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Federal Circuit Finds NuvaRing Patent Nonobvious Without Hindsight

In a non-precedential decision issued in Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling as being improperly grounded in hindsight. This decision...more

Federal Circuit Schools USPTO On Broadest Reasonable Claim Construction

In recent decisions, the Federal Circuit has found error in the USPTO Patent Trial and Appeal Board’s approach to obviousness rejections, including its reliance on the doctrine of routine optimization without evidence of an...more

CAFC Finds Harmless Error in USPTO Reliance On Doctrine of Inherency

In Southwire Co. v. Cerro Wire LLC, the Federal Circuit upheld the USPTO decision rendered in an inter partes reexamination proceeding that found Southwire’s patent invalid as obvious. Although the court found that the USPTO...more

CAFC Vacates USPTO Single Reference Obviousness Rejection For Inadequate Showing Of Expectation of Success

In a split decision with Judge Lourie dissenting, the Federal Circuit vacated an obviousness rejection that had been affirmed in an ex parte appeal to the USPTO Patent Trial and Appeal Board. The decision was rendered in In...more

Federal Circuit Criticizes PTAB Reliance On Routine Testing

In Honeywell International, Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit vacated the decision of the USPTO Patent Trial and Appeal Board that invalidated Honeywell’s patent in an inter partes...more

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more

No Nexus For Novartis Gilenya Patent

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more

Court Rejects Theory Of Derivation Based On FDA Requirement

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more

Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patenting

The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors”...more

Federal Circuit Affirms Tygacil Formulation Patent

In Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline...more

Jazz Xyrem + Valproate Patent Claims Avoid IPR

The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute...more

Purdue OxyContin Patents Invalid Despite Stemming From Discovery Of Source Of Toxic Impurity

In Purdue Pharma L.P. v. Epic Pharma LLC, the Federal Circuit affirmed the district court decision holding four OxyContin patents invalid as obvious. In so doing, the court rejected Purdue’s arguments that its discovery of...more

PTAB Denies Challenge Of Abbvie Humira Patents

The USPTO Patent Trial and Appeal Board (PTAB) denied institution of two Inter Partes Review challenges brought by Amgen, Inc. against two Humira patents covering stable formulations of anti-human Tumor Necrosis Factor alpha...more

PTAB Trial Standard Of Review Requires Affirmance Despite Contrary Evidence

In Merck & Cie v. Gnosis S.p.A., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that held the challenged claims obvious in an Inter Partes Review (IPR) proceeding. Although the...more

Losing Competing Property Not A Teaching Away

In In re Urbanski, the Federal Circuit upheld the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding the claims of Urbanski’s patent application obvious. Urbanski had argued that the cited references taught...more

Obviousness Versus Obviousness-Type Double Patenting

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court’s finding that Prometheus’ claims were invalid as obvious, but in so doing it cited its own precedent regarding...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

PTAB Institutes Kyle Bass Lialda Patent IPR

After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more

Board Boots Bass Tecfidera IPR on the Merits

On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the...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

Simultaneous Invention as Secondary Evidence of Obviousness

I do not usually write about non-precedential Federal Circuit decisions, but I could not let the discussion of “simultaneous invention” in Columbia University v. Illumina, Inc., go without comment. As if protecting patents...more

Federal Circuit Says Secret Prior Art Is Prior Art for All Purposes

In Tyco Healthcare Group LP v. Ethicon Endo-Surgery, Inc., the Federal Circuit agreed with the district court that Ethicon’s prototype constituted prior art under 35 USC § 102(g) based on its earlier date of conception, but...more

Federal Circuit Notes High Burden of Invoking Inherency for Obviousness

In Par Pharmaceutical Inc. v. Twi Pharmaceuticals, Inc., the Federal Circuit vacated and remanded the district court decision holding the Par claims at issue obvious. The district court decision rested in part on the doctrine...more

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