Successful Representation of the Client in a Pharmaceutical Patent Dispute

Client LLC NPO Pharmvilar

Description

In the mid-1980s, an antiarrhythmic drug was developed and launched under the trade name "Allapinin," derived from plants of the Aconitum genus. It is important to note that the active ingredient defining the antiarrhythmic properties of the drug is the alkaloid lapaconitine (or its salt). The composition of other accompanying substances (alkaloids) was not specified. The patent protection for the drug "Allapinin" expired long before the current dispute, and a number of analogous drugs appeared on the market.

LLC NPO Pharmvilar (Client) – a pharmaceutical company with extensive scientific and production experience, has been manufacturing lapaconitine hydrobromide using its own patented method since 2014, and starting in 2018, the drug "Laporitmin," which is a reproduced drug in relation to the reference drug "Allapinin."

In 2017, the Client's Opponent (Opponent) obtained Russian Patent No. 2630967 (Patent) for an antiarrhythmic drug, which is a plant-based substance characterized in the patent's claim not only by specifying the main, previously known active ingredient – lapaconitine (or its salt), but also by six accompanying alkaloids. In the Opponent's opinion, these six accompanying alkaloids define the technical result along with lapaconitine (or its salts) and determine the antiarrhythmic and other activity of the drug according to the Patent.

Thus, it happened that any reproduced drug that contains the widely known compound lapaconitine or its hydrobromide as the active ingredient, as well as accompanying alkaloids, the set of which could unintentionally coincide with the composition of the drug according to the Patent, could automatically fall under the scope of the Patent's rights.

In 2019, the Opponent filed a lawsuit with the Arbitration Court of Moscow to protect the right to the invention under the Patent. Taking into account the changes in the claims, the Opponent demanded to stop sales and withdraw from circulation the Client's drug, cancel its state registration, pay compensation of 95 million rubles, and stated other claims.

Solution

The Consultant, together with the Client, thoroughly investigated the case and proposed a comprehensive defensive strategy. In addition to other arguments for defense, the main efforts were focused on invalidating the Patent. The complexity of invalidating the Patent lay in the fact that before the priority date, only the active ingredient - lapaconitine (or its salt) - was indicated in the antiarrhythmic substance obtained from plants of the Aconitum genus, as well as in drugs based on it. The composition of the accompanying alkaloids was not specified.

The case for invalidating the Patent was heard twice in Rospatent and twice in the Intellectual Property Court. As a result, the Consultant managed to prove that the Patent did not meet the patentability requirement of "inventive step." The Consultant argued that it was obvious to a person skilled in the art from the prior art that both the main technical result and all additional technical results of the invention were solely due to the known properties of the main active ingredient of the patented drug, namely lapaconitine (or its salt). It was also proven that all accompanying alkaloids mentioned in the Patent were known from the prior art, and that these alkaloids are present in the composition of the plant-based substance obtained from plants of the Aconitum genus, while their set and quantity depend on the method of obtaining the substance, and their detection in the substance depends solely on the accuracy of the substance analysis method. Moreover, it was shown that the patent application did not evident the influence of the six accompanying alkaloids in the Patent (both individually and in combination) on the technical results achieved by the invention. The Consultant also managed to prove that the patent application on the date of filing did not indicate any other technical results besides the antiarrhythmic activity and effects related to the antiarrhythmic activity.

Result

The dispute lasted over four years. As a result of the coordinated work of the Consultant's patent attorneys and lawyers, as well as interaction with the Client, the Patent was declared invalid by the decision of Rospatent, which was confirmed by the Intellectual Property Court. As a result, the Arbitration Court of Moscow dismissed the Opponent's claim for infringement of the right to the invention under the Patent.

After the completion of the dispute on the merits, the Consultant initiated the process of recovering court expenses incurred by the Client.

The successful handling of this case proved that the Patent was issued unlawfully, and the Opponent's claims were unfounded. The Client was able to continue the production of its drug, which is included in the list of vital and essential drugs. Moreover, invalidation of the Patent eliminated the risk of similar claims being filed against other manufacturers of reproduced drugs whose composition is equivalent to the reference drug "Allapinin," known in the pharmaceutical industry for over 30 years.