The Federal Circuit’s Review of Bayer’s Erectile Dysfunction Treatment Suggests Tolerance for a Wide Girth When Aiming for a Narrow Point

In Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. November 1, 2017), the Federal Circuit overturned the District of Delaware’s finding that Watson failed to prove by clear and convincing evidence that the subject matter encompassed by the claims of Bayer’s U.S. Patent 8,613,950 (the ‘950 patent) was obvious under 35 USC 103. The CAFC invalidated claims 9 and 11 of the ’950 patent as unpatentably obvious. The Federal Circuit made this determination de novo based on the underlying findings of fact from the district court.
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shutterstock_99945896The value of an early stage biotech company is driven primarily by the quality and scope of its intellectual property. As such, these companies’ primary goal is to stake out and consolidate a defensible claim in their technology space.

In sizing up an early stage company’s IP portfolio during due diligence, many investors and acquirers

For the first time, the Federal Circuit addressed the requirement of “actual notice” of a published patent application in order for a patent holder to obtain damages before issuance of a patent. The case arose from the appeal of a district court’s grant of summary judgement that Adobe Systems was not liable for patent pre-issuance damages under 35 U.S.C. § 154(d), because it had no knowledge of the published U.S. Patent Application that matured into the asserted U.S. Patent No. 8,578,820.
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The Federal Circuit recently denied Dow Chemical’s request for rehearing and rehearing en banc of Dow Chem. Co. v. Nova Chems. Corp. decided on August 28, 2015. The panel decision found that when multiple methods of measurement for a claimed parameter exist, a patentee must designate which method is being used. For a review of the court’s decision in the Dow Chem case, see our previous article here
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Momenta brought suit against Teva and Amphastar asserting that (i) Teva’s importation into the U.S. of an enoxaparin product would infringe Momenta’s ‘886 patent under 35 U.S.C. § 271(g), (ii) Amphastar’s manufacture in the U.S. of enoxaparin infringes the ’886 patent under 35 U.S.C. § 271(a), and this infringement does not fall within the safe harbor of 35 U.S.C. § 271(e)(1), and (iii) Amphastar’s sale of enoxaparin in the U.S. infringes the ‘886 patent under 35 U.S.C. § 271(g).
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The patent eligibility of diagnostic testing methods remains uncertain after the Federal Circuit refused to rehear Ariosa v. Sequenom. In Ariosa, the Federal Circuit panel found that Sequenom’s patent on fetal DNA testing was patent ineligible, despite noting the high commercial value of the technology. The panel concluded that the claims failed Mayo’s two step analysis for patent eligibility. The claims recited a method for detecting fetal DNA (cffDNA), which can be used for non-invasive genetic testing of the fetus in a variety of applications.
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Here in Washington, D.C., the Trans-Pacific Partnership (TPP) is the latest talk of the town. The TPP is a proposed trade agreement among twelve Asia-Pacific countries concerning a variety of economic policy matters, including intellectual property. TPP’s membership includes several of the U.S.’s largest trading partners, e.g., Canada, Japan, and Mexico. The membership countries reached agreement in early October after years of negotiation. Congress is expected to vote on the agreement in 2016. The full text released on November 15, 2015; the whole of Chapter 18 relates to intellectual property. Overall, it appears that the patent-related provisions in the TPP reflect well-established U.S. patent practice. If ratified, the TPP would likely benefit U.S. companies as it would simplify worldwide patent procurement.
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Section 27 of the America Invents Act, passed on September 16, 2011, requires the USPTO to conduct a study on genetic testing and provide Congress with recommendations for providing confirmatory genetic diagnostic testing where those tests or the information needed to conduct those tests are covered by patents and exclusive licenses. Confirmatory genetic diagnostic testing is “the performance of a genetic diagnostic test, by a genetic diagnostic test provider, on an individual solely for the purpose of providing the individual with an independent confirmation of results obtained from another test provider’s prior performance of the test on the individual.”
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The Federal Circuit in Shukh v. Seagate held that “concrete and particularized reputational injury can give rise to Article III standing” under 35 U.S.C. § 256. Standing under § 256 exists “when a plaintiff has either an expectation of ownership of a patent or a concrete financial interest in the patent.” In Shukh, the Federal Circuit expanded the scope of § 256 standing stating “a trier of fact could conclude that Dr. Shukh’s omission from the disputed patents had a concrete impact on his reputation in his field,” and accordingly vacated the district court’s grant of summary judgment and remanded for further proceedings.
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