West Virginia based Mylan Inc. has announced that the United States Patent and Trademark Office (PTO) has issued a final office action rejecting Israel-based Teva Pharmaceutical Industries Ltd.’s application seeking a reissue of U.S. Patent No. 5,800,808 (the “‘808 Patent”), which was found to be invalid by the Court of Appeals for the Federal Circuit in July 2013.
Mylan, the U.S. partner of Hyderabad, India based pharmaceutical and bulk chemicals manufacturer, Natco Pharma Limited, says it is pleased that the PTO rejected the reissue application, confirming the indefiniteness for the second time and consistent with the Federal Circuit’s decision, and that the PTO continues to find all claims to be unpatentable.
Natco and Israel-based Teva have been engaged in a patent fight over the Multiple Sclerosis drug Copaxone in the lucrative U.S. market and elsewhere. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis (RRMS) product, Copaxon (glatiramer acetate injection) 20mg/mL. Teva had previously prevailed in the District Court regarding nine Copaxone patents, including the ‘808 patent, and the Federal Circuit Court ruling last year by the upheld some of the Copaxone patents that expire in May 2014, while invalidating the ‘808 patent.
Mylan reports that the PTO’s final rejection issued on Thursday finds the first claim of the reissue application, which is identical to the only claim in the ‘808 Patent, to be indefinite and both claims of the reissue application to be unpatentable based on obvious-type double patenting. In its ruling, the PTO refused to extend patent protection on Copaxone past the patents that will expire May 31, 2014.
However, the U.S. Supreme Court has granted certiorari in the litigation relating to the ‘808 Patent in response to Teva’s petition; although, unlike its position in the PTO where Teva declared that the ‘808 Patent is invalid due to indefiniteness, Teva is arguing to the Supreme Court that the Federal Circuit improperly ruled that the patent was invalid for indefiniteness.
Copaxone has been proven to reduce the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a first clinical episode and have MRI features consistent with MS. Copaxone is approved by the U.S. Food and Drug Administration (FDA), and indicated for the treatment of MS, and had registered a revenue of $4.2 billion in the US during 2013. With Teva’s Copaxone patents expiring in September 2015 held invalid by a last year’s Federal Circuit Court ruling, sales of generic versions of the drug will theoretically be possible beginning in June, however, there’s still uncertainty regarding what the Supreme Court will ultimately decide.
India’s Business Standard newspaper reported that Natco Pharma’s stock price rallied 7 percent to Rs 760 on the Bombay Stock Exchange (BSE) on Friday after the company announced that the United States Patent and Trademark Office (PTO) had rejected Teva’s patent reissue application for Copaxone.Natco’s stock had tanked 16 percent to Rs 670 on Tuesday, after reports that the US Supreme Court has agreed to hear an appeal filed by Teva regarding generic Copaxone. By agreeing to hear the case, the high court raised doubt as to whether the US Court of Appeals for the Federal Circuit’s July 2013 ruling would stand.
“The final rejection issued today finds the first claim of the reissue application, which is identical to the only claim in the ‘808 patent’, to be indefinite and both claims of the reissue application to be unpatentable based on obvious-type double patenting. In its ruling, the PTO refused to extend patent protection on Copaxone past the patents that will expire in May 2014,” The Business Standard’s K. Rajani Kanth cites Natco affirming in a filing to the BSE on Friday, noting that the final rejection issued today finds the first claim of the patent reissue application, which is identical to the only claim in the ‘808 Patent, to be indefinite and both claims of the reissue application to be unpatentable based on obvious-type double patenting.
The Business Standard also reports that Natco Pharma has clarified in a statement in response to speculation as to the role of Natco related to potential launch or pricing of generic Copaxone in the United States, confirming that the final decision as to when or whether and pricing of generic Copaxone is launched in the US rests with Mylan.
The New York Times Business Day’s Andrew Pollackmarch reports that treatment with Teva’s proprietary Copaxone costs $5,060 per month or about $60,000 a year per patient. MarketWatch’s Robert Daniel reports that Natco Pharma Ltd. has said it would launch glatiramer acetate, the generic version of Copaxone, at about 40% of the price of the branded Teva drug.
The Business Standard says Natco affirms that it remains committed and is working to take steps and deploy the necessary resources to ensure that a quality generic US FDA approved Copaxone is made available to patients suffering from multiple Sclerosis upon market information.
Natco Pharma Limited is 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 ”
Natco currently has more than 2500 employees, and it consistently ranked among fastest growing pharmaceutical companies in India. The Natco Research Center has 70,000 Sq.ft of laboratory space and 15,000 Sq.ft of additional laboratory space for high potency compounds. The company has been granted 66 Indian Patents and International Patents, with another 41 Indian and 85 International patent applications filed, and exports API’s and Formulations to roughly 50 countries around the globe from its portfolio of Oncology, Neurology and CNS drugs, including Anti-Neoplastics, Anti-Depressants, Anti-Migraine, Anti- Osteoporosis, Anti-Asthma, Proton Pump Inhibitors, and Therapeutic Peptides.
Mylan Inc., which was 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 U.S. prescriptions, brand name or generic, are filled with a Mylan product.
Generic drugs are typically sold at substantially lower prices than branded counterparts, since their development/approval process is relatively brief and less costly. These products are required to 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.
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.
Ironically, Natco/Mylan’s opponent in the patent fight over Copaxone, Teva Pharmaceutical Industries, is the world’s largest maker of generic drugs.
Natco Pharma Ltd.
Teva Pharmaceutical Industries Ltd.
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Natco Pharma Ltd.
Natco Pharma Ltd.