12 NEWS IN BRIEF


ViiV improves access to Tivicay


Specialist HIV company ViiV Healthcare has announced it will license its HIV medicine Tivicay (dolutegravir) to the Medicines Patent Pool, with the aim of increasing access to the drug in developing countries.


The news comes two months after Tivicay was approved by the EMA, and eight months after the FDA gave its approval to market the drug.


According to figures quoted by ViiV, 99 percent of children and 93.4 percent of adults living with HIV reside in developing countries.


ViiV’s chief executive Dominique Limet said that the World Health Organization recently cited dolutegravir as a development priority for future anti-retroviral treatments for children.


Roche buys IQuum to develop molecular diagnostics


Swiss pharmaceutical company Roche has bought US-based molecular diagnostic company IQuum for $275 million.


Roche will acquire IQuum’s Laboratory- in-a-tube (Liat) system, which allows healthcare professionals to perform rapid molecular diagnostic testing and make treatment decisions in an environment closer to patients, with minimal training.


Roland Diggelmann, chief operating officer for Roche Diagnostics, said: “We welcome IQuum’s employees, who will continue to focus on the development and manufacturing of the Liat Analyzer and assays.”


IQuum’s chief executive and founder Shugi Chen said: “We are very excited to continue developing innovative solutions as part of the Roche Molecular Diagnostics team.”


LSIPR Newsletter 04:14


Federal Circuit rules against Roche in Tamiflu case


NEW JERSEY, US


Te US Court of Appeals for the Federal Circuit has thrown out a lower court ruling that found Natco Pharma infringed a patent covering Roche’s flu drug Tamiflu (oseltamivir phosphate).


In a two-to-one decision, the appeals court found that the ‘483 patent, held by pharmaceutical company Gilead, is invalid for obviousness-style double patenting. Te ruling gives Natco another opportunity to try to invalidate the patent so it can make a generic version of Tamiflu.


Gilead, along with Tamiflu marketers Roche and Genentech, sued India-based Natco aſter it filed an ANDA with the US FDA, seeking approval to make a product covered by the ‘483 patent.


During the case, filed at the US District Court for the District of New Jersey, Natco argued that the ‘483 patent was invalid for obviousness-type patenting over Gilead’s ‘375 patent, which like the ‘483 patent is directed at antiviral compounds and the method for their use.


Gilead said that even though the ‘483 patent expires 22 months aſter the ‘375 patent, as the ‘375 patent was issued aſter the ‘483 patent it could not serve as a reference for double patenting.


Te district court agreed, and found that Natco infringed the Tamiflu patent.


Natco appealed against the ruling to the Federal Circuit, which on April 22 vacated the district court’s decision and remanded the case.


In a statement on its website, Natco said it was pleased with the Federal Circuit’s decision. According to IMS Health figures quoted in the statement, Tamiflu’s US sales reached about $495 million in the 12 months to September 2013.


A spokesperson for Genentech told LSIPR: “We are disappointed with the decision by the Court of Appeals for the Federal Circuit, but note that the appellate court did not opine on patent validity, and nor had the district court previously.”


She added: “We are studying the court’s decision, and considering various options and next steps.” n


Actavis wins Lialda generic appeal FLORIDA, US Actavis triumphs


Te US Court of Appeals for the Federal Circuit has reversed a lower court decision that found Actavis’s generic version of Shire’s ulcerative colitis drug Lialda (mesalamine) infringes US patent 6,773,720.


Circuit judge Todd Hughes ruled on March 28 that the US District Court for the Southern District of Florida’s constructions of Lialda’s active ingredient’s “inner lipophilic matrix” and “outer hydrophilic matrix”, claimed in the ‘720 patent, “impermissibly broaden” the ordinary meaning of the terms.


Roche grows molecular diagnostics


Te appeals court has referred the case to the district court for further proceedings using claim constructions consistent with its opinion. Te ‘720 patent claims a controlled release oral pharmaceutical composition for treating inflammatory bowel diseases including Crohn’s disease and mild to moderate ulcerative colitis.


www.lifesciencesipreview.com


Dublin-headquartered Shire sued Actavis for patent infringement aſter the pharmaceutical company, also based in Dublin, filed an ANDA with the US FDA for approval to market a generic version of Lialda.


It told LSIPR in a statement that it “remains dedicated to defending its IP”.


According to IMS Health figures quoted by Actavis, Lialda generated revenues of $576 million in the 12 months to January 31, 2014. n


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