article 4, a patent application claiming a product or process is considered to be contrary to public health when the product or process presents a “health risk”.  The article further states that the “health risk” will be characterized when the pharmaceutical product comprises, or the pharmaceutical process results in a substance that has been prohibited in the country”.    

If a product or process is found to pose a “health risk” (as defined in the Annex I of the Ministry of Health’s Ordinance #344 of 1998), ANVISA will deny prior approval and will send the application back to INPI for further handling. At this point, INPI will publish the definitive dismissal of the application. In other words, the application is denied.

The guidelines contain a new approach in the examination of patent applications claiming pharmaceutical products and processes of interest under the Brazilian government’s drug policies and pharmaceutical assistance of the National Healthcare System (SUS). Under Article 5, ANVISA will examine these applications of interest and prepare a “technical” opinion as to whether the claims meet the patentability requirements under Brazilian law.  This opinion will be sent to INPI for use as a third-party observation under Article 31 of the Patent Statute of 1996.  Once INPI receives ANVISA’s opinion, it is “free” to decide whether or not to agree with it.  In the event INPI disagrees with ANVISA’s opinion and grants the patent application, it will send ANVISA a list containing all granted patents and will continue to make this list available to ANVISA (Article 7 of the guidelines).  

The guidelines do not contain any information as to what ANVISA can or should do with the list of granted patents received from INPI.  Actions that ANVISA could take include filing a post-grant opposition or seeking invalidity of the patent before Federal Courts. 

Article 9 of the guidelines creates an Interagency Group between the two agencies. The purpose of this group is to seek to “harmonize” the understanding between the ANVISA and INPI regarding the application of patent law in “polemic” topics such as Markush claiming, selection inventions, the patentability of new uses, salts, polymorphs and antibodies, as well as other issues relevant to the pharmaceutical industry.  One concern is that such “harmonization” could result in an unlawful administrative ban of claims that are currently being allowed INPI. As such, Article 9 gives ANVISA power to influence the INPI in a multitude of ways. 

Additionally, it is important to note that the new guidelines come after several decisions were obtained against ANVISA by various pharmaceutical companies (See our post here) holding that that the agency lacked the statutory authorization to examine patentability requirements under Brazilian law.  After these early decisions were rendered (which held that ANVISA’s prior approval review was restricted solely to the analysis of potential public health issues and not patentability requirements), ANVISA amended its guidelines to include a provision stating that “the granting of patents that do not fulfil the patentability requirements violates public health”. This change was interpreted by the courts as an attempt by the agency to escape the unfavorable case law and avoid the new guidelines.  

As a whole, the guidelines read like an attempt by ANVISA to revive its ability to participate in the examination of pharmaceutical patent applications.  Interestingly, many the associations representing generic companies in Brazil such as ABIFINA and Pro Generics are celebrating the guidelines as a victory for the local industry. 

Continue to watch the BRIC Wall Blog for continuing updates on these new guidelines in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho from Licks Attorneys.

 

 

 

Brazil: Courts confirm preliminary injunction based on pending patent applications

On March 15, 2017, the Sao Paulo State Court of Appeals confirmed a preliminary injunction barring Uniao Quimica, a Brazilian generic company, from launching a generic version of Allergan’s Combigan® (brimonidine tartrate and timolol maleate).  Combigan® is prescribed for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.   

The preliminary injunction was granted in view of three patent applications filed by Allergan and pending before the Instituto Nacional da Propriedade Industrial (INPI) since 2003 (namely, patent application no. PI0302584-5 filed in 2003 as well as divisional application nos. BR1220140116901-9 and BR122014016915-9 filed in 2012).  Application no. PI0302584-5 was rejected by INPI; however, an administrative appeal is pending. 

Allergan argued that the backlog and inefficiency of INPI had been punishing to the pharmaceutical company.  Specifically, Allergan argued that not granting the preliminary injunction based on the pending application would be “allowing third parties to freely infringe the application during its pendency”, and that the “patent owner would be absolutely deprived of effective means to protect its invention during the prosecution of the application, a proceeding the patent owner has no control over”. 

After the Trial Court issued an injunction on September 28, 2016, Uniao Quimica filed an interlocutory appeal challenging the grounds of the decision.  The reporting Appellate Judge, Hon. Francisco Loureiro, stayed the injunction concluding that the patent owner was only allowed to exclude others based on its patent rights after issuance of the patent by INPI. 

However, in a split decision (2-1), other members of the panel dissented from Hon. Loureiro, thus rejecting the interlocutory appeal and confirming the preliminary injunction.  The Hon. Cesar Ciampolini issued the deciding vote, stating that the preliminary injunction should be granted for the following reasons: (i) INPI’s inexcusable delay in examining patent applications; (ii) the rapid pace at which technology becomes obsolete; (iii) counterpart patents has been granted in several countries; (iv)  Uniao Quimica did not deny that its products were copies of Combigan®; and (v) Uniao Quimica’s behavior in launching generic copies was a matter of unfair competition and should not be allowed by the courts.

Although Uniao Quimica may still appeal to higher courts, the decision is an interesting outcome in view of INPI’s backlog in examining patent application.

Please continue to watch the BRIC Wall Blog for updates on the examination of patent applications by INPI.

This post was written by Lisa Mueller, Felipe Mesquita and Roberto Rodrigues Pinho of Licks Attorneys.

 

Two Important Decisions Addressing ANVISA’s Prior Approval of Pharmaceutical Patents in Brazil

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.  These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country. 

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:  novartisdecision genentechdecision).  Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin). 

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute.  In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI) is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products. 

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil.  Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.  Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).   The judge, the Honorable Iolete Oliveira, accepted  Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:  (1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health. 

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis.  The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis. 

Please continue to watch the BRIC Wall Blog for continuing updates on Brazil’s prior approval of pharmaceutical patent applications.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho, LLM candidate at Stanford University.

An Overview of the USTR’s 2016 Special 301 Report on the State of IPR in Brazil

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 report (Report) reviewing the state of intellectual property rights (IPR) protection and enforcement in U.S. trading partners around the world. The Report details the results of extensive research and analysis, which led to placing eleven countries on the priority watch list and twenty-three on the watch list. Brazil remains on the Watch List in 2016.   

Despite efforts to protect against online piracy, significant concerns remain over the high levels of piracy and counterfeiting in Brazil. In order to create public awareness and enact enforcement campaigns, the National Council on Combating Piracy and International Property Crimes (CNCP) was identified in past years as an effective entity for carrying out public awareness and enforcement campaigns. Unfortunately, the CNCP was underutilized and overall ineffective in 2015. In the Report, the United States urges Brazil to provide resources for intellectual property (IP) enforcement and seeks further commitments from the country on the strengthening of its IPR protection and enforcement measures. 

The Report also addresses the continued problem of significant delays in the examination of patents and trademarks, which, on average, take about eleven and three years, respectively. In early 2016, the United States-Brazil Patent Prosecution Highway pilot program was enacted to expedite the patent examination process in Brazil, specifically for inventions related to the oil and gas sector. Despite this positive step forward, there is still a duplicative review of pharmaceutical patent applications by the National Sanitary Regulatory Agency (ANVISA) which lacks transparency, exacerbates delays of patent registrations for innovative medications, and prevents patent examination by the National Institute of Intellectual Property (INPI).  

Furthermore, although there are laws and regulations in Brazil to protect veterinary and agricultural chemical products against unfair commercial use of undisclosed test data and other data generated to maintain marketing approval, these same laws and regulations do not apply to pharmaceutical products. Additionally, the Report notes that actions are being taken by INPI to invalidate or shorten the term of certain “mailbox” patents for pharmaceutical and agricultural chemical products. The Report concludes that the strengthening of IPR enforcement and protection for foreign and domestic right holders as well as expediting the examination of trademarks and patents is essential for continued innovation and investment in Brazil.  

This post was written by Lisa Mueller and Kate Merath.

 

 

 

 

 

 

Brazilian Patent Office and the Patent Prosecution Highway Program

The Patent Prosecution Highway (PPH) pilot program between the U.S. Patent and Trademark Office (U.S. PTO) and the Brazilian Patent and Trademark Office (INPI) began on January 11, 2016. The goal of the PPH Pilot Program is to speed up the examination of patent applications pending before INPI once a notice of allowance has been issued by the U.S. PTO in a corresponding U.S. application (including related family members).

The PPH Pilot program is limited to applications filed after January 1, 2013 that claim priority to a U.S. or Brazilian application. In addition, the application must claim inventions related to oil and gas technologies, including extraction, refining, transportation and other activities–specifically, those encompassed by International Patent Codes B01, B63, C09K8, C10, E02, E21, F15, F16, F17, G01.

To participate in the PPH pilot program, an applicant must submit a copy of the Notice of Allowance issued by the U.S. PTO. Additionally, pursuant to Rule # 154/2015, an Applicant must file a request (using service code 277) and pay the requisite fee of R$1,775 (approximately US $420).

On February 10, 2016, INPI granted priority examination to the first patent applications filed under the PPH pilot program. The applications were: BR 10 2013 000290-9 filed by Suncoke Technology and Development LLC on January 4, 2013; BR 10 2013 032934-7 filed by Afton Chemical Corporation on December 20, 2013; and BR 10 2014 017479-6 filed by Afton Chemical Corporation on July 16, 2014. The small number of Applicants (just two) invoking the PPH pilot program thus far might be the result of the subject matter limitations of the PPH pilot program.

While the PPH pilot program can be viewed as an important step by INPI in addressing the patent application backlog, the limitation of the program only to oil and gas inventions (to the exclusion of inventions in important fields such as telecommunications, pharmaceuticals and biotechnology), may result in Rule # 154/2015 being challenged before Federal Courts.

An English translation of INPI’s Rule # 154/2015, implementing the Pilot Program, is available here:  RULE154

This post was written by Lisa Mueller and Roberto Rodrigues.

 

Brazil mailbox litigation update: First case to be heard by the Federal Court of Appeals on March 24, 2015

Finally, the Federal Court of Appeals for the 2nd Circuit (Federal Court) will have an opportunity to rule on mailbox cases in Brazil. On March 24th, the Federal Court will hear an appeal filed by the Brazilian Patent Office (INPI) against the decision rendered by Judge Brandão of the 25th Federal District Court who rejected the lawsuits arising from the cases stating that the suits were a violation of the “legitimate expectation” principle.  The panel will comprise Reporting Appellate Judge, the Honorable Messod Azulay from the 2nd Panel of the Court of Appeals and the Honorable Simone Schreiber.

The potential good news for the patent owners is that the Honorable Andre Fontes (who is known to be anti-patent) will not be present during the hearing as he is away on holiday. A member of the First Panel, probably the Honorable Abel Gomes, will be third Appellate Judge in the hearing. Therefore, the composition of the panel appears to be favorable for the patent owners.  Reporting Appellate Judge Azulay is expected to reject INPI’s appeal and maintain the trial court decision.

Currently, fourteen appeals are pending before the Federal Court (eight in the first specialized panel and six in the second specialized panel).

Please watch the BRIC Wall Blog for further updates on mailbox litigation in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues and Mario Reis of Licks Attorneys

Brazil mailbox litigation update: Good news to start the year for the pharmaceutical industry

On January 22, 2015, another mailbox case was favorably decided for a pharmaceutical company.  This latest case was decided by Judge Ana Amelia Antoun of the 9th Federal District Court.  Judge Antoun is the fourth Judge to decide a mailbox case and the third Judge to issue a favorable decision for a pharmaceutical company.

The Judge rejected the Brazilian Patent Office’s (INPI) request to reduce the term of the patent.  Instead, the Judge maintained the term of the patent for a period of ten years from grant. According to the Judge, INPI’s delay in examining the application required the application of the constitutional principles of trust and good faith that govern the relationship with public administration. The Judge followed the reasoning of the previous two judges who favorably decided for pharmaceutical companies.

Judge Antoun is handling nine mailbox cases.  We expect that she will issue similar decisions in the remaining cases relatively soon. Additionally, it is expected that the appeals pending before the Federal Court of Appeals will be decided in March 2015.

Please watch the BRIC Wall Blog for further updates on mailbox litigation.

This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys.