Courtenay C. Brinckerhoff

Courtenay C. Brinckerhoff

Foley & Lardner LLP

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USPTO Sued Over December 2015 Holidays

Elm 3DS Innovations, LLC has sued the USPTO in the U.S. District Court for the Eastern District of Virginia to challenge its authority to declare that December 22-24, 2015 were “holidays” because the USPTO had experienced a...more

8/22/2016 - Administrative Authority Inter Partes Review Proceedings Power Outages Statutory Deadlines Ultra Vires USPTO

Construing Markush Group Claims

In Multilayer Stretch Cling Film v. Berry Plastics, the Federal Circuit provided a detailed discussion of the construction of claims that use Markush group language. The decision emphasizes the closed nature of the...more

8/19/2016 - Claim Construction Extrinsic Evidence Patent Litigation Patent Validity Patents

AbbVie Sues Amgen On 10 Of 100 Humira Patents

On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more

8/10/2016 - AbbVie Amgen ANDA Biosimilars BPCIA Commercial Marketing Patent Dance Patent Infringement Patent Litigation Pharmaceutical Industry Pharmaceutical Patents

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

8/3/2016 - National Cancer Moonshot Patent Applications Patent Prosecution Patents Request for Continued Examination USPTO USPTO Pilot Program

The Promise And Pitfalls Of 3D Printing

3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more

8/1/2016 - 3D Printing Bilski CLS Bank v Alice Corp Contributory Infringement FDA Induced Infringement Intellectual Property Protection Manufacturers Medical Devices Patent Infringement Patents Pharmaceutical Industry Professional Conferences USPTO

En Banc CAFC Requires UCC Sale For On Sale Bar

In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more

7/22/2016 - Amicus Briefs CAFC En Banc Review Hospira Manufacturers On-Sale Bar Orange Book Outsourcing Patent Invalidity Patent Litigation Patents Pharmaceutical Industry Remand Uniform Commercial Code (UCC)

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more

7/18/2016 - CLS Bank v Alice Corp Examiners Guidance Update Life Sciences Patent Litigation Patent-Eligible Subject Matter Petition for Writ of Certiorari Pharmaceutical Patents Section 101 Sequenom USPTO

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more

7/15/2016 - Actual Damages Biosimilars Confidentiality Agreements Direct Infringement Hospira Induced Infringement Injunctive Relief Janssen Pharmaceuticals On-Sale Bar Patent Infringement Patent Invalidity Patent Litigation Pharmaceutical Industry Pharmaceutical Patents Treble Damages

The PRICED Act Would Expedite Biosimilar Market Entry

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more

7/13/2016 - Biologics Biosimilars BPCIA Drug Pricing Exclusivity Pharmaceutical Industry Pharmaceutical Patents Proposed Legislation Research and Development Trans-Pacific Partnership

New USPTO P3 Program Offers Applicant Participation In After Final Conference

The USPTO has launched a new after final program available starting July 11, 2016. The Post-Prosecution Pilot Program (P3) combines features of the After Final Consideration Pilot 2.0 (AFCP 2.0) and Pre-Appeal Brief...more

7/12/2016 - Comment Period Final Action Notice of Appeal Patent Applications Patents Request for Continued Examination USPTO USPTO Pilot Program

CAFC Finds Cryopreservation Method Patent Eligible

The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S....more

7/8/2016 - CAFC CLS Bank v Alice Corp Examiners Mayo v. Prometheus Method Claims New Guidance Patent-Eligible Subject Matter Remand Section 101 USPTO Vacated

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more

7/8/2016 - Amgen Apotex Biosimilars BPCIA Commercial Marketing FDA Approval Notice Requirements Patent Dance Patent Infringement Petition for Writ of Certiorari Pharmaceutical Industry Pharmaceutical Patents Preliminary Injunctions Sandoz v Amgen

Court Invalidates Improper Multiple Dependent Claims

In Trustees of the University of Pennsylvania v. Eli Lilly and Co., the U.S. District Court for the Eastern District of Pennsylvania refused to correct improper multiple dependent claims and instead held them invalid under 35...more

6/30/2016 - Dismissals Mistake Noninfringement Patent Invalidity Patent Litigation Patents

Supreme Court Deals Blow To Diagnostic Method Patents, Denies Cert In Sequenom

“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom, the silence is deafening–and could have a chilling impact...more

6/29/2016 - Ariosa Diagnostic Method Patent Litigation Patent-Eligible Subject Matter Personalized Medicine Petition for Writ of Certiorari Pharmaceutical Patents Section 101 Sequenom USPTO

Supreme Court Declines to Review Sequenom Ruling

The U.S. Supreme Court has denied certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc. (No. 15-1182), declining to review the Federal Circuit’s June 12, 2015, decision that certain methods of detecting paternally...more

6/28/2016 - Ariosa CLS Bank v Alice Corp Diagnostic Method Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter Petition for Writ of Certiorari Section 101 Sequenom USPTO

CAFC Upholds Same Day Continuation Applications

The Federal Circuit decided not to disturb the “longstanding administrative construction” of 35 USC § 120 that permits the filing of a continuation application on the same day its parent application grants as a patent. The...more

6/23/2016 - CAFC Continuous Applications HTC Patent Applications Patent Litigation Patents Same-Day Continuations USPTO

Supreme Court Defers Certiorari Decision In Amgen Sandoz Biosimilar Patent Dance Dispute

On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the...more

6/21/2016 - Amgen Biosimilars BPCIA Patent Dance Patent Litigation Petition for Writ of Certiorari Pharmaceutical Patents Sandoz Sandoz v Amgen SCOTUS Solicitor General

Federal Circuit Emphasizes Reason In Application Of Broadest Reasonable Interpretation

As we wait for the Supreme Court decision in Cuozzo Speed Technologies, LLC v. Lee, where the Court has been asked to decide whether the USPTO Patent Trial and Appeal Board (PTAB) should apply the “broadest reasonable...more

6/16/2016 - Broadest Reasonable Interpretation Standard Claim Construction Cuozzo Speed Technologies v Lee Examiners Inter Partes Review Proceedings Patent Litigation Patent Trial and Appeal Board USPTO

Supreme Court Adopts More Flexible Standard For Enhanced Damages For Willful Infringement

In Halo Electronics, Inc. v. Pulse Electronics, Inc., the Supreme Court rejected the Federal Circuit’s two-part Seagate test for awarding enhanced damages under 35 USC § 284, finding that both the substantive requirement for...more

6/15/2016 - 35 U.S.C. § 284 Enhanced Damages Halo v Pulse Judicial Discretion Octane Fitness v. ICON Patent Infringement Patent Litigation Patents Preponderance of the Evidence SCOTUS Seagate Willful Infringement

PTAB Institutes Post Grant Review Against Chemical Process Patent

The USPTO Patent Trial and Appeal Board has instituted Post Grant Review (PGR) proceedings against a patent directed to a process for treating contaminated media. The petition for PGR challenged that patent on written...more

6/8/2016 - Patent Litigation Patent Trial and Appeal Board Patents Post-Grant Review Written Descriptions

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more

5/31/2016 - America Invents Act ANDA Confidentiality Agreements Generic Drugs Joint Venture Merck Non-Compete Agreements On-Sale Bar Patent Invalidity Patent Litigation Pharmaceutical Patents Reversal Watson Pharmaceuticals

CAFC Affirms Finacea Gel Infringement Under Doctrine of Equivalents

In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more

5/24/2016 - ANDA CAFC De Novo Standard of Review Doctrine of Equivalents Estoppel FDA Approval Generic Drugs Orange Book Patent Infringement Patent Litigation Pharmaceutical Patents Prior Art

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

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