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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

Federal Trade Commission v. Actavis, Inc. (2013)

The Supreme Court ruled 5-3 today in favor of the Federal Trade Commission in FTC v. Actavis, Inc. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer's opinion reversed the...more

6/18/2013 - Actavis Inc. ANDA FTC FTC v Actavis Generic Drugs Patents Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

U.S. Supreme Court Rules Human Genes Cannot Be Patented While Approving Patentability of Synthetic Genes in Issuing Key Myriad...

The Supreme Court ruled unanimously June 13, 2013 in favor of Plaintiffs/Petitioners in Association of Molecular Pathologists v. Myriad Genetics on the question of whether isolated DNA is patent eligible. The opinion found a...more

6/18/2013 - AMP v Myriad DNA Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

The Supreme Court rendered its opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. ("the Myriad case"), and in many ways it was anticlimactic: the Court adopted the Department of Justice's position...more

6/14/2013 - AMP v Myriad DNA Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

The Broader Meanings of the CLS Bank Decision

Much has and will continue to be written about the Federal Circuit's en banc decision in CLS Bank Int'l v. Alice Corp. last week, and most of the commentary has and will be critical of the path the court took in arriving at...more

5/28/2013 - Claim Construction CLS Bank CLS Bank v Alice Corp Computer-Related Inventions Patent-Eligible Subject Matter Patents SCOTUS

Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013)

Enactment of the Leahy-Smith America Invents Act in 2011 focused the patenting community on the changes of U.S. patent law from "first to invent" under the 1952 Patent Act to "first inventor to file" under the AIA as the...more

5/24/2013 - America Invents Act Confidentiality Infringement Patents Prior Art

The Myriad Case and "Gene" Patents: Much Ado about Nothing?

The biggest concern of the biotechnology industry caused by the impending Supreme Court decision in the AMP v. Myriad Genetics case is the threat to existing patents having claims to isolated human DNA (and the DNA from other...more

5/15/2013 - AMP v Myriad Biotechnology DNA Gene Patenting Human Genes Myriad Patents

What We May Learn from the Myriad Oral Argument

The U.S. Supreme Court heard oral argument in Association for Molecular Pathology v. Myriad Genetics, Inc. on Monday, and many have commented on the Court's interrogation of the parties' representatives (and the government)...more

4/19/2013 - DNA Myriad Oral Argument Patent-Eligible Subject Matter Patents SCOTUS The Association of Molecular Pathology v Myriad Genetics Trial Strategies

Myriad Genetic Database Under Siege

With the U.S. Supreme Court set to consider the patent-eligibility of claims to isolated human DNA in AMP v. Myriad Genetics this morning, another aspect of Myriad’s control over BRCA testing technology is being contested. ...more

4/15/2013 - AMP v Myriad Human Genes Myriad Patent-Eligible Subject Matter Patents Product of Nature Doctrine SCOTUS

A Response to Dr. Mason's "Rebuttal" to Criticisms of His Genomics Medicine Article

Much of the gene patenting debate has appeared, to experienced patent practitioners, to be akin to a conversation with Kevin Kline's character in A Fish Called Wanda, or perhaps a passage from P.G. Wodehouse's The Luck of the...more

4/12/2013 - DNA Human Genes Patent-Eligible Subject Matter Patents

Supreme Court Oral Argument in FTC v. Actavis

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

4/2/2013 - ANDA Competition FDA FTC v Actavis Generic Drugs Manufacturers Patents Pharmaceutical Reverse Payment Settlement Agreements SCOTUS Watson Pharmaceuticals

Is Lack of Preemption the Key for the Supreme Court to Decide in Myriad's Favor?

The U.S. Supreme Court will hear arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on April15th, and the parties and their different cadres of amici have submitted briefs of varying degrees of...more

3/27/2013 - DNA Human Genes Myriad Patent-Eligible Subject Matter Patents Preemption SCOTUS

IPO Files Amicus Brief in Support of Respondents in AMP v. Myriad Genetics

In an amicus brief filed last week in support of respondents Myriad Genetics, Inc. et al., the Intellectual Property Owners Association (IPO) asked the Supreme Court to affirm the Federal Circuit's decision in Association for...more

3/20/2013 - AMP v Myriad Human Genes Intellectual Property Owners Association Patent-Eligible Subject Matter Patents SCOTUS

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

3/15/2013 - ANDA Drug Manufacturers FDA Generic Drugs Patents Proposed Legislation Reverse Payment Settlement Agreements

AIPLA Submits Amicus Brief to Supreme Court in AMP v. Myriad Genetics

There is a great cultural divide that has been illuminated by the Myriad case (AMP v. Myriad Genetics), between producers of technology and its consumers, governments and non-government organizations such as patient groups...more

3/14/2013 - AMP v Myriad Human Genes Patent-Eligible Subject Matter Patents SCOTUS

Myriad Sets Forth Its Case to the Supreme Court

Myriad Genetics filed its responsive brief with the Supreme Court last Thursday in AMP v. Myriad Genetics ("the Myriad case"). It is a certainly a serviceable brief that makes the patent law arguments that need to be made...more

3/12/2013 - AMP v Myriad Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

Par/Paddock Answers FTC Before Supreme Court

Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more

2/28/2013 - Actavis Inc. ANDA Anti-Competitive FTC Generic Drugs Hatch-Waxman Par/Paddock Patents Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Gunn v. Minton (2013)

A patent issue exerted its Circe-like effect on the Supreme Court again today in Gunn v. Minton, a decision overruling the Texas Supreme Court on the question of whether the existence of a patent issue in a legal malpractice...more

2/21/2013 - Attorney Malpractice Federal Question Jurisdiction Grable Factors Gunn v Minton Mixed Motive Cases Patents SCOTUS

Bowman v. Monsanto: Oral Argument

The Supreme Court heard oral argument today in Bowman v. Monsanto Co., with Mark P. Walters representing Farmer Bowman, Seth Waxman representing Monsanto, and Melissa Arbus Sherry representing the Department of Justice. ...more

2/20/2013 - Bowman v Monsanto Genetically Engineered Seed Infringement Patent Exhaustion Patents SCOTUS

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic...more

2/15/2013 - ANDA Cephalon Clear and Convincing Evidence Expert Testimony Generic Drugs Hatch-Waxman Infringement Patents Pharmaceutical Presumption of Validity Reversal Reverse Payment Settlement Agreements Standard of Proof

It Ain't Necessarily So Down on the Farm: Not All Farmers Agree with Farmer Bowman in Bowman v. Monsanto

The "conventional wisdom" surrounding the Bowman v. Monsanto case now before the Supreme Court on certiorari is that it is "David v. Goliath," the salt-of-the-earth farmer versus the corporate monolith, and an example of the...more

2/1/2013 - Biotechnology Bowman v Monsanto Farms Genetically Engineered Seed Infringement Patent Exhaustion Patents SCOTUS Seeds

BayhDol25 Files Amicus Brief in Bowman v. Monsanto

"Happy families are all alike; every unhappy family is unhappy in its own way." - Leo Tolstoy, Anna Karenina A great many amicus briefs have been filed in support of affirmance of the Federal Circuit's decision in Bowman...more

1/31/2013 - Bayhdol25 Biotechnology Bowman v Monsanto Licenses Patents Royalties Seeds

Government Sticks to Its Guns in Bowman v. Monsanto Amicus Brief

Over the past decade, the Supreme Court's increased interest in patent law cases was paralleled by briefs from the Solicitor General advising the Court to grant certiorari. The apparent influence of the government has waned...more

1/29/2013 - Genetically Engineered Seed Infringement Monsanto Patents SCOTUS Seed Set

House Considers Alternative Patent Royalty Scheme for Genetically Engineered Seed

The tendency for members of the House of Representatives to exhibit ignorance of the patent system, so amply demonstrated in the "debate" over H.R. 6621 at the end of the last Congress (see "Congressional Misunderstandings...more

1/15/2013 - Department of Agriculture Genetically Engineered Seed Patents

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