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Federal Circuit Questions Written Description For Antibody Claims

The October 5, 2017 Federal Circuit decision in Amgen Inc. v. Sanofi is getting a lot of attention for its commercial impact, because the court vacated the permanent injunction that prevented Sanofi and Regeneron from...more

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more

Federal Circuit Schools USPTO On Broadest Reasonable Claim Construction

In recent decisions, the Federal Circuit has found error in the USPTO Patent Trial and Appeal Board’s approach to obviousness rejections, including its reliance on the doctrine of routine optimization without evidence of an...more

CAFC Finds Harmless Error in USPTO Reliance On Doctrine of Inherency

In Southwire Co. v. Cerro Wire LLC, the Federal Circuit upheld the USPTO decision rendered in an inter partes reexamination proceeding that found Southwire’s patent invalid as obvious. Although the court found that the USPTO...more

CAFC Vacates USPTO Single Reference Obviousness Rejection For Inadequate Showing Of Expectation of Success

In a split decision with Judge Lourie dissenting, the Federal Circuit vacated an obviousness rejection that had been affirmed in an ex parte appeal to the USPTO Patent Trial and Appeal Board. The decision was rendered in In...more

Federal Circuit Provides More Guidance On Biosimilar Patent Litigation

In Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira....more

Federal Circuit Finds No Standing Requirement For Appellees

In Personal Audio LLC v. Electronic Frontier Foundation, the Federal Circuit ruled that an IPR petitioner does not need to satisfy Article III standing requirements in order to participate in a patent owner’s appeal from a...more

Federal Circuit Criticizes PTAB Reliance On Routine Testing

In Honeywell International, Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit vacated the decision of the USPTO Patent Trial and Appeal Board that invalidated Honeywell’s patent in an inter partes...more

A Look At The USPTO Patent Eligible Subject Matter Report

On July 24, 2017, the USPTO issued a 48-page report on Patent Eligible Subject Matter. The report summarizes key court decisions interpreting and applying 35 USC § 101, international views on eligible subject matter, and...more

Federal Circuit Finds Regeneron Transgenic Mouse Patent Invalid For Inequitable Conduct With Intent Inferred From Litigation...

In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron...more

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more

Are State-Owned Patents Immune From IPRs Under The Eleventh Amendment?

In separate non-precedential decisions issued by three different panels, the PTAB has permitted state university patent owners to invoke the Eleventh Amendment in Inter Partes Review proceedings. Each panel found that IPR...more

Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more

District Court Invalidates Dietary Supplement Patents On Motion To Dismiss

The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a...more

Does Amgen Have Viable State Law Claims Against Sandoz Arising From The Zarxio Biosimilar Patent Dispute?

In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more

Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized...more

Supreme Court Decision Largely Favors Biosimilar Applicants

The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more

Industry Perspectives On The Biosimilar Patent Dance

The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more

Supreme Court Finds Patent Rights Exhausted Overseas

In Impression Products, Inc. v. Lexmark International, Inc., the Supreme Court reversed the en banc decision of the Federal Circuit, and held U.S. patents rights exhausted by the patent owner’s sale of a patented article...more

Court Questions Applicability of Function Way Result Test In Chemical Cases

In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit reviewed a preliminary injunction based in part on a finding of likelihood of success in establishing infringement under the doctrine of equivalents....more

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more

Supreme Court Grants Cert In SAS To Decide Required Scope Of PTAB Decision

On May 22, 2017, the Supreme Court granted certiorari in SAS Institute, Inc. v. Lee, where it has been asked to decide whether the PTAB is statutorily required “to issue a final written decision as to every claim challenged...more

USPTO Patent Term Adjustment Error Costs Patent Owners Time And Money

The USPTO appears to have dropped its plans to overhaul the Information Disclosure Statement (IDS) process, but that’s no excuse for its failure to process IDSs in accordance with its current rules. Most egregiously, the...more

Are Secret Sales Prior Art Under The AIA?

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement triggered the on-sale bar under pre-AIA 35 USC § 102(b) and under AIA 35 USC §...more

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

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