Enablement Inquiries

News & Analysis as of

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

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

Plausibility vs. Enablement

U.S. Patent No. 8,330,305 covers protecting devices from impact damage. The patent claims detecting that the portable device will impact a surface, and, if the risk of damage to the portable device from the impact exceeds a...more

Prior Art Enablement Looks to Applicant’s Specification to Determine Ordinary Level of Skill - In re Morsa

Addressing the issue of whether an anticipatory prior art reference was enabling, the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the U.S. Patent Trademark Office (USPTO) Board of Patent Appeals and...more

Morsa II: Admissions Enable Prior Art

In its 2013 decision in In re Morsa, the Federal Circuit vacated an anticipation rejection where “both the Board and the examiner failed to engage in a proper enablement analysis” to establish the enabling quality of the...more

Enablement: Multiple Measurement Methods Can Lead to the Same Result - Ethicon Endo-Surgery, Inc. v. Covidien, Inc.

Addressing the issues of indefiniteness and non-infringement for both utility and design patents, the U.S. Court of Appeals for the Federal Circuit reversed and vacated in part the district court’s grant of summary judgment...more

Claimed Formulation Not Obvious Despite Recitations Falling Within Prior Art Ranges - Allergan, Inc. v. Sandoz Inc.

Addressing obviousness issues, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s finding that patents were valid and infringed, despite undeniably including recitations falling within a prior art...more

The Value Of Prophetic Examples

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 against obviousness, written...more

Lumigan Patents Upheld by Unexpected Results

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

Attacking Patents on Written Description & Enablement Grounds in Inter Partes Review

Although Inter Partes Review (IPR) is limited to grounds of unpatentability based upon prior art references, it is nevertheless possible to raise issues of written description or enablement by applying intervening prior art...more

Saul better make his own call: new liability for enablers of organised crime

The law in England and Wales will shortly be reformed so that those enabling the criminal activities of an organised crime group, including professionals, can be prosecuted more easily. All businesses need to be alive to the...more

Enablement is Key – Especially in Biotech Patents

Enablement is the requirement that a patent teach a person skilled in the art (the field of the invention) how to make and use the invention without undue experimentation. In other words, a patent must describe the invention...more

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

Federal Circuit Finds Wyeth Restenosis Claims Invalid as Not Enabled

In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112....more

Federal Circuit Finds Prosecution History Disclaimer in Enablement Arguments

In Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit upheld a narrow claim interpretation based on prosecution history disclaimer. The court held that the applicants’ arguments against an enablement rejection...more

Challenging the Enabling Quality of Prior Art

In In re Morsa, the Federal Circuit reversed an anticipation rejection where the applicant had challenged the enabling quality of the cited prior art reference, even though the applicant had not submitted evidence in support...more

Patent Watch: In Re Morsa

On April 5, 2013, in In re Morsa, the U.S. Court of Appeals for the Federal Circuit (Rader, Lourie, O'Malley*) affirmed-in-part, vacated-in-part and remanded the USPTO Board of Patent Appeals and Interferences decision...more

Federal Circuit Upholds Fentora Patents, But Affirms Non-Infringement

In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s...more

Patent Watch: Cephalon, Inc. v. Watson Pharms., Inc.

On February 14, 2013, in, the U.S. Court of Appeals for the Federal Circuit (Reyna, Bryson, Wallach*) reversed-in-part and affirmed-in-part the district court's judgment following a bench trial that Watson did not infringe...more

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