Bayer awarded about $73k for infringement of its rivaroxaban patent

The Moscow Arbitration Court found that the manufacture and marketing of a generic version of rivaroxaban infringed Bayer's patent and awarded RUB 6.32 mln against two companies. Bayer had claimed RUB 12.64 mln.

The generic entered the market before patent expiry

Promomed Rus registered the drug in January 2024. In April, Bayer sent the company and the manufacturer a warning letter demanding that they refrain from placing the drug on the market until the patent protection expired. Nevertheless, on June 27, 2024, Biokhimik placed the drug on the market, and it subsequently became the subject of government procurement contracts, including contracts worth RUB 3.48 million, RUB 19.81 million, RUB 22.21 million, and RUB 4.19 million.

Bayer sought a finding of infringement against Promomed Rus, Biokhimik, and Biopreparat and requested that Promomed Rus and Biokhimik be held jointly and severally liable for RUB 12.64 mln.

Partial invalidation of the patent did not save the generic

A key feature of the case was the history of the original Patent No. 2297415. In 2025, the patent was partially invalidated, following which Rospatent issued Patent No. 2836548 with an amended claim set.

The defendants argued that there had allegedly been a "gap" in patent protection. The court rejected this argument: partial invalidation of a patent does not terminate the right in the part that remains protected, while the new patent merely records the amended scope of protection. Accordingly, Patent No. 2836548 is effective from the original filing date — December 11, 2000 — through December 4, 2024.

Who was held liable and for what

The court found all three defendants to have infringed the patent. Promomed Rus and Biokhimik were responsible for manufacturing and placing the drug on the market, while Biopreparat was responsible for offering it for sale, selling it, and otherwise placing it on the market.

However, monetary compensation was awarded only against Promomed Rus and Biokhimik, jointly and severally. No monetary compensation was awarded against Biopreparat.

Why was RUB 6.32 mln awarded instead of 12.64 mln?

Bayer calculated the compensation as twice the value of a license to use the invention. An expert retained by the rights holder determined a royalty rate of 10.78%, while the value of the license, based on the government contracts, was calculated at RUB 6,321,495.24. This resulted in a claim of RUB 12,642,990.48 (about $146,366).

The court considered the double amount excessive and awarded only the single value of the right to use the invention, exactly half of the amount claimed.

The amount is broadly in line with other notable Russian pharmaceutical patent disputes. For example, in another Bayer case involving a generic version of sorafenib, the court awarded RUB 6.44 million. Thus, the award here is substantial, but not exceptional for this type of dispute.

What does this mean for the pharmaceutical market?

Having been issued only after the patent had expired, the decision is generally favorable to patent holders who continue to face active attempts by generic manufacturers to bring medicines to market before the expiration of patent exclusivity. The decision is also notable in light of recent Russian Supreme Court practice: in Review No. 2 of 2026, the Supreme Court indicated that bringing a generic to market before the expiry of patent protection may constitute an act of unfair competition. Thus, launching a drug before patent expiry may create not only patent-related but also antitrust risks.

The decision confirms the viability of calculating compensation on an economically substantiated basis by reference to the value of a license, although the court appears inclined to reduce the claimed double amount by reference to the principles of reasonableness and proportionality.

The court's conclusion concerning the continuity of the exclusive right is also significant. When conducting a freedom-to-operate analysis, generic manufacturers should carefully examine any patent issued in replacement of a patent that has been partially invalidated.