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Orexo AB v. Actavis Elizabeth LLC (Fed. Cir. 2018)

The varying appellate fortunes of patentees regarding the question of obviousness is illustrated nicely in the Federal Circuit decision in Orexo AB v. Actavis Elizabeth LLC handed down earlier this month. The statute, 35...more

Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2018)

Determining obviousness is always a reconstruction, imperfectly done, of a past that never was. The prior art is consulted and the question asked, would the worker of ordinary skill in the art have been able to achieve the...more

Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018)

Federal Circuit Affirms PTAB in Appeal of CRISPR Interference - Barring the unlikely event that the Federal Circuit rehears en banc today's decision in Regents of the University of California v. Broad Institute, Inc. (or,...more

Federal Circuit Affirms PTAB Decision in CRISPR Case

On Monday, September 10, 2018, the Federal Circuit handed down its decision in the University of California’s (“California”) appeal of the decision by the Patent Trial and Appeal Board (“the Board”) that there is no...more

Red Fox Genome Sheds Light on Domesticated Dogs (and Maybe Humans)

The red fox (Vulpes vulpes) has been the subject of a controlled breeding experiment in Russia, at the Institute of Cytology and Genetics of the Russian Academy of Sciences, to select for genetic determinants associated with...more

9/5/2018  /  DNA , Genome Project , Life Sciences

Amgen Inc. v. Hospira, Inc. (D. Del. 2018)

Intent Matters in Safe Harbor under BPCIA - Earlier this week, Judge Richard G. Andrews, U.S. District Court Judge for the District of Delaware decided a veritable plethora of post-trial motions (by both parties) in Amgen...more

PTAB Rules Inter Partes Review Time Bar Depends on Service of Process Date

Patent law has traditionally been considered to be fraught with traps for the unwary, which in practice just means that it is unwise to assume anything (see Carl S. Koening, "Clarifying Patent Terminology and Patent Concepts...more

Koala Genome Sequenced

Many people of a certain age will remember their first awareness of the koala coming from a television commercial in the 1960's for an Australian airline ("I hate Qantas"). Thereafter, of course, zoos, like the San Diego Zoo...more

St. Regis Mohawk Tribe Petitions Federal Circuit for En Banc Review of Panel Decision Voiding Sovereign Immunity in Inter Partes...

On July 22nd, the Federal Circuit issued its opinion in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., affirming the decision by the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office that...more

USPTO Issues Updated PTAB Practice Guide for Post-grant Review Proceedings

On August 8th, the U.S. Patent and Trademark Office issued revisions to its Patent Trial and Appeal Board (PTAB) Guide, first promulgated in 2012 as part of the Office's implementation of inter partes review (IPR), post-grant...more

Trustees of Boston University v. Everlight Electronics Co. (Fed. Cir. 2018)

It is black-letter law that a claim must be enabled throughout its full scope in order to satisfy the enablement requirement of 35 U.S.C. § 112(a); see, e.g., Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1378–79 (Fed....more

FDA Issues Plan for Further Facilitating Biosimilar Development

Earlier this month, the U.S. Food and Drug Administration announced a new initiative, the Biosimilars Action Plan: Balancing Innovation and Competition in furtherance of its efforts "to ensure that this balance between...more

NantKwest, Inc. v. Iancu (Fed. Cir. 2018) (en banc)

En Banc Federal Circuit Finds § 145 Appellants Generally Will Not Be Liable for Patent Office's Attorneys' Fee - The Federal Circuit handed down its en banc decision on Friday regarding the question of whether under 35...more

Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2018)

Federal Circuit Rejects Use of Tribal Immunity to Shield Patents in IPR Proceedings - The Federal Circuit issued its opinion on Friday in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals, affirming the decision by the...more

WIPO Launches Coordinated Examination before Top Five Patent Offices

The World Intellectual Property Organization (WIPO) launched a pilot program on July 1st termed Collaborative Search and Examination (CS&E) that will enable an applicant to have searching performed by all five of the major...more

Representatives Introduce Bill to Roll Back AIA Changes in U.S. Patent Law

In the 1970's, the New York Tristate area was entertained by (or subjected to) television and radio ads for a discount stereo outlet named Crazy Eddie's. Under the tag line "Our Prices are Insane," the ads involved a number...more

Senators Ask FTC to Investigate Biosimilar Litigation Settlement Agreement

The high cost of biologic drugs was one of the (if not the) most compelling motivations for Congress to adopt a biosimilar pathway as part of the Affordable Care Act in 2010 (aka "Obamacare"). Passage of the Biologic Price...more

Status of U.S. Biosimilar Approvals and Pending Applications*

The Biologics Price Competition and Innovation Act (BPCIA) was enacted as part of the Affordable Care Act (colloquially called "Obamacare," Public Law 111-148). It gave the U.S. for the first time a pathway for FDA approval...more

Supreme Court Grants Certiorari in Helsinn Healthcare v. Teva Pharmaceuticals

On June 25, 2018, the Supreme Court granted certiorari on Helsinn Healthcare's petition to overturn the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals that its patents were invalid by application of...more

WesternGeco LLC v. ION Geophysical Corp. (2018)

On Friday, June 22, 2018, the Supreme Court reversed the judgment of the Federal Circuit in WesternGeco LLC v. ION Geophysical Corp. Justice Thomas (joined by Chief Justice Roberts and Justices Kennedy, Ginsburg, Alito,...more

Supreme Court Denies Certiorari Again in Patent Eligibility and Safe Harbor Cases

Like Sherlock Holmes' quiet dog, the significance of the Supreme Court's patent eligibility jurisprudence following their decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corp. v. CLS Bank...more

Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd. (D. Del. 2018)

Method of Treatment Claims Patent Eligible Even without Reciting Dosages - It appears that Judge William C. Bryson, U.S. Appellate Court Judge on the Federal Circuit bench, is riding the circuit these days, peripatetically...more

XY, LLC v. Trans Ova Generics, L.C. (Fed. Cir. 2018)

Judge Pauline Newman has been concerned regarding constitutional issues raised by the U.S. Patent and Trademark Office Patent Trial and Appeal Board's implementation of inter partes review as provided by the Leahy-Smith...more

AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc. (Fed. Cir. 2018)

Ever since the Supreme Court loosened the reins on declaratory judgment actions in patent cases twelve years ago, in MedImmune v. Genentech, courts have decided cases fleshing out the metes and bounds of the factual...more

Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd. (Fed. Cir. 2018)

Last week, the Federal Circuit found all patent claims invalid for obviousness in an inter partes review, in Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd. But the Court did not render its decision...more

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