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Legal Affairs Safe Harbor Protects Post-Approval Activities Recent Decision Makes Testing Occurring After Approval Exempt from Infringement Isabelle Blundell The Hatch-Waxman Act, which became law in 1984, created a shortened process, the Ab- breviated New Drug Application (ANDA), for manufacturers to seek approval for ge- neric versions of proprietary drugs. Ever since, generic-drug manufacturers have had increasing success in lowering barriers to en- try in the marketplace. As a further boon to these manufacturers, the patent laws were amended to provide them with protection—a safe harbor—from claims of infringement for pre-approval ac- tivities geared toward showing the equiva- lence of the generic to the brand-name drug. Remarkably, the Court of Appeals for the Federal Circuit has now extended the reach of safe harbor protection to testing activities occurring after approval of the drug. While this ruling serves Hatch-Waxman's goal of encouraging the introduction of generic drugs, it inflicts severe collateral damage on patents for methods of ascertaining the com- position of such drugs. In Momenta Pharmaceuticals v. Amphas- tar Pharmaceuticals (2012), the Federal Cir- cuit held that all uses of a patented invention, even those conducted after FDA approval of the generic drug, benefit from the exemption from infringement claims so long as the use of the invention is, in the language of the safe harbor provision, "reasonably related to the development and submission of informa- tion under a Federal law which regulates the manufacture, use, or sale of drugs…" Momenta, the first to win approval of a generic version of enoxaparin (a/k/a Lo- venox®), a low molecular weight version of heparin that helps prevent the formation of blood clots, developed and patented a method for identifying the composition of the batches of enoxaparin. Because enoxapa- rin is, like heparin, a mixture of biopolymer chains that have variability in both structure and formula, the FDA requires rigorous on- going testing to identify the composition of each batch of the drug before it can be sold. Momenta's method became the only listed method in the US Pharmacopoiea and sanc- tioned by FDA. Even though other valid methods are available, Amphastar, which also gained marketing approval for enoxaparin, uses Momenta's patented method for identifying its batches during manufacturing. Momenta sued, complaining that Amphastar infringed its patent. Safe-Harbor Provision In a split panel decision, the Federal Cir- cuit construed the safe-harbor provision to protect Amphastar's post-marketing activi- ties because, even though the information is not submitted to the FDA, but merely kept available as proof of compliance in the event EMD Millipore is a division of Merck KGaA, Darmstadt, Germany EMD Millipore and the M logo are trademarks of Merck KGaA, Darmstadt, Germany. © 2012 EMD Millipore Corporation, Billerica, MA, USA. All rights reserved. of FDA inspection, the testing results are needed to comply with Amphastar's ANDA to ensure that each new batch of the generic drug meets the equivalency requirements. The court found ample support in the Su- preme Court's decision of Merck v. Integra (2005). The high court interpreted the safe- harbor statute broadly and held that pre- marketing activities conducted to develop information intended to be submitted to the FDA, but which was ultimately not submit- ted, fell within the ambit of the provision. So long as the information is of the kind that would be submitted to the FDA, the activi- ties are "reasonably related" and thus fall under the exemption, even though the re- search was aimed at developing new drugs and not at developing generic versions of an already approved drug. See Safe-Harbor Protection on page 12 Why hop when you can fly? EMD Millipore cell culture media: Top performance, faster time to market In the world of cell culture media, you need two wings to fly: strong cell growth, plus high productivity. EMD Millipore Cellvento™ CHO-100 delivers both – straight off the shelf, and in top quality. This chemically defined, non-animal origin product is made with selected high-quality raw materials, and specially formulated for consistent lot-to-lot productivity. Thanks to our outstanding regulatory documentation, it can even help fast track your approvals. For superior performance in cell growth and cell production, ask your business partner about Cellvento™ CHO-100 – and watch your production really take off. www.emdmillipore.com/cellvento Genetic Engineering & Biotechnology News | genengnews.com | October 1, 2012 | 11