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AstraZeneca Challenges Osimertinib Registration in Russian Court

At the beginning of September, a major British-Swedish pharmaceutical group, AstraZeneca, made headlines by taking legal action in the Moscow Arbitration Court. They aim to dispute the Russian Ministry of Health’s decision regarding the approval of the oncology drug, Osimertinib, as submitted by Russian pharmaceutical firm Axelfarm.

Osimertinib is a substance invented by AstraZeneca and protected in Russia and Eurasian region by an Eurasian patent valid until 2032.

AstraZeneca considers the drug Osimertinib to be a reproduced pharmaceutical product (generic), meaning a drug with the same qualitative and quantitative composition of active ingredients as its pharmaceutical product Tagrisso, which is supplied to Russia.

The drug is indicated as a therapy for non-small cell lung cancer with EGFR gene mutations. According to data from the phase III ADAURA clinical trial, Osimertinib reduces the risk of recurrence or death by 80% when used as adjuvant therapy for the early stages of this type of cancer.

Axelfarm first submitted documents for the registration of Osimertinib in December 2020. In 2021, AstraZeneca claimed a violation of patent rights for Tagrisso. However, the company’s lawsuit remained unresolved. According to the court’s decision, the intention to register a generic cannot be considered a threat of patent rights infringement.

The preliminary hearing for this new case is scheduled for October 30th.

There were other legal precedents concerning Osimertinib, for example, in the USA AstraZeneca achieved favorable resolutions in its patent infringement litigations with Zydus Pharmaceuticals, Cadila Healthcare, MSN Laboratories, and MSN Pharmaceuticals in 2021 and with Alembic Pharmaceuticals in 2022.

In the meantime, AstraZeneca itself faced a different challenge concerning Tagrisso patents. This is because Puma Biotechnology and Pfizer’s Wyeth initiated their own lawsuit against AstraZeneca in 2022 for infringement of two US patents, the results of which are yet to be seen.

PLAYSTATION CALLS FOR FAIR PLAY

In 2023 Sony Interactive Entertainment Inc, the owner of PLAYSTATION trademarks, initiated multiple court cases against counterfeiters in the Russian Federation. The court recognized several cases of infringement of IP rights and awarded monetary compensation for sales of fake PLAYSTATION game consoles on popular marketplaces. Despite the currently limited presence in the market, many companies such as SONY continue to carefully monitor and combat illegal trademark use.

The Commercial Court Registry shows 27 cases initiated by Sony Interactive Entertainment Inc. in 2023 against various individuals in different regions of the country including 12 last August. That is a remarkable increase comparing to one case filed by Sony during the entire year of 2022. Some of the cases have already been decided in favor of Sony Interactive Entertainment satisfying the claims in full or partially. Some cases are based on trademark infringement while the decisions refer to illegal sale of PLAYSTATION gamepads on the widely used online platform Wildberries. Rapidly raising popularity of online retail platforms brings more counterfeit opportunities, so the marketplaces take actions to prevent and fight infringement. Wildberries, for example, introduced their own tool called digital arbitration.

Regarding Sony’s increase in court activity in comparison to the years preceding 2022, the reason could be legalization of parallel import which allowed third parties to import the goods labelled by brands that had left the Russian market. Although parallel import allows only genuine goods, once the borders have been opened for third party importers, the higher percentage of fake products calls for increased attention from the right holders.

Among other companies actively combatting IP rights infringement is Robert Bosch GmbH that has already filed 163 cases in 2023 and Harman International Industries Incorporated – the Samsung-owned company, holder of JBL trademarks – which is a Plaintiff in more than 430 court cases in Russia this year.

These numbers show that despite the unstable environment and suspension of activity many manufacturers and trademark holders find it important to keep the counterfeit level as low as possible and continue to carefully sustain their reputation for consumers.

Harman’s JBL speakers designs protection: to be continued

If one asks for a list of companies that protect its rights abroad to the fullest, we would definitely recall Harman International Industries (hereinafter – Harman) producing electronic audio devices. This American company owned by Samsung Corporation is widely known for such brands as JBL and AKG. Over the last two years, Harman has been especially active in struggling against infringement of its intellectual property. For instance, Harman has filed more than a 1000 lawsuits with the Russian commercial courts. This overview contains key information about the latest legal proceedings initiated by Harman.

Remarkably, Harman keeps fighting not only for its trademark rights. In addition, this company is constantly monitoring the cases of illegal imitation or copying its industrial designs. Therefore, Harman approaches courts with various claims: to destroy the revealed counterfeit goods, to terminate the illegal use of patents, to pay compensation for trademark rights infringement, etc. The vast majority of these lawsuits were satisfied. Moreover, a substantial part of the cases was considered via simplified procedure without parties’ participation and series of hearings.

One more legal proceeding is about to be held. In October 2023 the Commercial Court of Moscow will start litigation between Harman and one of the leading consumer electronics retailers in Russia M.Video-Eldorado Group (hereinafter – M.Video) on the case no. А40-147100/2023. Harman accuses M.Video of violating its exclusive rights for design of portable wireless speakers and requests compensation. With no doubt, opposing such solid market participant as M.Video will be complicated and durable.

The current court cases demonstrate that many foreign companies don’t tend to weaken their grip over brands, patents and other incorporeal property in the Russian jurisdiction.

Eurasian patent for technology for the production of immunoglobulin for the treatment of COVID-19

The global easing of the regime of preventive measures against coronavirus infection after almost two years of the pandemic does not yet guarantee a regime of absolute calm. The COVID-19 virus and its evolving strains remain, although already familiar, still a significant threat.

Against this background, Russian scientists continue to protect with patents new methods for obtaining components of possible drugs for the prevention and treatment of coronavirus infection, improving both their effectiveness and reducing the cost of obtaining such components.
A new method for producing immunoglobulin G, for which Eurasian patent No. 044535 was issued in August, was developed by the National Immunobiological Company.
The process of obtaining a patented component includes the selection of donor plasma, alcohol fractionation of plasma to obtain precipitate II+III according to Cohn, dissolution of the resulting precipitate II+III in a buffer solution, viral solvent-detergent inactivation and chromatographic purification.
It was the use of blood components containing antibodies to SARS-CoV-2 that became one of the first solutions that doctors around the world proposed for the prevention and control of COVID-19. Over the long months of the pandemic, the proposed method has repeatedly proven its effectiveness, which also depended on the receipt of the starting components.
The method of Russian scientists, protected by a Eurasian patent, uses a simpler and more routine analytical method for collecting plasma samples – enzyme-linked immunosorbent assay (ELISA), which allows testing a large number of plasma samples in a short time.
The drug obtained according to the technology has a higher degree of viral safety compared to analogues and contains 6-22 times more diverse antibodies than the original plasma, which provides a wider range of antiviral activity and makes drugs based on immunoglobulin G much more effective.

The UK government’s code of practice on copyright and AI

Sir Patrick Vallance, the Government Chief Scientific Adviser, completed a review with proposals on pro-innovation regulation for digital technologies. In a response published on 15 March 2023, the Government acknowledged the urgent need to regulate the relationship between intellectual property and generative AI. The government is now working with users and rights holders on a code of practice on copyright and AI. The code of practice aims to make licences for data mining more available. It will help to overcome barriers that AI firms and users currently face, and ensure there are protections for rights holders. This ensures that the UK copyright framework promotes and rewards investment in creativity. It also supports the ambition for the UK to be a world leader in research and AI innovation.
The Intellectual Property Office invited industry representatives from the technology, creative and research sectors to form a working group. These sectors will help to ensure a balanced and pragmatic code of practice. It will enable both the AI and creative sectors to grow in partnership.
Working group meetings commenced on 5 June 2023. The government expects parties to enter into the final code of practice on a voluntary basis. If the code of practice is not adopted or agreement is not reached, legislation could be considered.

IP Court ruled to issue supplemental patent for RYALTRIS® nasal spray despite Rospatent refusal

In a recent decision of June 6, 2023, the IP Court overturned the Rospatent Refusal to extend the term of patent RU2687551 for RYALTRIS® nasal spray in the territory of the Russian Federation

The decision of Rospatent of July 21, 2022 to refuse extension of the patent term has been based on the conclusion that the set of claims proposed for the supplemental patent does not characterize a product relating to RYALTRIS® nasal spray (Marketing Approval LP – 006768), since the amount of one of the excipients (Na CMC) in the claims is recited as a range, but not as a specific value, as in the approved product. This was considered to be an obstacle for the patent term extension, since according to the Russian legislation, after issuance of a marketing approval for a pharmaceutical, a patent term can be extended with a supplemental patent issued with the claims adapted to cover exactly the composition of the drug approved for use.

The patent owner, Glenmark Specialty S.A., a subsidiary of the global research-based pharmaceutical company Glenmark Pharma, disagreed with the Rospatent decision and appealed to the IP Court.

A team of experienced PATENTICA representatives, Ms. Ekaterina Petrova, MSc. Biotech., patent attorney, and Mr. Alexander Tymofeev, lawyer, prepared and submitted before the IP Court an appeal supporting that the proposed set of claims totally covers RYALTRIS® nasal spray. The IP Court has appointed a court expert, specialist in the art,  who conducted detailed comparison analysis of the features recited in the independent claim with the composition of the nasal spray RYALTRIS®  disclosed in the instruction for medical use, and came to the same conclusion that all of the features of the independent claim proposed by the applicant fully coincide with the characteristics of the drug RYALTRIS®. Thanks to the professional expertise and convincing arguments prepared by PATENTICA representatives, whose opinion has been supported by the court expert evidence, and in view of Art. 1363(2) of the Civil Code, the IP Court has come to a justifiable conclusion that the term of patent RU2687551 relating to RYALTRIS® nasal spray shall be extended in the territory of the Russian Federation (IP Court decision СИП-954/2022 of June 6, 2023, https://kad.arbitr.ru/Card?number=%D0%A1%D0%98%D0%9F-954/2022).

Europe Launches Game-Changing Patent System

Europe made a giant step forward in patent protection on June 1, 2023, as it introduced the Unitary Patent system, a ground-breaking approach that promises a new era of efficiency and collaboration in patent safeguarding.

The Unitary Patent system represents a major shift in how patents are handled in Europe. Designed to modernize the patent landscape, this innovation brings a range of benefits that will make patent processes smoother and more transparent for everyone involved. From cost savings and simplified procedures to improved clarity and stronger legal protection, the Unitary Patent system aims to provide a better experience for its users.

It will now be possible to file a single patent application, pay single renewal fee in one currency once the patent is granted and even take the legal proceedings through the Unified Patent Court (UPC), a singular system introduced simultaneously. With the UPC’s debut, patent enforcement becomes centralized, offering a platform for resolving cases at a broader European level.

Seventeen countries with combined GDP over EUR 12 trillion (nearly 80% of the entire EU’s GDP) and 300 million of inhabitants have already joined the new system. These include Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia, and Sweden. It is anticipated that eight more EU member states will enroll in the future.

With the Unitary Patent system now operational, Europe is better positioned to support inventors and entrepreneurs in protecting their intellectual property, driving progress across the region.

Applications for copycats go abandoned or refused

In the spring of 2022, there were batches of applications for trademarks copying famous brands filed with the Russian PTO by different Russian applicants. The fears of legitimate right holders turned to be premature since such application either go abandoned or face citations of prior rights.

For example, a Sochi based company Trade technologies LLC filed 83 applications for such trademarks as Apple, Boeing, Chanel, Lamborghini and many others. Among these filings 51 applications have already faced Office Actions issued by examiners, while two are under formal examination due to non-payment of the official fees with the rest being under substantial examination with no results published so far, however, the outcome is very likely to be the same.

Another company that filed 30 applications for well-known trademarks such as Dior, Givenchy and others was Smart Beauty LLC located in Moscow. It was the publicity that the company seemed to aim the most, because filing and examination fees have not been paid on 26 out of them, which has already resulted in 18 decisions on recognition of applications abandoned, and similar decisions are expected shortly on the rest of them. As for the 4 applications where the fees have been paid, two have received Office Actions and two are still under examination.

Thus, among 113 of known applications filed by these two companies as of today there has been not a single registration decision issued by the PTO. Some applications go abandoned due to non-payment of the fees, whereas those that do proceed to examination receive Office Actions with grounds against registration of the claimed marks. These statistics are another disproof of the rumors about IP in Russia being in precarious position.

In April 2022 the head of the Russian PTO announced trademark examination to be carried out in accordance with the law regardless of the applicants’ country of origin. Prosecution practice shows that the Office has been staying this course.

Can foreign IP holders enforce their rights in Russia?

Announcements about some well-known brands leaving the Russian market coupled with the partial legalization of parallel import have created a false impression about absence of IP protection for right holders from “unfriendly” states. However, court practice proves that foreign companies continue to successfully enforce their trademark rights.

Despite the suspension of direct import of goods to Russia, foreign right holders pay close attention to the situation in the market and monitor illegal use of their trademarks. Having discovered counterfeit, companies address courts to stop the infringements and claim damages. About 30 lawsuits involving well-known fashion house Dior Couture have been considered since February 2022 and decided in favor of the right holder awarding the Plaintiff damages of about 1,8 million rubles for illegal trademark use.

Another well-known French fashion house Chanel has also participated in more than 25 solved cases over the last year and has been awarded about 1 million rubles in compensation for infringement of its trademarks. Not only right holders themselves, but also administrative bodies initiate court actions against illegal use of foreign IP. For example, different courts have considered over 20 court claims filed by police and customs against infringement of ADIDAS AG bringing the defendants to administrative responsibility, imposing fines and seizing counterfeit goods.

These examples encourage other foreign companies to come to action. For example, since October 2022, the American clothing manufacturer Calvin Klein has filed more than 60 lawsuits demanding to recover more than 7 million rubles for the counterfeit goods, and some of them have already been satisfied.

In the first half of 2022 there have been a few erroneous decisions taken by courts in several Russian regions ruled against the right holders from “unfriendly” states. These rulings, widely discussed by the media, were merely wrong decisions on the ground and later on got cancelled in the following instances.

The Constitutional Court: expenses in administrative proceedings should be reimbursable!

The Constitutional Court of the Russian Federation has ruled to develop legal norms and mechanisms regulating compensation of expenses incurred in the Chamber for Patent Disputes of the Russian PTO. Until corresponding changes are introduced into the legislation, the winning party may claim from the losing party the costs borne in the administrative proceedings in addition to court expenses, only if the decision is appealed in court.

The Constitutional Court of the Russian Federation has addressed the issue of compensating legal costs borne in the administrative proceedings over a patent dispute in its Resolution of January 10, 2023 N 1-P in connection with the complaint filed by “NIKA-PETROTEK”. In its ruling, the Court has pointed out first of all, that expenses incurred by a person in the course of administrative proceedings in a dispute on granting legal protection to the intellectual property are not subject to compensation as losses, rather, they should be attributed to court expenses. Further, the Court has mentioned that there are several problematic questions in this regard: formally both the subject of administrative proceedings in Rospatent and the subsequent litigation, as well as the procedural status of the participants in such proceedings do not coincide, furthermore, the outcome of the proceedings can have its variations.

At the same time, the Court has stressed that absence of possibility for recovering expenses incurred in the Chamber for Patent Disputes may prevent the parties from resorting to administrative proceedings, therefore, the gap in the legislation should be eliminated by corresponding norms on compensational mechanism. The Resolution does not prescribe the term within which the legislation changes are to be introduced, however, it contains the reimbursement principal for the transitional period. Namely, until the corresponding legal norms are taken, the winning party can add the costs incurred in the administrative proceedings to the court expenses and claim them from the losing party, however, this is possible only of the decision of the Chamber has been appealed in court. If the case does not go to court and stops at the administrative stage, compensation of costs is yet impossible.

Previously appealing examination decisions in the Chamber for Patent Disputes, oppositions and invalidation actions considered by the Russian PTO were at the parties own expense.  The Resolution of the Constitutional Court made a large step forward towards reimbursements of such costs.

The Bronze Horseman designation might be registrable as a trademark, but only with the consent of competent authorities

On October 21, 2022 the Presidium of the IP Court upheld Rospatent refusal to register Bronze Horseman designation as a trademark, thus supporting a previous decision of IP Court as the first instance court. However, as follows from the text of this decision, the Claimant has a chance to register the trademark, provided permission of the cultural heritage authorities is granted.

In August 2020, Aqua-Color company from St. Petersburg filed a trademark application for “The Bronze Horseman” designation, which is a popular name of the famous equestrian monument to the Russian Emperor Peter the Great made in 1782 by the French sculptor Etienne Falconet.

In July 2021, examination at Rospatent ended up in a refusal, which was appealed without success at the Chamber for Patent Disputes. In the refusal, Rospatent noted that the monument is an object of cultural heritage, as well as its name, which was given to the monument by the Russian poet Alexander Pushkin in his poem of the same title, which was first published in 1837 and cited in multiple works of literature and art and cannot be trademarked without a consent from competent authorities. In this way, its registration as a trademark could be a violation of the law on cultural heritage and contrary to the public interests.

The applicant, discontent with the refusal decision, filed a lawsuit against Rospatent in the IP Court, based on a purported violation of its legal rights and providing examples of other trademark registrations containing the same designation.

The first instance court partially supported the Office, agreeing that the monument indeed qualifies as a well-known and precious cultural heritage item and under Art. 1483 of the Russian Civil Code its popular name cannot be trademarked without a consent of a competent authority; so the disputed decision was deemed correct in this part.

However, Rospatent conclusion that registration of the trademark will be contrary to public interests was revised as no justification was provided. Therefore, the decision was reversed in this part and sent back to Rospatent for a revision.

The Presidium of the IP Court considered the cassation plea filed by Aqua-Color and upheld the first instance court decision. A panel of judges deemed the Claimant’s reference to approved list of cultural heritage items (which does not include the monument itself, but rather the whole complex of structures in the historic center of St. Petersburg) to be misleading and a partial reverse of the disputed Rospatent decision to be reasonably substantiated. Patentica will monitor this interesting case, which might create a court precedent for other similar cases involving cultural heritage objects.
https://kad.arbitr.ru/Card/c1fc81aa-87aa-4fc6-9639-e34d026a3854

Spare parts and expendables shall be delivered to the Russian customers during the whole term of service of a product

In 2022, many companies suspended their activities in Russia, which led to a legal controversy as to whether the companies leaving the Russian market are nevertheless obliged to continue supplying  spare parts and technical support to retailers and customers and, if yes, to how long after the date of the actual sale.

While it is a question of mutual consent for commercial products, the consumer market in Russia is regulated by the consumer protection legislation. According to Article 6 of the law of the Russian Federation “On Protection of Consumer Rights” of 1992, a manufacturer is obliged to ensure the possibility of using the product during its entire service life. For this purpose, the manufacturer must support repair and maintenance of the goods, as well as the release and supply to trade and repair organizations the volume and assortment of spare parts required for repair and maintenance during the manufacture period of the goods and during the service life of the goods even after they are no longer manufactured.

If no service life period is set, support must be provided within ten years from the date of transfer of the goods to a consumer.

With regards to the trademark rights, to avoid potential cancellation of a trademark registration on the basis of 3-years period of non-use, it is strongly recommended for trademark owners to keep a trademark license to at least one seller of spare parts in Russia even upon termination of business activity.

With the current influx of products supplied into Russian market by parallel import channels, maintaining trademark rights certainly provides better grounds to combat counterfeit goods.

https://www.statista.com/statistics/1347702/russia-parallel-imports/

Patentica will closely monitor current cases to provide a comprehensive overview of the situation with spare parts.