Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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Judge Finds Biosimilar Patent Procedures Optional

Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and...more

3/24/2015 - Biosimilars BPCIA FDA Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Sandoz v Amgen

The Remicade Biosimilar Patent Dispute

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of...more

3/11/2015 - Biologics Price Competition and Innovation Act of 2009 Biosimilars Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Sandoz

Why Did the Supreme Court GVR the Shire Lialda Case?

On January 26, 2015, the Supreme Court granted certiorari, vacated, and remanded Shire Development LLC v. Watson Pharmaceuticals, Inc., to the Federal Circuit “for further consideration in light of Teva Pharmaceuticals USA,...more

1/30/2015 - Certiorari Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Remand SCOTUS Shire Development v Watson Teva v Sandoz Vacated

Supreme Court Calls for Some Deference in Claim Construction Standard of Review

On January 20, 2015, the Supreme Court issued its decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., finding that the Federal Rules of Civil Procedure call for some deference in the claim construction standard of...more

1/23/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

Federal Circuit Judges Disagree on Use of Post Filing Date Evidence of Nonobviousness

On October 20, 2014, the Federal Circuit issued an order denying the petition for rehearing or rehearing en banc filed in Bristol-Meyers Squibb Co. v. Teva Pharmaceuticals, USA, Inc. While the order itself may not be...more

10/22/2014 - Bristol-Myers Squibb Obviousness Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Teva Pharmaceuticals

Update on Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

On September 17, 2015, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose...more

9/18/2014 - Biotechnology Chemicals Myriad-Mayo Patent-Eligible Subject Matter Patents Pharmaceutical Professional Conferences USPTO

Federal Circuit Finds Apotex ANDAs Do Not Infringe Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either...more

9/3/2014 - ANDA Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Humira Patent Invalid for Obviousness Type Double Patenting

In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, the Federal Circuit affirmed the district court’s finding that a second patent covering AbbVie’s Humira product is invalid under the doctrine of obviousness-type...more

8/26/2014 - Obviousness Patent Litigation Patents Pharmaceutical

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more

8/8/2014 - ANDA Antitrust Litigation FDA Pharmaceutical Prescription Drugs

Federal Circuit Holds That Even Functional Claims Require Structural Fence Posts

In AbbVie Deutschland Gmbh v. Janssen Biotech, Inc., the Federal Circuit affirmed the district court decision that found AbbVie’s patents directed to anti-IL-12 antibodies invalid for lack of adequate written description. As...more

7/14/2014 - Biotechnology Functionality Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents

Putting Structure and Function Into Context for USPTO Patent Subject Matter Eligibility Guidance

The USPTO’s ”Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” has been criticized for requiring a product to be markedly different in...more

7/9/2014 - Minerals Patent-Eligible Subject Matter Patents Pharmaceutical Pharmaceutical Patents Public Comment USPTO

Federal Circuit Looks for a Different Kind of Unexpected Results in BMS v. Teva

In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to...more

7/3/2014 - ANDA Bristol-Myers Squibb Obviousness Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs Teva Pharmaceuticals

The New USPTO Patent Eligibility Rejections Under Section 101

Well, it’s happening. Office Actions with new patent eligibility rejections based on the USPTO’s March 4, 2014 Guidance are being mailed out to patent practitioners across the nation. While some new rejections under §101 were...more

5/7/2014 - Guidance Update Patent-Eligible Subject Matter Pharmaceutical Pharmaceutical Patents Public Comment Section 101 USPTO

Update on Myriad Appeal and Announcing a Public Forum on the USPTO 101 Guidelines

Myriad has appealed the district court decision that denied its motion for a preliminary injunction against Ambry Genetics Corp. According to a report in Bloomberg BNA Life Sciences Law & Industry Report™, on April 14, 2014,...more

4/17/2014 - Ambry AMP v Myriad Appeals Life Sciences Myriad Myriad v Ambry Patent Infringement Patent Litigation Patents Pharmaceutical USPTO

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

4/15/2014 - FDA Generic Drugs Hoffman LaRoche Patent Litigation Patents Pharmaceutical Prior Art Summary Judgment

The State of Vaccines Under the USPTO 101 Guidelines

In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical...more

4/1/2014 - Biologics Pharmaceutical USPTO Vaccinations

Federal Circuit Finds Easy Solution to Avodart Solvate Written Description Question

Are claims that recite a “solvate” of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit...more

3/13/2014 - Chemicals Claim Construction FDA GlaxoSmithKline Patent Litigation Patents Pharmaceutical Written Descriptions

Do Pharmaceutical Compositions Have Patent Subject Matter Eligibility Under the New USPTO Guidelines?

The USPTO’s new patent subject matter eligibility guidelines (the “Guidelines”) include examples that apply the multi-factored analysis mandated by the Guidelines to compositions that include one or more “natural products” as...more

3/11/2014 - Patent Litigation Patent-Eligible Subject Matter Patents Pharmaceutical USPTO

Federal Circuit Upholds Lyrica Patents

In a non-precedential decision issued February 6, 2014, the Federal Circuit affirmed a district court decision that upheld the four Orange Book listed patents for Pfizer’s Lyrica® product. According to the court’s rules, the...more

2/12/2014 - Drug Compounding Patent Infringement Pfizer Pharmaceutical Pharmaceutical Patents Teva Pharmaceuticals Written Descriptions

The Danger of Self-Colliding Divisional Applications in the EPO

Last week I had the honor of speaking at the 27th Annual Pharmaceutical/Chemical Patent Practice Update put on by the New Jersey Intellectual Property Law Association’s Chemical Practice Committee. The entire program was...more

12/19/2013 - Chemicals EPO EU Life Sciences Patents Pharmaceutical

Federal Circuit Invalidates Galderma Differin Patents

In Galderma Laboratories v. Tolmar, Inc., the Federal Circuit reversed the district court’s findings that the Orange Book-listed patents for Galderma’s Differin® 0.3% gel product were not invalid as obvious. In so doing, the...more

12/12/2013 - ANDA Obviousness Patents Pharmaceutical Prior Art

Federal Circuit Finds LUNESTA Patent Infringement Based on ANDA Product Description Not Avoided by Other Certifications

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more

10/1/2013 - ANDA Claim Construction FDA Infringement Patents Pharmaceutical Prescription Drugs

Applied Biosystems Seeks PTA for 2007 Patent

On August 21, 2013, Life Technologies, Corp., Life Technologies, Ltd., Applied Biosystems LLC, and Molecular Probes, Inc. (collectively, “Plaintiffs”) brought suit in the U.S. District Court for the Eastern District of...more

8/28/2013 - America Invents Act Equitable Tolling Novartis Patent Reform Patent Term Adjustment Patents Pharmaceutical

Federal Circuit Finds Taclonex Patent Not Obvious, Reverses USPTO Decision

In Leo Pharmaceutical Products, Lt. v. Rae, the Federal Circuit issued a rare decision reversing an obviousness determination by the USPTO Patent Trial and Appeal Board (PTAB)....more

8/21/2013 - Obviousness Patents Pharmaceutical Pharmaceutical Patents Prior Art USPTO

Federal Circuit Finds No Written Description Support For Novozymes Amylase Patent

In Novozymes A/S v. DuPont Nutrition Biosciences APS, the Federal Circuit determined that the Novozymes amylase patent at issue did not satisfy the written description requirement of 35 USC § 112, because the disclosure did...more

7/25/2013 - Biotechnology Patent Applications Patent Infringement Patent Litigation Patents Pharmaceutical Written Descriptions

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