News & Analysis as of

Patent Infringement Enablement Inquiries Pharmaceutical Patents

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Written Description and Enablement Depend on What a Patent 'Claims,' Not What the Claims Cover

The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more

Lathrop GPM

Federal Circuit Upholds Validity of Entresto Patent In Precedential Decision Concerning Written Description and Enablement

Lathrop GPM on

In a Jan. 10 precedential ruling by the United States Court of Appeals for the Federal Circuit, the validity of the U.S. patent covering Novartis’s blockbuster drug Entresto was upheld, reversing an earlier decision by the...more

Knobbe Martens

Federal Circuit Revisits Standard for Enablement of Antibody Claims

Knobbe Martens on

In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the...more

Levenfeld Pearlstein, LLC

Enablement Unchanged: Amgen v. Sanofi and the Future of Software Patents

In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more

Axinn, Veltrop & Harkrider LLP

The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi

The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more

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

Amgen Inc. v. Sanofi Live Coverage

On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

Knobbe Martens

“Some” Enablement Isn’t Enough for PacBio

Knobbe Martens on

PACIFIC BIOSCIENCES OF CALIFORNIA v. OXFORD NANOPORE TECHNOLOGIES - Before Lourie, Taranto, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: Enablement is required for...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

Smart & Biggar

Federal Court finds Eli Lilly’s tadalafil dosage form and process patents invalid

Smart & Biggar on

UPDATE: On September 30, 2020, Eli Lilly appealed both decisions by Justice St-Louis: Eli Lilly v Apotex (A-234-20 and A-239-20); Eli Lilly v Pharmascience and Riva (A-236-20); Eli Lilly v Mylan (A-237-20); and Eli Lilly v...more

McDermott Will & Emery

Broad Genus of HCV Compounds Wasn’t Enabled or Described

McDermott Will & Emery on

In a case relating to compounds for the treatment of the Hepatitis C virus (HCV), the US Court of Appeals for the Federal Circuit upheld a district court’s grant of judgment as a matter of law (JMOL) for lack of enablement...more

Knobbe Martens

Federal Circuit Review - October 2019

Knobbe Martens on

The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Patterson Belknap Webb & Tyler LLP

Hepatitis C Patent Falls for Non-Enablement, Wiping Out $2.5 Billion Infringement Verdict

In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

One-E-Way, Inc. v. ITC, Fed. Cir. Case 2016-2105 (June 12, 2017) - A divided panel reverses a determination of indefiniteness by the ITC, ruling that under Nautilus, the claim language, in combination with the...more

Goodwin

UPDATE Amgen v. Apotex: Amgen argues they have met their burden to prove infringement

Goodwin on

As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written...more

Goodwin

Amgen v. Apotex: District Court Decides that the ’138 Patent is Not Invalid on Some Grounds; Enablement is Still an Open Issue

Goodwin on

As we previously reported, on July 5, the Federal Circuit affirmed the district court’s grant of a preliminary injunction enjoining Apotex from launching its biosimilar version of Amgen’s Neulasta (pegfilgrastim) until it...more

Foley & Lardner LLP

Lumigan Patents Upheld by Unexpected Results

Foley & Lardner LLP on

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013)

A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This...more

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