Life Sciences Patents

News & Analysis as of

Business Litigation Report - August 2016

Circuit Courts Align to Shield SEC Administrative Proceedings from Collateral Constitutional Attack - In response to the financial crisis of the late 2000s, Congress passed the Dodd-Frank Wall Street Reform and Consumer...more

PTAB Life Sciences Report

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents....more

Federal Circuit Finds Life Sciences Subject Matter Patent Eligible

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion vacating the summary judgment of invalidity of U.S. Patent No. 7,604,929 (“the ’929 Patent”) and sent the case back to the District Court...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

PTO Provides Additional Guidance on Patent Eligibility of Life-Sciences Method Claims

On July 14, 2016, the PTO sent a memorandum to the examining corps regarding the recent rulings in Rapid Litigation Management Ltd. v. Cellzdirect, Inc., Appeal No. 2015-1570 (Fed. Cir. July 5, 2016), and Ariosa Diagnostics,...more

Method For Preserving Hepatocytes Patent-Eligible, Despite Use Of Newly-Discovered Natural Cell Characteristics

Rapid Litigation Management, Inc. v. CellzDirect, Inc., No. 2015-1570 (Fed. Cir. July 5, 2016) - The Federal Circuit recently held that a patent covering a process for producing a preparation of frozen liver cells...more

Federal Circuit Offers Path Through Section 101 Thicket for Biotech Method Patents

In its July 5, 2016 decision in Rapid Litigation Management Ltd and In Vitro, Inc. v. CellzDirect, Inc. and Invitrogen Corp., the Federal Circuit held that patent claims directed to an improved method of cryopreserving...more

Carry on as Before: Supreme Court Refuses Sequenom’s Petition

To the surprise of many, including myself, the Supreme Court denied Sequenom’s petition for writ of certiorari (“Petition”). Sequenom asked the Court whether the inventive concept required under the Mayo/Myriad framework can...more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

Femto-Sec Tech, Inc. v. Lensar, Inc. (C.D. Cal. 2016)

Patent Having Claims That Apply Law of Nature Is Patent-Eligible - On June 8, 2016, the U.S. District Court for the Central District of California issued an order denying a motion to dismiss, and found that U.S. Patent...more

Subject Matter Eligibility Guidance -- Example on Screening for Gene Alterations

Last month, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

UPDATE: Subject Matter Eligibility under 35 U.S.C. § 101 – Life Sciences

The United States Patent And Trademark Office (USPTO) issued a memorandum on May 4, 2016 (May 2016 Memo) to the Patent Examining Corps to provide further Examiner instructions relating to subject matter eligibility under 35...more

U.S. Trade Representative Issues 2016 Special 301 Report

On April 27th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR), issued the 2016 Special 301 Report. According to the USTR website, "[i]ntellectual property is a critical source of economic growth and...more

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

USPTO Updates Alice Guidance with Examiner Instructions, More Work Needed

On May 4, the USPTO issued a new memorandum for patent examiners, “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection” (“Examiner...more

Patentable Subject Matter in the Life Sciences: New USPTO Guidance Impacts Diagnostic Methods and Natural Products

The United States Patent and Trademark Office issued on May 6, 2016, updated guidance to its patent Examiners that would have an impact on patent applications covering diagnostic methods and natural products. The new...more

USPTO Releases Patent Eligibility Update

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

USPTO Issues Subject Matter Eligibility Update

On May 5, 2016, the USPTO published a Memorandum to the Patent Examining Corps titled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” The...more

USPTO Releases Next Iteration of Examiner Guidance on Patent Subject Matter Eligibility

On May 5, 2016, the USPTO released an update to its examiner guidance on patent subject matter eligibility. The update includes a new set of life science examples, a memorandum to the patent examining corps with instructions...more

May 2016 Update to Examiner Guidance on Patent Subject Matter Eligibility

A Federal Register notice is scheduled to publish on May 6, 2016 updating the 2014 interim guidance on patent subject matter eligibility and the July 2015 update on subject matter eligibility. On May 4, 2016, a related...more

Supreme Court Denies Petition to Review Expanded Theory of Joint Infringement

On Monday the Supreme Court denied certiorari in Limelight Networks Inc. v. Akamai Technologies Inc. et al, Case No. 15-993. Limelight had petitioned the Court in January, urging for review of the Federal Circuit’s en banc...more

Legislative Developments in Post-Grant Proceedings

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

Celltrion Opposes Expedited Trial and Delayed Launch Date

On Monday, Celltrion filed a response to the letter Janssen submitted to the Court on April 12 requesting an expedited trial schedule. Celltrion maintains that Janssen improperly argues the merits of Janssen’s claim of...more

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the...more

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