Updates to the Brazilian Food and Drug Administration OTC Drug Guidelines

It has been 13 years since the Brazilian Food and Drug Administration (ANVISA) updated the guidelines regulating which drugs can receive over-the-counter (OTC) status. The much-anticipated guidelines, which issued on August 3, 2016 as Rule #98, revoke the previous Rule #138, which was established in 2003. Rule #138 established which drugs could be sold as OTC medications, according to their therapeutic indications. Drugs currently recognized as safe for over-the-counter use under Rule #138 will continue to be categorized as such until a reassessment can be completed and compliance with Rule #98 evaluated; however the new guidelines allow ANVISA to simultaneously reassess the status of currently available OTC drugs while expanding the number of new products available to consumers.

Rule #98 was previously submitted to Public Inquiry #27 on April 8, 2015. According to ANVISA’s report on the public inquiry, the general feedback was that the new rule will have a positive impact on the market, especially with regards to increasing patient’s access to drugs and the recognition of pharmacists’ roles in healthcare. It is expected that Rule #98 will expand the number of OTC drugs in the Brazilian market, which will increase price competition and marketing efforts towards consumers, rather than physicians.

In order to be compliant with Rule #98, drugs must comply with the following seven criteria:

  1. The drug must have been commercially available for a minimum of 10 years (five years in Brazil), as a prescription drug, or five years, as an OTC drug, in countries where regulations are similar to ANVISA.
  2. The drug must exhibit a high level of safety: the causes of the adverse reactions must be well known and easily reversed, the drug must have a low level of toxicity, a safe therapeutic window, and a low level of interactions with other drugs and food.
  3. The clinical condition treated by the drug cannot evolve rapidly, and its symptoms must be easily identifiable by the consumer.
  4. The drug must pose a low risk when used off label or in overdose scenarios.
  5. The drug cannot be indicated for continuous use; rather, it can only be used for a short period of time or a fixed period of time, which must be identified in the drug’s label (except for drugs labeled for prevention).
  6. The consumer must be capable of using the drug without any physical assistance from a healthcare professional.
  7. The drug cannot cause chemical dependency in consumers.

Companies looking to obtain OTC status for a particular drug can do so at any time; status can be applied for with the Marketing Approval Application, or after the drug has already been approved. The OTC status request must be supported by the required documents listed in Rule #98, ensuring compliance with the above-identified criteria. The company must also support its request with a risk reduction plan, which will inform the ANVISA how it will monitor occasional risks arising from the commercialization of the drug as an OTC product. Once the OTC status is approved, the decision will be published by ANVISA in the Official Gazette and be made available online. The publication will include the active pharmaceutical ingredients (API) in the drug. Once published, companies will have 180 days to make appropriate amendments to the drug packaging and label, as well as have the product sales status changed to OTC.

Importantly, Rule #98 defines which products are not entitled to receive OTC status, which includes drugs that require parenteral administration, or drugs that are commercially packaged, as the quantity of the API per package exceeds the maximum limits established by ANVISA.

The enforcement of Rule #98 will begin 30 days after its publication on September 3, 2016.  Please continue to check the BRIC Wall Blog for additional updates on the enforcement of these new guidelines in Brazil.

This blog post was written by Lisa L. Mueller, Caitlin E. Mac Nair of Michael Best, Ricardo Campello and Roberto Rodrigues of Licks Attorneys.

Update on Patentability of Diagnostic Claims: Brazil (Part 2 of an 8-part Series)

This is the second update to our 2014 10-part series “The Thorny Problem of Patentable Eligible Subject Matter.” Since that series, the U.S Patent and Trademark Office (USPTO) issued further guidance on December 16, 2014, updated in July 2015 and May 2016 (May 2016 Update), for evaluating subject matter eligibility under Section 101 (Guidance). The new Guidance superseded the March 4, 2014 Guidance.  Part 1 – Update on Patentability of Diagnostic Claims: Australia can be found here.

On July 16, 2016, the USPTO issued a memo commenting on recent decisions by the U.S. Supreme Court (Supreme Court) and the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in two subject matter eligibility cases directed to life sciences method claims: Sequenom v. Ariosa and Rapid Litigation Management v. CellzDirect, (Rapid Litigation Management) respectively. The memo concludes that neither decision changes the subject matter eligibility framework and that the existing Guidance and training examples are consistent with these cases; however, the memo also notes that the Rapid Litigation Management decision further clarifies the inquiry involved in determining whether a claim is directed to a judicial exception. In particular, the Federal Circuit stated that the “directed to” analysis of a process claim requires more than “merely identify[ing] a patent-ineligible concept underlying the claim” and instead requires an analysis of whether “the end result of the process, the essence of the whole, was a patent-ineligible concept.”

The May 2016 Update provided more detailed instructions for Examiners regarding the formulation of a rejection under Section 101 and evaluation of an Applicants response thereto. Specifically, Examiner’s must identify the exception to patentable subject matter (referred to as a “judicial exception”) that is being claimed, explain what is recited  in the claim and why it is an exception, and identify any additional elements that define claim features/limitations/steps that are beyond the exception. The Examiner must then explain why the additional elements individually AND in combination do not result in the claim as a whole amounting to “significantly more” than the exception.

The May 2016 Update also provided additional examples for application of the Guidance to specific types of life science claims, which were not well represented in the December 2014 Guidance.

As discussed in our 2014 series, Article 10 of Brazilian Intellectual Property law (IPL) defines what is not considered to be an invention or a utility model and thus, patent ineligible subject matter.  In fact, Article 10 may be considered the counterpart of 35 U.S.C. § 101 in the U.S. According to Article 10, the following are not considered be patent eligible subject matter:

  1. Discoveries, scientific theories, and mathematical methods;
  2. Purely abstract concepts;
  3. Schemes, plans, principles or methods of a commercial, accounting, financial, educational, publishing, lottery or fiscal nature;
  4. Literary, architectural, artistic, and scientific works or any aesthetic creation;
  5. Computer programs per se;
  6. Presentation of information;
  7. Rules of games;
  8. Operating or surgical techniques and therapeutic or diagnostic methods for use on the human or animal body; and
  9. Natural living beings, in whole or in part, and biological material, including the genome or germplasm of any natural living being, when found in nature or isolated therefrom, and natural biological processes.

Additionally, Article 18 of Brazilian Intellectual Property law further limits what may be patentable and indicates that the following are not patentable:

  1. Anything that is contrary to morals, good customs, and public security, order, and health;
  2. Substances, matter, mixtures, elements or products of any kind, as well as the modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus; and
  3. Living beings, in whole or in part, except transgenic micro-organisms* meeting the three patentability requirements provided for in Article 8 (i.e., novelty, inventive activity, and industrial application) and which are not mere discoveries.

*For the purposes of this law, transgenic micro-organisms are organisms, except the whole or part of plants or animals, that exhibit, due to direct human intervention in their genetic composition, a characteristic that cannot normally be attained by the species under natural conditions.

Additionally, on July 15, 2016, the Ministry of Development, Industry and Foreign Trade, National Institute of Industrial Property (INPI) published Part II of its guidelines for the examination of patent applications relating to patentability (Guidelines).  According to Paragraph 1.38 of the Guidelines, a diagnostic method is not considered an invention when the series of steps that comprise the method are applied “in a human or animal body”.  Specifically, Paragraph 1.39 states that:

A diagnostic method for application in the human or animal body in accordance with the provisions of item VIII of Article No. 10 of IPL falls within, when it meets the following criteria:  (i) it has direct application in the human or animal body, such as, for example, in the base of determining the allergic conditions by diagnostic examination applied in the body, or requires the presence or participation of the patient for its interpretation; and (ii) allows the conclusion of the clinical state of the patient, or indicate various possible clinical states, just based on data processing, analysis or interpretation, information and/or clinical results associated with the patient.

The following is an example provided in the Guidelines of a diagnostic method not considered to be an invention (and hence not patentable):

  1. Automated diagnostic method of a patient, characterized in that it comprises the steps of:
    1. examining the patient to provide at least a first symptom element having a first relative degree of importance to the symptom;
    2. examining the patient to provide at least a second symptom element having a second relative degree of importance to the symptom;
    3. apply the relative degrees of importance for the symptoms, in order to obtain a diagnostics core for the conclusion of a medical condition.

Paragraph 1.41 of the Guidelines makes it clear that methods consisting of in vitro tests that are carried out on blood samples or other tissue removed from the body are considered to be an invention because such tests are not applied to a human or animal body and thus do not “conclude regarding the clinical state of the patient”.  However, this same paragraph also notes that diagnostic methods may include a combination of in vivo and in vitro steps.  In these instances, “…if the claimed method includes technical steps carried out in vivo, which are inseparable from the in vitro step, the method as a whole will be regarded as being applied on the body and, therefore, it will not be considered invention.  In addition, the treatment of tissues, cells or body fluids after they have been removed from the human or animal body, or methods applied onto them, such as methods in vitro, are considered entitled to protection.  The methods of measurement of enzymes and blood glucose, complete blood count, serology tests, among others, are included in this case.”

Paragraph 1.42 of the Guidelines further specifies that methods of obtaining information from a human or animal body where the data collected is just an “intermediate result that, by itself, is not enough for defining a diagnosis, are not considered diagnosing methods.”  Therefore, such methods are considered to be inventions and thus entitled to protection.

We at the BRIC Wall thought it would be insightful to update our analysis of subject matter eligibility under Brazilian patent law for diagnostic method claims based on the May 2016 updated Guidance and Life Science examples.

Analysis of Life Sciences Examples from May 2016 Update to USPTO Guidance

Example 29 – Diagnosing and Treating Julitis

Background:  Example 29 of the May 2016 Update relates to a hypothetical situation relating to an autoimmune disease called “Julitis.”  An Applicant for a patent discovered that Julitis could be diagnosed by detecting the presence of the hypothetical “JUL-1” protein in patients’ plasma, skin, hair and nails.  Applicant has disclosed detecting JUL-1 using anti-JUL-1 antibodies that may be naturally occurring (e.g., a human anti-JUL-1 antibody isolated from a patient known to have julitis), or non-naturally occurring (e.g., a porcine anti-JUL-1 antibody created by injecting pigs with JUL-1, or a specific monoclonal antibody named “mAb-D33”).

Two representative claims from this Example are analyzed below.

Claim 1. A method of detecting JUL-1 in a patient, said method comprising:

  1. obtaining a plasma sample from a human patient; and
  2. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.

Claim 2. A method of diagnosing julitis in a patient, said method comprising:

  1. obtaining a plasma sample from a human patient;
  2. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; and
  3. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.

Analysis of claims 1 and 2:  Both claims 1 and 2 would constitute patent eligible subject matter in Brazil. In the U.S., claim 1 constitutes patent eligible subject matter, while claim 2 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the claim is directed to a judicial exception (i.e., the correlation between the presence of JUL-1 and the presence of julitis in the patient) and as a whole does not amount to significantly more than the exception itself.

Example 31 – Screening for Gene Alterations

Background:  Applicant discovered the “wild-type” sequence of the human BRCA1 gene (i.e., the typical sequence of the gene in humans), and has also discovered naturally occurring alterations from the wild-type sequence that are correlated with an increased likelihood of developing breast or ovarian cancer. Applicant’s disclosure provides methods of screening patients for alterations in the BRCA1 gene by comparing a patient’s BRCA1 sequence with the wild-type BRCA1 sequence. The compared sequences can be germline (genomic) DNA sequences, RNA sequences, or cDNA sequences.

At the time the invention was made and the application was filed, scientists routinely compared DNA sequences using two-data generating techniques:  (1) hybridizing two different DNA molecules (e.g., a probe and DNA isolated from a patient sample), and detecting whether the molecules bind to each other and form a hybridization product and (2) amplifying (making copies of) at least part of a DNA molecule such as DNA isolated from a patient sample, by using a set of primers to produce amplified nucleic acids, and then sequencing the amplified nucleic acids.  The probes and primers used in these techniques are short single-stranded DNA molecules that typically have a naturally occurring nucleotide sequence.

In one embodiment, Applicant discloses using a computer-implemented micromechanical method known as Scanning Near-field Optical Microscopy (SNOM) to detect hybridization of a single probe to its target. At the time the invention was made and the application was filed, the use of SNOM to study DNA hybridization had been discussed in several articles in widely-read scientific journals. However, scientists were not commonly or routinely using SNOM to study DNA hybridization at the time the invention was made and the application was filed.  Instead, scientists at the time typically used autoradiography to detect hybridization products.

In another embodiment, Applicant discloses using Cool-Melt polymerase chain reaction (Cool-Melt PCR) to amplify BRCA1 DNA from the patient sample. Cool-Melt PCR uses lower melting and annealing temperatures than conventional PCR, which results in Cool-Melt PCR having a 20-fold higher sensitivity of mutation detection than conventional PCR.  At the time the invention was made and the application was filed, Cool-Melt PCR was known and used by a few scientists in the field.  Several years after filing the application, Cool-Melt PCR became a standard laboratory technique that appeared in virtually every laboratory manual and was conventionally used by most scientists in the field to amplify mutant nucleic acids.

Three representative claims from this Example are analyzed below.

Claim 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

Claim 70. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:

  • hybridizing a wild-type probe to a BRCA1 gene isolated from said sample; and
  • detecting the presence of a hybridization product by measuring conformational changes in the probe that are indicative of hybridization to the BRCA1 gene with scanning near-field optical microscopy.
  • Claim 80. The method of claim 1, wherein said comparing BRCA1 sequences further comprises:
  • amplifying by Cool-Melt PCR all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids; and
  • sequencing the amplified nucleic acids.

Analysis of claims 1, 70, and 80:  Claims 1, 70, and 80 would constitute patent eligible subject matter in Brazil.  In the U.S., claim 1 constitutes patent ineligible subject matter, as the May 2016 Update indicates that the “comparing” amounts to an abstract idea, which is a judicial exception, and the claim as a whole does not amount to significantly more than the exception itself.  In contrast, claims 70 and 80 are patent eligible in the U.S., as each claim recites additional elements that distinguishes the claim from well-understood, routine, or conventional techniques in the field (i.e., SNOM and Cool-Melt PCR, respectively), and, therefore, each of claims 70 and 80 as a whole amounts to significantly more than the exception itself.

In view of the above, Brazilian patent law is less restrictive concerning the eligibility of diagnostic method claims as compared to U.S. patent law, at least for the foreseeable future.

This post was written by Lisa L. Mueller and Melissa E. Kolom of Michael Best, and Roberto Rodrigues and Anna Carolina Correa of Licks Attorneys.

Expediting Patent Prosecution in Brazil

Although it was encouraging when Brazil implemented new laws in the mid-1990s that expanded the scope of patentability to include pharmaceutical and biotechnology inventions, the Brazilian Patent Office (INPI) has not been able to accommodate the dramatic influx of patent applications that followed. At present, a serious backlog in patent prosecution delays the examination of applications by an average of 10 years, weakening the intellectual property infrastructure in Brazil. In an attempt to address the backlog and expedite patent prosecution, several pilot programs have been introduced. These programs include the Green Patent pilot program, the implementation of Rules #151/2015 and #80/2013 and the Patent Prosecution Highway (PPH) pilot program.

Green Patent Pilot Program

The goal of this program, coined the “green” patent program, is to examine applications related to alternative energy, transportation, energy conservation, waste management, and agriculture (other qualifying technologies are listed here), in two years or less. Launched in 2012, Brazil was the first country to implement such a program. The program is currently in its 4th phase and is accepting applications filed under the Patent Cooperation Treaty (PCT).

In order to participate in the program, an applicant must submit an application that contains no more than 15 total claims (of which three are independent), and has not previously undergone technical examination. A submission of the form specific to the pilot program must be completed, and examination and publication must be requested. According to the INPI, the progress of applications in the program can be tracked online. However a limited period of time remains to participate in the Green Patent pilot program.

INPI Rule #151/2015

Rule #151/2015 of November 10, 2015, revised the conditions for requesting priority examination of a patent application. Specifically, Rule #151/2015 allows expedited patent prosecution for elderly (above 60 years of age) or ill applicants, or applicants that can show a third party is reproducing the subject matter of their patent application. Rule #151/2015 revoked the specific provision which allowed the Ministry of Health to request prioritized examination of applications involving drugs regularly purchased by the Brazilian Public Health System. However the Ministry of Health can still request priority examination of strategic drugs for the Public Health System pursuant to Rule #80/2013 (discussed below), and the Brazilian government has retained the right to prioritize the examination of applications relevant to national emergency or public interest.

For more information, an English translation of Rule #154/2015, which implements the PPH pilot program, is available: Rule154.

INPI Rule #80/2013

Rule #80/2013 of April 9, 2013, establishes the possibility of expedited examination of applications relating to the diagnosis, prophylaxis and treatment of Acquired Immunodeficiency Syndrome (AIDS), cancer or other neglected diseases.  Neglected diseases include:

  • Chagas Disease;
  • Dengue / Dengue hemorrhagic fever;
  • Schistosomiasis;
  • Leprosy;
  • Leishmaniasis;
  • Malaria;
  • Tuberculosis;
  • Buruli ulcer;
  • Neurocysticercosis;
  • Echinococcosis;
  • Bouba;
  • Fascioliasis;
  • Paragonimiasis;
  • Filariasis;
  • Rabies;
  • Helminthiasis;
  • Manifestations from intoxications or poisonings due to poisonous and venomous animals.

There is no limitation on the use of Rule #80/2013 and any applications expedited become the responsibility of the Board of Patent – DIRPA.    Determination of whether or not an application would qualify for expedited examination under Rule #80/2013 and whether or not there would be any disadvantage associated with requesting such expedited examination must be done on a case-by-case basis. Interestingly, since 2013, Rule #80/2013 has only been used 28 times.

Judicially Induced Fast-Track Examination of Patent Applications

In addition, applicants can request the Federal Courts issue an order imposing a “judicially induced fast-track” examination of a pending application.  Specifically, during the last few years, several applicants have filed lawsuits in the Federal Courts requesting expedited examination of a patent application.  Several applicants have been successful in obtaining injunctive relief with the Courts ordering INPI to complete examination of a pending application within 60 days. The 60 day period to conclude examination takes into consideration sections 48 and 49 of Statute #9,784/99, which provides general rules governing federal proceedings. The attached graphic summarizes the decisions issued by each of the four intellectual property (IP) specialized courts as well as by the appellate courts.  Both the 1st and 2nd Panels from the Court of Appeals for the 2nd Federal District, which are in charge of hearing appeals against decisions from the four IP specialized courts, have affirmed the decisions from the lower courts ordering INPI to expedite examination of pending applications.

Patent Prosecution Highway (PPH) Pilot Program

Implemented on January 11, 2016, the PPH pilot program is an agreement that exists between the United States Patent and Trademark Office (USPTO) and the INPI. Limited to oil and gas inventions (e.g. extraction, refining, and transportation) filed after January 1, 2013, the PPH allows expedited examination of a Brazilian application for which a corresponding U.S. application has received a Notice of Allowance from the USPTO. In order to participate, an Applicant must submit a copy of the Notice of Allowance issued by the USPTO for the related U.S. application, and pursuant to Rule #154/2015, the Applicant must also file a request using service code 277, and pay the requisite fee of R$1,775 (approximately US$420). While the PPH pilot program is an important step by the INPI in addressing the patent application backlog, the subject matter limitation to oil and gas technologies may result in future legal challenges before the Federal Courts.

Will there be any improvement in the backlog anytime soon?

Given the current political and economic crisis in Brazil, it is unlikely that applicants will see an improvement in the backlog any time soon.  Moreover, the Ministry of Health will likely support launches at risk in order to have copies of lower cost drugs available in the Brazilian market.  While not the best news for applicants, the worst case scenario is that pending applications will remain in the same place in INPI’s queue.

 

Please continue to watch the BRIC Wall Blog for updates on patent examination in Brazil.

This post was written by Lisa Mueller and Caitlin Mac Nair of Michael Best and Roberto Rodrigues of Licks Attorneys.

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: Federal District Court in Rio de Janeiro Declares AstraZeneca’s Patent Covering Fosladex Invalid

On October 15, 2015, Judge Caroline Somesom of the 31st Federal Court in Rio de Janeiro invalidated AstraZeneca’s Brazilian patent No. PI0107445-8 covering Faslodex® (fulvestrant). Faslodex® is used to treat metastatic breast cancer in women who have gone through menopause.  Specifically, a nullity lawsuit was filed in 2013 by Eurofarma Ltda, a Brazilian generic company, against Astrazeneca and the Brazilian Patent and Tradmark Office. In its lawsuit, Eurofarma argued that the patent was obvious in view of EP Patent Application No. 346014, U.S. Patent No. 4,212,863 and several other publications from cancer research journals. Judge Somesom agreed with Eurofarma and held the patent invalid.

In May 2015, a court-appointed expert issued a formal report holding the patent invalid for lack of inventive step. According to the expert, the mere “adaptation” of a subcutaneous injectable formulation to an intramuscular injectable formulation would have been an obvious modification to a person of ordinary skill in the art. In his decision invalidating the patent, Judge Somesom agreed with the conclusions of the court-appointed expert. However, this is not the final word on the matter. Judge Somesom’s decision can be appealed to the Federal Court of Appeals for the Second Circuit.

For the second time in 2015, a patent covering of blockbuster drug of Astrazeneca’s has been invalidated.  The first instance involved Astrazeneca’s Crestor patent.

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

AstraZeneca’s Crestor® Patent is Invalidated by the Brazilian Federal Courts

On June 5, 2015, the 13th Federal District Court of Rio de Janeiro invalidated Astrazeneca’s patent BR PI0003364-2 covering Crestor® (rosuvastatin). The Judge, the Honorable Marcia Nunes Barros, agreed with the arguments submitted by the Brazilian Patent Office and National Sanitary Vigilance Agency (ANVISA) that the patent was obvious over the prior art. The Honorable Barros is the same Judge that recently issued a decision holding that ANVISA was allowed to examine patentability requirements during prior approval/consent analysis under Article 229-C of the Patent Statute.

According to the decision, the use of the tribasic calcium phosphate to stabilize statins was expressly recommended in the prior art document PT 547 000E. Even though the use of the term “potentially” in the prior art did not denote certainty regarding stabilization, according to the Court, this meant that tribasic calcium phosphate was “probably useful for stabilizing statins”.

Additionally, although the prior art document recited a pH value of at least 8, preferably 9, for the stabilization of statins, the Court held that this pH value related to the stabilization of fluvastatin and not rosuvastatin. The Court referred to the Handbook of Pharmaceutical Excipients, which stated that tribasic calcium phosphate had a pH value of 6.8 at 20% solubility.

The Court held that a person of ordinary skill in the art (POSITA) would have known from PT 547 000E that tribasic calcium phosphate could be used to stabilize statins. Therefore, because the pH of a stabilizing agent varies based on concentration, a POSITA would have been motivated to investigate using tribasic calcium phosphate to stabilize a statin (in other words, it was “obvious to try”). The Court found this to be true because the pH value of 8 recited in PT 547 000E referred to the stabilization of a different statin (fluvastatin) and not rosuvastatin. Other prior art, such as WO 97/23200, described using a pH value of between 7.0 to 8.0 to stabilize the HMG-CoA inhibitor, E)-3,5-dihydroxy-7-[4′-4″-fluorophenyl-2′-cyclopropyl-quinolin-3′-yl]-6-heptenoic acid.

Therefore, according to the Court, a PHOSITA at the time of the invention would have understood that different statins required different pH values for stabilization. Even though tribasic calcium phosphate only had a pH value of 6.8 based on its solubility data, the Court held that a PHOSITA would have been motivated to test tribasic calcium phosphate as a stabilizing agent for rosuvastatin.

Interestingly, despite the fact that the court-appointed expert issued a report concluding that the patent was valid, the Judge mentioned international standards for assessing inventive step, including the U.S. Supreme Court’s decision in KSR Int’l Co. v. Teleflex, Inc., in concluding that the technical solution presented in the patent was obvious to try and that there was a reasonable expectation of success.

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

13th Federal District Court of Rio de Janeiro Holds that ANVISA Can Examine Patentability Requirements of Patent Applications Claiming Pharmaceutical Inventions

One of the most contentious issues in the Brazilian pharmaceutical landscape is role of National Sanitary Vigilance Agency (ANVISA) during the prior approval/consent analysis of patent applications claiming pharmaceutical inventions. Article 229-C of Brazil’s Patent Statute (Statute) provides that ANVISA shall have the right to provide approval of patent applications claiming pharmaceutical inventions (often referred to as “prior approval” or “prior consent”). Specifically, Article 229-C provides that: “The grant of patents for pharmaceutical products and processes shall depend upon the prior approval from the National Sanitary Vigilance Agency.”

During the past few years, the courts in Brazil have issued decisions holding that Article 229-C did not grant ANVISA the power to examine patent applications for compliance with the patentability requirements under the Statute. Moreover, these cases held that ANVISA was solely limited to determining whether or not a patent application was against public health according to Article 18, I of the Statute and nothing more.

The most favorable decisions for patent owners were issued by District Courts sitting in Brasilia. Specifically, several Courts issued preliminary injunctions ordering ANVISA to grant prior approval of patent applications claiming pharmaceutical inventions holding that the examination of patentability requirements by ANVISA was illegal (for example, in May 2015, the 15th Federal District Court granted a preliminary injunction requested by Novartis on a writ of mandamus filed against ANVISA).

However, on June 11, 2015, the Honorable Marcia Nunes de Barros of the 13th Federal District Court sitting in Rio de Janeiro denied a preliminary injunction and held that ANVISA was permitted to examine a patent application claiming pharmaceutical inventions for compliance with the patentability requirements. The case was filed by Abbvie, Inc. and related to two patent applications involving Kaletra® (lopinavir/ritonavir).

In a 30-page decision, the Judge described the importance of Article 229-C and ANVISA’s ability to examination patent applications for compliance with the patentability requirements under the Statute in order to avoid the patenting of inventions to merely “incremental innovations”. Specifically, the Judge stated that: “…taking into consideration the systematic element, it seems clear, as already exposed, that the goal of the rule that included ANVISA in the proceeding of deciding about pharmaceutical patents, was clearly to include a vision over public health during examination, in a way to avoid the granting of undue patents, with highlights to the incremental ones”.

Unfortunately, but not surprisingly, this unfavorable decision will be used by ANVISA with respect to currently pending and future filed patent applications. However, it is too soon to assess how this decision will impact the current framework relating to Article 229-C and ANVISA with respect to patent prosecution. This decision should be carefully analyzed and rebutted by patent owners in order to avoid what could be a potential game changer in the pharmaceutical sector that might negatively impact innovator companies in Brazil.

Patent owners should keep in mind that the Federal Courts sitting in Brasilia have traditionally been more inclined to hold that ANVISA cannot examine patent applications for compliance with patentability requirements. Hopefully, this decision will not impact Judges sitting in Brasilia.

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