L. Atnagulova. "Dolfin" and "Duolor": What Is the Difference?
Facts of the case
Zentiva Pharma LLC faced unfair actions by a former partner in relation to the medical device "Dolfin", used for diseases of the upper respiratory tract.
After moving production (to another site), the former manufacturer of this device decided to put into circulation a formally new medical device under a different trade name within the same therapeutic area.
This supposedly new device was created entirely on the basis of the technical documentation that had been used in manufacturing the "Dolfin" device, and in all essential characteristics it replicated the original.
Resolution of the Ninth Arbitration Court of Appeal of 01.06.2022 No. 09AP-26009/2022-GK in case No. A40-97920/21–12–655.
Defense strategy
Zentiva faced the task of developing an effective strategy to defend its violated rights, taking the following nuances into account. The infringer registered the supposedly new device with Roszdravnadzor and obtained a patent for its product "Duolor".
The patent was issued on the basis of the device having a new feature.
In one part of the "Dolfin" device, the unscrupulous manufacturer made three small holes in the cap instead of one solid hole.
Such a small detail gave it patent protection and allowed it to strengthen its position in the event of a dispute.
Difficulties of the court proceedings
Having found no effective tools in the field of contract law, Zentiva defended its rights by filing a claim for the protection of exclusive rights to its patent (utility model), obtained before production began at the contract site.
In the field of pharmaceuticals and chemistry there is still little similar court practice, so two main questions were put before the court:
- Is the defendant entitled to use its own patent as a shield against any claims for the protection of rights to the original solution?
- Does the defendant's device (product) have all the features stated in the independent claim of the patent for the "Dolfin" device?
The answer to the first question decided the further fate of the court proceedings
01. If the defendant's having its own patent stood in the way of satisfying the claim for the protection of rights to Zentiva's patent, the only way to continue the proceedings in court would have been the administrative route (an objection to the decision to grant legal protection to the utility model). This would have meant additional costs for the business that would not have led to the desired result: stopping the sale of the competing product.
02. The answer to the second question was made the basis for the decision on the merits of the dispute, based on several expert examinations (pre-trial and court-ordered).
Cancellation of the registration certificate of "Duolor"
The court fully satisfied Zentiva's claims, prohibiting the infringers from using the utility model under patent of the Russian Federation No. 151829, namely from manufacturing, selling, offering for sale and storing for these purposes the medical device "Duolor", and also recovered from them the court costs of the expert examination and the payment of the state duty.
We also had the registration certificate (RC) of "Duolor" cancelled.
In accordance with subparagraph "b" of clause 57 of Decree of the Government of the Russian Federation of 27.12.2012 No. 1416 "On Approval of the Rules of State Registration of Medical Devices", one of the grounds for cancelling the registration of a medical device is a court decision on violation of the rights of a right holder to the results of intellectual activity and the means of individualization equated to them in the circulation of medical devices.
Outcome of the court case
On the basis of this provision and the decision of the Arbitration Court of the city of Moscow, on 8 December 2022 the Federal Service for Surveillance in Healthcare issued an order cancelling registration certificate No. RZN 2020/12031 for the medical device "Duolor".
- Thus, from 8 December 2022, the sale (storage, offering for sale, sale (wholesale and retail)) of the medical device "Dualor" under No. RZN 2020/12031 is impossible.
- The circulation of unregistered medical devices is punishable by criminal liability under Article 238.1 of the Criminal Code of the Russian Federation. This is the first case of cancellation of a registration certificate on the domestic market.
Significance of the case
The particular feature of patent disputes is that the fact of infringement of intellectual rights is established by comparing the defendant's product with the independent claim of the plaintiff's patent.
Thus, the actual similarity / identity / interchangeability of the two devices does not play a decisive role in such disputes.
The circumstances of the production of the competing product (theft of technology or simple borrowing) also have no legal significance.
It is precisely the "magic formula" of the independent claim in the patent that is of critical importance: if, at the patenting stage, words and expressions or drawings were chosen that do not reflect the real features of the product being manufactured, the usefulness of the patent in a dispute with a competitor tends to zero.
Law enforcement practice
Significance and novelty of the case
In considering the dispute, the court rightly referred to clause 4 of Article 1358 of the Civil Code of the Russian Federation, according to which:
"If, in using an invention or utility model, there is also used… each feature given in the independent claim of the patent claims of another utility model, and in using an industrial design, each essential feature of another industrial design or a set of features of another industrial design producing on an informed consumer the same overall impression as that produced by the industrial design, provided that the products have a similar purpose, the other invention… or the other industrial design are also deemed to be used."
Law enforcement practice
On the market, this provision is rarely invoked, with preference given to a lengthy process of challenging the defendant's patent. Obviously, this choice of a "struggle of two patents" is due to a long-standing decision of the Supreme Arbitration Court of the Russian Federation.
Significance of the case for business
The application in this case of clause 4 of Article 1358 of the Civil Code of the Russian Federation, taking into account the specifics of "evergreen patents" in pharmaceuticals, where minimal differences of a generic from the originator drug / of an updated medical device from one produced earlier are patented, is of great importance for business, since it reduces litigation costs and time.
Author of the article: Lyudmila Atnagulova
