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Personalized Medicine Patent Litigation

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

Foley & Lardner LLP

Unpacking The Solicitor General’s Brief In Vanda

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Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders...more

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

Foley & Lardner LLP

Personalized Therapy Patent Falls as Patent-Ineligible

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In a non-precedential opinion, the Federal Circuit held as patent-ineligible patent claims to personalized therapy to treat patients who would benefit from inhaled nitric oxide treatment and withhold treatment from patients...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

Foley & Lardner LLP

Federal Circuit Finds Method Withholding Treatment Ineligible For Patenting

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In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting “excluding” specific patients from treatment...more

Husch Blackwell LLP

Personalized Medicine Patents: Federal Circuit Gives Personalized Medicine Patents A Shot In The Arm

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For those of you who may have lost hope regarding the patentability of personalized medicine discoveries, here’s some encouragement. Recently the Federal Circuit affirmed the validity of a patent directed to a method of...more

Foley & Lardner LLP

Inherent Disclosure Satisfied Written Description

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In Yeda Research and Development Co., Ltd. v. Abbott GMBH & Co. KG, Slip Op. 2015-1662 (Fed. Cir. 2016), the Federal Circuit held that a claim to an isolated protein described by its partial amino acid sequence satisfies 35...more

Foley & Lardner LLP

Federal Circuit’s Recent Primer on Patent-Eligibility

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A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception. Rapid Litig. v. CellzDirect, Inc.., 2015-1570...more

Foley & Lardner LLP

Supreme Court Deals Blow To Diagnostic Method Patents, Denies Cert In Sequenom

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“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom, the silence is deafening–and could have a chilling impact...more

Foley & Lardner LLP

Will the Supreme Court Clarify Patent-Eligibility?

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The United States Supreme Court is set to render its decision on the grant or denial of Sequenom, Inc.’s (“Sequenom’s”) petition for writ of certiorari that posed the issue: ..Whether a novel method is patent-eligible...more

Ladas & Parry LLP

IP Developments In Biotechnology And Trade Secrets

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2016 has been a year of IP changes and these changes have had an effect upon biotechnology as well as trade secrets. Patents: Will the U.S. Supreme Court Grant Cert. In Ariosa v. Sequenom? Ariosa v. Sequenom was...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

Foley & Lardner LLP

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

Foley & Lardner LLP

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

Foley & Lardner LLP

Patent Subject Matter Eligibility – Impact on Litigation and Prosecution

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Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that...more

Foley & Lardner LLP

Protecting Diagnostic Innovation – Two Actor Infringement Liability

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In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more

Foley & Lardner LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

The ACLU, Working for the Man

The ACLU championed its efforts in the AMP v. Myriad case as being another instance of the group fighting for the rights of the many and the powerless against corporate America and the oligarchical few. In a paradox, it now...more

Foley & Lardner LLP

Another Patent Challenge for Personalized Medicine

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The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

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