The United States Court of Appeals for the Federal Circuit is deciding whether to reconsider en banc its panel decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. Numerous amici have lined up in support of rehearing. At stake is what room recent U.S. Supreme Court jurisprudence leaves for obtaining patent claims involving diagnostic innovations that use established processes.
Author: George W. Johnston
The United States Patent and Trademark Office (“USPTO”) has published a request for comments in the Federal Register for a proposed pilot program which would allow for a single Administrative Patent Judge (APJ) to determine whether to institute an inter partes review (IPR), with two additional APJs being assigned to the IPR if a trial were instituted.
Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity
In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..
In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms Inc., the Federal Circuit followed previous precedent in holding that the combination of compounds is not “obvious to try” if unexpected properties are supported by evidence. The patent-at-issue was directed to an antihypertension drug, Tarka®, which is the combination of an angiotension-converting enzyme inhibitor (such as trandolapril or quinapril, both double-ring compounds) and a calcium channel blocker. The jury found that the patent had not been proven invalid and defendant, on appeal, argued that “if a combination of classes of components is already known, all selections within such classes are obvious to try . . . .” The Federal Circuit found that there was substantial evidence supporting the jury’s verdict that obviousness had not been proved by clear and convincing evidence because of the unpredicted “longer-lasting effectiveness” achieved with the drug.
Patent indemnification agreements, common in asset purchases, mergers and acquisitions, manufacturing, and patent licensing agreements, reduce the possibility of liability should a third party later assert its patent against the asset purchaser or licensee. However, entering into such agreements to mitigate risk can actually increase exposure. During the damages stage of patent infringement lawsuits plaintiffs often seek, with varying success, to bring in evidence of the existence of a defendant’s indemnification agreement to show that defendant knew of the patent and committed willful infringement. Thus, the very vehicle used to shift the risk of monetary liability can sometimes itself be used as a mechanism to enhance damage awards.
According to the Tufts Center for the Study of Drug Development, the pharmaceutical industry, particularly Big Pharma, has decidedly changed course, shifting its R&D focus away from small molecule drugs towards biotech products. Such biotech products are muscling out small molecules’ prior domination of the top 10 drug product sales. For example, in 2012, biotech products accounted for 71% of the revenues generated by the world’s top selling biopharmaceutical products. This remarkable growth mirrors the successful evolution of biotech research over the last three decades. Drilling down further, the Tufts Report notes that monoclonal antibody (mAb) biotech products saw the largest increase in growth over the last decade and now account for almost 60% of the biotech products being clinically developed by the largest pharmaceutical companies.