LSIPR Newsletter 12:14


NEWS 7 Cipla and Meda sue Apotex over Dymista application


DELAWARE, US Drugs companies


Cipla and Meda


Pharmaceuticals have sued Canada-based Apotex as they seek to protect the nasal spray Dymista (Azelastine hydrochloride, fluticasone propionate).


Te pair took action in response to Apotex’s Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) that sought approval to market a generic version of the drug, used to treat allergies.


Although developed by Cipla, Sweden-based Meda has the rights to commercialise the drug.


In their complaint, which was filed at the US District Court for the District of Delaware,


and announced on December 2, the pair said Apotex’s ANDA would infringe US patent numbers 8,163,723 and 8,168,620, which cover the Dymista composition and its approved uses.


Both patents are not due to expire until 2026.


Te complaint, Meda said, was filed within 45 days of receiving Apotex’s notice that it had filed the ANDA.


Tis triggers an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months, unless ordered otherwise by a district court.


Meda holds the New Drug Application to manufacture and market Dymista in the US to treat seasonal allergic rhinitis. n


WASHINGTON, DC, US


Sandoz too quick off the mark in Amgen suit: US court In the


judgment, Taranto explained that


Novartis’s generic arm Sandoz has lost a patent case regarding its biosimilar version of Amgen’s psoriasis and arthritis drug Enbrel (etanercept).


Sandoz had asked the US Court of Appeals for the Federal Circuit to overturn a lower court decision that said the company had filed a lawsuit against Amgen prematurely.


Sandoz sued Amgen last year at the US District Court for the Northern District of California, seeking a judgment that its planned biosimilar version of Enbrel would not infringe two Amgen patents because they should be declared invalid.


Te patents at issue, which were licensed to Amgen by pharmaceutical company Roche, are US numbers 8,063,182 and 8,163,522—a composition and a method patent.


Te district court rejected Sandoz’s claims and said it had filed the lawsuit prematurely, sparking an appeal from the Switzerland- based company.


But, in a decision released on December 5, the Federal Circuit upheld the decision.


Judge Richard Taranto said the lawsuit was premature because Sandoz had not sought approval for the generic version from the US Food and Drug Administration (FDA).


www.lifesciencesipreview.com


Sandoz said it was conducting a phase III trial of a drug “it hopes to make the subject of an FDA application”.


He added: “Sandoz’s phase III trial may fail in material ways. If so, perhaps Sandoz will not file for approval, thereby eliminating altogether the patent dispute it has asked the district court to adjudicate.


“At a minimum, that scenario could alter the content of any patent dispute,” Taranto wrote, dismissing the appeal.


Biosimilars are similar to generic drugs but are biopharmaceutical products only. Te system for allowing them in the US was created by the Biologics Price Competition and Innovation Act, implemented in March 2010.


Te FDA accepted its first biosimilar application in July this year. Tat application involved both Sandoz and Amgen, with Sandoz obtaining approval to market a biosimilar of Amgen’s Neupogen (filgrastim) drug.


Sandoz and Amgen did not respond to a request for comment. n


MEZZOTINT / SHUTTERSTOCK.COM


AUREMAR / SHUTTERSTOCK.COM


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20