India Patent Act Changes

By Julie Shursky Behind South Africa, India is managing the world’s second largest HIV treatment program.  In 2015, more than 900,000 patients received antiretroviral treatment in India.[1]  Despite the enactment of various government-funded health insurance programs and organizations to combat infectious and chronic diseases such as HIV/AIDS, the Indian government continues to struggle in financing adequate healthcare facilities for its citizens, causing a significant number of Indian citizens to “fund their health needs through out-of-pocket expenses.”[2]  In an effort to protect and manage its market, India enacted Section 3(d) and established patent laws that allow its government to grant compulsory licenses for pharmaceutical products. In an effort to increase the availability of low-cost drugs, the Indian Patent Act of 1970 (“1970 Act”) prohibited the patentability of pharmaceutical products.[3]  The 1970 Act, however, permitted patents on the manufacturing process of said products,[4] which led to the booming of India’s generic drug sector through capitalizing on innovation by multinational companies that were

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Supreme Court Unanimously Rules for Generic Manufacturers in Improper Patent Listing Case

By Charles Pierce In Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, 566 U.S. ___ (2012), the Supreme Court unanimously clarified the prerequisites of 21 U.S.C. §355(j)(5)(C)(ii)(I) counterclaims seeking to correct or delete patent information that a name-brand pharmaceuticals manufacturer submits to the FDA. Repaglinide is a drug that has been approved by the FDA for the treatment of diabetes.  The FDA approved three methods: repaglinide alone, repaglinide in combination with metformin, and repaglinide in combination with thiazolidinediones.  The compound was covered by the ‘035 patent that Novo had owned, but the patent had expired in 2009.  Novo currently owns the ‘358 patent, a method-of-use patent which claims “a method for treating [diabetes by] administering . . . repaglinide in combination with metformin.” Generic drug makers, rather than submit a new drug application (NDA), may submit an abbreviated new drug application (ANDA) that piggy back on the brand’s NDA.  Following the expiration of the ‘035 patent, Caraco filed such an

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Federal Circuit Defines Language of 35 U.S.C. § 271(e)(2) in a Hatch-Waxman Controversy

By Kevin M. Repper In the case of AstraZeneca Pharmaceuticals LP v. Apotex Corp., No. 2011-1182 (Fed. Cir. 2012), Astrazeneca holds the rights to three patents related to the drug rosuvastatin calcium. Two of the three patents involve methods of using rosuvastatin compounds. One of which is a method of treating heterozygous damilial hypercholesterolemia (HeFH) and the other is a method of lowering cardiovascular disease risk for individuals who have normal cholesterol levels but demonstrate elevated circulating C-reactive protein (CRP). The method of use patents expire in 2021 and 2018, respectively. Apotex, a generic pharmaceutical manufacturer, filed an Abbreviated New Drug Applications (ANDA) with the FDA seeking to market generic rosuvastatin for treating hypercholesterolemia (HoFH) and hypertriglycerdemia while omitting or “carving out” patented indications directed towards the treatment of HeFH and elevated CRP. Under the Hatch-Waxman Act, the filed ANDA must provide a list of all the related patents and if the method of use patents do not claim a

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Feature Comment: Building a Solid IP Portfolio – Strategies for Innovator Pharmaceutical Companies

By John K. Weatherspoon, PhD[1] The importance of having valid, enforceable patent protection was a key theme discussed at the recent Life Sciences Summit held in Long Island, NY, from September 22-23, 2010.   With over 400 attendees at the summit, primarily from the pharmaceutical and biotechnology industries, there was extensive discussion of having solid Intellectual Property (IP) protection which is critical especially for commercializing new therapeutics.  By “solid” IP protection, and in the case of patent protection, this is intended to refer to patents that are ultimately deemed both valid and enforceable. With representatives from large, midsize and emerging biopharmaceutical companies present at the summit, there was particular interest in the importance of IP in the commercialization of new therapeutics, including new pharmaceutical products or “Active Pharmaceutical Ingredients” (APIs).  The importance of solid IP protection can’t be emphasized enough, especially in today’s challenging economic climate.  In the case of emerging biopharmaceutical companies seeking investor funding, a solid IP portfolio is

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