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The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

2/26/2015 - America Invents Act Hatch-Waxman Hedge Funds Inter Partes Review Proceedings Market Manipulation Patent Trial and Appeal Board Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs Price Manipulation Standing

Game Over for Myriad -- Update: (Or, and then there was one were none)

As discussed for the past month, Myriad has finally given up trying to defend its BRCA gene testing franchise. The one remaining matter, Myriad's case against GeneDx has settled, as announced by the company today....more

2/17/2015 - America Invents Act Genetic Testing Inter Partes Review Proceedings Myriad Patent Litigation Patents

Morocco Decides to Recognize EP Applications and Patents

The President of the EPO and the Minister of Industry, Trade, Investment and the Digital Economy of Morocco announced on January 19th that Morocco would permit EP applications and granted EP patents to be validated in that...more

2/12/2015 - EP Patent European Patent Office Morocco Patents

Game Over for Myriad - (Or, and then there was one)

As discussed at the end of January, Myriad has given up its Quixotic quest to validate its BRCA gene testing franchise and has abandoned its several lawsuits (many of which were consolidated before the District of Utah under...more

2/11/2015 - Genetic Materials Myriad Patent Litigation Patent-Eligible Subject Matter Patents Pharmaceutical Manufacturers Pharmaceutical Patents

Rep. Goodlatte Introduces His Patent Reform Bill (Again) -- Part II

As discussed in a prior post, Rep. Bob Goodlatte (R, VA-6th) and a bipartisan collection of sponsors* introduced a bill, once again entitled the "Innovation Act" (H.R. 3309 in the last Congress; H.R. 9 in this one) directed...more

2/10/2015 - Innovation Act Patent Reform Patents Proposed Legislation

Porcine Breed Diversity in China

It seems that Orwell was right: all pigs are equal, but some are more equal than others. The question of how diverse different breeds of domesticated animals may be has begun to be addressed with the completion of many...more

2/3/2015 - China Genetic Materials Patents

Pro-Patent Coalition Writes Letter to the House and Senate Judiciary Committees

Last week, what is described as "a broad coalition" representing patent holders and inventors sent a letter to Representatives Bob Goodlatte (VA, 6th) and John Conyers (MI, 13th), Chairman and Ranking Member, respectively, of...more

1/30/2015 - CLS Bank v Alice Corp Highmark v. Allcare Innovation Act Inventors Legislative Committees Limelight v Akamai Nautilus Inc. v. Biosig Instruments Octane Fitness v. ICON Patent Reform Patents

Big Ten Lobbies Congress to Tread Lightly on "Patent Reform"

One of the frustrations for participants in the patent wars of the early 21st Century has been the failure of many of the most vulnerable stakeholders to take a stand against overreaching proposals by proponents of a crisis...more

1/30/2015 - Big Ten Conference Innovation Act Legislative Agendas Lobbying Patent Reform Patents

Myriad Throws in the Towel

In the aftermath of the Supreme Court's decision in AMP v. Myriad Genetics in 2013, Myriad (paradoxically to those either not paying attention or who over interpreted the scope of the Court's holding in its opinion) filed...more

1/28/2015 - AMP v Myriad Covenant Not to Sue Declaratory Judgments DNA Genetic Testing Multidistrict Litigation Myriad Myriad v Ambry Patent Infringement Patent Litigation Patents SCOTUS Settlement Agreements

What's Next? Some Consequences of the Teva v. Sandoz Decision

Supreme Court Building #3It has escaped almost no one's notice that the Supreme Court has spent the past decade or so being much more involved in patent law than in preceding twenty years. Evident but perhaps less discussed...more

1/23/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

Teva v. Sandoz: The Dissent

The recent history of Supreme Court patent cases has made the dissent a seemingly endangered species, the Court consistently deciding important patent cases by 9-0 votes and, at best, garnering concurring opinions for...more

1/22/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

The Uncomfortable Intersection between the Practice of Medicine and Reality

The disconnect between patents and medicine (and more particularly, between physicians who prescribe patented drugs and the pharmaceutical companies who produce them) was illustrated nicely in a recent dustup between doctors...more

12/30/2014 - Patents Pfizer Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Physicians UK

Some Human Embryonic Stem Cells Are Once Again Patent-eligible in Europe

Last Thursday, the European Court of Justice rendered a decision in International Stem Cell (ISCO) Corporation v. Comptroller General of Patents, Designs and Trademarks (UK) that significantly modified the landscape for human...more

12/24/2014 - EU Patent-Eligible Subject Matter Patents Popular Stem cells

In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation (Fed. Cir. 2014)

In a decision that will surprise no one (written by Judge Dyk, which made the conclusions foregone from the first page of the opinion), the Federal Circuit today affirmed the Utah District Court's decision denying Myriad...more

12/18/2014 - Multidistrict Litigation Myriad Patent Litigation Patents Popular Preliminary Injunctions

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

12/15/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA Intellectual Property Litigation Life Sciences Patent Litigation Patents Pharmaceutical Pharmaceutical Patents Prescription Drugs

Japanese Foundation for Cancer Research v. Lee (Fed. Cir. 2014) - When you file a disclaimer, you'd better mean it

The Federal Circuit reversed a District Court decision this week in a case involving an improperly filed statutory (terminal) disclaimer, in Japanese Foundation for Cancer Research v. Lee. Caught between miscommunication...more

12/12/2014 - Patents Terminal Disclaimer

Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. (Fed. Cir. 2014)

That it is more difficult today to be a patentee able to defend her patent rights than any time since the 1940's is nicely illustrated by the Federal Circuit's decision in Par Pharmaceutical, Inc. v. TWI Pharmaceuticals,...more

12/4/2014 - ANDA Par Pharmaceutical Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents

How the Kirtsaeng Decision Could Ruin the U.S. Branded Drug Industry

The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8...more

11/26/2014 - Books Canada Copyright Copyright Infringement DOHA Exports FDA First Sale Doctrine Generic Drugs Imports International Treaties Medicaid Medicare Patents Pharmaceutical Patents Popular WTO

Genetic Technologies Ltd. v. Laboratory Corp. of America Holdings (D. Del. 2014)

Another district court (actually, a magistrate judge) has succumbed to the siren song, or drank the Kool-Aid, or (fill in your favorite Apocalyptic metaphor here) of applying the Supreme Court's Mayo v. Prometheus decision in...more

11/25/2014 - CLS Bank v Alice Corp Mayo v. Prometheus Patent Litigation Patent-Eligible Subject Matter Patents Section 101

Ariosa v. Sequenom -- Ariosa's Responsive Brief

The Federal Circuit heard oral argument in the Ariosa v. Sequenom case last Friday, and a discussion of that argument will be posted in due course. Having posted on Sequenom's opening brief and the amicus brief filed by BIO,...more

11/12/2014 - AMP v Myriad DNA Genetic Materials Patent Infringement Patent Litigation Patents Sequenom

Lex Machina Looks at ANDA Cases

Lex Machina, a commercial venture spinning out of the "quantitative statistics" trend in patent scholarship popularized by Mark Lemley, Kimberly Moore, David Schwartz, and others, has released a Report on ANDA litigation that...more

11/6/2014 - ANDA FDA Generic Drugs Information Reports Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents

President and Fellows of Harvard College v. Lee (Fed. Cir. 2014)

One of the most iconic inventions of the biotechnology era is the "Harvard Oncomouse" invented by Philip Leder and Timothy Stewart in the early 1980's. One of the first transgenic mice transformed with DNA encoding something...more

10/30/2014 - Biotechnology Harvard University Inter Partes Reexamination Patent Infringement Patent Litigation Patents Pharmaceutical Patents

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

10/24/2014 - Distributors Drug Distribution Generic Drugs Manufacturers Patents Pharmaceutical Manufacturers Pharmaceutical Patents Trans-Pacific Partnership

The Indefiniteness of What is "Routine, Well-understood and Conventional" in Assessing Patent Eligibility of Diagnostic Method...

Castigating the Supreme Court, at least in patent circles, has become as prevalent as the Court's forays into patent law have been to overrule the Federal Circuit. While even those who give the Court the benefit of the doubt...more

10/21/2014 - Diagnostic Method Patent Infringement Patent Litigation Patent-Eligible Subject Matter Patents

Amgen Poised to Enter Biosimilars Market

As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab...more

10/9/2014 - Amgen Biosimilars Biotechnology Patent Litigation Patents

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