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Patent Related Changes To Bayh-Dole Act Regulations

Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that...more

Claim Construction Of An Enantiomeric Chemical Structure

In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more

Federal Circuit Finds ANDA Jurisdiction Before PIV Certification

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more

How The Fanapt Product Label Established Infringement Of Personalized Treatment Claims

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we...more

USPTO Issues Patent Eligibility Examination Guidance Under Berkheimer

As announced in a Federal Register Notice dated April 20, 2018, the USPTO has issued a new memorandum to the Examining Corps providing supplemental patent eligibility examination guidance under Berkheimer, a Federal Circuit...more

Federal Circuit Upholds Vanda Fanapt Personalized Method Claims Against Patent Eligibility Challenge

In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a...more

Federal Circuit Finds Composition of Matter Ineligble For Patenting

In a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for...more

An Economic Test For Patent Eligibility?

In the non-precedential decision issued in Exergen Corp. v. Kaz USA, Inc., Judge Moore considered the time and money it took to develop the invention at issue when deciding that the claims satisfy the patent eligibility...more

USPTO Withdraws Newly Characterized Antigen Test For Written Description Of Antibodies

The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the...more

When Does an RCE Stop the PTA Clock?

In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must...more

PTAB Enters Sua Sponte Patent Eligibility Rejections

We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance....more

Federal Circuit Emphasizes Need For Reasonable Expectation Of Success

In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the...more

Three Things To Know About Rule 130 Declarations

A few weeks ago I joined Kathleen Fonda, Ph.D., J.D., Senior Legal Advisor in the USPTO’s Office of Patent Legal Administration, and Gary Ganzi, J.D., Senior Counsel and Head of Intellectual Property for Evoqua Water...more

Prosecution History Informs Claim Meaning Even Without Unmistakable Disclaimer

Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court “tiptoes” the “fine line between reading a claim in light of the specification, and...more

How Much is That Issue Fee Payment in the Window?

A new USPTO fee schedule took effect on January 16, 2018, which usually means that all fees must be paid at the new (higher) rate. However, thanks to revisions to 35 USC § 151 effected by the Patent Law Treaties...more

New Year's Resolutions For The U.S. Patent System

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

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

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

Canada Provides More Guidance On Patent Eligibility Of Diagnostic Method Claims

While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and...more

USPTO Patent Fees To Go Up January 2018

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

USPTO Expands Collaborative Search Pilot Program

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

Federal Circuit Finds NuvaRing Patent Nonobvious Without Hindsight

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

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

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