Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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Will The Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

3/10/2017 - aBLA Amgen Biosimilars BPCIA Dismissals Genentech Information Sharing Patent Dance Patent Infringement Patents Pharmaceutical Patents Subject Matter Jurisdiction

PTAB Puts Method Of Treatment Patents Under The 101 Knife

While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more

3/4/2017 - Administrative Appeals Diagnostic Method Ex Partes Reexamination Mayo v. Prometheus Method Claims Patent Invalidity Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents Personalized Medicine SCOTUS Section 101 USPTO

Will You, Won't You Join The Biosimilar Patent Dance?

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the...more

2/24/2017 - aBLA Biologics Biosimilars BPCIA Confidential Information FDA Generic Drugs Injunctive Relief Motion to Compel Patent Dance Patent Infringement Pharmaceutical Patents

Federal Circuit Finds "Consisting Of" Requires Reversing Infringement Of Shire Lialda Patent

The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so...more

2/18/2017 - ANDA Appeals Orange Book Patent Infringement Patents Pharmaceutical Patents Reversal

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

2/9/2017 - Appeals Derivation Proceeding FDA Innovation Inventions Obviousness Patent Invalidity Patents Pharmaceutical Industry Prior Art

How Will Trump Change The FDA?

President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or...more

1/23/2017 - ANDA Biologics CLIA Drug Pricing FDA Generic Drugs Pharmaceutical Industry Post-Market Approval Prescription Drugs Trump Administration

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

1/19/2017 - Affordable Care Act Biotechnology Competitive Bidding Drug Pricing Healthcare Reform Imports Medicare Pharmaceutical Industry Prescription Drugs Repeal Stocks Trump Administration

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

1/19/2017 - Amgen Biosimilars BPCIA Certiorari Commercial Marketing Declaratory Judgments License Applications Notice Requirements Patent Dance Patent Infringement Patents Pharmaceutical Industry Pharmaceutical Patents Remedies Sandoz Sandoz v Amgen SCOTUS Solicitor General

District Court Dismisses USPTO December 2015 Holidays Case

On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December...more

12/28/2016 - Administrative Procedure Act Appeals Dismissals Electronic Filing Filing Deadlines Holidays Inter Partes Review (IPR) Proceeding Motion to Dismiss Patent Litigation Patents Power Outages Reviewability Determinations USPTO

Solicitor General Sides With Sandoz On Interpretation Of Biosimilar Statute

The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance”...more

12/27/2016 - Amgen v Apotex Biosimilars BPCIA Commercial Marketing Denial of Certiorari Patent Infringement Patents Sandoz Sandoz v Amgen Solicitor General

PTAB Holds Oral Hearings In Tecfidera Patent IPR and Interference

On November 30, 2016, the USPTO Patent Trial and Appeal Board (PTAB) held oral hearings in two different inter partes proceedings involving the Biogen Tecfidera® patent with the latest expiation date. First, it heard...more

12/7/2016 - Inter Partes Review (IPR) Proceeding Interference Claims Oral Argument Patent Trial and Appeal Board Patents Pharmaceutical Patents USPTO

Swearing Behind A Reference With Reasonably Continuous Diligence

In Perfect Surgical Techniques, Inc. v. Olympus America, Inc., the Federal Circuit vacated and remanded a USPTO Patent Trial and Appeal Board decision in an Inter Partes Review proceeding, finding that the PTAB imposed too...more

11/23/2016 - America Invents Act Appeals Due Diligence Evidence Inter Partes Review (IPR) Proceeding Patent Trial and Appeal Board Patents Remand Rule-of-Reason Analysis Section 102 USPTO Vacated

USPTO Examination Time Goals -- How Much Time Should Examiners Have To Examine A Patent Application?

As part of its ongoing efforts to improve patent quality, the USPTO is reevaluating its examination time goals and seeking public feedback on how much time examiners should have to examine a patent application. Examination...more

11/15/2016 - Administrative Proceedings Patent Examination Time Patent Examinations Patents Popular Public Comment USPTO

USPTO Again Proposes To Revise Duty Of Disclosure In View Of Therasense

More than five years after the Federal Circuit’s en banc decision in Therasense and its first proposed rulemaking under that decision, the USPTO has issued a new proposed rulemaking to adapt its duty of disclosure rule (37...more

11/4/2016 - 37 CFR § 1.56 Duty to Disclose Federal Register Inequitable Conduct Materiality Patent Applications Popular Prior Art Therasense USPTO

District Court Denies Extra Patent Term Adjustment When National Stage Entry Date Falls On A Holiday

Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a...more

11/3/2016 - America Invents Act National Stage Entry Date Patent Examinations Patent Filings Patent Term Adjustment Patents USPTO

Biogen TYSABRI Patents Spared Inter Partes Review

The USPTO Patent Trial and Appeals Board (PTAB) declined to institute Inter Partes Review (IPR) proceedings against three Biogen Idec TYSABRI patents. The IPR petitions were filed by Swiss Pharma International, and asserted...more

11/1/2016 - Biogen Idec Inter Partes Review (IPR) Proceeding Patent Trial and Appeal Board Patents Pharmaceutical Patents Popular USPTO

Higher US Patent Fees On The Horizon

The USPTO has published a proposed fee schedule for patent fees likely to take effect October 1, 2017–the start of the USPTO’s next fiscal year. The proposed fee schedule makes “slight” changes to many fees, and more...more

10/20/2016 - America Invents Act Filing Fees Patent Fees Patent Public Advisory Committee (PPAC) Patents Public Comment USPTO

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

10/20/2016 - Burden of Persuasion Inter Partes Review (IPR) Proceeding Obviousness Patent Infringement Patent Litigation Patent Trial and Appeal Board Patents Pharmaceutical Patents Prior Art

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

10/7/2016 - Biosimilars FDA Obviousness Patent Litigation Patents

Inherent Disclosure Supports Priority Claim

In Yeda Research and Development Co. v. Abbott GmbH and Co., the Federal Circuit invoked the doctrine of inherent disclosure to uphold a priority claim to a German priority application that only partly described the claimed...more

10/4/2016 - Inherent Disclosure Doctrine Patent Applications Patent Litigation Patents Priority Patent Claims Written Descriptions

CAFC Says Functional Claim Language Does Not Create Divided Infringement

In LifeNet Health v. LifeCell Corporation, one of the many issues the Federal Circuit decided was that functional claim language did not create a divided infringement situation, even though an independent actor could impact...more

9/26/2016 - Appeals Divided Infringement Functionality Indefiniteness JMOL Judgment As A Matter Of Law Jury Verdicts Patent Infringement Patents Written Descriptions

Magistrate Judge Nixes TB Test Kit Claims

In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent...more

9/21/2016 - Method Claims Motion to Dismiss Patent Litigation Patent-Eligible Subject Matter Patents Section 101

Apotex Biosimilar Cleared Of Infringement But Pre-Marketing Notice Still Required

In what may be the first decision on the merits in a patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), the U.S. District Court for Southern District of Florida has found that...more

9/20/2016 - Apotex Biosimilars BPCIA Patent Dance Patent Infringement Patents Pharmaceutical Patents

District Court Upholds Eligibility Of Personalized Medicine Method Claims For FANAPT

In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Stark of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT®...more

9/7/2016 - Patent Infringement Patent Litigation Patent-Eligible Subject Matter Patents Pharmaceutical Industry Pharmaceutical Patents

Help The USPTO Leverage Prior Art From Related Patent Applications

The USPTO is seeking input on how it can leverage prior art information available on-line in related patent applications in order to “improve patent examination quality and efficiency” and reduce “applicant’s burden to...more

9/2/2016 - Duty to Disclose Patent Application Information Retrieval (PAIR) Patent Applications Patent Examinations Prior Art Public Comment USPTO

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