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.