US Federal Circuit Court invalidated patents asserted against Sandoz by Teva Pharmaceuticals in litigation over generic version of Copaxone

Princeton, New Jersey, 29-7-2013 — /EuropaWire/ — Sandoz announced today that the US Federal Circuit Court of Appeals has invalidated several patents asserted against the company by Teva Pharmaceuticals in litigation concerning a generic version of Copaxone® – one of the leading products marketed for the treatment of multiple sclerosis.

The ruling, which includes the only asserted patent to expire in September 2015, narrows a 2012 decision by the US District Court for the Southern District of New York and potentially clears the way for market entry of generic Copaxone® as soon as May 2014, the expiration date of the remaining patents, pending US Food and Drug Administration (FDA) approval.

“We are extremely pleased with this ruling,” said Jeff George, Global Head of Sandoz. “Based on this decision, Sandoz and Momenta will continue to work with FDA to advance review of our ANDA, so that this critical generic product can be made available to patients after patents covering Copaxone® expire in 2014.”

The case involved nine patents asserted by Teva for patent infringement associated with submission to FDA of an Abbreviated New Drug Application (ANDA) for generic Copaxone®. The asserted patents included seven FDA Orange Book patents and one non-Orange Book patent expiring in May 2014, and one non-Orange Book patent expiring in September 2015.

In 2012, the District Court found all nine patents valid and infringed and issued injunctions enjoining FDA from approving any ANDA for generic Copaxone® and enjoining the defendants in the case from making, using, offering for sale, or selling generic Copaxone® until September 2015, the date of the latest expiring asserted patent. The Federal Circuit opinion will vacate the District Court’s finding and injunctions, clearing the way for FDA to grant final approval of a Copaxone® ANDA and for potential commercialization of an approved generic of Copaxone®.

The ANDA for generic Copaxone® is under FDA review and continues to advance. Sandoz and Momenta remain confident that the ANDA will be approved under the 505(j) pathway as a substitutable generic. M356 (glatiramer acetate injection) is a generic version of Copaxone®, a synthetic polypeptide medicine, developed in collaboration with Momenta and currently under review by FDA. Copaxone® is indicated for reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS), including patients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis.

Disclaimer

This release contains certain forward-looking statements relating to Sandoz’s business, which can be identified by terminology such as “clears the way,” “will,” “can be made available,” “potential,” “under FDA review,” “confident,” or similar expressions, or by express or implied discussions regarding the potential outcome of any future court proceedings, regarding potential marketing approvals for M356, or regarding potential future revenues from M356. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of Sandoz regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that, should Teva seek further review of the court’s ruling, Sandoz will be successful in the outcome of such proceedings. Nor can there be any guarantee that M356 will be approved for sale in any market, or at any particular time. Neither can there be any guarantee that M356 will achieve any particular levels of revenue in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the inherent uncertainties involved in the US litigation process; the impact that the foregoing factors could have on the values attributed to the Novartis Group’s assets and liabilities as recorded in the Group’s consolidated balance sheet; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Sandoz is providing the information in these materials as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

About Sandoz
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz offers a broad range of about 1,100 high-quality, affordable products that are no longer protected by patents. With nearly 26,000 employees in approximately 140 countries, Sandoz holds the #1 position globally in biosimilars, injectables, ophthalmics and dermatology as well as a strong global #5 position in inhalables. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). In 2012, Sandoz posted sales of USD 8.7 billion.

For further information

Sandoz US Communications:
Chris Lewis
+1 609 627 5287; chris.lewis@sandoz.com
Sandoz Global Communications:
Neil Moorhouse
+49 8024 476 2597; neil.moorhouse@sandoz.com