News & Analysis as of

Petition for Writ of Certiorari Patents Pharmaceutical Patents

Fitch, Even, Tabin & Flannery LLP

U.S. Supreme Court to Consider “Full Scope” Enablement of Claims

On November 4, the United States Supreme Court granted a petition for writ of certiorari to review the Federal Circuit’s decision in Amgen Inc., v. Sanofi. Certiorari was limited to the question of whether the enablement...more

Knobbe Martens

Medical Device Patentee Petitions Supreme Court Regarding On-Sale Bar and Price Quotes

Knobbe Martens on

A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more

White & Case LLP

Biogen rehearing denied: Is SCOTUS the next step?

White & Case LLP on

On March 16, 2022, the Court of Appeals for the Federal Circuit denied Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc. ("Petition Denial"), in which a Federal Circuit...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions: Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V.,...

Mylan appealed from a Patent Trial and Appeal Board (Board) discretionary denial of institution of an inter partes review (IPR) proceeding. The Board declined to institute Mylan’s IPR under NHK-Fintiv, a multi-factor analysis...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

Kilpatrick

Amgen Petitions for Certiorari to Reconsider Enablement of Genus Claims

Kilpatrick on

As we reported earlier this year, Amgen filed a petition for rehearing en banc to the Federal Circuit, arguing that the panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims with...more

Kilpatrick

Balancing Hatch Waxman and the Sham Litigation Exception

Kilpatrick on

As previously reported on March 31, 2021, AbbVie Inc. has petitioned the U.S. Supreme Court for a writ of certiorari to review the Third Circuit’s ruling determining the biopharma company’s patent infringement suit was a sham...more

Haug Partners LLP

Objective Indicia of Nonobviousness – Considered as Part of a “Totality of the Evidence” Approach or a “Prima Facie Framework”?

Haug Partners LLP on

On February 11, 2021, Amarin Pharma, Inc. (“Amarin”) filed a petition for a writ of certiorari with the Supreme Court seeking reversal of the Federal Circuit’s decision to affirm a finding that Amarin’s patents are invalid as...more

Fenwick & West LLP

Written Description of Therapeutic Efficacy

Fenwick & West LLP on

Inventors are generally counseled to file a patent application as soon as they have a patentable invention to avoid potential forfeiture of important rights in today’s first inventor-to-file system. However,...more

Haug Partners LLP

Are Biopharma Genus Patent Claims Dead?

Haug Partners LLP on

A recent Supreme Court petition for certiorari alleges that genus claims are no longer viable under the Federal Circuit’s recent application of enablement and written description law.The petition has huge ramifications not...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #3

C.R. Bard Inc. v. AngioDynamics, Inc., Appeal No. 2019-1756, -1934 (Fed. Cir. Nov. 10, 2020) - Our Case of the Week is one of two cases decided this week in which the Federal Circuit finds that a district court jumped the...more

McDonnell Boehnen Hulbert & Berghoff LLP

DOE Infringers Petition for Certiorari over PHE "Tangential Relationship" Test

Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...more

McDonnell Boehnen Hulbert & Berghoff LLP

Solicitor General Recommends That Supreme Court Deny Certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals

On Friday, December 6, 2019, the United States filed its brief in response to the March 18, 2019 order of the Supreme Court inviting the Solicitor General to express the views of the United States on the petition for...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Amgen v. Sanofi

The Supreme Court denied certiorari last week in Amgen Inc. v. Sanofi, in a case that asked the Court to review the Federal Circuit's jurisprudence related to the written description requirement of 35 U.S.C. § 112(a)....more

Jones Day

PTAB Denies Stay Pending Sovereign Immunity Cert Petition

Jones Day on

In Microsoft Corp. v. Saint Regis Mohawk Tribe, the PTAB refused to stay ten IPRs filed by Microsoft while Patent Owner St. Regis appeals a Federal Circuit decision that tribal sovereign immunity cannot be asserted in an IPR...more

Kramer Levin Naftalis & Frankel LLP

Supreme Court Issues Highly Anticipated Decision Interpreting the Biologics Price Competition and Innovation Act

On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to reach the high court. The BPCIA establishes a regulatory pathway for...more

Kramer Levin Naftalis & Frankel LLP

Supreme Court to Consider Biologics Price Competition and Innovation Act

On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more

Goodwin

Breaking News: Supreme Court Grants Petition and Cross-Petition for Certiorari in Amgen v. Sandoz

Goodwin on

The Supreme Court has granted Sandoz’s petition for certiorari, and Amgen’s cross-petition for certiorari in Amgen v. Sandoz. The Order is excerpted below and can be found here...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Releases Memorandum on Subject Matter Eligibility

On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amicus Briefs in Support of Sequenom's Petition for Certiorari: Dr. Chakrabarty, A Scientist's View

In March, following the Federal Circuit's denial of Sequenom's petition for rehearing en banc, Sequenom filed a petition for certiorari for Supreme Court review of the Federal Circuit's decision in Ariosa Diagnostics, Inc. v....more

McDonnell Boehnen Hulbert & Berghoff LLP

Amicus Briefs in Support of Sequenom's Petition for Certiorari: Eli Lilly and Company et al.

In March, following the Federal Circuit's denial of Sequenom's petition for rehearing en banc, Sequenom filed a petition for certiorari for Supreme Court review of the Federal Circuit's decision in Ariosa Diagnostics, Inc. v....more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post: Coalition for 21st Century Medicine Comments on Expected Ariosa Cert Petition

The collective experience of the Members of the Coalition for 21st Century Medicine in trying to obtain much needed patent protection for their novel, life-saving technologies has led to one inescapable conclusion: It is...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Denies En Banc Petition in Amgen v. Sandoz

The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more

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