Tentative FDA Approval for Oral Pediatric HIV Treatment
Mylan Inc. recently announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR), which is a U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world, means the formulations meet all of the agency’s quality, safety and efficacy standards. Mylan’s products are expected to be eligible for purchase in early 2015.
The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource-limited countries including all low-middle income, least-developed countries and sub-Saharan Africa.
CAFC Finds Promise Not to Infringe Insufficient in ANDA Litigation
On September 26, 2013, the United States Court of Appeals for the Federal Circuit issued a panel decision in Sunovion Pharmaceuticals v. Teva Pharmaceuticals USA et al.
Sunovion appealed from the decision of the United States District Court for the District of New Jersey granting summary judgment that Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively “Reddy”) do not infringe claims 1, 2, and 8 of Sunovion’s U.S. Patent 6,444,673 (the “’673 patent”). The Federal Circuit panel, per Judge Lourie, with Judges Schall and Reyna joining in the decision, concluded that, although the district court did not err in construing the asserted claims, Sunovion was entitled to a judgment of infringement as a matter of law under 35 U.S.C. § 271(e)(2)(A).
Sunovion owns the rights to the ’673 patent, which is directed to pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in the chiral drug marketed as a sleep medication under the brand name LUNESTA®. Pursuant to 21 U.S.C. § 355(b)(1), the ’673 patent is listed as referenced to LUNESTA® in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (commonly known as the “Orange Book”). During the second quarter of 2013 alone, LUNESTA® had sales of nearly $200 million.
The dispute started when Reddy submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, which included a so-called paragraph IV certification with respect to the ’673 patent under the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), seeking approval to manufacture, use, and sell 1 mg, 2 mg, and 3 mg eszopiclone tablets as generic versions of Lunesta® prior to the expiration of the ’673 patent. As the Hatch-Waxman Act allows Sunovion to do, they then initiated a patent infringement lawsuit, asserting that Reddy’s ANDA submission constituted an act of infringement of claims 1, 2, and 8 of the ’673 patent according to 35 U.S.C. § 271(e)(2)(A).
10.2.13 | Federal Circuit Cases, Patent Issues, posts | Gene Quinn
Advanced Patent Prosecution Workshop: Chemical & Pharmaceutical Claim Drafting
Last week, I attended PLI’s Advanced Patent Prosecution Workshop 2011 in New York where an esteemed panel of experts offered hands-on claim drafting and amendment writing techniques. The program was organized into four technological sections: Biotechnology, Chemical/Pharmaceutical, Electrochemical and Electronics/Computers. I attended the Chemical/Pharmaceutical segment where Michael Davitz, Partner at Axinn, Veltrop & Harkrider and Practice Center Contributor, discussed Chemical and Pharmaceutical Claim Drafting. Here are some highlights from his presentation….
- Development of a Patent Portfolio – patent portfolio is developed in the context of a business plan and where in the life cycle the product is.
- Generic Player – differentiate product from innovator and create difficulty for competitors, other generics.
- Innovator – at what stage is the development? Integrate FDA and patent filing strategies and develop patents with an eye towards forcing infringement.
- Strategies for Early-stage and Late-stage Products
- Developing a Portfolio of both Listed and Unlistable Patents
- Start with the end-game and plan backwards (more…)
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12.11.14 | Biotech, biotechnology patents, Pharma | Gene Quinn