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Administrative Agency Intellectual Property Science, Computers & Technology

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First U.S. Avastin and Herceptin Biosimilars

On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more

Clarifying or Conforming? The EPO Bows to the European Commission

by Jones Day on

In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more

Method-of-Treatment Claims That Did Not Require a Specific Level of Efficacy Held Unpatentable as Obvious in Light Of References...

The Patent Trial and Appeal Board (the “Board”) issued a final written decision in an inter partes review determining Claims 1-5 of U.S. Patent No. 8,889,135 owned by Abbvie Biotechnology Ltd. unpatentable as obvious...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

Known Solution to General Problem Provides Sufficient Motivation to Modify Prior Art

by Jones Day on

In a final written decision in Bass, et al., v. Fresenius Kabi USA, LLC (IPR2016-00254), the PTAB found that the challenged claims of Fresenius’s U.S. Patent No. 8,476,010, directed to a sterile pharmaceutical composition of...more

Deuterated Drugs Are New Chemical Entities

by Pepper Hamilton LLP on

FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more

Ex Parte Hafner Provides Clarity in Assessing Patent Subject Matter Eligibility for Software Patents

by Knobbe Martens on

In Ex Parte Hafner, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) reversed the Examiner’s rejection that claims directed to an energy transaction plan were subject-matter ineligible. Ex...more

Extension of U.S. Patent and Trademark Office’s Cancer Immunotherapy Pilot Program

On June 19, 2017, the U.S. Patent and Trademark Office (USPTO) announced that it would be extending the Cancer Immunotherapy Pilot Program, which permits patent applications pertaining to cancer immunotherapy to be examined...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In EmeraChem v Volkswagen the Circuit reverses a determination of obviousness because the ?Board did not provide the patentee with an adequate opportunity to address a prior art reference ?that formed a principal basis for...more

Lack of Enablement in Provisional Application Results in Loss of Priority

In Storer v. Clark, [2015-1802] (June 21, 2017) the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision awarding priority in an interference to Clark, on the grounds that Storer’s provisional application did...more

Is Software Patentable? Recent US Case Law Offers a Glimmer of Hope

by Field Law on

Many inventions involve software, and many inventors are interested in protecting such inventions with a patent. The question is: are software inventions patentable? Based on recent cases in the United States, the answer is:...more

Computer-Based Publishing Patent Goes Offline after Alice Inquiry

In a recent order from the District of Massachusetts, the court granted a defendant’s motion for summary judgment in a patent infringement dispute, finding the asserted patent claims invalid under 35 U.S.C. § 101. The court’s...more

Global Patent Prosecution Newsletter - June 2017

Revocation Proceedings Around the World - Mechanisms to challenge the validity of granted patents are available in many countries throughout the world. The June 2017 issue of Sterne Kessler’s Global Patent Prosecution...more

Speedy Justice: Ttab Reverses Refusal To Register CROSBY QUIC-TAG

by Ladas & Parry LLP on

In a non-precedential decision in In re The Crosby Group LLC, Serial 86780353 (April 17 2017), the Trademark Trial and Appeal Board (TTAB) held that there was no likelihood of confusion between the applicant’s CROSBY QUIC-TAG...more

Sandoz v. Teva: Supreme Court Nixes Post-Approval Waiting Period for Biosimilars

by Seyfarth Shaw LLP on

Seyfarth Synopsis: In its first opinion relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Supreme Court in Sandoz Inc. v. Amgen Inc. provided a win to biosimilar companies, eliminating the...more

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

by Snell & Wilmer on

On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

Federal Circuit Upholds Claim Construction – No Due Process Violations

by Jones Day on

On May 8, 2017, in Intellectual Ventures II LLC v. Ericsson Inc., 15-1739, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (PTAB) inter partes review (IPR) claim constructions in a non-precedential decision....more

Federal Circuit Review | May 2017

by Knobbe Martens on

Federal Circuit Affirms Different Invalidity Results at PTAB and District Court - In Novartis AG v. Noven Pharmaceuticals Inc., Appeal Nos. 2016-1678, 2016-1679, the Federal Circuit held that prior judicial opinions...more

CAFC: What a Person of Skill in the Art “Could” Do is Insufficient Evidence to Support Obviousness Finding

Duke University owns US 7,056,712 (‘712), which claims methods of treating a metabolic disorder known as Pompe disease. In particular, ‘712 claims methods of treating Pompe disease using a recombinant human acid...more

PTAB Denies Apple's Motion to Withdraw IPR Petition and Motion for Joinder

by Knobbe Martens on

The PTAB denied Apple’s motion to withdraw both its IPR petition and concurrent motion for joinder to prevent Apple from circumventing potential estoppel ramifications in Apple Inc. v. Papst Licensing GmbH & Co. KG,...more

Patent Grace Period Laws in the IP5 Patent Offices: Some Similarities But Largely Different

Life science and other high technology companies most frequently file patent applications in five IP offices (IP5), namely: the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), the Japanese...more

How Far Is Too Far? Institution Decision to Final Written Decision

by Brinks Gilson & Lione on

In making a final written decision of AIA proceedings, the Patent Trial and Appeal Board (“the Board”) is not bound by findings made in an institution decision. In three recent decisions, the Federal Circuit considered the...more

We Received a Patent Term Extension - Now What?

by Pepper Hamilton LLP on

This is the final article in our five-part series on PTE. Obtaining a patent term extension (PTE) is extremely valuable to an innovator. By design, PTE extends the patent term to recoup time lost to the rigorous...more

Summaries of All Supreme Court and Precedential Federal Circuit Patent Cases Decided Since Jun. 1, 2016

This paper is based on reports on precedential patent cases decided by the Federal Circuit distributed by Peter Heuser on a weekly basis. Please see full publication below for more information....more

Potential Impact of the Supreme Court’s Decision to Review the PTAB’s Practice of Issuing Partial Final Written Decisions in...

In a case with potential wide-ranging ramifications for patent validity challenges, on May 22, 2017, the Supreme Court granted a writ of certiorari in an appeal from an inter partes review (“IPR”) decision, SAS Institute v....more

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