News & Analysis as of

Pharmaceutical Patents

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited

by Knobbe Martens on

Federal Circuit Summaries - Before Prost, Lourie and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: When another patent for a drug issues after an ANDA is filed, there can...more

In Rare Decision, PTAB Grants Request for Rehearing, Reverses its Prior Decision, and Institutes IPR

Requests for rehearing at the Patent Trial and Appeal Board (the “Board”) are not uncommon; however, the Board rarely grants them. One reason for this result is the high standard applied to reverse a prior decision—abuse of...more

Federal Circuit Finds Personalized Medicine Invention Subject Matter Eligible

by Dorsey & Whitney LLP on

The Federal Circuit recently held claims for a personalized medicine treatment were patent eligible and valid. The claims at issue were directed toward administering specific dosages of a drug in the presence or absence of a...more

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Federal Circuit Upholds Vanda Fanapt Personalized Method Claims Against Patent Eligibility Challenge

by Foley & Lardner LLP on

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a...more

Federal Circuit Holds Vanda’s Method of Treatment Claims Pass Mayo/Alice’s Step One

by Morgan Lewis on

In a much-anticipated decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the US Court of Appeals for the Federal Circuit on April 13 affirmed the district court’s holding that Vanda’s...more

IP Rights Reform Is Price to Pay for Revamped Trans-Pacific Partnership Agreement

by Jones Day on

The Situation: Following the U.S. withdrawal from the original Trans-Pacific Partnership ("TPP") agreement last year, the 11 remaining TPP countries agreed to implement the original text in a new "TPP-11" agreement. However,...more

Hatch-Waxman goes to Taiwan

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more

Despite Change in Motion to Amend Practice by Aqua Products, PTAB Orders Scope of Remand to be Limited to Federal Circuit’s...

by Knobbe Martens on

In an IPR on remand from the Federal Circuit on appeal of a motion to amend, the PTAB considered the scope of briefings of the parties in view of the Federal Circuit’s recent en banc decision Aqua Products v. Matal. The PTAB...more

USPTO Says Overlapping Range In Prior Art Insufficient to Invalidate Method of Treatment Patent

by Dechert LLP on

Pharmaceutical patents frequently claim treatment methods that utilize a range of amounts or concentrations for the active ingredient or excipients included in the formulation. Given the prevalence of such patents, there is...more

Luitpold Pharmaceuticals, Inc. v. Pharmacosmos A/S (Fed. Cir. 2018)

Which parties to an IPR proceeding have standing to either appeal or participate in an appeal from an adverse final written decision by the Board? The Federal Circuit had previously held that a petitioner that did not...more

Global Patent Prosecution Newsletter - April 2018

Patents and a New Patent Linkage System in Taiwan - Patent protection in Taiwan is becoming of everincreasing importance as the country’s economic influence grows worldwide. The April 2018 issue of Sterne Kessler’s Global...more

Celltrion Moves for Summary Judgment in Janssen v. Celltrion

by Goodwin on

Last week, in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), Judge Wolf of the U.S. District Court for the District of Massachusetts granted...more

IPR Updates Relating to Adalimumab and Rituximab

by Goodwin on

Last week, the Patent Trial and Appeal Board (“Board”) instituted inter partes review of two patents directed to methods of administering adalimumab for the treatment of psoriasis, based on petitions filed by Sandoz:...more

Federal Circuit Review - March 2018

by Knobbe Martens on

Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more

USP States That It Will Not Revise Biologics Monographs Without Stakeholder Consensus

by Goodwin on

USP stated last week that it will not develop new product-specific monographs for biologics without stakeholder consensus in supporting their creation, including the support of FDA. USP had proposed revisions for these...more

Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit

Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in connection with Adello’s proposed biosimilar of Amgen’s...more

Immunex Files Reply In Support of Motion To Stay Dupixent® Patent Litigation

by Goodwin on

In the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex has filed a reply brief in support of its motion to stay the...more

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar...

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing...more

French Cour de Cassation Clarifies Requirement of Plausibility

by Jones Day on

The Decision: The French Cour de cassation, in a case concerning a dosage regime patent, recently clarified the "plausibility" requirement, an element of sufficiency of disclosure or inventive step. The Result: The wording...more

Judge Stark (D. Del.) Holds Generic Label is Insufficient to Prove Induced Infringement

GlaxoSmithKline v. Teva, No. 14-878-LPS-CJB (D. Del)- Following a seven-day trial last year, a jury found that Teva willfully induced infringement of claims of U.S. Patent No. RE40,000 from January 2008 to April 2011...more

AbbVie and Samsung Bioepis Announce Global Settlement of Adalimumab Disputes

by Goodwin on

Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for...more

Rx IP Update - March 2018

by Smart & Biggar on

No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more

No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding

by Smart & Biggar on

What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations against a generic entrant, but subsequently prevails in an infringement action...more

The Federal Circuit Stays IPR Pending Review of the PTAB’s Denial of St. Regis Mohawk Tribe’s Sovereign Immunity

by Knobbe Martens on

The PTAB ruled that the Saint Regis Mohawk Tribe could not assert sovereign immunity in IPRs of patents that Allergan had assigned to the Tribe relating to Restasis®. See The Saint Regis Mohawk Tribe is not entitled to...more

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