US patent office rules in favour of Mylan: Natco Pharma2 min read . Updated: 02 Sep 2016, 11:58 PM IST
Natco Pharma says US patent office ruled in Mylan's favour by striking down a patent related to Teva Pharmaceutical Industries drug Copaxone
Hyderabad: Natco Pharma Ltd on Friday said the US Patent and Trademark Office (PTO) had ruled in favour of its partner Mylan NV by striking down a third patent related to Israel-based Teva Pharmaceutical Industries Ltd’s blockbuster drug Copaxone.
The PTO “found all claims of U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co. Ltd and licensed to Teva Pharmaceuticals...unpatentable," Natco said in a statement.
Generically known as glatiramer acetate injection, Copaxone is an injectable drug to treat relapsing forms of multiple sclerosis which damages the central nervous system and affects some 400,000 Americans.
Copaxone 40 mg/mL had US sales of about $3.3 billion for the 12 months ending 30 June 2016, according to researcher IMS Health.
Natco teamed up with Mylan to challenge Teva’s Copaxone 20 mg and 40 mg patents. Under their agreement, Natco will supply the drug and Mylan market it in the US and both the companies will share the profits.
Several patents on the 20 mg formulation expired in 2014, but litigation over a later patent delayed the release of a generic version till June 2015.
Last week, the PTO invalidated two key patents on Copaxone 40 mg.
Teva is now left with two more patents to fend off generic competition for Copaxone 40 mg.
On 15 August, the PTO’s patent trial and appeal board (PTAB) found Mylan’s application against a fourth Copaxone 40 mg patent ineligible for post-grant review for procedural reasons.
However, Mylan said it will pursue all avenues to challenge the patent.
“Through significant investment in research and development and by challenging these invalid patents, we are working to bring a more affordable generic alternative of Copaxone to market," said Heather Bresch, chief executive officer of Mylan.
Natco and Mylan are still awaiting US Food and Drug Administration (USFDA) approval for the 20 mg drug, while another pair, Momenta-Sandoz, which also contested the patents were granted approval to launch the first generic.
Natco and Mylan believe that they are the first companies to have filed a substantially complete abbreviated new drug application containing a Paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the US upon successful litigation and final USFDA approval.
Momenta-Sandoz, DrReddy’s Laboratories Ltd and Synthon BV Pfizer Inc. are also in the race to launch a generic version of the 40 mg version.
To be sure the USFDA can’t approve any generics of Copaxone 40 mg until early 2017.
Analysts say though it’s a positive decision for the Natco-Mylan combine, the litigation could be long drawn out as Teva will aggressively defend its remaining two patents and try to delay the generic entry for as long as possible. without ruling out the possibility of an out-of-court settlement.
Natco Pharma shares rose 0.47% to ₹ 680.10 at the close of trading on the BSE on Friday; the benchmark Sensex gained 0.38% to close at 28,532.11 points.