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Back to Basics: Despite Winning the ‎Appeal, Failure to Appeal a ‎Preliminary Injunction Bond ‎Constituted Waiver of Damages

There is no denying the importance of preserving rights for appeal. A recent example of this came about in Novartis Pharmaceuticals Corp. v Accord Healthcare, Inc. et al., Civil Action No. 18-1043 (Memorandum Opinion dated...more

How Much Claim Construction ‎Significance? – Extrinsic Evidence and Significant Figures

In almost every claim construction, the courts make their claim construction ruling largely based on the intrinsic evidence – the claims, specification and prosecution history. However, the Federal Circuit (CAFC) bucked this...more

The Madrid Protocol - August 2022

The United States is a party to the Madrid Protocol, an international treaty simplifying and centralizing the process for registering trademarks on an international basis. This treaty allows owners of U.S. trademark...more

Impact of US v. Arthrex

The long-awaited decision in United States v. Arthrex held that the Patent Trial and Appeal Board (PTAB) is inconsistent with the Constitution’s Appointments Clause because the administrative patent judges (APJs) that...more

Bayer v. Baxalta: Meeting the Large Molecule Enablement Bar

Bayer v. Baxalta is a patent case dealing with several issues of claim scope, infringement, validity, and damages. Bayer Healthcare LLC v. Baxalta Inc., No. 2019-2418 (Fed. Cir. Mar. 1, 2021). Here, as a follow up to our...more

Functional Antibody Claims: Setting the Bar for Enablement

On February 11, 2021, in a unanimous decision, the Federal Circuit affirmed the district court’s holding that Amgen Inc., Amgen Manufacturing, Ltd., and Amgen USA, Inc.’s (collectively, “Amgen’s”) antibody composition claims...more

Federal Circuit Clarifies Hatch-Waxman Venue Question

On November 5, 2020, the Federal Circuit issued a precedential opinion deciding a patent venue question concerning Hatch-Waxman cases left open after the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands...more

The Madrid Protocol

The United States is a party to the Madrid Protocol, an international treaty simplifying the process for registering trademarks on an international basis. This treaty allows owners of U.S. trademark registrations and pending...more

Subject Matter Patentability – To Treat? or Not To Treat?

To treat? Or not to treat? – that was the question in the Federal Circuit decision in the case of INO Therapeutics LLC v. Praxair Distribution Inc.1 (2018-1019). INO provides an interesting development in the patent...more

Federal Circuit Affirms Noninfringement in BPCIA Case

On May 8, 2019, the Federal Circuit issued a precedential opinion affirming a district court’s finding of noninfringement in an action brought under the Biologics Price Competition and Innovation Act (“BPCIA”). Amgen Inc. et...more

Cannabis Meets Subject Matter Patentability

As the path to legality of cannabis and cannabis-related products progresses, the formerly illegal world of marijuana now confronts legal principles beyond law enforcement. And the patent laws are no exception. On April 17,...more

Proving Biosimilar Interchangeability – New FDA Guidance Provides Important Considerations for Making that Proof

Click here for PDF   On May 10, 2019, the United States Food and Drug Administration (FDA) issued a new draft Guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product....more

505(j) or 505(b)? Helping to Choose the Proper Pathway

On May 9, 2019, the United States Food and Drug Administration (FDA) released a final guidance entitled Determining Whether to Submit an ANDA or 505(b)(2) Application to guide an applicant’s decision on which abbreviated...more

Helsinn—Supreme Court Unanimously Confirms AIA “On Sale” Does Not Require “On Public Sale”

On January 22, 2019, the Supreme Court unanimously ruled that the provision of the America Invents Act (“AIA”) barring an inventor from obtaining a patent for an invention that was “in public use, on sale, or otherwise...more

How to Get that Final Approval - FDA Issues New Draft Guidance

On January 16, 2019, the United States Food and Drug Administration issued a new draft Guidance entitled “ANDA Submissions –Amendments and Requests for Final Approval to Tentatively Approved ANDAs”. This new FDA Guidance...more

Federal Circuit Held Vanda’s Method of Treatment Claims Are “Application of Nature Law”—While Chief Judge Prost Dissented

On April 13, 2018, in a split decision, the Federal Circuit held that Vanda Pharmaceuticals Inc.’s method of treatment claims are directed to patent-eligible subject matter under step one of the Mayo two-step test. Vanda...more

PTAB Issues Guidance on the Impact of SAS Institute on IPRs

The Patent Trial and Appeal Board (“PTAB”) recently issued guidance on the effects the Supreme Court of the United States’ decision in SAS Institute Inc. v. Iancu, No. 16-969 (U.S. Apr. 24, 2018) will have on the inter partes...more

No Inter Partes Review Sovereign Immunity For Restasis® Patents

On February 23, 2018, the Patent Trial and Appeal Board of United State Patent and Trademark Office (“the Board”) denied Saint Regis Mohawk Tribe’s (“the Tribe”) motion to terminate inter partes review (“IPR”) proceedings...more

Federal Circuit Provides Guidance on Evidence to Satisfy Burden of Proving Infringement in Hatch-Waxman Litigations

On February 9, 2018, the Federal Circuit affirmed the District of Delaware’s holding that Merck Sharp & Dohme Corp. (“Merck”) failed to meet its burden of proving that Amneal Pharmaceuticals LLC’s (“Amneal”) ANDA product...more

Process Step Order Cannot Save Claim with Conventional Manufacturing Steps From Obviousness

On October 26, 2017, the Federal Circuit, in a split decision, upheld the invalidity of the asserted claims of U.S. Patent No. 6,486,150 (“the ’150 patent”) as obvious under 35 U.S.C. § 103. See Merck Sharp & Dohme Corp. v....more

The Federal Circuit Explains Admissibility of Post-Priority Date Evidence Regarding Written Description and Enablement Proofs

Is post-priority date evidence admissible as relevant to determining whether a patentee has complied with the written description requirement? What about for enablement? Recently, the Federal Circuit answered those...more

Medical Diagnostic Patents Found to Claim Patent Ineligible Subject Matter—Motions to Dismiss Granted

On August 4, 2017, a pair of decisions reaffirmed that claimed methods which apply routine and conventional techniques to a law of nature are invalid and do not satisfy the “inventive concept” step of the patent eligibility...more

Sandoz Inc. V. Amgen Inc. Clears The Way For Potential Earlier Launch Of Biosimilars

In Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. June 12, 2017) the Supreme Court held (i) that biosimilar applicants may provide the requisite 180-days’ notice of commercial marketing to the reference product sponsor even...more

All Claim Limitations Must be Shown for Derivation Under 35 U.S.C. § 102(f) And Obviousness

Introduction - In proving a patent invalid (or infringed), all claim limitations must be considered. A recent case illustrates this maxim for both derivation under 35 U.S.C. § 102(f) and obviousness under 35 U.S.C. §...more

Direct Infringement Prong of 35 U.S.C. § 271(b) in a Hatch-Waxman Case May Be Satisfied When the Prescribing Physician Directs or...

On January 12, 2017, the Federal Circuit affirmed the district court’s holding that, under Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc), the acts of patients may be...more

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