Biotech Values

[DewDiligence]

Re: MNTA / Generic Copaxone

MNTA and NVS have claimed inequitable conduct by Teva
in procuring its US Copaxone patents. This is the first time
MNTA and NVS have shown their game plan for prevailing
against Teva in the Copaxone lawsuit that accompanies
the ANDA submitted by MNTA and NVS last summer. The
patents in question expire in 2014 (#msg-30960930).

http://online.wsj.com/article/BT-CO-20081114-712444.html

›Momenta Claims Teva Gave Conflicting Information on Copaxone

NOVEMBER 14, 2008, 1:06 P.M. ET
By Thomas Gryta

NEW YORK (Dow Jones)--Momenta Pharmaceuticals Inc. (MNTA) is accusing Teva Pharmaceutical Industries Ltd. (TEVA) of providing conflicting information to regulators to secure additional patents on its multiple sclerosis blockbuster Copaxone.

Momenta began the long process of challenging Copaxone's patents over the summer and is seeking to produce a generic version of the drug, which had 2007 sales of $1.7 billion, before 2014. The allegations, contained in a recent court filing, add more weight to Momenta's case but also highlight the uphill challenges faced by the company.

Teva wouldn't comment on the allegations contained in the court filing.

"These claims appear convincing and lead us to believe Momenta and Sandoz may hold the upper hand in litigation with Teva," said Cowen & Co analyst Eric Schmidt, the first on Wall Street to highlight the strategy.

Momenta is in a worldwide partnership with Novartis AG (NVS) unit Sandoz for generic Copaxone, with an even split of profits. They are challenging patents held by Teva that stretch until 2014.

Copaxone, a vital earnings driver for Teva, was approved in 1996 but its orphan drug exclusivity expired in 2003, leaving open the possibility of a generic challenge, though that may not come quickly because of the complexity of Copaxone's composition.

Teva sued Momenta and Sandoz in August after the Food and Drug Administration accepted an application for a generic version of Copaxone. The lawsuit from Teva automatically triggers a 30-month stay until the FDA can approve the application.

In the recent court filing, Momenta claims that original patents for the composition of Copaxone expired in 1991. But Teva asserted that compositions of the drug with lower molecular weights were less toxic, leading to a new generation of patents that stretch into 2014.

Momenta, however, says that information submitted by Teva to the FDA indicates that all molecular weight ranges are equally safe and effective and that Teva deceived the Patent and Trademark Office to obtain the patents.

The allegation of inequitable conduct could lead to a ruling that the relevant patents aren't enforceable, but the allegation isn't uncommon in patent litigation and it must be proved with clear and convincing evidence.

Momenta and Sandoz will have to show that the conflicting information would actually alter the ability of a patent to be issued, plus they will likely have to show that Teva actually intended to deceive the patent office.

The legal battle over generic Copaxone is likely to be long - Schmidt doesn't expect a trial to begin until 2010 - and it remains unclear how the FDA will evaluate the comparability of a generic with such a complex drug as Copaxone.

Gaining a legal victory is a major hurdle, especially against Teva - the world's largest generic company and a frequent patent challenger - but gaining FDA approval could also prove difficult because of the complexity of proving that the generic version is equivalent to the branded product.

Teva has repeatedly asserted that a "full-fledged clinical study" is needed to determine the comparability of the drug because of its complexity.

Of course, such clinical trials would be expensive and likely take years to complete. Momenta previously said it's used "analytic methods" to demonstrate the equivalence of the two drugs in its application with the FDA.‹