It’s that time of year when we make resolutions to improve our health, our relationships, our careers, or other areas of our lives. I’m not starting a new diet today (although if I were, the invention described in this patent...more
1/2/2018
/ Claim Construction ,
Foreign Patent Applications ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Applications ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
SCOTUS ,
USPTO
The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more
12/27/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preemption ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition
While Congress is trying to pass a tax reform bill that would cut corporate taxes, USPTO patent fees will increase effective January 16, 2018. The 72% jump in the Inter Partes Review request fee has gotten the most attention,...more
As announced in this October 30, 2017 Federal Register notice, the USPTO is expanding the Collaborative Search Pilot Program under which applicants can request that multiple intellectual property offices exchange search...more
11/9/2017
/ Collaboration ,
Expedited Approval Process ,
Federal Register ,
Foreign Patent Applications ,
Information Disclosure Statement ,
Japan ,
KIPO ,
Korea ,
Patent Applications ,
Patents ,
USPTO ,
USPTO Pilot Program
In a non-precedential decision issued in Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling as being improperly grounded in hindsight. This decision...more
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
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
10/7/2017
/ Appeals ,
Innovation ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101 ,
USPTO
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
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
9/16/2017
/ Administrative Appeals ,
Appeals ,
CAFC ,
Harmless Error ,
Inherency ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Invalidity ,
Patents ,
Prior Art ,
USPTO
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
9/11/2017
/ Appeals ,
Burden of Proof ,
Burden-Shifting ,
CAFC ,
Ex Parte ,
Obviousness ,
Patent Examinations ,
Patent Trial and Appeal Board ,
Patents ,
USPTO ,
Vacated
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
8/31/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Collateral Order Doctrine ,
FDA Approval ,
Federal Rules of Civil Procedure ,
FRCP 11 ,
Hospira ,
Judicial Review ,
Motion to Compel ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Writ of Mandamus
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
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
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
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
8/4/2017
/ Adverse Inference Instructions ,
Appeals ,
But For Causation ,
Discovery ,
Due Process ,
Fourteenth Amendment ,
Inequitable Conduct ,
Intent ,
Materiality ,
Patent Invalidity ,
Patent Prosecution ,
Patents ,
Pharmaceutical Patents ,
Sanctions ,
USPTO
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
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
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
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
7/12/2017
/ Biotechnology ,
CLS Bank v Alice Corp ,
Dietary Supplements ,
Motion to Dismiss ,
Myriad-Mayo ,
Patent Invalidity ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101
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
6/29/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Disclosure Requirements ,
Exclusive Remedy ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Remand ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Supremacy Clause ,
Unfair Competition
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
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
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Content Marketing ,
Dispute Resolution ,
FDA Approval ,
Food and Drug Administration (FDA) ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
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
6/12/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Inter Partes Review (IPR) Proceeding ,
License Applications ,
Life Sciences ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preponderance of the Evidence ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
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
6/8/2017
/ Exports ,
First Sale Doctrine ,
Foreign Sales ,
Imports ,
Impression Products v Lexmark International ,
IP License ,
Patent Exhaustion ,
Patent Infringement ,
Patents ,
Resales Agreements ,
Restraint on Alienation ,
SCOTUS ,
Single-Use/No Resale Restriction ,
Stream of Commerce
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