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6 May 2015Americas

US Supreme Court refuses to hear BMS’s Baraclude appeal

The US Supreme Court has rejected pharmaceutical company Bristol-Myers Squibb’s (BMS’s) appeal to review a ruling that found its patent covering a treatment for hepatitis B invalid.

The Supreme Court issued its refusal on Monday (May 4).

At the centre of the dispute was claim 8 of US patent 5,206,244, which covers hepatitis B drug Baraclude (entecavir).

In 2010, BMS sued Teva after the generic drug maker submitted an Abbreviated New Drug Application to the US Food and Drug Administration for approval to make its own generic version of the Baraclude drug.

Teva also filed a paragraph IV certification that claimed its generic product would not infringe patent ‘244, and that the patent was invalid on the grounds of obviousness.

Teva said that the patent was obvious because the entecavir molecule is similar in structure to the 2’-CDG compound, whose antiviral properties were known and existed in the prior art.

BMS filed its patent application in October 1990, but Teva had found examples of the 2’-CDG compound’s use as an antiviral drug in a 1984 paper from the Journal of Medicinal Chemistry.

According to Robert Zahler, the named inventor on the patent, BMS did not submit the use of 2’-CDG as an antiviral agent as prior art in its application to the US Patent and Trademark Office.

In 2013, in a 171-page judgment, judge Kevin Burke of the US District Court for the District of Delaware ruled in favour of Teva, finding its argument that the patent was obvious to be “multi-faceted and compelling”.

BMS appealed against the judgment, but the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling in June 2014.

In September 2014, Teva started selling its own generic version of Baraclude in 0.5mg and 1mg tablets.

A spokesperson for Teva told LSIPR: “We are pleased with the decision of the court. With this decision, this concludes the litigation in Teva’s favor and will allow us to further provide this valuable product to patients.”

BMS did not respond to a request for comment.

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