Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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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

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

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

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

STRONG Patents Act Would Fix Micro Entity Gap

Senator Coons (D-Del) has introduced patent reform legislation that is similar to but different from the Goodlatte Innovation Act pending in the House. One section of S. 632 that does not have a parallel in H.R. 9 relates to...more

3/6/2015 - America Invents Act Colleges Micro Entity Status Patent Reform Patents Proposed Legislation Universities

Federal Circuit Upholds Patent Term Adjustment Deduction for IDS Filed After Restriction Requirement

In Gilead Sciences, Inc. v. Lee, the Federal Circuit upheld the USPTO’s interpretation of the Patent Term Adjustment (PTA) statute as permitting the USPTO to charge “Applicant Delay” when an Information Disclosure Statement...more

3/3/2015 - Gilead Sciences Patent Prosecution Patent Term Adjustment Patents USPTO

Court Cites Objects of Invention in Claim Construction

Pacing Technologies, LLC v. Garmin International, Inc. is one of those Federal Circuit decisions that may send patent practitioners running to their files to double-check the phrasing used in their patent applications. Not...more

2/25/2015 - Claim Construction Garmin International Patent Litigation Patents

USPTO Seeks Input on Patent Quality

As announced in a February 5, 2015 Federal Register Notice, the USPTO is launching an enhanced quality initiative that includes a request for public comment on certain proposals and a two-day “Quality Summit” to be held March...more

2/18/2015 - Patents Public Comment Quality Assurance Programs USPTO

Concerns About the Goodlatte Innovation Act

On February 5, 2015, House Judiciary Committee Chairman Bob Goodlatte (R-Va.) introduced the Innovation Act, which is touted as “address[ing] the ever increasing problem of abusive patent litigation.” The bill was introduced...more

2/11/2015 - Innovation Act Patent Litigation Patent Reform Patents Pending Legislation

Federal Circuit Affirms Use of Broadest Reasonable Interpretation of Claims in IPR Proceedings

In affirming the decision of the USPTO’s Patent Trial and Appeal Board (PTAB) in In re Cuozzo Speed Technologies, LLC, the Federal Circuit upheld the PTAB’s use of the “broadest reasonable interpretation” of the claims in...more

2/6/2015 - Cuozzo Speed Technologies Inter Partes Review Proceedings Jurisdiction Patent Trial and Appeal Board Patents Prior Art

USPTO Seeks Input on Patent Privilege Issues

The USPTO is seeking public comment on patent privilege issues, regarding the legal protections afforded to communications between patent practitioners and clients in the U.S. and foreign countries. The USPTO is hosting a...more

2/4/2015 - Attorney-Client Privilege Patents Roundtable USPTO

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

Validity of Sequenom Patent Still to Be Decided

Although Sequenom has settled its dispute over U.S. Patent 6,258,540 with some parties, its case against Ariosa Diagnostics, Inc. remains active. Thus, we all should be waiting with bated breath to see whether the Federal...more

1/28/2015 - DNA Myriad Patent Litigation Patent-Eligible Subject Matter Patents Sequenom

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

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