6 NEWS IN BRIEF


LSIPR Newsletter 04:14 Aurobindo Pharma sued over Angiomax NEW JERSEY, US


US-based Te Medicines Co has sued Aurobindo Pharma aſter claims the Indian pharmaceutical company infringed two patents related to its heart drug Angiomax (bivalirudin).


Ivor Elrifi Heidi Erlacher


Cooley expands life sciences patent team


Cooley LLP has recruited Ivor Elrifi and Heidi Erlacher to its patent counselling team serving the life sciences and technology sectors.


The hiring of Elrifi and Erlacher, both from Mintz Levin, will mean Cooley LLP has the largest life sciences patent group in the US.


Jim Brogan, who chairs the firm’s IP practice, said: “The addition of Ivor, Heidi, and their team establishes Cooley as one of the pre-eminent, fully integrated IP firms ... This group’s deep experience and extensive relationships across the country and internationally will be invaluable.”


Alongside them will be a team of four former partners from Mintz Levin. The group will work in both the Boston and New York offices.


Mylan sues FDA following Celebrex decision


Mylan has filed suit against the FDA, challenging a decision regarding generic drug marketing exclusivity on the generic version of Pfizer’s arthritis drug Celebrex (celecoxib).


The pharmaceutical company said that the FDA “seriously erred” in its decision, and maintains that it is in a position to get final approval to market a Celebrex generic after the drug’s remaining patents expire on May 30.


In the decision, the FDA ruled that 180 days of marketing exclusivity is available only to applicants that have first filed a paragraph IV certification to an original patent, and then made a timely paragraph IV certification to a reissued patent.


This was despite an earlier appellate court decision that held the original patent invalid, and a later decision that held the reissued patent invalid.


Te lawsuit, filed at the US District Court for the District of New Jersey on April 11, was filed in response to Aurobindo’s application to market a generic version of the drug.


Te Medicines Co has asserted two patents in the lawsuit, US numbers 7,582,727 and 7,598,343.


Te New Jersey-based company says Aurobindo filed an ANDA with the US Food and Drug Administration (FDA) for approval to make a generic version of the drug without reasonable basis that it would infringe the patents.


Te ‘727 and ‘343 patents, which cover pharmaceutical formulations of bivalirudin and processes of making the drug, will expire in July 2028. In its complaint, Te Medicines Co said that it is entitled to a six-month period of exclusivity following the patents’ expiration.


Angiomax prevents the formation of blood clots during angioplasty. Te drug


ANDA under fire


registered sales of $608.6 million last year, which accounted for around 88 percent of Aurobindo’s net revenue.


Te Medicines Co is seeking a judgment that the ANDA was an act of infringement and that any commercial sale or manufacturer would amount to infringement.


It adds that a generic should be given approval before the patents have expired in 2028. It is also seeking damages and attorney’s fees.


Aurobindo did not respond to immediate requests for comment. n


Depomed settles with generics over Gralise dispute


NEW JERSEY, US


Depomed, a California-based pharmaceutical company, has settled litigation with two of three companies that sought to launch generic versions of its Gralise (gabapentin) product before patents covering it expire. Gralise is used to treat pain aſter shingles. Sales of the product totalled $36 million in 2013.


Te settlements with Incepta and Zydus allow the companies to start selling gabapentin tablets on January 1, 2024.


Depomed filed patent infringement cases against Actavis, Incepta and Zydus at the US District Court for the District of New Jersey in 2012, aſter the generic drug makers filed ANDAs with the US FDA to market generic versions of Gralise.


Depomed’s litigation with Actavis is still pending. n


Gralise dispute settled


www.lifesciencesipreview.com


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