Bristol-Myers and Pfizer Win Over Eliquis Patents

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On August 5, 2020, Bristol-Myers Squibb Co. and Pfizer Inc. obtained a federal court ruling upholding two patents on their best-selling blood-thinner medication Eliquis. Bristol-Myers Squibb Co. and Pfizer Inc. entered into a collaboration agreement in 2007 with the purpose of co-developing Eliquis. Eliquis launched in 2012 and is presently one of the world’s top-selling drugs, registering sales in the amount of $7.9 billion in 2019.

The August court ruling held that generic versions of Eliquis produced by pharmaceutical companies such as Sigmapharm, Sunshine Lake, and Unichem infringe on the Eliquis patents. The ruling blocks generic manufacturers from launching copycat versions of the blood-thinner product for at least six years.

The U.S. Food and Drug Administration approved the first generic versions of Eliquis in December 2019. Bristol-Myers Squibb Co. and Pfizer Inc. filed multiple lawsuits in advance of this regulatory approval in an attempt to block entry of the generic drugs on the market and preserve Eliquis’s significant position in the pharmaceutical market. As evidenced by the August ruling, this preemptive strategy has been successful for the Bristol-Myers Squibb-Pfizer partnership.

The favorable August ruling resulted in increased stock values for both Bristol-Myers Squibb Co. and Pfizer Inc. as investors and traders responded favorably to the news and the possibility of continued market dominance. In a press release issued on August 5, 2020, Bristol-Myers Squibb-Pfizer Alliance announced: “We believe this decision indicates the innovative science behind Eliquis and the strength of our intellectual property (IP).” https://news.bms.com/news/details/2020/The-Bristol-Myers-Squibb-Pfizer-Alliance-is-pleased-with-the-U.S.-District-Court-decision-to-uphold-both-the-composition-of-matter-COM-patent-US-6967208-and-formulation-patent-US-9326945-covering-Eliquis/default.aspx

The Alliance went on to acknowledge that the August ruling was “subject to appeal.” Still, it noted that “at present, the generic manufacturers currently involved in the case cannot launch their apixaban products until 2031.” Id.

Sigmapharm and Unichem have both appealed the August 5, 2020 ruling, and it remains to be seen if the ruling will be upheld on appeal.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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