Category Archives: Federal Circuit Decisions

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Federal Circuit Vacates Natural Product Challenge Of Dietary Supplement Claims

In Natural Alternatives Internat’l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. The claims at issue included method of treatment, product, and manufacturing claims. Here, I focus on the product claims. While the decision provides a … Continue reading this entry

Termination Of Product Development Precludes Standing To Appeal PTAB IPR Decision Upholding Patent

In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast to Amerigen, where the court found standing for a would-be generic competitor whose ANDA was subject to a Paragraph III certification against the … Continue reading this entry

Federal Circuit Digs Deeper Hole For Diagnostic Methods

In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, the Federal Circuit once again held diagnostic method claims invalid under 35 USC § 101. Footnote 4 of the majority decision blames the Supreme Court for this outcome, but Judge Newman’s dissent outlines her views on how the court could have followed all relevant Supreme Court … Continue reading this entry

Federal Circuit Affirms PTAB Lead Compound Analysis Upholding Vimpat Lacosamide Patent

The Federal Circuit decision in Mylan Pharmaceuticals, Inc. v. Research Corporation Technologies, Inc., highlights the difficulty of challenging a patent directed to a new chemical entity. The court affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that upheld the validity of RCT’s Vimpat lacosamide patent, which is approved for the treatment … Continue reading this entry

Federal Circuit Invalidates PTA Deduction Without Applicant Delay

In a long-awaited decision in Supernus Pharmaceuticals, Inc. v. Iancu (argued December 2017), the Federal Circuit held that the USPTO improperly imposed a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.” The PTA deduction at issue was charged under 37 CFR § 1.703(c)(8) … Continue reading this entry

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 claims against an obviousness challenge, including a factor that doesn’t always get much attention.… Continue reading this entry

Orange Book Listing Creates Injury To Support Standing To Appeal IPR Decision

Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and Appeal Board (PTAB) in a IPR proceeding. In Amerigen Pharmaceuticals v. UCB Pharma GMBH, the Federal Circuit held that … Continue reading this entry

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 OTDP reference against a pre-URAA parent patent having the same priority date, and upheld the validity of an Orange Book-listed patent for Novartis’s Zortress® … Continue reading this entry

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 Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring … Continue reading this entry

Not-Quite Prior Art Supports Obviousness Of Copaxone Patents In IPR Proceedings

In Yeda Research & Development Co., v. Mylan Pharmaceuticals Inc., the Federal Circuit affirmed the decisions of the USPTO Patent Trial and Appeal Board (PTAB) finding three Copaxone patents invalid as obvious in parallel Inter Partes review (IPR) proceedings. The companion decision pertaining to related district court litigation caught my attention for its use of originally confidential statements to FDA as … Continue reading this entry

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 sclerosis invalid as obvious. One thing that caught my attention was the use of originally confidential statements to FDA as evidence of … Continue reading this entry

Don't Touch That Priority Claim!

In Natural Alternatives Intl. Inc. v. Iancu, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that the patent at issue was not entitled to its earliest claimed priority date because NAI had deleted priority claims in a parent application that broke the priority chain. This decision highlights that a … Continue reading this entry

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 arguments on appeal, but this article focuses on the impact of a blocking patent on consideration of objective indicia of non-obviousness.… Continue reading this entry

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 brought in an Inter Partes Review (IPR) proceeding. In so doing, the court outlined four ways to prevail against … Continue reading this entry

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 (PTAB) and Federal Circuit an opportunity to explain and further define that category of prior art. GoPro, Inc. v. Contour IP … Continue reading this entry

FDA Xyrem Meeting Materials Qualify As Printed Publication

In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on appeal was whether FDA meeting materials available on a web page published in a Federal Register Notice qualified as a “printed publication” under 35 … Continue reading this entry

CAFC Finds Publication Did Not Inherently Disclose Aveed Composition

In Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art disclosed clinical studies that used the formulation, the Federal Circuit agreed the disclosures were not sufficient for inherency-based invalidity. … Continue reading this entry

Federal Circuit Upholds Zomig Patents Finding Intranasal Delivery Not Obvious

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 zolmitriptan formulations). Although an asserted reference could have been read to suggest an intranasal composition of zolmitriptan, both the district court and the Federal … Continue reading this entry

Federal Circuit Chastises PTAB Over Moving Target On Ex Parte Appeal

The Federal Circuit decision in In re Durance is a rare precedential decision in an ex parte appeal from a Patent Trial and Appeal Board (PTAB) decision rejecting a pending patent application. The Court took the USPTO to task for making the rejection a moving target throughout the appeal process and failing to consider Reply Brief … Continue reading this entry

Federal Circuit Finds Incorporation By Reference Inadequate For Priority Claim

In Droplets, Inc. v. E*Trade Bank, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that Droplet’s patent was not entitled to the priority date of a provisional application because of a defect in the priority claim. In so doing, the court held that the statutory requirement for a “specific … Continue reading this entry

Federal Circuit Finds INOMax Mental Steps Obvious As Ineligible Printed Matter

In Praxair Distrib., Inc. v. Mallinckrodt Hospital Prods. IP Ltd., the Federal Circuit found that the printed matter doctrine applies equally to physically embodied information and mental steps, and can be invoked in the patent eligibility context under 35 USC § 101 or the patentability context under 35 USC §§ 102 and 103. Does the court’s holding raise another … Continue reading this entry

Claim Construction Of An Enantiomeric Chemical Structure

In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of Latuda®. While the decision was in favor of the patentee, the required analysis suggests that applicants may want to consider using … Continue reading this entry

Federal Circuit Finds ANDA Jurisdiction Before PIV Certification

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was sufficient to establish infringement in the ANDA context. Here, we highlight the Federal Circuit’s threshold decision that the district court … Continue reading this entry

How The Fanapt Product Label Established Infringement Of Personalized Treatment Claims

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we consider how the Fanapt label was sufficient to establish infringement of personalized treatment claims in the ANDA context.… Continue reading this entry