Home >companies >US patent office rules in favour of Natco Pharma’s US partner Mylan

Hyderabad: Drugmaker Natco Pharma Ltd on Thursday said the US Patent and Trademark Office (PTO) has ruled in favour of its partner Mylan NV by striking down two patents held by Israel-based Teva Pharmaceutical Industries Ltd for its blockbuster drug Copaxone 40 mg/mL formulation.

“The US PTO has ruled in favor of Mylan in its inter partes review (IPR) proceeding and found all claims of two related Copaxone 40 mg patents to be unpatentable," Natco said in a statement.

Generically called 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.

The two US patents are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd.

Teva is now left with three more patents to fend-off generic competition for Copaxone 40 mg.

Natco said the PTO’s Patent Trial and Appeal Board (PTAB) will take a decision on Mylan’s third petition seeking inter partes review of US patent number 8,969,302 by 1 September.

On 15 August, the PTO’s PTAB found Mylan’s application against a fourth Copaxone 40 mg patent, US patent No. 9,155,776, ineligible for post-grant review for procedural reasons. However, Mylan said it believes that the latest favourable ruling in the IPR against the ‘250 and ‘413 patents strongly undermines the ‘776 patent as well.

“As such, Mylan will proceed with pursuing all avenues to challenge the ‘776 patent," Natco said.

“We believe the Board’s decision is comprehensive, well-reasoned, and highly persuasive in detailing the bases for the invalidity of Teva’s 40 mg patents, and we look forward to further demonstrating the invalidity of the patents covering Copaxone 40 mg/mL," said Heather Bresch, chief executive officer of Mylan.

Natco teamed up with Mylan to challenge Teva’s Copaxone 20 mg and 40 mg patents. As per the agreement, Natco supplies the drug and Mylan markets 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 till June 2015.

Natco and Mylan are still awaiting US Food and Drug Administration (USFDA) approval for the 20 mg drug, while another pair Momenta-Sandoz who also contested the patents were granted approval to launch the first generic.

Analysts say Momenta-Sandoz, despite little competition, failed to make a significant dent on Teva’s market share of Copaxone, as the latter was able to hold on to its market by giving aggressive rebates, contracting with payers, and shifting a large number of patients to long acting 40 mg version which is protected by patents up until 2030.

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.

Copaxone 40 mg/mL had US sales of approximately $3.3 billion for the 12 months ending 30 June 2016, according to IMS Health.

Dr. Reddy’s Laboratories Ltd and Synthon BV-Pfizer Inc. are also in the race for 40 mg version.

Analysts say though it’s a positive decision for the Natco-Mylan combine, the litigation could be a long-drawn one as Teva will aggressively defend its patents and try to delay the generic entry for as long as possible, given its history for the 20 mg version.

“The fourth patent will be a tough nut to crack; also, Teva recently got a new patent for 40 mg version, making things even more difficult," said Afzaal Mohammed, pharma expert at Karvy Stock Broking Ltd.

Natco on Thursday said that it successfully completed USFDA inspection for its Chennai plant.

The company said the Chennai plant was inspected by USFDA between 8 and 12 February. The plant produces cytotoxic active pharmaceutical ingredients (APIs) for oncology products.

“This was the first time Natco’s Chennai facility was inspected by USFDA; the closure will help the company to grow its US business," Mohammed of Karvy said.

At 2.26pm, shares of Natco rose 4.59% and were trading at 685.30 on BSE, while the benchmark Sensex gained 0.49% to 27,922.66 points.

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