Changes to the IP Landscape in Turkey-Industrial Designs

On December 22, 2016, Turkey adopted a new IP Code of Property no. 6769 IP (IP Code), which repealed and replaced the Decree Laws on Patents and Utility Models, on Trademark and Service Marks, on Industrial Designs, and on Geographical Indications (Decree Law).  The new IP Code entered into effect on January 10, 2017.  In this multi-part series, we will address how this new IP Code changes the IP landscape in Turkey.  In our second installment of the series, we will examine the changes to the codes relating to industrial designs.  In part one, we examined the changes to the codes involving patents and utility models.

Submission of the Description of the Designs

Under the new IP Code, during examination, the submission of the description of an industrial design is optional.  This is because the information provided in the description does not affect the scope of the protection of the design.  In contrast, the former Decree Law required such a description to be provided during examination.  The new IP Code avoids an obligatory requirement for registering a design.

Industrial Designs will be Examined for Novelty

During examination, a design will now be examined for“novelty”.  Designs found not to be novel will be ex-officio refused.  The former Decree Law did not provide an ex-officio novelty search stage during examination.  In fact, novelty could only be questioned through a post-grant opposition or an invalidity action before the IP Courts.

Visible Parts of a Complex Product

According to the IP Code, only the visible parts of a complex product are protectable.   However, in order for the visible parts of a complex product to be protected, the visible parts must meet novelty and distinctive character requirements.  A design is considered to be novel if before the application date no identical design has been made available to the public anywhere in the world.

A design is understood to have an distinctive character if the overall impression it creates on the informed user is significantly different from the overall impression created on the same user by any design which has been made public (in Turkey or anywhere else in the world) before the application date of the design.  In the assessment of the distintiveness, the emphasis of the evaluation will be on the common features of the design; however, the degree of freedom of the designer in developing the design will also be taken into consideration.

Spare Parts of a Complex Product

According to Decree Law, the owner of a registered design could not assert its rights with respect to a visible part of a complex product until three years after the time period after which the design was first made available to the public. The new IP Code introduces a new derogation stating that the this three year period is not be applicable if the protected spare part design is mentioned among the list of “equivalent parts” issued by the Ministry of Science, Industry, and Technology.

Shorter Opposition Period

Under the new IP Code, the post grant-opposition period is now three instead of six months.  The reduction from six to three months will reduce the total registration time to less than a year.

Non-Registered Industrial Design Rights

In order for a design to be protected as a “non-registered” design, the design must first be made available to the public in Turkey.  The duration of protection for a non-registered design is three years from the date the design was first made available to the public (in Turkey).  Interestingly, non-registered design protection is intended to protect fast changing designs which are not intended to be registered for long periods by the design owner.  This type of protection will avoid registration costs for the designs for which registration is not preferred.  However, the owner of a non-registered design will be requested to evidence of ownership and that the design was first made available to the public in Turkey when enforcing its rights.

Non-registered designs are also protectable without any time limit under the unfair competition provisions of the Turkish Code of Commerce which remain in force.  During the next few years, it will be interesting to watch whether the Courts in Turkey will still allow such unfair competition cases after the completion of the 3 year protection period.

Enforcement of Non-Registered Designs

Under the new IP Code, designs are protectable for three years from the date of first public disclosure, if such disclosure was made in Turkey.  This protection is available for non-registered designs to prevent the use by third parties of identical or similar non-registered designs.  The IP Code also provides a common provision for the compensation of damages arising from intellectual property rights including registered and non-registered designs.  As a result, a design holder can ask for material damages which include actual damages and loss of income.  The loss of income can be calculated pursuant to one of the three (3) options mentioned in the IP Code, namely, the loss of income of the plaintiff, the income of the defendant or in accordance with an exemplary license fee.  Upon request by the plaintiff, the Court can increase the damages for the design holder under specific circumstances.  Moreover, the design holder can also seek moral/reputational damages.

Under the IP Code, a design holder can ask the Court to issue a preliminary and/or permanent injunction, compensation, the confiscation/destruction of the infringing goods and the tools and machinery (such as those used for manufacturing the infringing products), the publication of the verdict in a daily newspaper or any similar award.

Please continue to watch the BRIC Wall Blog for the remainder of the series on changes to the intellectual property landscape in Turkey.

This post was written by Lisa Mueller and Kate Merath of Michael Best and Okan Can of Deris.

The much awaited Indian National IPR Policy has arrived!

On May 13, 2016, the much awaited National Intellectual Property Rights (IPR) Policy was released by the Indian Government. The goal is to create awareness about the importance of IPRs as a marketable financial assets and economic tools.  The twenty-eight page policy lays down seven objectives and the necessary steps to be undertaken by the relevant Ministries/departments.  A copy of the policy is attached here:  National_IPR_Policy_12.05.2016.  A brief summary of the objects of the policy are provided below.  A more in-depth analysis of each of these objectives will be provided in subsequent BRIC Wall blog posts.

What are the main objectives of the new National IPR Policy?

  1. To create public awareness on the economic, social and cultural benefits of IPRs among all sections of society

A nationwide promotion program is proposed for the purpose of improving the awareness about the benefits of IPRs and their value to rights holders and the public, including the less visible IP generators and holders.  The goal is the creation of an atmosphere where creativity and innovation are encouraged in private and public sectors, research and development (R&D) centers, industry and academia thus leading to the generation of protectable IP that would ultimately be commercialized.  “Creative India; Innovative India” is the proposed slogan for this program.

  1. To stimulate the generation of IPRs

There is a need in India to tap the talent pool contained in R&D institutions, enterprises, universities and technical institutes to stimulate the creation of IP assets. The policy proposes a comprehensive IP audit or base line survey across these sectors to allow for the formulation and implementation of targeted programs.  Focus will be placed on facilitating researchers and innovators in areas of national priority, and initiating the steps necessary to ensure that the benefits of the IPR regime reach all inventors, especially micro, small and medium enterprises (MSMEs), start-ups and grass root innovators.

  1. To have strong and effective IPR laws, which balance the interests of rights owners with larger public interest

While India has an effective and TRIPs compliant IPR regime, it is important for it to protect its rich traditional medicinal knowledge from misappropriation.  One suggestion proposed by the policy is to undertake a review of India’s existing intellectual property laws, in consultation with the relevant stakeholders, and update and revise these laws to remove any anomalies and/or inconsistencies, if needed.  This suggestion is important as it shows the willingness of the Indian Government to take a fresh look at India’s existing laws and improve upon them for the better.

  1. To modernize and strengthen service-oriented IPR administration

The administration of the Copyright Act, 1957 and the Semiconductor Integrated Circuits Layout-Design Act, 2000 will now be brought under the aegis of the ‘Department of Intellectual Policy and Promotion’ (DIPP).  Additionally, a cell (namely, a dedicated team/department) for IPR Promotion and Management (CIPAM) is proposed to be created.  According to the policy, it is believed that this will facilitate more effective and synergetic working between various IP offices, as well as the promotion, creation and commercialization of IP assets. The policy also envisages promoting awareness about patents to IPR officials at all levels regarding the objects and reasons behind India’s IPR laws and international obligations.

  1. Obtaining value for IPRs through commercialization

The policy envisages a concerted effort for capitalizing India’s existing IP assets by creating a public platform to connect creators and innovators to potential users, buyers and funding institutions.

  1. To strengthen the enforcement and adjudicatory mechanisms for combating IPR infringements

The policy envisages various measures to strengthen the enforcement of IPRs such as sensitizing inventors and creators of IP on the available measures for protecting and enforcing their rights, a need to build the capacity of enforcement agencies at various levels, the strengthening of IPR cells in State police forces, devising measures to check counterfeiting and piracy, conducting regular IPR workshops, etc.  The policy also emphasizes the need to adjudicate IPR disputes through specialized commercial courts and to explore alternate dispute resolution mechanisms.

  1. To strengthen and expand human resources, institutions and capacities for teaching, training, research and building skills in IPRs

The policy notes that in order to harness the full potential of IPRs for India’s economic growth, it is essential to develop and increase the pool of IPR professionals and experts in all spheres such as policy and law, strategy development, administration and enforcement.  It is believed that developing such a reservoir of experts will facilitate the generation of IP assets in India and their utilization towards commercial development.

This post was written by Lisa Mueller with ‘IP Alerts’ shared by Arun Kumar of K & S Partners.

 

IPO’s patent to Gilead’s Sovaldi challenged at Delhi High Court

On May 9, 2016, the Indian Patent Office (IPO) granted a patent to Gilead Pharmasset, LLC (Gilead) for its blockbuster anti Hepatitis-C virus (HCV) drug, sofobuvir  (known commercially as “Solvaldi”) holding that the invention was novel, inventive and did not fall within the preclusion of Section 3(d) of the Indian Patents Act. The 58 page order rejected six pre-grant oppositions that had been filed and ordered the granting of the application.

In 2014, NATCO Pharma, the Initiative for Medicines, Access & Knowledge (I-MAK) and DELHI Network of Positive People (DNP), BDR Pharma, Sankalp Pharmaceuticals Pvt Ltd., Optimus Group and India Cores (collectively, the “pre-grant opponents”) filed pre-grant oppositions against Gilead’s application on various grounds.  In early 2015, the IPO, without holding any opposition proceedings, issued an order (the 2015 order), rejecting the application for falling under the preclusion of Section 3(d) of the Indian Patents Act, despite finding the claims to be novel and inventive. However, the 2015 order relied heavily on the interpretation given by Indian Supreme Court in Novartis vs. GOI, CA No.2706-2726/2013 para 180-192, that the term “efficacy” in section 3(d) meant “therapeutic efficacy”. The Controller also stated in his order that Gilead showed only “cytotoxicity data to prove the difference in properties which is insufficient to prove significant increase in the therapeutic efficacy. The data does not show any clinical trials to prove the improvement in the therapeutic efficacy”.  The Controller also distinguished any relevance this application had with Roche vs. Cipla stating, “The Judgement of Honourable Delhi Court in case of Roche vs. Cipla does not apply on this case as Erlotinib and Gefitinib were different in groups by substitution of a methyl groups with ethnyl group at the third meta position whereas in the present case the difference lies only in the orientation of fluoro group of compound XI of D1.  Finally, by rejecting the application, the Controller avoided initiating any pre-grant opposition.  As a result, Gilead challenged the 2015 order before the Delhi High Court, which remanded the matter to the IPO.  A new Controller was assigned the task of reinitiating the proceedings.  In February 2016, the IPO began hearing the oppositions in an inter parte manner amidst demonstrations by activists and non-government organizations (NGOs) supporting patient rights and access to medicine.

The key arguments presented by the pre-grant opponents were: (a) lack of novelty, (b) lack of inventive step and (c) non-patentability in view of section 3(d). Considering the arguments of all the parties, the Controller in a very detailed technical analysis, held that the invention involved both novelty as well as inventive step and overcame the patentability barrier set by section 3(d).  Specifically, he observed that with respect to novelty, the prior art neither exemplified nor provided an enabling disclosure with respect to the claimed compound. Therefore, an arbitrary selection without the use of hindsight was impossible.  As a result, he held that the claimed compounds were not anticipated by the cited prior art.

Regarding inventive step, the Controller agreed with Gilead that the cited prior art documents failed to provide a clear teaching for a person skilled in the art to arrive at a substitution pattern as recited in the claims.  Moreover, the extent of unpredictability in the synthesis of the nucleoside compounds of this class was well established by the cited prior art documents. Therefore, a skilled person aware of the complexity of the structure activity relationship involving the anti-HCV activity of ribonucleosides and the unpredictability of arriving at the desired result by specific substitution, would simply not be motivated to arrive at the claimed invention in view of the teaching of the prior art. In fact, it was noted that, substantial experimentation would be required to obtain the claimed invention.

With regard to unpatentability under section 3(d), the Controller held that it was difficult to accept that claimed compounds were derivatives of known compounds when such compounds having anti-HCV activity were simply not exemplified in any of the cited prior art documents.  Specifically, the Controller noted that the claimed compounds were not polymorphs, isomers, salts, etc. of a known compound.   Moreover, relying on the decision of the Delhi High Court in the Roche vs. Cipla (2015), the Controller held that the claimed invention exhibited an added layer of enhanced efficacy as the specification provided comparative activity and toxicity data in mice and monkeys.  Moreover, further comparative activity data had been filed during examination. Additionally, the Controller observed that medicine prepared from the claimed compounds has resulted in a breakthrough treatment of HCV infection and the medicine is approved in many countries including United States of America and India. Thus, the claimed invention was found to be outside the prohibition under section 3(d) rejection.

However, this case is far from over.  On May 13, 2016, I-MAK and DNP filed an appeal with the Delhi High Court on the grounds that the decision of the Indian Patent Office is contrary to the public interest, fails to assess the full scientific and legal evidence presented and ignores key Indian patent law and judicial precedent.  Please watch the BRIC Wall Blog for further updates on this appeal.

This post was written by Lisa Mueller of Michael Best.

 

The Turkish Intellectual Property Court Rules on the Patentability of Genes and Other Nucleic Acid Sequences

Background

Familial Mediterranean fever (FMF) is an inherited condition resulting from mutations in the FMF gene and is characterized by recurring episodes of painful inflammation in the abdomen, chest and/or joints. These episodes are often accompanied by fever and sometimes a rash or headache. The FMF gene provides instructions for making a protein called pyrin (also known as marenostrin), which is found in white blood cells.

A Turkish patent issued on October 22, 2007, claiming an isolated gene sequence encoding FMF, nucleic acid probes specific for the normal or mutated FMF gene and a method of detecting the presence or absence of mutations related to FMF an isolated gene.

An invalidity action was instituted against the patent in the Istanbul 1st Court of Intellectual Property (Court).  Specifically, the third party filer requested invalidity of all of the issued claims.  The Court appointed a panel of three experts (a first panel of experts) to assist in evaluating the patentability of the claims.  In invalidity proceedings in Turkey, a panel of experts is hired to assist in evaluating the technical aspects of a patent and to conduct an assessment on novelty and inventive step in light of the documents submitted by the party requesting invalidity.  Interestingly, in this proceeding, because the Court was not satisfied with the first panel, a second panel was hired to replace the first panel.

Ultimately, the Court held the Turkish Patent partially invalid. Specifically, the Court held that claims directed to an isolated gene sequence were invalid and claims covering the probe specific for the normal or mutated FMF gene and the primers for amplification were valid.  The decision can be appealed to the Supreme Court of Turkey by one or both of the parties.  The Supreme Court may maintain or reverse the decision of the Court.  If reversed, the Court can issue a new decision or insist that the original decision be maintained.  If the Court insists on maintaining the original decision, the case will be referred to the General Council of the Supreme Court which will issue a final decision.

Issues Discussed by the Court

The two main points addressed by the Court were (1) the patentability of isolated genes; and the (2) patentability of a method and probe for detecting nucleic acids under Turkish Patent Law.

Patentability of an isolated gene based under Turkish Patent Law

Interestingly, in this case, the Court and the panel of experts held conflicting views on the patentability of genes. Specifically, the Court held that an isolated gene was not patentable because it existed in nature and, as such, should be classified as a discovery. The Court referred to Decree Law No. 551, Article 6 (reproduced below), in support of its decision that discoveries are not patentable.  Additionally, because Turkey is a member of the World Trade Organization (WTO), the Court further held that under TRIPS, Article 27 (reproduced below) certain subject matter could be excluded from being “patentable” in Turkey.

Decree Law No. 551 on the Protection of Patent Rights, Article 6

Non-Patentable Subject Matter and Inventions

  1. The following, not being inventions by nature, shall remain outside the scope of this Decree-Law:
    (a) discoveries, scientific theories, mathematical methods;
    (b) plans, methods and rules for performing mental acts, conducting business activities and playing games;
    (c) literary and artistic works, scientific works, creations having aesthetic characteristics, computer programs;
    (d) methods of collecting, arranging, presenting and transmitting information that have no technical features;
    (e) methods of diagnosis, therapy and surgery applicable to the human or animal body.
    The provisions in subparagraph (e) of the first paragraph of this Article shall not apply either to the actual products and compositions used in connection with the said methods or to the manufacturing process thereof.

    Patents shall not be granted for inventions relating to the following:
    (a) subject matter contrary to public policy or generally accepted standards of morality;(b) plant and animal varieties or processes for breeding plant or animal varieties that are based mainly on biological factors.

    The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Article 27

    Patentable Subject Matter

  1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.  Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
  2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
  3. Members may also exclude from patentability:
    (a)    diagnostic, therapeutic and surgical methods for the treatment of humans or animals;(b)    plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

The first panel concluded that the invention was merely a discovery and, as a result, not patentable.  In their written opinion to the Court, the second panel disagreed and concluded that biotechnological inventions were patentable.  Specifically, the second panel stated that there was nothing in Decree Law No. 551 on the Protection of Patent Rights, Article 6 (see above), regarding the patentability of methods of treatment, second medical use and biotechnological inventions.  Moreover, the panel noted that Turkey was a member of the Budapest Treaty for Patents in Microbiological Inventions.  Additionally, the panel referred to Decree Law No. 551, Article 46 (reproduced below) to demonstrate that microorganisms and microbiological processes were recognized under Turkish law as patentable inventions. For these reasons, the panel argued that Turkish Patent Law allowed patent protection for elements existing in nature.

Decree Law No. 551 on the Protection of Patent Rights, Article 6 (Reproduced below)

Explicitness of the Description

  1. The description shall be written in sufficiently explicit and comprehensive terms for a person skilled in the technical field concerned to carry out the invention.
    Where the invention relates to a microbiological process and the related microorganism is not accessible to interested parties, the description shall be deemed to meet the requirements specified in the first paragraph of this Article if the following conditions are fulfilled:
    (a) the description contains information regarding the characteristics of the microorganism;
    (b) the applicant has deposited, no later than on the filing date of the application, a culture of the microorganism with an authorized institution established in accordance with international conventions.
    The said institution shall be mentioned in the publication provided for in the second paragraph of Article 55.

The panel cited Directive 98/44/EC (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of biotechnological inventions, reproduced below) and argued that genes isolated using novel and technical processes were patentable (Note:  Turkey is not a member of the European Union (It is a candidate country).  As a result, this directive is not applicable in Turkey.).  Additionally, in the panel’s opinion, a gene isolated from its natural environment for the first time and having a technical effect might be patentable, even if identical to a gene existing in nature.  Therefore, according to the panel, biotechnological inventions are patentable.

Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of biotechnological inventions, Article 5

Article 5

  1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
  2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
  3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

The Court invited the second panel to be heard in the hearing.  During the hearing, two of the experts changed their written opinion and stated that gene sequences should be accepted as a discovery.  As a result, despite the favorable written opinion of the panel, the Court held that a gene sequence is not patentable.

Patentability of a method and probe for detecting nucleic acids

The Court held that probes and methods for detecting nucleic acids were patentable.  Specifically, the Court‘s reasoning was as follows. A probe can only be produced when a mutated gene sequence is known. It is not possible to identify or detect a mutated gene with any probe production processes without knowing the gene sequence. Therefore, the novelty of a probe does not depend on its technique of production but on the sequence of the mutated gene. Since a mutated gene sequence is unique, the probe is patentable, even though probes are simply the chemical copy of the mutated gene and a molecule. As a result, the Court held that the claimed probe and method for detecting nucleic acids claimed in the patent were novel and met the requirement of inventive step.

Conclusion

As mentioned previously, the Court held the Turkish Patent invalid.  This decision can be appealed to the Supreme Court.

A new draft Turkish IP Code has been published and is expected to be enacted in the very near future.  According to the draft, gene sequences are not patentable if the discovery of such sequences is simply the result of a “simply discovery”.  In other words, new gene sequences that are not isolated through novel and inventive methods will not be patentable in Turkey.

Please continue to watch the BRIC Wall Blog for updates on this important case and the expected changes in the Turkish IP Code.

This post was written by Lisa Mueller and Himani Nadgauda of Michael Best & Friedrich LLP, and Okan Can and Muazzez Koruturk of Deris Attorneys at Law Partnership.

 

Current State of Data Protection and Exclusivity in Russia

The BRIC Wall Blog is pleased to present the following guest post by Ivan Burkov, Ph.D.

It has been 3.5 years since Russia joined the World Trade Organization (WTO) and implemented the right of data exclusivity for innovative pharmaceutical products. In this short period of time, the definition of data exclusivity has changed and precedent setting litigation has ensued. In this post, I attempt to delineate the most important events to date regarding data exclusivity in Russia and evaluate its protective potential.

Background

Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) specifies that the members of the WTO shall take the necessary steps to ensure the protection of undisclosed proprietary data submitted to obtain the registration of a pharmaceutical product, the origination of which involved considerable effort.

Upon accession to the WTO, Russia documented its agreement to ensure the protection of undisclosed information and test data in paragraph 2 of the Protocol of Accession of the Russian Federation to the WTO. The right of data exclusivity became effective on August 22, 2012, the official date of Russian Federation accession to the WTO. The concept was later introduced into the article 18 of Federal law № 61-FZ “On the Turnover of Medicines”, a central law for pharmaceutical industry in Russia. According to this new law, data exclusivity was defined as follows:

Receipt, disclosure and use for commercial purposes and for the purposes of medicine state registration of the information of the results of preclinical and clinical studies provided by an applicant for the registration of the medicine is not permitted without the applicant’s consent during 6 years from the date of the medicine state registration.

Concept evolution 

The original definition of data exclusivity did not specify the type of protected medicine (whether the medicine had to be an original/first-ever registered medicine or something else) or how the term was to be split between registration (data) exclusivity and market exclusivity. Since implementation of data exclusivity in 2012, the concept has been actively discussed by the industry players, law firms and other interested parties, and most stakeholders agree that data exclusivity protection alters Russian market attractiveness in the eyes of innovative medicines producers. However, no specific court cases had been instituted and it was not known whether any company had successfully used the right of data exclusivity to protect its product(s) from generic competition (as information regarding extrajudicial dispute resolution procedures was not publically available).

On December 22, 2014, the Russian president signed Federal law № 429-FZ, which introduced certain amendments to the Federal law № 61-FZ “On Circulation of Medicines”. One of the amendments (the effective date of which is January 1, 2016) affects data exclusivity. As a result, beginning January 1, 2016, data exclusivity will be defined as follows:

It is not permitted to use for the commercial purposes the results of pre-clinical trials of medicinal products and clinical trials of medicines, provided by the applicant for state registration of the medicine without his consent for the period of six years from the date of state registration of the reference medicine in the Russian Federation.

Compared to the original definition, the new definition limits the opportunities in which pre-clinical and clinical trial data are eligible for protection. Specifically, their use is prohibited for commercial purposes only. Additionally, data exclusivity is now granted to reference medicines, where a reference medicine is defined as:

 …a medicine which previously has never been registered in Russia, whose quality, efficacy and safety have been confirmed by the results of pre-clinical and clinical trials and which is used for the assessment of bioequivalence or therapeutic equivalence, quality, efficacy and safety of a generic (biosimilar) medicine.

The amendments also specify a division of the six year term between registration* (what is often referred to as “data” exclusivity in other jurisdictions) and market exclusivity: four (registration exclusivity) plus two (market exclusivity) years for generic drugs and three (registration exclusivity) plus three (market exclusivity) years for biosimilars.

* Registration exclusivity is determined from the date of registration of a reference medicine and prohibits a generic/biosimilar applicant from using the protected data of the originator for the purpose of seeking a state registration.

Russian company fights off Novartis in data exclusivity dispute

Early in 2015, Russia saw its very first court case involving data exclusivity. Specifically, Novartis Pharma AG (Novartis) claimed that local company Biointegrator LLC (Biointegrator) violated the prohibition against using Novartis’ preclinical and clinical data during state registration of its product “Nescler”, a generic version of Novartis’ fingolimod (sold under the brand name Gilenya®). Gilenya® is approved for the treatment of relapsing-remitting forms of multiple sclerosis in adults. In the suit, Novartis asked the court to cancel Biointegrator’s state registration.

Instead of focusing on the data exclusivity issue itself, the semantic vector of the case shifted towards determining the actual timing of the submission of the generic dossier. Biointegrator argued that cancellation of the registration was not appropriate because the application for state registration of “Nescler” had been submitted by another company (on April 2, 2012) prior to the date of implementation of data exclusivity provisions (August 22, 2012). Subsequent to these events, ownership rights were transferred from the other company to Biointegrator pursuant to a commercial agreement. In view of these facts, the court of first instance agreed with Biointegrator and rejected Novartis’ request for cancellation.

Undeterred, Novartis appealed. The appeal court held that an application for registration of a generic product submitted by another company did not exempt Biointegrator from liability since the generic company’s abbreviated clinical development (bioequivalence studies) relied on Novartis’ protected data and was initiated after the implementation of the data exclusivity provisions. As a result, the court agreed with Novartis’ arguments and canceled the marketing authorization of the generic product.

Unhappy with the appeal court’s decision, Biointegrator appealed to the court on intellectual rights (Intellectual Rights Court), which ruled for Biointegrator and restored the decision of the first instance court, allowing the generic product to return to the market. The arguments of the Intellectual Rights Court in holding for Biointegrator were as follows.

First, both parties agreed that Biointegrator was liable to follow the corresponding provisions of the Federal law, since the state registration application for “Nescler” was submitted after the date when the provisions for data exclusivity concept became effective. Nonetheless, the panel of judges did not agree with the appeal court that Biointegrator had used Novartis’ protected data, holding that the decision was made in violation of substantive norms. Specifically, the Intellectual Rights Court held that the appeal court incorrectly concluded that the right of data exclusivity covered any information relating to the preclinical and clinical trials of the original medicine. More specifically, according to the Intellectual Rights Court, the Federal law “On Circulation of Medicines” provides for a fast-track registration procedure for generic medicines. It requires that information on the clinical trials of an original medicine be published in specialized sources (namely, scientific journals, etc.) and that documented results of a generic’s bioequivalence/therapeutic equivalence studies be provided. Moreover, the court stated that the “…systematic interpretation of the provisions on data exclusivity suggests that the specified prohibition does not apply to publically available information, including scientific publications, and legislator recognizes the use of such information legitimate”.

The Intellectual Rights Court determined that the effectiveness of the generic product in the treatment of multiple sclerosis was based on information contained in previously published articles describing the results of clinical trials involving Gilenya® (specifically, the articles entitled “A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis” and “Oral Fingolimod or Intramuscular Interferon for Relapsing Multiple Sclerosis”). At the same time, the definition of data exclusivity under the Federal law “On Circulation of Medicines” prohibited the use of the “results of pre-clinical trials of medicinal products and clinical trials of medicines, provided by the applicant for state registration of the medicine. Unfortunately, Novartis was unable to prove that Biointegrator used undisclosed data from Gilenya®’s registration dossier, which led to the unfavorable decision by the Intellectual Rights Court.

Impact on the industry 

Data exclusivity and intellectual property protection in general are essential for the pharmaceutical industry, where extremely large sums of money are invested in developing highly risky health care solutions. At the same time, maintaining the transparency of clinical trial data is of great significance and is expected by patients, healthcare providers, companies and health authorities around the world. For example, the European Medicines Agency (EMA) bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. Since January 1, 2015, the EMA has been proactive publishing clinical reports submitted as part of marketing-authorization applications for human medicines.

The Novartis case demonstrates that Russian authorities treat the right of data exclusivity only in connection with undisclosed, non-public information of the results of preclinical and clinical trials of an original medicine. Thus far, a very limited number of original medicines have undergone their first-ever clinical development in Russia. Rather, in most of the cases, information on the clinical trials for a medicine is already publically available from a number of sources at the time the originator seeks local registration in Russia. Therefore, the Novartis case may open the way for generic companies to bypass the legal right of originators to protect its data.

Although the Novartis case has its own unique set of facts and stare decisis is not officially practiced in Russia, innovative companies should take note of this case and its implications as an additional risk for their original products in the Russian market. At the end of the day and in the long term, the lack of intellectual property protection in Russia may affect generic producers themselves, as the attractiveness of a market which does not guarantee sufficient protection for innovators will decrease.

This post was edited by Lisa Mueller.

This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances. The opinions expressed herein are those of the author. Comments or questions on this article can be addressed to the author (vanyaburkov@gmail.com) or Lisa Mueller (llmueller@michaelbest.com).

Biologics and Biosimilars Bits and Bytes – December 10, 2015

Amgen files for first European Approval of a Biosimilar to Humira®

On December 4, 2015, Amgen Inc. (Amgen) announced the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for ABP 501, a biosimilar version of AbbVie Inc.’s (AbbVie) Humira® (adalimumab). According to Amgen, its MAA submission included analytical, clinical and pharmacokinetic data. Amgen conducted Phase 3 comparative efficacy and safety studies in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. Amgen indicated that its Phase 3 studies met their primary endpoints showing clinical equivalence to Humira®. The safety and immunogenicity of ABP 501 was also comparable to Humira®. Additionally, data to support the transition of Humira® patients to ABP 501 was also included in the filing.

This MAA filing follows Amgen’s November 25, 2015 filing of a 351(k) application with the U.S. Food and Drug Administration (FDA) for ABP 501.

Coherus Files Two New IPR Petitions against AbbVie’s Patents Covering Humira®

On December 7, 2015, Coherus Biosciences Inc. (Coherus) filed two new IPR petitions, IPR2016-00188 and IPR2016-00189, against AbbVie’s U.S. Patent Nos. 9,017,680 and 9,073,987 covering Humira®. These filings come almost a month after the November 9th filing by Coherus of IPR petition, IPR2016-00172, against another AbbVie patent covering Humira®, U.S. Patent No. 8,889,135. Coherus’ three IPR petitions can be found here: 1. IPR201600188 2. IPR201600189 3. IPR201600172. This brings the total number of IPR petitions filed against AbbVie patents covering Humira® to five. Earlier this year, on June 26, 2015 Amgen filed IPR petitions, IPR2015-01514 and IPR2015-01517 against two other AbbVie patents, U.S. Patent Nos. 8,916,157 and 8,916,158.

Infliximab Biosimilar Approved in Korea

On December 4, 2015, Samsung Bioepis Co., Ltd., (Samsung Bioepis) announced that Korea’s Ministry of Food and Drug Safety (MFDS) approved Renflexis®, a biosimilar version of Remicade® (infliximab), also known as SB2. Renflexis® was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This is the second biosimilar approved in Korea for Samsung Bioepsis, a joint venture between Biogen and Samsung Biologics. The first approval was in September 2015 for Brenzys®, a biosimilar version of Enbrel® (etanercept), also known as SB4.

In February 2013, Samsung Bioepis and Merck & Co. (Merck) announced a development and commercialization agreement under which Merck would commercialize multiple pre-specified and undisclosed biosimilar products in certain partnered territories. Under terms of the agreement, Samsung Bioepis was responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Merck was responsible for commercialization. As a result, Merck will commercialize Renflexis® in South Korea and plans to launch in the first half of 2016.

This post was written by Lisa Mueller.

 

Indian Patent Office Rejects Pfizer’s Patent for Tofacitinib – Again!

Background

Pfizer Products, Inc. (Pfizer) filed Indian patent application 991/MUMNP/2003 (‘991 application) entitled “Chiral Salt Resolution” in the Indian Patent Office (IPO) on October 27, 2003. The ‘991 application is a national phase application of WO 02/096909 (PCT/IB02/01905) filed on May 29, 2002. WO 02/096909 claims priority to U.S. application no. 60/294,775 filed on May 31, 2001 and U.S. application no. 60/341,048 filed on December 6, 2001.

The ‘991 application describes methods for effecting chiral salt resolution from racemic mixtures of enantiomers, particularly precursor enantiomers, for use in making pyrrolo[2,3-d]pyrimidine compounds. The pyrrolo[2,3-d]pyrimidine compounds are inhibitors of protein kinases, such as the enzyme Janus Kinase 3 (JAK3). The specification describes the enantiomer, 3-{(3R,4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile, also known as tofacitinib.   Tofacitinib, which is sold as XELJANZ®, is approved for use in the treatment of rheumatoid arthritis.

The closest prior art, WO 01/42246 (D1), also owned by Pfizer, was filed on November 23, 2000 and published on June 14, 2001. D1 claims priority to U.S. application no. 60/170,179 filed on December 10, 1999. D1 relates to pyrrolo[2,3-d]pyrimidine compounds (which are inhibitors of protein kinases, such as JAK3) and the use of these compounds in the treatment of various diseases, such as lupus, multiple sclerosis, rheumatoid arthritis, etc. Example 14 of D1 discloses 3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1yl}-3-oxo-propionitrile, the racemate of the enantiomer claimed in claim 1 of the ‘991 application. Additionally, D1 discloses all conformational isomers (e g., cis and trans isomers). Although D1 does not disclose any specific enantiomers, it teaches that compounds have asymmetric centers and thus exist in different enantiomeric and diastereomeric forms. Specifically, the specification states, “This invention relates to the use of all optical isomers and stereoisomers of the compounds of the present invention, and mixtures thereof, and to all pharmaceutical compositions and methods of treatment that may employ or contain them. In this regard, the invention includes both the E and Z configurations. The compounds of formula I may also exist as tautomers.”

Although D1 published after the earliest claimed priority date of the ‘991 application (May 31, 2001), it claimed an earlier priority date (December 10, 1999). D1 was also filed in India and granted as Indian Patent No. IN 241773.

A first examination report was issued in the ‘991 application on March 13, 2008. Pfizer filed a reply and amended claims on January 27, 2009. The Examiner issued a hearing letter ordering the Applicant to attend a hearing on January 22, 2015. During the hearing, the Examiner raised a new objection that the claims were unpatentable under Section 3(d) of the India Patents Act 1970, as amended (Patent Act). Ultimately, the application was rejected. Pfizer appealed and on October 31, 2014, the Intellectual Property Appellate Board (IPAB) set aside the order and directed the IPO to reconsider the application.

On February 3, 2015, Pfizer submitted an amended claim set amending claim 1 as recited below and canceling the remaining claim (claim 2).

Amended claim 1:

  1. The compound 3-{(3R,4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1yl}-3-oxo-propionitrile or a pharmaceutically acceptable salt thereof. 

In addition, Pfizer submitted copies of declarations of Dr. James D. Clark and Dr. Mark Edward Flanagan.

A hearing was held on January 22, 2015. The issues discussed were: (1) lack of novelty of claim 1 in view of D1; and (2) the unpatentability of claim 1 under Section 3(d) of the Patent Act.

During the hearing, Pfizer argued that D1 was not prior art and hence not novelty destroying because it was published after the priority date of the ‘991 application. With respect to the rejection of the claim under Section 3(d), Pfizer argued that this section was not applicable to the ‘991 application. Specifically, Pfizer argued that Section 3(d) applied to salts and isomers of a known substance. Although the rejected application was directed to an isomer, there was no known substance known to the public through a prior publication. Although D1 was filed earlier, it was not prior art. Therefore, because the compound of example 14 was a published after the priority date of the ‘991 application, it could not be considered a “known substance” for purposes of Section 3(d).

September 3, 2015 Decision by the Assistant Controller of Patents and Designs (Assistant Controller)

Regarding the novelty rejection, the Assistant Controller rejected Pfizer’s argument that D1 was not prior art. Specifically, the Assistant Controller referred to Section 13(1)(b) which refers to “anticipation by prior claiming” and states that “the invention is claimed in any claim of any other complete specification published on or after the date of filing of the applicant’s complete specification, being a specification filed in pursuance of an application for a patent made in India and date before or claiming the priority date earlier than that date”. The Assistant Controller noted that for the purpose of determining novelty, an application for a patent filed in the Indian Patent Office before the filing date of a complete specification of a later filed application but published later, is prior art for the purposes of “prior claiming”.

The Assistant Controller also noted that Pfizer was the applicant for both the ‘991 application and D1. Moreover, the Assistant Controller did not find any “distinctive” difference between the claimed compound and the compound disclosed in D1, noting that the compound claimed in the ‘991 was the enantiomer of the compound disclosed in D1. Additionally, the Assistant Controller stated that Pfizer failed to furnish comparative data distinguishing the features of the claimed compound over D1 (which was a similar compound). Instead, Pfizer provided comparative data of the four enantiomeric forms of the compound disclosed in D1 and published in 2008 in the Journal of Medicinal Chemistry (Journal), which, according to the Assistant Controller, was irrelevant.

Regarding the rejection under Article 3(d), the Assistant Controller referred to the decision in Novartis AG v/s Union of India (Civil Appeal Nos. 2706-2716 of 2013) which held that an applicant must establish the therapeutic enhanced efficacy of the claimed compound over a base compound. According to the Assistant Controller, Pfizer failed to provide experimental data demonstrating that 3-{(3R,4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1yl}-3-oxo-propionitrile exhibited enhanced efficacy over the compound in D1 (namely, 3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1yl}-3-oxo-propionitrile). Instead, Pfizer submitted experimental data comparing the efficacy of the claimed compound with three other possible enantiomers disclosed in the Journal. No where did the Journal provide data demonstrating enhanced efficacy of the claimed compound with the compound disclosed in D1. Specifically, the Assistant Controller stated, “[T]he applicant is supposed to establish the enhancement of therapeutic efficacy of the specifically claimed form over D1 by substantive research data. They failed to provide such findings.”

The Assistant Controller concluded:

From the present amended claim 1, it can be concluded that the compound claimed in claim 1 is the enantiomer of compound of the cited document 1 and hence not novel and inventive as stated above. However, in absence of disclosure of any test result and comparative data over the base compound 3-{4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1yl}-3-oxo-propionitrile (compound in D1), I do not admit that the claimed compound has enhanced efficacy over the base compound in D1 and hence not patentable under Section 3(d) of Patents Act. The applicant’s contention that D1 can’t be the document to assess the patentability aspect of the invention claimed, since not known only to the public is not acknowledged.

After having considered the submissions submitted by the applicant in the hearing, the written submission and amended claims filed, in view of the above discussions and findings by me, it is hereby ordered that the invention disclosed and claimed in the instant application i.e., ‘3-{(3R,4R)-4-Methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1yl}-3-oxo-propionitrile or a pharmaceutically acceptable salt thereof’ (amended claim 1 submitted on 30/01/2015) is not considered as an invention under the provisions of the Act as discussed above and I therefore, hereby refuse this Application No. 991/MUMNP/2003 to proceed further.

This post was written by Lisa Mueller and Nidhi Anand of Chadha & Chadha