Source: https://www.glaserweil.com/news-resources/insights?author=dan-liu
Timestamp: 2019-04-22 04:00:10+00:00

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On June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., finding that Sequenom’s patent claiming methods of using cell-free fetal DNA (“cffDNA”) for prenatal diagnosis test is patent ineligible under 35 U.S.C. § 101. The Sequenom’s patent is directed to a revolutionary finding that there is cffDNA in the blood stream of a pregnant woman. The presence of cffDNA in maternal blood samples provides a safer, cheaper, and faster alternative to the conventional invasive methods to determine fetal genetic abnormalities, such as Down Syndrome. Several popular prenatal diagnosis tests, including Sequenom’s MaterniT21 and Ariosa’s Harmony, embody Sequenom’s discovery.
On May 13, 2015, the Federal Circuit issued the much-anticipated decision in Akamai Technologies, Inc. v. Limelight Networks, Inc. following a remand from the Supreme Court. The Federal Circuit, in a 2-1 decision, held that “direct infringement liability of a method claim under 35 U.S.C. § 271(a) exists when all of the steps of the claim are performed by or attributed to a single entity[.]” This is consistent with its 2008 Muniauction decision, where the Federal Circuit first made clear that “direct infringement requires a single party to perform every step of a claimed method.” The Akamai Court concluded that when “one party, acting as ‘mastermind’ exercises sufficient ‘direction or control’ over the actions of another,” the “single entity” requirement may be met and the direct infringement may be found. Sufficient direction or control may occur in a principal-agent relationship, a contractual arrangement, or a joint enterprise.
In In re Cuozzo Speed Technologies, LLC, the first ever appeal of the final written decision from an inter partes review (“IPR”) before the Patent Trial and Appeal Board (“PTAB” or the “Board”), the Federal Circuit decided two novel and fundamental questions arising under the newly enacted IPR proceedings created by the America Invents Act of 2011 (“AIA”). On both issues, the Federal Circuit agreed with the PTO, holding (1) institution decisions by the Board are almost never reviewable on appeal, either interlocutory or after the Board’s final written decision, and (2) that the “broadest reasonable interpretation” standard is the proper standard for claim construction in IPR proceedings.
For patent infringement defendants filing an Inter Partes Review (“IPR”) petition to challenge the validity of the patents asserted against them has become popular, largely because of the high rate of patents rendered invalid as a result of the petitions. Thus, knowing when to file an IPR petition is crucial.
Since 2010, the Supreme Court has issued four decisions on patent-eligible subject matter under 35 U.S.C. § 101. In the most recent decision, Alice Corp. v. CLS Bank, the Court continued the restrictive approach set forth in its own precedents in Gottschalk v. Benson, Parker v. Flook, and Diamond v. Diehr, and invalidated patents directed to computerized methods for mitigating settlement risk by using a third-party intermediary. The most significant passage in the Alice decision is that the Court expressly adopted the two-step test it elaborated in Mayo Collaborative Services v. Prometheus Laboratories for all types of patent subject matter issues, including laws of nature, natural phenomena, and abstract ideas.
Hatch-Waxman Litigation in a NutshellHatch-Waxman litigation refers to pharmaceutical patent litigation between a brand drug manufacturer and a generic drug manufacturer under the Hatch-Waxman Act (“Act”). The Act was enacted to facilitate generic drug entry into the market while encouraging pioneer drug development. This is achieved by providing carefully balanced statutory incentives, such as a five-year data exclusivity to the brand firm and a 180-day market exclusivity to the first generic firm, and procedures for approval and marketing of generic drugs.

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