Moneycontrol
Last Updated : Feb 01, 2017 07:43 AM IST | Source: Moneycontrol.com

Natco gets a booster dose on favorable patent ruling in US

Natco and Mylan believe that they are the first companies to have filed a substantially complete abbreviated new drug application containing a Para-IV certification for a 3 times per week Glatiramer Acetate Injection 40 mg/mL, and expect 180 days of marketing exclusivity in the US.

 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More
Viswanath Pilla
Moneycontrol Bureau

Drug maker Natco Pharma on Tuesday said that the United States District Court for the District of Delaware has ruled in favor of its partner Mylan invalidating four patents held by Israel-based Teva Pharmaceutical Industries.

These patents relate to multiple sclerosis blockbuster drug Copaxone 40 mg/mL.

The invalidated patents are United States Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries, Ltd.

On December 2, 2016, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) had struck down three of these patents ('250, '413 and '302) in its inter partes review (IPR) proceedings initiated by Mylan.

Mylan also challenged the '776 patent in an IPR proceeding. The PTAB is expected to issue its institution ruling on the '776 patent IPR by May 16, 2017.

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 approximately USD 3.3 billion for the 12 months ending November 30, 2016, according to IMS Health.

Copaxone generates a fifth of Teva's 20 billion in annual sales. Teva said it will appeal the decision in a statement.

Analysts say the decision is a blow to Teva – which is trying to delay the generic entry for Copaxone 40 mg for as long as possible.

The original version of Copaxone, consisting of 20 milligrams taken every day, already has generic-drug competition but Teva has succeeded in switching many patients to the newer version.

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.

"Today's ruling by the US District Court is yet another positive step in our effort to bring to market a more affordable generic version of Copaxone® 40 mg/mL," said Mylan CEO Heather Bresch.

"We will continue to challenge the validity of patents as a way to expedite the availability of generic drugs and help deliver access and savings to patients and the overall healthcare system," Bresch said.

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 and Synthon BV Pfizer 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.

Shares of Natco rose 4.5 percent to close at Rs.689.95 on BSE, while the benchmark Sensex declined 0.70 percent to end 27,655.96 points.

First Published on Jan 31, 2017 06:45 pm
More From
Loading...
Sections
Follow us on
Available On
PCI DSS Compliant