MoFo Life Sciences

November 22, 2019 - United States, FDA, Litigation, Biotech, Healthcare, Pharma, Regulatory, Intellectual Property
FDA Approves 25th Biosimilar
On November 15, Pfizer’s adalimumab product became the 25th biosimilar approved by FDA under the Biologics Price Competition and Innovation Act (BPCIA). The road to the 25th approval has been long and has involved some of the biggest companies and medications in the pharmaceutical
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September 04, 2019 - United States, Litigation, Biotech, Pharma, Intellectual Property, Cell + Gene Therapy
Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel
By: Janet Xiao Ph.D. and Meghan McLean Poon Ph.D.
In a recent decision, Ajinomoto v. ITC , the Federal Circuit addressed the issues of doctrine of equivalents and prosecution history estoppel as applied to patent claims reciting specific amino acid sequence of a biologic. On appeal, the Federal Circuit affirmed the decision by
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July 09, 2019 - United States, Litigation, Pharma, Intellectual Property
Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy
By: Karen G Potter Ph.D.
On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services ,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature.
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June 05, 2019 - United States, Product Liability + Class Action, Litigation, Pharma
Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer
By: Erin M. Bosman and Julie Y. Park
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck Sharp &
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January 11, 2019 - Litigation, European Union, Pharma, Regulatory, Intellectual Property
The EU General Court’s Ruling on Pay for Delay
By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann
The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European Commission (“Commission”) decision. The Court confirmed the Commission’s finding that
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March 01, 2018 - United States, Litigation, Pharma, Intellectual Property
PTAB Rejects Tribal Immunity Proceedings
By: Matthew I. Kreeger
On February 23rd, 2018, a panel of the Patent Trial and Appeal Board (PTAB or “Board”) decided that: (1) Indian tribal sovereignty did not apply to post-grant proceedings established under the America Invents Act (AIA) and (2) licensing agreements between a tribe and a
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Topic Archives: Litigation

FDA Approves 25th Biosimilar

Analyzing Biologics Under the Doctrine of Equivalents and Prosecution History Estoppel

By: Janet Xiao Ph.D. and Meghan McLean Poon Ph.D.

Federal Circuit Diagnoses the Patent Eligibility Problem – But Denies a Remedy

By: Karen G Potter Ph.D.

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

By: Erin M. Bosman and Julie Y. Park

The EU General Court’s Ruling on Pay for Delay

By: Wolfgang Schönig, Andreas Grünwald, Jens Hackl, Theresa Oehm and Robert Grohmann

PTAB Rejects Tribal Immunity Proceedings

By: Matthew I. Kreeger