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39 Biotechnology L. Rep. 1 (2020)

handle is hein.journals/bothnl39 and id is 1 raw text is: Selected Developments in Biotechnology Law and the Biotechnology Industry By STEVEN J. ZWEIG FEDERAL CIRCUIT THROWS OUT LARGEST U.S. PATENT VERDICT In 2016, Merck & Co., Inc. won a US$2.54 billion verdict against Gilead Science, Inc. The verdict-the largest ever in a U.S. patent case-was based on a finding that Gilead's hepatitis C drugs Sovaldi and Harvoni infringed Merck's patent on a hepatitis C treatment it had acquired when it bought Idenix Phar- maceuticals. However, that jury verdict was then thrown out by a federal judge in Delaware two years later, on the basis that Merck's patent was invalid for lack of disclosure. The judge held that the disclosure was inadequate because an excessive amount of ex- perimentation would be required to create the pat- ented drug. The Federal Circuit then heard Merck's appeal of that decision and recently upheld it, agreeing with the lower court that the patent lacked adequate dis- closure and so was invalid. FEDERAL CIRCUIT AFFIRMS HOSPIRA'S INFRINGEMENT OF AMGEN'S EPOGEN While US$70 million is not US$2.54 billion (the verdict overturned above), it's still a signifi- cant amount of money. It's also the amount that the Federal Circuit recently (December 16, 2019) confirmed that Hospira will have to pay for in- fringing on Amgen's Epogen patent through the creation of batches of a drug substance for Hospi- ra's biosimilar. Among other arguments advanced, Hospira tried to argue that its creation of 21 batches Steven J. Zweig is the Managing Editor of Biotechnology Law Report. of the substance was protected by the Safe Harbor provision under 35 U.S.C. § 271(e)(1), but the Fed- eral Circuit rejected that argument for 14 of the 21 batches, finding that they were not manufactured solely for uses related to the development and sub- mission of information to the Food and Drug Administration (FDA)-and hence were outside the Safe Harbor. WORLD HEALTH ORGANIZATION PREQUALIFIES ITS FIRST BIOSIMILAR MEDICINE Breast cancer is the most common form of can- cer for women. A very effective early stage treat- ment, trastuzumab, a monoclonal antibody, costs $20,000 on average for a treatment regime. That cost puts it out of reach for many women, espe- cially in developing countries. The World Health Organization (WHO) has in- cluded trastuzumab on its WHO Essential Medicines List since 2015. But essential or not, if patients can't afford it, it will not help them. Trastuzumab biosimi- lars cost, on average 65% less than the originator medicine, making it much more affordable. Several biosimilars have been on the market, but even at a 65% discount, they are still too expensive for many when purchased privately. Prequalification by the WHO of a biosimilar ver- sion of trastuzumab produced by Samsung Bioepis NL B.V. in the Netherlands provides the WHO's im- primatur and furnishes quality assurance: it's a deter- mination that the WHO finds it comparable to the originator medicine in terms of quality, efficacy, and safety. That in turn will make it eligible for purchase by United Nations agencies and increase the likelihood of purchase by national health pro- grams, which will further drive down the cost and increase availability. 1 39 Biotechnology Law Report 1 Number 1, 2020 © Mary Ann Liebert, Inc. DOI: 10.1089/bir.2019.29154.sjz News Briefs

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