8 NEWS


LSIPR Newsletter 02:13 Bristol-Myers Squibb loses Baraclude patent fight with Teva DELAWARE, US


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


Te ruling only affects B-MS’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 FDA.


In a 171-page judgment published on 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 carbocyclic 2’-deoxyguanine (2’-CDG) and modify it by adding a carbon atom to arrive at entecavir 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 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 B-MS filed a lawsuit and secured a 30-month block on the generic’s launch. B-MS’s entecavir patent was due to expire in February 2015.


B-MS: disappointed with the court’s decision.


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 B-MS 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


James Flaherty, an associate at Foley Hoag LLP in Boston, said: “Te district court’s obviousness decision is certainly detailed, with 58 pages devoted to findings of fact and 67 pages to legal standards and conclusions. Tis 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. n


Nuvo Research and Apotex reach Pennsaid patent settlement DELAWARE, US


Canadian pharmaceutical firms Nuvo Research and Apotex have agreed a patent settlement allowing Apotex to launch a generic version of Nuvo’s arthritis treatment Pennsaid (diclofenac sodium) in the US in April 2014, or earlier under certain circumstances.


Te settlement ends five months of litigation—in August 2012, Nuvo attempted to block the release of generic versions of Pennsaid by filing patent infringement claims against Apotex and generic drug manufacturer Lupin Pharmaceuticals at the US District Court of Delaware.


Nuvo’s composition of matter patent for


Pennsaid expired in 2003, but the company was granted a patent for methods of administering the treatment in September 2012, which expires in 2029. Nuvo has also developed a follow-on product, Pennsaid 2%, which is awaiting approval from the US FDA.


Under the terms of the settlement, Apotex is free to launch a generic version of Pennsaid on the earlier date of either 45 days aſter the first commercial shipment in the US of Pennsaid 2% or April 1, 2014.


Nuvo has yet to reach a settlement with Lupin, but Tina Loucaides, vice president and general counsel at Nuvo, said proceedings will be initiated.


“Apotex was the first generic Pennsaid filer, so they had priority, but we’ll now be


concentrating on settling with Lupin. We’re very pleased to have reached a settlement with Apotex, and our strategy now is to focus on Pennsaid 2%, which we believe is a better product,” she said.


Kathleen Carr, a partner at Edwards Wildman Palmer LLP in Boston, said the terms of the settlement are unusual.


“Te follow-on 2% product, which has not yet been approved, potentially could end up triggering the 1.5% original product for launch 45 days later. So, the newly developed product would only be on the market for 45 days before a generic version of the original product would be allowed market entry,” she said. n


Life Sciences IP Review


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