Supreme Court Denies Injunction Request To Block Release Of Generic MS Drug, But Patent Fight Not Over Yet

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multiple sclerosis supreme courtPetah Tikvah Israel-based Teva Pharmaceutical Industries Ltd. has suffered a setback in its fight to forestall release of generic competitors for its proprietary Copaxone Multiple Sclerosis drug. However, the company is expressing optimism that potential for recovery of Patent Infringement Damages may dissuade aspirant generic competitors from proceeding until a final Supreme Court ruling on its appeal of a lower-court decision that would invalidate its patent claim.

In late March, the Supreme Court of the United States (SCOTUS) granted the Company’s Copaxone certiorari petition, agreed hear Teva’s appeal of a decision from the United States Court of Appeals for the Federal Circuit that had invalidated the claim of U.S. Patent 5,800,808 (the “808 patent”).

That patent, which expires on September 1, 2015, claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis (RRMS) product, Copaxone (glatiramer acetate injection) 20mg/mL, which reduces frequency of relapse in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Copaxone was approved for RRMS in 1996 after its effectiveness and safety profile were proven across five clinical studies.

Regarding the SCOTUS decision last week, Teva comments that while Chief Justice of the United States Roberts found Teva had demonstrated “a fair prospect of success on the merits” in its appeal of the United States Court of Appeals for the Federal Circuit decision that invalidated the “’808 patent”claim, he denied the Company’s application to stay the Federal Circuit’s decision due to the potential for the Company to recover patent infringement damages from parties that bring generic glatiramer acetate injection products to market when the Copaxone patent expires on September 1, 2015.

Noting that they had previously prevailed in the District Court, which had upheld the validity of nine Copaxone patents that expire in May 2014, including the ‘808 patent, Teva says it will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone.

Generic drugs are typically sold at a substantially lower price than branded counterparts, since their development/approval process is relatively brief and less costly. These products contain the same active ingredients as found in the innovative drug, and meet similar regulatory requirements as the innovative drug. Reliance on generic drugs continues to grow due to the need to control healthcare costs, particularly given the increasing elderly population.

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Teva says any purported generic version of Copaxone would be required to obtain the approval of the Food and Drug Administration prior to being made available to the public, and argues that the inability to fully characterize the active ingredients of the product leads “many experts” to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.

There is no small irony in that Teva claims to be the world’s leading generic world’s largest maker of generic drugs, with a global product portfolio of more than 1,000 products and a direct presence in approximately 60 countries, and has in the past harshly criticized brand-name manufacturers that attempted to block block generic versions of their proprietary-branded and more expensive medicines. However, the company expresses confidence that Copaxone will remain a proprietary global market product the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.

However, the company is also vigorously promoting a new 3-times-a week (as opposed to daily) Copaxone 40 mg variant approved by the FDA in January, that would not be subject to generic competition, and would make it more difficult for health care insurers to insist that patients opt for once-a-day generics. According to a report by the New York Times Business Day’s Andrew Pollackmarch Teva hopes to convert some 30,000 of the approximately 85,000 American Copaxone users to the new version of Copaxone, as a possible hedge against generic competition He notes that Teva has pegged the cost of the new Copaxone at $4,641 a month, which is lower than the older once-a-day version, which costs $5,060 per month.

Teva says Copaxone is thought to work by modifying the immune system. While Relapsing-Remitting Multiple Sclerosis (RRMS) is most commonly considered a disease that affects the central nervous system (CNS), but it also involves another biological system — the immune system, which plays an important role in helping to maintain overall health. The immune system is a complex biological system made up of a network of cells, tissues, and proteins that all play a role in the body’s immune response. In RRMS, confused — or inflammatory — T cells attack the myelin that protects the axons, or nerve tissue, in the CNS.

In four major studies, Copaxone had demonstrated effectiveness in reducing frequency of RRMS relapses as well as reducing some types of brain lesions seen on magnetic resonance imaging (MRI).

Teva observes that of the therapies approved to treat RRMS, as well as treatments currently being studied, are thought to have an impact on the immune system, but are respectively are thought to do so in different ways. Copaxone is thought to modify the immune processes believed to be responsible for activating MS, and consequently it may interfere with immune functions. For example, treatment with Copaxone may interfere with the body’s ability to recognize foreign invaders and defend against infection, and that while there is currently no known evidence that Copaxone reduces the body’s normal immune response, this has not been systematically evaluated.

Meanwhile would-be generic Copaxone competitor supplier Mylan Inc. is cheering Justice Roberts’ denial of Teva’s injunction application pending the Supreme Court’s decision on Teva’s appeal, noting that this is the second time that the Chief Justice has denied Teva’s request for such an injunction. Novartis’ Sandoz unit and Momenta Pharmaceuticals are also aspiring generic Copaxone makers.

Mylan CEO Heather Bresch commented in a release that “We are pleased with the Chief Justice’s decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. Food and Drug Administration on May 25, 2014.”

Mylan is the U.S. partner of Hyderabad, India based pharmaceutical and bulk chemicals manufacturer, Natco Pharma Limited, a vertically integrated pharmaceutical company heavily focused in research and development and in manufacturing drug intermediates, Active Pharmaceutical Ingredients (API) and finished formulations. The company has a global network, affirms a customer centric approach, and claims proven technology and know-how for speciality formulations. Its stated mission is “To manufacture and market affordable medicines that comply with global standards and to achieve market leadership in domestic as well as international markets ”

However if Mylan, Sandoz, and Momenta proceed with marketing generic versions of Copaxone, they’ll open themselves to liability for patent infringement damages if Teva’s appeal ultimately prevails in the Supreme Court. A decision on that case is expected sometime before the end of June, 2015.

Mylan Inc., first known as Milan, was founded in White Sulphur Springs, West Virginia. in 1961 by ex U.S. Army buddies, Milan “Mike” Puskar and Don Panoz, who flipped a coin to see whose the business would take and who would be the company’s first president. Puskar and Panoz began distributing products to doctors and pharmacists from an old Pontiac Bonneville. Today, Mylan claims that eighty percent of U.S. prescriptions are filled with a generic medicines, and 11 percent of of U.S. prescriptions, brand name or generic, are filled with a Mylan product. Mylan says the average amount consumers can save by filling a prescription with a generic rather than a brand name medicine runs about 80% to 85%, and represented a saving in U.S. health care system expenditures by about $1 Trillion between 2002 and 2011, according to IMS Health.

Teva Pharmaceutical Industries Ltd.
Mylan Inc.
Natco Pharma Ltd.
The New York Times

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Mylan Inc.

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