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USPTO Issues Updated Guidance on Obviousness

For the first time in nearly 15 years, the U.S. Patent and Trademark Office (USPTO) has issued “Updated Guidance for Making a Proper Determination of Obviousness” under the U.S. Supreme Court’s ruling in KSR Int’l Co. v....more

Obviousness Of Method Claim Requires Expectation of Success for Recited Purpose

In Eli Lilly and Co. v. Teva Pharmaceuticals International GmbH, the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board decision upholding Teva’s patents directed to specific methods of treatment using an...more

Evidence of Copying Must Be Considered In Obviousness Analysis

In Liqwd, Inc. v. L’Oreal USA, Inc., the Federal Circuit vacated a decision of the USPTO Patent Trial and Appeal Board (PTAB) that failed to take into account evidence of copying in its obviousness analysis. The Federal...more

Federal Circuit Reverses PTAB On Reasonable Expectation Of Success For TARCEVA Patent

In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more

A Fresh Look At The Lead Compound Analysis

I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the...more

Federal Circuit Says No OTDP Between Novartis Patents That Straddle URAA

In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an...more

Federal Circuit Protects Novartis Gilenya Patent From Obviousness-Type Double Patenting

In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the...more

Invalidity Of Copaxone Patents Supported By Statements To FDA

In In re Copaxone Consolidated Cases, the Federal Circuit affirmed the district court decision finding four patents directed to a specific dosing regimen for using COPAXONE® 40 mg/ml to treat patients with relapsing multiple...more

Federal Circuit Takes A Narrow View Of Reasonable Expectation Of Success

The Federal Circuit decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. addressed several aspects of obviousness doctrine. We previously wrote about the impact of a blocking patent on consideration of objective...more

Blocking Patent Discounts Objective Indicia Of Non-Obviousness

In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court decision finding four Acorda Orange Book-listed patents for Ampyra® invalid as obvious. Acorda raised a number of...more

Federal Circuit Outlines Four Options For Overcoming Obviousness Rejections Based On Routine Optimization

In E.I. DuPont De Nemours & Co. v. Synvina C.V., the Federal Circuit reversed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that had upheld Synvina’s chemical process patent against an obviousness challenge...more

Sales Catalog From Dealer Trade Show Qualifies As Printed Publication

Petitioners in Inter Partes Review proceedings have looked beyond typical patent and scientific literature to find a “printed publication” that might invalidate a patent. This has given the USPTO Patent Trial and Appeal Board...more

Federal Circuit Upholds Zomig Patents Finding Intranasal Delivery Not Obviousness

In Impax Laboratories Inc. v. Lannett Holdings Inc., the Federal Circuit upheld the district court decision finding that defendants had failed to establish obviousness of AstraZeneca’s Zomig patents (directed to intranasal...more

Federal Circuit Emphasizes Need For Reasonable Expectation Of Success

In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the...more

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

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