Latest Publications


Domestic Cat Genome Sequenced

Earlier this month, an international effort* led by Stephen J. O'Brien at the Oceanographic Center, Nova Southeastern University, Ft. Lauderdale, Florida reported the complete genomic sequencing of the domestic cat, Felix...more

8/21/2014 - DNA Genetic Materials

Apotex Inc. v. UCB, Inc. (Fed. Cir. 2014)

Last week, the Federal Circuit affirmed a finding of inequitable conduct in Apotex v. USB, a relatively rare occurrence in the years after the Federal Circuit's decision in Therasense v. Becton, Dickenson. In the Therasense...more

8/20/2014 - En Banc Review Inequitable Conduct Patent Litigation Patents Pharmaceutical Pharmaceutical Patents USPTO

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

8/14/2014 - Biologics Biosimilars Biotechnology FDA Pharmaceutical PHSA Prescription Drugs

How to Protect a Product of Nature

"The more things change . . ." is the beginning of an old saw, and that saying has particular relevance just days after the USPTO stopped accepted comments on its Subject Matter Eligibility Guidance. After all, this isn't...more

8/4/2014 - DNA Patent-Eligible Subject Matter Patents Roslin USPTO

In re Patel (Fed Cir 2014)

The Supreme Court has made a sport of reversing the Federal Circuit over the past decade or so, and other than reserved (and sometimes not so reserved) statements by members of the lower court, the Federal Circuit has...more

7/31/2014 - Alice Corporation CLS Bank CLS Bank v Alice Corp Patent Infringement Patent Litigation Patents SCOTUS USPTO

IPO Names Top 100 Patenting Universities

The Intellectual Property Owners (IPO) recently published a list of the top 100 universities worldwide granted patents in 2013. As reported in the IP Record, these universities are...more

7/25/2014 - IPO Patents Universities

Continued Chaos in Obama Administration Patent Policy

President Obama has reportedly decided against nominating Johnson & Johnson executive Philip Johnson in the face of political pressure from the hi-tech industry and Members of Congress, including Senator Charles Schumer...more

7/10/2014 - Patent Reform Patents USPTO

Docs @ BIO: The Rest of the Story - Bloomberg BNA Hosts Panel on Subject Matter Eligibility

Last month at the BIO convention, Randy Kubetin, Managing Editor of Bloomberg BNA's Life Sciences Law & Industry Report moderated a panel entitled "Patent Eligibility from the Trenches: Practical Implications of the Supreme...more

7/9/2014 - AMP v Myriad Mayo v. Prometheus Myriad Patent Litigation Patent-Eligible Subject Matter Patents SCOTUS USPTO

Docs @ BIO: Hello, I Must Be Going - Judge Randall Rader Says Goodbye at BIO

Last week, Judge Randall R. Rader, until recently Chief Judge of the Court of Appeals for the Federal Circuit, opened a day-long session on Intellectual Property Law by saying farewell. In a speech at varying times...more

7/3/2014 - Judges Patents

Docs @ BIO: BNA Issues Report on PTO's Patent Eligibility Guidance

Sounding an appropriately alarmist note, the Bureau of National Affairs (BNA) Life Sciences Law and Industry Report issues the results of a study on how the U.S. Patent and Trademark Office is administering its March 4, 2014...more

7/1/2014 - AMP v Myriad Biotechnology Guidance Update Mayo v. Prometheus Patent-Eligible Subject Matter Patents Public Comment SCOTUS USPTO

Supreme Court Issues Decision in Alice Corp. v. CLS Bank - Alice Corp. v. CLS Bank International (2014)

This morning, in Alice Corp. v. CLS Bank, the Supreme affirmed the Federal Circuit's per curiam opinion in CLS Bank v. Alice Corp. in a unanimous opinion by Justice Thomas with a concurring opinion by Justice Sotomayor joined...more

6/20/2014 - Alice Corporation Bilski CLS Bank CLS Bank v Alice Corp Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter Patents Risk Mitigation SCOTUS Software

Good News, Bad News and More Inflammatory Rhetoric in Myriad Genetics Case

While the rest of the patent world was focused on Supreme Court opinions (issued and pending) and Congressional action vel non on threats like patent trolls, the consolidated Multi District Litigation between Myriad Genetics...more

6/18/2014 - Genetic Markers Genetic Materials Genetic Testing Myriad Myriad v Ambry Patent Infringement Patent Litigation Patent Trolls Patents

Braintree Laboratories, Inc. v. Novel Laboratories, Inc. (Fed. Cir. 2014) - Whither the Meaning of "a" as a Claim Term

Every once in a while a Federal Circuit panel construes a common claim term contrary to how it has been construed in prior precedent, usually based on the particular situation or circumstance the Court is addressing and...more

6/13/2014 - ANDA Claim Construction Generic Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Patents

In re Dinsmore (Fed. Cir. 2014) - Court Upholds PTO Determination That Reissue Cannot Cure Improper Terminal Disclaimer

Despite thirty years of efforts by the Federal Circuit to bring consistency and transparency to patent law (and the last dozen years of the Supreme Court's efforts to the contrary), in many respects patent law remains "full...more

6/11/2014 - Patent Applications Patent Infringement Patent Litigation Patents Reissue Patents USPTO

Nautilus, Inc. v. Biosig Instruments, Inc. (2014)

In the universe of the toxic interplay between the Federal Circuit and the Supreme Court, an affirmance or even a begrudging acknowledgement of the Federal Circuit's "special expertise" in patent law has become as rare as the...more

6/4/2014 - Medical Devices Nautilus Inc. v. Biosig Instruments Patent Infringement Patent Litigation Patents SCOTUS

PTAB Grants First Motion for Leave to Amend in Inter Partes Review

Representatives from the U.S. Patent and Trademark Office, led by Janet Gongola, Senior Advisor to the Deputy Director of the U.S. Patent and Trademark Office, spent the better part of last month traversing the U.S....more

5/28/2014 - America Invents Act Inter Partes Review Proceedings Motion to Amend Patent Trial and Appeal Board Patents USPTO

Tobinick v. Olmarker (Fed. Cir. 2014)

Interferences are not yet dead, although their echo is expected to attenuate over the next decade or so as a result of the provisions of the Leahy-Smith America Invents Act that converted the U.S. from a first-to-invent...more

5/21/2014 - America Invents Act Patent Infringement Patent Litigation Patent Reform Patents

U.S. Trade Representative Issues 2014 Special 301 Report

On April 30th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR) issued the 2014 Special 301 Report. According to the USTR website, the "USTR is fully committed to unlocking opportunity for those Americans to...more

5/20/2014 - Innovation IPR Obama Administration Omnibus Trade and Competitiveness Act Technology Technology Transfer Agreements Trade Policy Trade Secrets Trans-Pacific Partnership

In re Packard (Fed. Cir. 2014)

Often times it appears that, serendipitously or by design, the Federal Circuit issues an opinion on an aspect of patent law that the Supreme Court is also considering. And sometimes the shadow of the Court's impending...more

5/20/2014 - Ambiguous Certiorari Indefiniteness Patent Infringement Patent Litigation Patents

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity

The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more

5/15/2014 - Biosimilars BPCIA FDA Guidance Update Medical Research Pharmaceutical

Sherry Knowles Speaks Truth to the Power of the PTO on ยง 101 Guidelines

Last week, Sherry Knowles, former chief patent counsel for GlaxoSmithKline and now principal at Knowles Intellectual Property Strategies, LLC submitted to Managing Intellectual Property magazine a detailed critique of the...more

5/2/2014 - AMP v Myriad Biotechnology GlaxoSmithKline Mayo v. Prometheus Patent Litigation Patents Pharmaceutical SCOTUS Section 101 USPTO

Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014)

The Federal Circuit extended the scope of the judicially created doctrine of obviousness-type double patenting (OTDP) in a split decision rendered in Gilead Sciences Inc. v. Natco Pharma Ltd. In doing so, the panel majority...more

4/29/2014 - Gilead Sciences Natco Pharma Obviousness OTDP Patent Infringement Patent Litigation Patents

University of Pittsburgh v. Varian Medical Systems, Inc. (Fed. Cir. 2014)

The Federal Circuit used its decision that the District Court erred in certain of its claim construction determinations to reverse a jury award of greater than $100 million, but left intact large portions of the District...more

4/16/2014 - Biotechnology Patent Infringement Patent Litigation Patents Pharmaceutical

Shire Development, LLC v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2014)

Claim construction in patent cases, and the propensity for the Federal Circuit to disagree with a district court's conclusions regarding the scope and meaning of claim terms, remains one of the most vexing aspects of patent...more

4/10/2014 - Claim Construction Generic Drugs Patent Infringement Patent Litigation Patents Pharmaceutical

Endo Pharmaceuticals Inc. v. Actavis, Inc. & Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2014)

The Federal Circuit's decision in the consolidated appeals of Endo Pharmaceuticals Inc. v. Actavis, Inc. and Endo Pharmaceuticals Inc. v. Roxane Laboratories, Inc. amply demonstrates the concept that you should be careful...more

4/9/2014 - ANDA FTC v Actavis Generic Drugs Patent Litigation Patents Pharmaceutical Prescription Drugs

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