Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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Federal Circuit Upholds USPTO Post-Wyeth Patent Term Adjustment Procedures

In Daiichi Sankyo Co. v. Lee, the Federal Circuit upheld the USPTO’s post-Wyeth Patent Term Adjustment (PTA) procedures, and found that the USPTO did not abuse its discretion when it limited the Interim Procedures to...more

7/7/2015 - Administrative Procedure Act Patent Litigation Patent Term Adjustment Patents Summary Judgment USPTO Wyeth

Examination Delay Earns Patent Term Adjustment Only In One Application

In Mohsenzadeh v. Lee, the Federal Circuit affirmed the district court’s decision that the USPTO’s delay in issuing a Restriction Requirement in a parent application does not earn Patent Term Adjustment (PTA) for the ensuing...more

7/3/2015 - Delays Divisional Applications Patent Applications Patent Litigation Patent Term Adjustment Patents Summary Judgment USPTO

Federal Circuit Strikes Final Blow to Celebrex Patent

In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...more

6/27/2015 - Continuation-in-Part Divisional Applications Double Patent Drug Manufacturers OTDP Patent Applications Patent Invalidity Patent Litigation Patents Pfizer Pharmaceutical Manufacturers Pharmaceutical Patents Reissue Patents Safe Harbors USPTO

Federal Circuit Reverses Unreasonable PTAB Claim Construction, Upholds Idle Free Standard for Motions to Amend

The Federal Circuit decision in Microsoft Corp. v. Proxyconn, Inc., addressed several important issues relating to post-grant patent trials conducted by the USPTO Patent Trial and Appeal Board (PTAB), including the PTAB’s...more

6/24/2015 - Broadest Reasonable Interpretation Standard Claim Construction Inter Partes Review Proceedings Microsoft Motion to Amend Patent Invalidity Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents Post-Grant Review Remand USPTO

USPTO Pilots Expedited Patent Appeal Program But at What Price?

In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more

6/19/2015 - Federal Register Inventors Patent Applications Patent Litigation Patent Term Adjustment Patent Trial and Appeal Board Patents Pharmaceutical Patents Request for Continued Examination USPTO

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more

6/15/2015 - Diagnostic Method Inventions Mayo v. Prometheus Myriad Patent Applications Patent Infringement Patent Invalidity Patent Litigation Patent-Eligible Subject Matter Patents Personalized Medicine Preemption Preliminary Injunctions Sequenom Summary Judgment

Federal Circuit Finds Nunc Pro Tunc Agreement Does Not Confer Standing

The tenuous nature of an exclusive licensee’s standing to enforce a patent was something I learned early in my legal career, when I was a judicial clerk at the Federal Circuit. In Alps South LLC v. Ohio Willow Wood Co., the...more

6/11/2015 - Joinder License Agreements Nunc Pro Tunc Patent Infringement Patent Litigation Patents Standing

Federal Circuit Hears Oral Arguments in Neupogen Biosimilar Case

On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s...more

6/4/2015 - Amgen Biologics BPCIA Oral Argument Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz v Amgen

Another Sequenom Patent Appeal Heads to the Federal Circuit

While Sequenom’s appeal of the district court’s summary judgment of invalidity of U.S. Patent 6,258,540 under 35 USC § 101 has been pending at the Federal Circuit, the USPTO has been considering the validity of the patent...more

6/3/2015 - Appeals DNA Inter Partes Review Proceedings Patent Invalidity Patent Litigation Patent-Eligible Subject Matter Patents Sequenom

Dependent Claims Give Rise to Improper Broadening Reissue

In ArcelorMittal France v. AK Steel Corp., the Federal Circuit found that the addition of a dependent claim to a reissue application improperly broadened the scope of the original independent claims beyond the two-year period...more

5/28/2015 - Claim Construction Law-of-the-Case Patent Infringement Patents Reissue Patents

Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

5/22/2015 - Classen Immunotherapies Elan Pharmaceuticals FDA Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents Safe Harbors

Federal Circuit Finds No Direct Infringement of Akamai Patents

The Federal Circuit issued its remand decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., this time affirming the district court decision that Limelight was not liable for infringing Akamai’s patents because...more

5/20/2015 - Direct Infringement Induced Infringement Limelight v Akamai Patent Infringement Patent Litigation Patents

First Look at False Marking Under the AIA

In Sukumar v. Nautilus, Inc., the Federal Circuit took its first look at the standing requirements to bring a false marking case under the American Invents Act (AIA). The court rejected Nautilus’ arguments that only “market...more

5/15/2015 - America Invents Act False Marking Market Participants Nautilus Inc Patent Litigation Patents Private Right of Action

California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more

5/14/2015 - ANDA Antitrust Provisions Bayer CA Supreme Court Cipro Class Action Generic Drugs Pay-For-Delay Pharmaceutical Manufacturers Pharmaceutical Patents

Federal Circuit Keeps Sandoz Biosimilar Off the Market for Now

The Federal Circuit is set to hear oral arguments in Amgen v. Sandoz on June 3, but in the meantime has granted Amgen’s motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market until...more

5/7/2015 - Appeals Biosimilars BPCIA Oral Argument Patent Litigation Patents Preliminary Injunctions Sandoz v Amgen

Keeping Up With Kyle Bass

In the few weeks since I first wrote about Kyle Bass and the Coalition for Affordable Drugs he formed to challenge Orange Book-listed patents that he believes “have little value other than to drive up prescription drug...more

5/6/2015 - Inter Partes Review Proceedings Orange Book Patent-in-Suit Patents Pharmaceutical Patents

Why the Grace Period Restoration Act Is a Bad Idea

Representatives Sensenbrenner (R-WI) and Conyers (D-MI) have introduced the “Grace Period Restoration Act of 2015? (H.R. 1791) to “correct the drafting problem in the Leahy-Smith American Invents Act relating to the grace...more

5/1/2015 - America Invents Act Grace Period Inventors Patents Proposed Legislation USPTO

Biosig Claims Pass Reasonable Certainty Test

In its decision on remand from the Supreme Court, the Federal Circuit once again held the Biosig patent claims not indefinite, reversing the district court decision to the contrary. The decision came in Biosig Instruments,...more

4/29/2015 - Indefiniteness Nautilus Inc. v. Biosig Instruments Patent Litigation Patents SCOTUS

Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

4/25/2015 - AbbVie Amicus Briefs Biosimilars Biotechnology BPCIA FDA Patent Litigation Pharmaceutical Patents Sandoz v Amgen

An In-Depth Look at USPTO Patent Quality Problems

The comment period for the USPTO’s proposed patent quality initiatives is open until May 6, 2015, and the Office of Inspector General for the Commerce Department has given stakeholders plenty to think about in its final...more

4/22/2015 - Comment Period OIG Patents Quality Assurance Programs USPTO

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

4/15/2015 - Fund Managers Inter Partes Review Proceedings Orange Book Patent Infringement Patents Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs Standing

Apotex Has Standing Despite Benicar Patent Disclaimer

In Apotex Inc. v. Daiichi Sankyo, Inc., the Federal Circuit held that Apotex has standing to seek a declaratory judgment that it does not infringe Daiichi Sankyo’s patent, even though Daiichi Sankyo has disclaimed the patent...more

4/10/2015 - Apotex Daiichi Sankyo Disclaimers Patent Infringement Patent Litigation Patents Standing

Waiting on Sequenom

As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. In the meantime,...more

4/8/2015 - Diagnostic Method Healthcare Interim Guidance Patent-Eligible Subject Matter Patents Personalized Medicine Sequenom USPTO

No Collateral Challenge of Patent Application Revival

In Exela Pharma Sciences, LLC v. Lee, the Federal Circuit held that the USPTO’s decision to revive a patent application “is not subject to third party collateral challenge” under the Administrative Procedures Act (APA). In so...more

4/1/2015 - Administrative Procedure Act Patent Applications Patent Litigation Patents USPTO

Patent Term Adjustment in the Post-RCE Period

We know from Novartis v. Lee that a patent application does not earn “B delay” type Patent Term Adjustment (PTA) from the time an RCE is filed until a Notice of Allowance is issued, but an application still can earn PTA for...more

3/27/2015 - Notice of Allowance Patent Term Adjustment Patents Request for Continued Examination USPTO

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