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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

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

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity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

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

Senju Pharmaceutical Co. v. Apotex Inc. (Fed. Cir. 2014)

Applying the doctrine of claim preclusion (previously termed res judicata), a fractured majority of the Federal Circuit held that prior ANDA litigation to final judgment precluded reassertion of amended claims in the same...more

4/8/2014 - Patent Infringement Patent Litigation Patents Pharmaceutical

Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)

The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo...more

3/19/2014 - AMP v Myriad Mayo v. Prometheus Myriad Patent-Eligible Subject Matter Patents Pharmaceutical SCOTUS USPTO

Utah Judge Denies Myriad's Preliminary Injunction Motion

In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more

3/12/2014 - AMP v Myriad BRCA DNA Genetic Materials Human Genes Myriad Myriad v Ambry Patent Litigation Patents Pharmaceutical Preliminary Injunctions

GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed. Cir. 2014)

The Federal Circuit issued an opinion on Monday in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. illustrating how difficult it can be to overturn a district court determination based on a question of fact, at least when the...more

2/27/2014 - Chemicals GlaxoSmithKline Patent Litigation Patents Pharmaceutical Prescription Drugs

Patenting Necessary for Continued Innovation in Biotech/Pharma Industries, Academics Conclude

Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical. This has been due in part to political opposition to licensing university technology (and the purported soiling of the...more

2/12/2014 - Bayh-Dole Act Biotechnology Innovation Patent Applications Patents Pharmaceutical Universities

More Q&A from Webinar on Top Patent Law Stories of 2013

On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013." The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories. Posts...more

1/24/2014 - 23andMe America Invents Act AMP v Myriad Biotechnology Bowman v Monsanto FTC v Actavis Innovation Act Life Sciences Monsanto Myriad Patent Infringement Patent Litigation Patent Reform Patent Trolls Patents Pharmaceutical SCOTUS

Allergan, Inc. v. Athena Cosmetics, Inc. (Fed. Cir. 2013) -- FDCA Does Not Preempt State Unfair Competition Laws

If you have ever wondered how popular eyelash enhancers like RevitaLash and Latisse produce their effects, Allergan, Inc. v. Athena Cosmetics, Inc. provides the answer: these products comprise prostaglandin derivatives. The...more

1/17/2014 - Cosmetics FDCA Patent Litigation Patents Pharmaceutical Prescription Drugs Unfair Competition

AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the...more

12/31/2013 - AstraZeneca Drug Manufacturers Generic Generic Drugs Nexium Patent Infringement Patents Pharmaceutical Prescription Drugs Prilosec

In Defense of Patenting

Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more

12/20/2013 - Bayh-Dole Act BRCA GATT Inventors Licenses Myriad Patent Reform Patent-Eligible Subject Matter Patents Pharmaceutical Prior Art Royalties Technology Universities WTO

NIH Declines to Exercise March-in Rights over Abbott Laboratories' Norvir®

Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more

11/12/2013 - Abbott Laboratories Bayh-Dole Act NIH Patents Pharmaceutical Prescription Drugs

Where Do We Stand?

Some of our commenters have asked (with greater or lesser degrees of stridency) that we "take a position" on claims like the Myriad method claims at issue in the lawsuits brought against Ambry Genetics, Gene-by-Gene, and...more

11/1/2013 - Ambry DNA Genetic Materials Human Genes Myriad Patents Pharmaceutical

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for...more

9/17/2013 - ANDA Biopharmaceutical Patent Litigation Patents Pharmaceutical

Leo Pharmaceutical Products, Ltd. v. Rea (Fed. Cir. 2013)

The Federal Circuit's jurisprudence regarding obviousness as determined by the U.S. Patent and Trademark Office continues its post-KSR development in Leo Pharmaceutical Products, Ltd. v. Rea, which involves an obviousness...more

8/14/2013 - Inter Partes Reexamination Obviousness Patents Pharmaceutical Prescription Drugs USPTO

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

7/19/2013 - ANDA Drug Manufacturers FTC FTC v Actavis Generic Drugs Pharmaceutical Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Supreme Court Denies Certiorari in Momenta Case

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

6/26/2013 - ANDA Certiorari FDA Infringement Patents Pharmaceutical Preliminary Injunctions Prescription Drugs Safe Harbors SCOTUS Split of Authority

U.S. Supreme Court Rules That “Reverse Payment” Settlements in ANDA Litigation Are Not Presumptively Unlawful But Must Be Assessed...

The Supreme Court ruled 5-3 on June 17, 2013 in favor of the Federal Trade Commission in FTC v. Actavis. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer’s opinion...more

6/19/2013 - Actavis Inc. ANDA FTC FTC v Actavis Generic Drugs Patents Pay-For-Delay Pharmaceutical Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

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