Data Exclusivity in Russia – One Year Later

On August 23, 2012, a six year regulatory data protection (RDP) came into effect in Russia coinciding with Russia’s accession to the World Trade Organization. The law regarding RDP can be found in Article 18.6 of the “Law on Circulation of Medicines.” The wording of Article 18.6 is somewhat awkward as shown in the below English translation which states:

“It is not permitted receipt, disclosure and use for commercial
purposes and for the purposes of state registration of medicines of the
information on the results of preclinical studies of medicines and
clinical studies of medicines provided by an applicant for registration
of a medicine without his agreement for 6 years from the date of state
registration of the medicine.

Non-observance of this prohibition established by this part will entail
liability in accordance with the legislation of the Russian Federation.

It is prohibited circulation of the medicines on the territory of the
Russian Federation that were registered in violation of this part.”

Although almost a year has passed since the RDP provision came into effect, it is too early to draw any conclusions as to whether or not RDP really works. Although it appears that during the last year no generic company has received marketing authorization during the six-year RDP period, a number of concerns still exist regarding the enforceability of Article 18.6.

A strong and enforceable RDP system must provide the following:

1. The RDP must be applied in connection with the granting of a marketing authorization for a generic medicine;

2. The RDP must provide for a ban on the granting of a marketing authorization for a generic medicine whose dossier contains reference to preclinical and clinical studies of an innovator medicine and the results of generic company’s bioequivalence studies; and

3. The RDP must be effective for six years from the date of the granting of the first marketing authorization of the innovator medicine.

Unfortunately, the current wording of Article 18.6 provides none of these requirements. Specifically, there is nothing in Article 18.6 that states that it applies with respect to generic drugs. Second, there is nothing in the Article that specifies that a ban on the granting of marketing authorization should be applied if a generic company’s dossier contains reference to the preclinical and clinical studies of the innovator medicine supported by the results of generic company’s bioequivalence studies. Finally, the Article simply does not specify that the six-year RDP period is effective as of the date of the granting of the first marketing authorization of the innovator medicine. In fact, it is unclear under the Article whether an innovator company would be the correct RDP holder.

The substantial loopholes in Article 18.6 will create serious problems for successful enforcement of RDP for an innovator company. Unless Article 18.6 is amended and/or the existing loopholes in the Ministry of Health’s administration regulations on granting marketing authorization are closed, there is a substantial risk that RDP may not be enforceable in Russia. Presently, we are not aware of any discussion regarding possible amendments to either Article 18.6 or the administration regulations. Therefore, innovator companies should be careful in relying on RDP in Russia when determining the date for loss of exclusivity for their branded medicines in Russia.

This post was written by Tatiana Lyu and Vladislav Ugryumov of Gowlings and Lisa Mueller.

Patent Term Extension in Russia

In Russia, a patent issuing on an invention has a term of 20 years from its filing date. However, the term of a patent relating to a medicine, pesticide or agrochemical substance requiring a market authorization from the Ministry of Health (MOH) may be extended if such approval is delayed for a period of more than five years from the filing date of the application. The maximum amount of extension available is five years (which is granted if approval is delayed for more than 10 years from the filing date of the application).

Medicine, pesticide and agrochemical substances are defined in the Patent Term Extension (PTE) regulations and these definitions correspond to the definitions set forth in the laws “On Circulation of Medicines” and “On safe Circulation of Pesticides and Agrochemicals.” Specifically, these definitions are as follows:

1. Medicines – a substance or a combination thereof that comes into contact with a human or animal organism that penetrate into the organs and tissues of the human or animal organism and are used for the prophylaxis, diagnosis (except for a substance or the combination thereof which do not come into contact with a human or animal organism), treatment of disease, and rehabilitation for maintaining, preventing or terminating pregnancy and which are obtained from blood plasma, organs, tissues of a human or animal organism, plants, minerals or by synthetic methods using biological techniques. Thus, pharmaceutical substances and drugs are considered to be medicines.

2. Pesticides – chemical or biological substances used to control pests and plant diseases, weeds, pests of stored agricultural products, household pests and external parasites of animals, as well as to regulate the growth of plants, the pre-harvest removal of leaves (defoliants) and the pre-harvest drying of plants (desiccants).

3. Agrochemicals – fertilizers, chemical ameliorants and feed additives intended for plant nutrition, regulation of soil fertility and the feeding of animals. This term does not apply to peat used for other purposes.

According to the PTE regulations, an invention relates to a medicine, pesticide or agrochemical if:

1. The claims characterize the invention as a compound or a group of compounds represented by a general structural formula and the specification discloses the possibility of using the compounds or group of compounds as an active ingredient of a medicine, pesticide or agrochemical; or

2. The claims characterize the invention as a medicine, pesticide or agrochemical composition.

There is no limitation on the number of patents for which a request for PTE can be filed provided that each of the patents for which such a request is filed contains at least one independent claim (and optionally, one or more corresponding dependent claims) that contain all features of the approved medicine, pesticide or agrochemical product. In practice, a PTE is granted for patents containing product claims (namely, to a compound or a group of compounds united by a general chemical structure; for example, Markush claims), pharmaceutical composition or formulation claims, EPC 2000 claims and “use”-type claims (such as Swiss and German type claims). For each patent to be extended, the period of extension is calculated from the filing date of the application until the date of receipt of the first market approval minus five years.

A patentee (or his patent attorney) must file a request for patent term extension prior to the expiration of the patent term and before the expiration of six months after receipt of the market approval or the date of the issuance of the patent, whichever occurs later. The MOH posts notices of approval on its website and will also mail a certificate of approval to the patentee or his representative. It is imperative that patentees closely monitor the website of the MOH for a notice of approval for a product pending approval. Specifically, there have been reports of delays between the date of issuance of the certificate of approval and receipt of the certificate by the patentee (Such delays are being reported even though under Russia’s regulations the MOH is required to issue the certificate of approval within five days of approval). In some instances, the patentee has received its certificate six months after receiving approval.

The following documents must be submitted when filing a request for PTE in the Russian Federal Service for Intellectual Property (ROSPATENT):

1. A notarized copy of the first market approval issued by the MOH;

2. A list of claims from each patent for which a PTE is sought which cover the medicine, pesticide or agrochemical;

3. Documents and patentee’s comments that prove that the chemical formulation of the medicine, pesticide or agrochemical for which the first market approval has been granted and the patented compound/composition are identical (There is no specified list of documents accepted by ROSPATENT in establishing such identity; however, examples of some documents that can be submitted include, a medicine pharmacopoeia, extracts from the registration dossier, the package insert, extracts from the Medical Guides such as the Merck Index, etc.); and

4. An original Power of Attorney signed by the patentee.

There is no obligation for the patentee to include the calculation for the PTE when filing the request as ROSPATENT is required to calculate the length of the extension itself. However, it is recommended that the patentee include the calculation when filing its PTE request in order to avoid errors from ROSPATENT in making the calculation.

If ROSPATENT denies a patentee’s application for PTE, a patentee can file a lawsuit against ROSPATENT within three months of the date of refusal of the PTE request. Such a lawsuit can be filed with the Russian Intellectual Property (IP) Court. In the event the IP Court also denies the application for PTE, its decision can be appealed at the Presidium of the IP Court and then to the Supreme Commercial Court

This post was written by Tatiana Lyu and Vladislav Ugryumov of Gowlings and Lisa Mueller.

Supplementary Protection Certificates and Pediatric Extensions in Croatia

On July 1, 2013, Croatia became the 28th member of the European Union (EU). With a view to its accession to the EU, Croatia amended its laws to provide for Supplementary Protection Certificates (SPCs) for medicinal (human and animal) and plant protection products as well as pediatric extensions.

The requirements for obtaining an SPC in Croatia are:

1. The medicinal or plant product must be protected by a “basic” patent that is still in force;

2. A valid marketing authorization has been granted in Croatia and is the first authorization to market the product as a medicinal or plant product in Croatia; and

3. The product has not already been the subject of a certificate in Croatia.

The length of an SPC is calculated from the filing date of the “basic” patent until the date of grant of the first marketing authorization in the EU, minus five years. The maximum duration of an SPC is five years.

A “basic” patent is any patent which, in the country where the SPC is applied for, protects an active ingredient (AI) forming the subject-matter of the marketing authorization and of the SPC. The patent may claim the AI as such. Alternatively, it may claim a formulation comprising the AI, a process for preparing the AI or the formulation, a medical or agrochemical use of the AI or of the formulation, etc. The “basic” patent to be used as the basis for an SPC can be designated by its holder; in other words, if a company owns more than one patent for a certain AI in Croatia, that company will be able to choose which of such patents to designate as the “basic” patent (provided that the grant date of such “basic” patent still allows for the filing of an SPC in Croatia).

An application for an SPC must be filed six months from the date of grant of the local marketing authorization or, if the marketing authorization has been granted before the grant of the “basic patent”, within six months from the date of the publication of the mention of grant of the patent. Additionally, there is a six month transition period that expires on January 1, 2014. During this transition period, the owner of a “basic” patent in Croatia can apply for an SPC provided that the relevant first marketing authorization was granted on or after January 1, 2003. Patent owners with patents in Croatia covering medicinal and plant products should review their products to see whether any marketing authorizations were received on or after January 1, 2003 which may allow for an SPC to be filed before the deadline of January 1, 2014.

An application for an SPC in Croatia should include the following information and enclosures:

1. Information on the requester and its representative;

2. The patent number of the “basic” patent and the title of the invention;

3. The number and date of the first authorization to place the product on the market in Croatia; and if the authorization in Croatia is not the first authorization to place the product on the market in the EU, the number and date of that authorization; and

4. Proof of payment of the prescribed fee.

Additionally, it is possible to apply for a pediatric extension of an SPC for an additional six months. A request for a pediatric extension can be filed simultaneously with an SPC application if the applicant has received notice of compliance with a pediatric investigation plan or up to two years before the expiration date of the SPC.

This post was written by Lisa Mueller and Micaela Modiano of Modiano & Partners

New Russian Intellectual Property Court is Open

We are very pleased to have a guest post from the Moscow office of the Gowlings law firm on the opening of the new Russian Intellectual Property Court.

The new Russian Intellectual Property (IP) Court has officially opened its doors and begun hearing cases. The opening of this court represents a significant milestone in the advancement of intellectual property protection in Russia.

On July 2, 2013, the Plenum of the Supreme Commercial Court of the Russian Federation approved the commencement of the new IP Court. The IP Court is located in the center of Moscow (Mashkova St., 13), near the Supreme Commercial Court.

The IP Court is part of the larger system of arbitrazh or commercial courts and will perform many functions including: (1) reviewing decisions made by ROSPATENT (the Russian Federal Service for Intellectual Property), including patent and trademark grant and revocation cases first tried by the Chamber for Patent Disputes, an administrative body within ROSPATENT; (2) determining issues of IP ownership and authorship; (3) determining the cancellation of trademark registrations for non-use (among other things); and (4) acting as a cassation (second appeal) court for IP infringement cases decided in commercial courts of first instance and first appeal courts.

The IP Court is headed by Lyudmila A. Novoselova, an ex-judge of the Supreme Commercial Court. Ms. Novoselova was an unusual choice, as she was previously a corporate law specialist. In addition to Judge Novoselova, the IP Court consists of 12 other judges, several of whom have some IP experience or a technical background.

The opening of this new specialized IP Court evidences the Russian Government’s commitment to IP protection and improved harmonization of its laws with those of other countries. In fact, over the last few years, Russia has been steadily fostering a more friendly and conducive environment for innovation and entrepreneurship. The creation of the IP Court follows the recent creation of the Skolkovo Foundation by former President Medvedev. The Skolkovo Foundation is the agency responsible for the Skolkovo Innovation Center, a giant government-funded technology and innovation hub that is located just outside of Moscow.

Finally, it is expected that the IP Court will play a significant role in helping to protect the IP rights of innovators and brand owners during the upcoming Sochi Olympics (the 22nd Winter Olympics) to be held in February 2014. Typically, at such events, there is a very significant need to enforce IP rights against ambush marketers, counterfeiters and parallel importers (although the right for parallel import is currently a hot topic in Russia). The new IP Court is expected to provide an efficient, reliable and transparent mechanism for combating any abuses of IP.

The BRIC Wall would like to thank Gowlings RUSSSIA/CIS for this guest post which was edited by Lisa Mueller.

International Survey of the Patentability of Genes, Proteins and Other Genetic Materials

On June 13, 2013, the United States Supreme Court issued its long-awaited decision in Association for Molecular Pathology v. Myriad Genetics, Inc.  In its decision, the Court held that cDNA was patent eligible but genomic DNA (and fragments including oligonucleotides) was not.  However, the decision should be noted not only for what it said, but also for what it did not say.  Specifically, the decision left many unanswered questions. For example, what about the patent eligibility of proteins and protein fragments?

We at the BRIC Wall thought to help put the Myriad case in context internationally, it would be helpful to conduct a survey comparing the patentability of genes, proteins and other genetic materials in a variety of countries.  The results of our efforts can be found at the following link (FINALVERSIONOFCHART2JULY5). The link will take you to a chart which examines the patentability of genes, proteins and other genetic material in 32 countries.

The collection of the information in this chart is truly the result of a great international collaboration.  The BRIC Wall would like to thank the following law firms for their contributions: Adams & Adams, AGIP KSA, Barreda Moller, Castellanos & CO., Central Intellectual Property & Law, Chadha & Chadha, China Sinda Intellectual Property, Clarke Modet & Co., Dannemann Siemsen, Dr. Shlomo Cohen & Co., Ferrere, Gowlings, Invenco, Kawaguti & Partners, Katzarov, Lee & Li, Modiano & Partners, Olivares & CIA, S.C., Noetinger & Armando, Quevedo & Ponce, Spruson & Ferguson and Tilleke & Gibbins.  Also, the BRIC Wall would like to thank our colleagues from Michael Best & Friedrich for their contributions to the chart:  Paul Jenny, Anthony Wenn and Sansun Yeh.