News & Analysis as of

Life Sciences Supreme Court of the United States

Merck Sharp & Dohme B.V. v. Warner Chilcott Co. (Fed. Cir. 2017)

The Supreme Court most recently revisited the proper standards for making an obviousness determination ten years ago, in KSR Int'l. Co. v. Teleflex. Inc. While in some ways changing the obviousness standard, for example...more

Business Litigation Report - August 2017

Supreme Court Highlights Importance of Statute-Specific Venue Rules - The Supreme Court upended nearly thirty years of practice when it ruled, in the TC Heartland LLC v. Kraft Foods Group Brands LLC U.S. , 137 S.Ct. 1514...more

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

[Webinar] What TC Heartland Means for Your Business: Practical Strategies For The Next Era Of Patent Litigation - June 29th,...

by BakerHostetler on

This timely webinar will provide insight for business leaders and legal counsel on the implications of the recent U.S. Supreme Court decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, which has reshaped procedural...more

The Importance of Label Licenses to Life Sciences Companies After Lexmark

On May 30, 2017, in Impression Products, Inc. v. Lexmark International, Inc., the U.S. Supreme Court held that a domestic or foreign sale of a patented product exhausts all U.S. patent rights in that product. The case was...more

Industry Perspectives On The Biosimilar Patent Dance

by Foley & Lardner LLP on

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

Potential Impact of the Supreme Court’s Decision to Review the PTAB’s Practice of Issuing Partial Final Written Decisions in...

In a case with potential wide-ranging ramifications for patent validity challenges, on May 22, 2017, the Supreme Court granted a writ of certiorari in an appeal from an inter partes review (“IPR”) decision, SAS Institute v....more

Chemistry & Nanotechnology Developments to Watch in 2017

As cases and outcomes make their way into the news this year, we will be watching the following developments closely and sharing them with the IP community....more

Supreme Court Limits Foreign Reach of the U.S. Patent Act

The supply from the United States of a single component of an invention, for assembly of the invention abroad, is not patent infringement under Section 271(f)(1) of the Patent Act. This is according to a unanimous ruling this...more

Supreme Court Grants Certiorari in Amgen v. Sandoz

by Knobbe Martens on

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

Biosimilars: Supreme Court Grants Certiorari in Amgen v. Sandoz

On Friday, January 13, the Supreme Court granted certiorari in Amgen v. Sandoz (Nos. 15-1039 & 15-1195). The Supreme Court originally deferred its decision on the parties’ certiorari petitions in order to consider the...more

USPTO's Patent Subject Matter Eligibility Roundtable on Dec. 5, 2015

by Fenwick & West LLP on

On December 5, 2016 the USPTO will hold its second Patent Subject Matter Eligibility Roundtable to discuss issues in patent eligibility. The USPTO published a list of eighteen questions in anticipation of the event, dealing...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

Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility...

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic...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

May 2016 Update to Examiner Guidance on Patent Subject Matter Eligibility

by Reed Smith on

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

by Fish & Richardson on

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

Biotech Industry Supports Cert in Sequenom to Avert “Crisis of Patent Law and Medical Innovation”

The biotechnology and life sciences community has voiced broad support for Sequenom’s recent request that the Supreme Court review the Federal Circuit’s decision holding Sequenom’s diagnostic fetal DNA patent ineligible under...more

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

by BakerHostetler on

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

Judge Dyk Would Add Reduction To Practice To Patent Eligibility Requirement

by Foley & Lardner LLP on

As noted in a previous article, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc.. The per curiam order was accompanied by two separate concurring opinions, one authored by Judge Lourie...more

Three Pressing Challenges for Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Can a natural product still be patented in Australia?

by FPA Patent Attorneys on

Yes. While various commentaries have suggested that patentable subject matter will be restricted in Australia under the recent High Court Myriad decision to exclude naturally occurring products (whether or not isolated), my...more

What did the Australian High Court actually say about the patent eligibility of cDNA?

by FPA Patent Attorneys on

As the dust from the impact of the Australian Myriad decision begins to settle, now is the time to revisit what many have said regarding patent eligibility of cDNA, against what the final appeal Court actually said. On...more

“Does a nucleic acid constitute patent eligible subject matter under Australia law?”

by FPA Patent Attorneys on

That is the question that we hoped Australia’s final appeal Court to have answered in the Myriad decision that it handed down last week. Some observers have been quite forthright on the point: ‘Yes, the High Court of...more

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