News & Analysis as of

Personalized Medicine Patent Invalidity

Foley & Lardner LLP

Personalized Cancer Therapy Found Nonobvious

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In OSI Pharmaceuticals, LLC v. Aoptex Inc. (Fed. Cir. 2018-1925, Oct. 4, 2019), the Federal Circuit reversed the Patent Trial and Appeal Board’s (Board) decision that certain claims of US Patent No. 6,900,221 were...more

Bradley Arant Boult Cummings LLP

For the First Time, a Medical Treatment Patent Is Ruled Invalid Under Mayo/Myriad

As discussed in a previous blog post, since Mayo v. Prometheus, critics of medical treatment patents have advocated that such patents should be banned from patenting. While such arguments seemed futile based on the consistent...more

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Federal Circuit Finds INOMax Mental Steps Obvious As Ineligible Printed Matter

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In Praxair Distrib., Inc. v. Mallinckrodt Hospital Prods. IP Ltd., the Federal Circuit found that the printed matter doctrine applies equally to physically embodied information and mental steps, and can be invoked in the...more

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PTAB Puts Method Of Treatment Patents Under The 101 Knife

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While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more

McDonnell Boehnen Hulbert & Berghoff LLP

Prometheus Labs., Inc. v. Roxane Labs., Inc. (Fed. Cir. 2015)

The Federal Circuit affirmed a judgment of invalidity based on obviousness in a decision rendered in Prometheus v Roxane. In doing so, the Court might also have given an indication of the types of claims for "personalized...more

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Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

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Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

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FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

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Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

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Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

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On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more

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