Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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USPTO 101 Guidance: Microneedles Versus Prosthetic Devices

When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a...more

5/20/2016 - Guidance Update Medical Devices Patent-Eligible Subject Matter Patents Section 101 USPTO

Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes...more

5/17/2016 - Amgen Apotex Biosimilars BPCIA FDA Patent Dance Patent Infringement Patent Litigation Pharmaceutical Industry Sandoz Sandoz v Amgen

New USPTO Guidance On Patent Eligibility Of Natural Products

The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although...more

5/16/2016 - CLS Bank v Alice Corp Guidance Update Mayo v. Prometheus Natural Products Patent-Eligible Subject Matter Patents USPTO

New USPTO Guidance On Patent Eligibility Of Diagnostic Methods

The patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic...more

5/10/2016 - Diagnostic Method Mayo v. Prometheus Patent Invalidity Patent Litigation Patent-Eligible Subject Matter Patents Sequenom USPTO

USPTO Issues New Patent Eligibility Examples

The USPTO has issued new patent eligibility examples, including several examples relating to diagnostic methods and “nature-based” products. Surprisingly, most of the claims are said to satisfy 35 USC § 101. The USPTO also...more

5/10/2016 - Diagnostic Method Examiners New Guidance Patent Applications Patent-Eligible Subject Matter Patents USPTO

District Court Applies Mayo To Treatment Claims But Denies Motion To Dismiss BMS Keytruda Litigation

The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be...more

5/5/2016 - Bristol-Myers Squibb CLS Bank v Alice Corp Federal Rule 12(b)(6) Mayo v. Prometheus Merck Motion to Dismiss Patent Infringement Patent Litigation Patent-Eligible Subject Matter Presumption of Validity SCOTUS Treatment Method Patents

Having A Bad Hair Day? The Federal Circuit Agrees That Method Of Cutting Hair Is Invalid Under 101

While I do not usually write about non-precedential decisions, In re: Brown caught my eye as an interesting patent eligibility case. It does not relate to diagnostics or computer programs, but rather to the art of cutting...more

5/2/2016 - Abstract Ideas CLS Bank v Alice Corp Mayo v. Prometheus Patent Applications Patent Invalidity Patent Litigation Patent-Eligible Subject Matter

Will The Celsis Appeal Put An End To 101 Rejections Of Laboratory Method Claims?

On April 5, 2016, the Federal Circuit heard oral arguments in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., where the U.S. District Court for the Northern District of Illinois held invalid claims directed to a “method of...more

4/29/2016 - Appeals CLS Bank v Alice Corp Mayo v. Prometheus Method Claims Patent Invalidity Patent Litigation Patent-Eligible Subject Matter SCOTUS USPTO

Jazz Xyrem + Valproate Patent Claims Avoid IPR

The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute...more

4/18/2016 - Generic Drugs Inter Partes Review Proceedings Jazz Pharmaceuticals Obviousness Patent Litigation Patent Trial and Appeal Board Pharmaceutical Industry

Court Can't Review Policy Behind Patent Term Adjustment Statute

In Singhal v. Lee, the U.S. District Court for the Eastern District of Virginia dismissed a complaint that challenged the Patent Term Adjustment (PTA) awarded to two patents, because the complaint failed to state a claim upon...more

4/14/2016 - Novartis Patent Litigation Patent Term Adjustment Patent Terms Patents Request for Continued Examination USPTO

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35...more

4/12/2016 - Biotechnology CLS Bank v Alice Corp Corporate Counsel Diagnostic Method DNA Federal Rule 12(b)(6) Genetic Technologies Ltd. Machine-or-Transformation Test Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter SCOTUS

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more

4/12/2016 - Amgen Biosimilars BPCIA FDA Injunctive Relief Notice Requirements Patent Litigation Petition for Writ of Certiorari Pharmaceutical Patents Sandoz Sandoz v Amgen SCOTUS

Will the Federal Circuit Invalidate 13,500 Continuation Patents?

The Federal Circuit is set to hear oral arguments in Immersion Corp. v. HTC Corp. on May 6, 2016. According to the amicus brief filed on behalf of the United States, if the court affirms the district court decision “over...more

4/8/2016 - Amicus Briefs Chevron Deference HTC America Patent Applications Patent Invalidity Patent Litigation USPTO

Second Time Is The Charm For Kyle Bass Challenges Of Ampyra Patents

The USPTO Patent Trial and Appeal Board (PTAB) has decided to institute inter partes review (IPR) proceedings against the Ampyra patents based on the second set of petitions filed by Kyle Bass and the Coalition for Affordable...more

4/1/2016 - Estoppel Inter Partes Review Proceedings Patent Invalidity Patent Litigation Patent Trial and Appeal Board Pharmaceutical Patents Printed Publications Prior Art

Sequenom Throws Diagnostic Method Patents At The Mercy Of The Supreme Court

It comes as no surprise that Sequenom has filed a petition for certiorari to the Supreme Court, asking the Court to review the Federal Circuit decision that upheld the district court decision that held its diagnostic method...more

3/28/2016 - Diagnostic Method Mayo v. Prometheus Method Claims Patent Invalidity Patent Litigation Patent-Eligible Subject Matter Petition for Writ of Certiorari SCOTUS Section 101 Sequenom

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...more

3/25/2016 - ANDA AstraZeneca Forum Shopping General Jurisdiction Generic Drugs Minimum Contacts Mylan Pharmaceuticals Patent Infringement Patent Litigation Personal Jurisdiction Pharmaceutical Patents Proposed Legislation Specific Jurisdiction

Patent Term Adjustment In South Korea

According to this bulletin from Lee International IP & Law Group in South Korea, Korean patents filed on or after March 2012 may be entitled to Patent Term Adjustment if they issued more than 4 years after the filing date and...more

3/18/2016 - Delays Fees KIPO Patent Applications Patent Term Adjustment Patents Request for Examination South Korea

PTAB Institutes Kyle Bass IPRs Against Juxtapid Patents

The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may...more

3/16/2016 - Inter Partes Review Proceedings Orange Book Patent Litigation Patent Owner Preliminary Response Patent Trial and Appeal Board Prior Art Priority Disputes Provisional Applications

Federal Circuit Recognizes Limited Patent Agent Privilege

In In re Queen’s University At Kingston, a divided panel of the Federal Circuit recognized a limited “attorney”-client privilege for patent agents. The majority’s decision to recognize a patent agent privilege is based...more

3/15/2016 - Attorney-Client Privilege Duty of Candor Duty to Disclose Patent Agent Privilege Patent Applications Patent Litigation USPTO

Amgen Launches Enbrel Biosimilar Patent Litigation

Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more

3/4/2016 - Amgen Biosimilars BPCIA Inter Partes Review Proceedings Patent Dance Patent Infringement Patent Litigation Patent Trial and Appeal Board Pharmaceutical Patents Sandoz Sandoz v Amgen

District Court Invalidates Cleveland Clinic Diagnostic Patents On Motion To Dismiss

Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the...more

3/3/2016 - AMP v Myriad Biotechnology CLS Bank v Alice Corp Diagnostic Method Patent Invalidity Patent Litigation Patent-Eligible Subject Matter SCOTUS Sequenom

Patent Term Adjustment Versus Double Patenting

In Magna Electronics, Inc. v. TRW Automotive Holdings Corp., No. 1:12-cv-654; 1:13-cv-324 (Dec. 10, 2015), Judge Maloney of the U.S. District Court for the Western District of Michigan granted TRW’s motion for partial summary...more

2/26/2016 - Double Patent Gilead Sciences OTDP Patent Invalidity Patent Litigation Patent Term Adjustment Terminal Disclaimer

Sandoz Asks Supreme Court To Reverse Biosimilar Decision

On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more

2/19/2016 - Amgen Apotex Biosimilars BPCIA Injunctive Relief Patent Dance Patent Litigation Petition for Writ of Certiorari Pre-Market Notification Sandoz Sandoz v Amgen SCOTUS

En Banc Federal Circuit Limits Patent Exhaustion

In Lexmark International, Inc., v. Impression Products, Inc., the en banc Federal Circuit upheld a patent holder’s rights against exhaustion under two circumstances: (1) where the patent holder had sold a patented article...more

2/18/2016 - First Sale Doctrine Foreign Markets IP License Kirtsaeng v. John Wiley & Sons Lexmark Patent Exhaustion Patent Litigation Pharmaceutical Industry Quanta SCOTUS

Remicade Biosimilar Closer To Approval, But Patent Dance Goes On

Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3...more

2/15/2016 - Apotex Biosimilars BPCIA FDA Approval Janssen Pharmaceuticals Patent Dance Patent Infringement Patent Litigation Pharmaceutical Patents Sandoz v Amgen

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