14 February 2013Patents

Bristol-Myers Squibb loses Baraclude patent fight with Teva

A US judge has invalidated pharmaceutical company Bristol-Myers Squibb (BMS)’s patent covering its hepatitis B treatment Baraclude, agreeing with generic manufacturer Teva Pharmaceuticals that the invention of the active compound in the drug was obvious to anyone skilled in medicinal chemistry.

The ruling only affects BMS’s patent rights in the US. Unless overturned or reversed, it will allow Teva to produce a competing generic product subject to approval from the US Food and Drug Administration (FDA).

In a 171-page judgement published on Tuesday, February 12, Judge Burke of the US District Court of Delaware said that the evidence of prima facie obviousness put forward by Teva was “multi-faceted and compelling,” and that BMS’s evidence of non-obviousness “was not particularly compelling..[and]…did not strongly persuade the court.”

Teva argued that a person of ordinary skill in the art – in this case, a medicinal chemist – would have had reason or motivation to select the lead chemical compound 2’ CDG and modify it by adding a carbon atom to arrive at entecavir (the active compound in Baraclude) based on common knowledge, existing prior art and traditional drug making methods at the time of discovery.

Teva also argued that entecavir’s inventors were guilty of inequitable conduct for failing to disclose information to the US Patent and Trademark Office (USPTO) at the time of filing, but Burke rejected this claim.

A spokesperson for the BMS said the company is disappointed with the court’s decision and believes it is incorrect.

“[BMS] will appeal [against] the court’s decision and we are evaluating all other legal options to vigorously defend our intellectual property rights,” she said.

A Teva spokesperson said the company is pleased with the ruling but did not wish to comment further.

Teva filed for FDA approval of its generic version of Baraclude in 2010, but BMS filed a lawsuit and secured a 30-month block on the generic’s launch. BMS’s Baraclude patent was due to expire in February 2015.

James Flaherty, an associate at Foley Hoag LLP in Boston, said: “The district court’s obviousness decision is certainly detailed, with 58 pages devoted to findings of fact and 67 pages to legal standards and conclusions. This level of detail and analysis is wise given the lukewarm reception obviousness challenges to chemical patents have received at the Federal Circuit in recent years.”

Flaherty also said that the impact the ruling has on the generics market depends on whether the Federal Circuit chooses to affirm or reverse it.

“An affirmance would give renewed hope and support to generic drug manufacturers challenging chemical patent claims on the basis of obviousness, while a reversal will continue the trend of obviousness attacks on chemical patents facing an uphill battle at the Federal Circuit,” he said.

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