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Beginning the Patent Process

The second step in bringing your medical device to market is to understand whether you can protect your invention. This article is part two of a series that presents the three big issues in intellectual property: Do...more

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more

Mayo, Myriad, and Multi-factor balancing tests

Updated subject matter eligibility guidance from the USPTO - On the same day that the Supreme Court’s opinion was handed down in Assoc. for Mol. Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), the U.S. Patent...more

Genentech’s Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc. (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2,...more

Computer-Aided Selection Method Fails Patent-Eligibility

In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and...more

Methods of Medical Treatment: Still Not an “Invention” in Canada

On January 27, 2014, the Federal Court of Appeal in Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co., 2014 FCA 17 (Novartis), upheld the Federal Court’s denial of an application for a prohibition order under...more

News from Down Under -- High Court of Australia Confirms That Claims to Methods of Medical Treatment Are Patentable in Australia

In the decision of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (order), the High Court of Australia, Australia's supreme court, confirmed that methods of medical treatment are a "manner of manufacture" and...more

Hydraulic Fracturing in Illinois: Draft Regulations to Protect Chemical Proprietary Information

Last month, the Illinois Department of Natural Resources (“IDNR”) published its first draft of the regulations (62 Ill. Adm. Code 245) (the “HFRA Draft Regulations”) under the Illinois Hydraulic Fracturing Regulatory Act (225...more

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

Supreme Court Decides Landmark Gene Patent Case

Actress Angelina Jolie recently spent around $3200 to take one of Myriad Genetics’ many breast cancer screening tests. When the test revealed that a mutation existed somewhere in a sequence of 81,000 nucleotides found on her...more

Bloomberg Law: Actavis Court Requires Case-by-Case Analysis of Anticompetitive Effects of Reverse-Payment Settlements

This article analyzes the US Supreme Court's recent antitrust decision in FTC v. Actavis, which held that that courts should apply the rule of reason in analyzing reverse-payment settlements. ...more

Federal Circuit Clarifies Standards for a Clinical Trial to Be Public Use

In 2007, Dey L.P., Dey Inc., and their parent company Mylan, Inc. (collectively, "Dey") sued Sunovion Pharmaceutical, Inc. ("Sunovion"; formerly known as Sepracor, Inc.) for infringement of five of Dey's patents....more

Association for Molecular Pathology v. Myriad Genetics

Supreme Court Ruling that Human Genes May Not Be Patented

Full text copy of the unanimous U.S. Supreme Court ruling in Association for Molecular Pathology v. Myriad Genetics that human genes may not be patented because they occur naturally in nature. From Greg Stohr writing for...more

Rubin v. General Hospital Corp. (Fed. Cir. 2013)

On March 28, the Federal Circuit in Rubin v. General Hospital Corp. affirmed judgment by the District Court for the District of Massachusetts dismissing the suit brought by Drs. Berish Rubin and Sylvia Anderson against The...more

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

January 2013: European Litigation Update

The European Court of Justice (ECJ) on European Supplementary Protection Certificate (SPC) for Further Medical Uses: With a remarkable ruling from July 2012 (Neurim Pharmaceuticals, C-130/11), the European Court of Justice...more

Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible

Seven organizations of health care professionals argue in an amici brief filed in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") that Myriad's isolated DNA and cDNA claims, as well as claim...more

The Life Sciences Report - Spring 2012

In this issue: - New Procedures for Challenging Patent Validity - Aggressive Healthcare Fraud Enforcement Likely to Continue in 2012 - Life Sciences: The Rodney Dangerfield of Venture Capital -...more

Mayo v. Prometheus Limits Diagnostic Test Patenting

Tuesday the Supreme Court unanimously decided Mayo Collaborative Services v. Prometheus Labs, a decision of considerable significance to the diagnostics industry. The Court reversed the Federal Circuit Court of Appeals,...more

Mayo Collaborative Services v. Prometheus Laboratories -- What the Supreme Court Said

In a decision he has waited six years to write (having dissented from the Court's decision not to decide similar issues in Laboratory Corp. v. Metabolite Labs., Inc. in 2006), Justice Breyer (and a unanimous Court) overturned...more

The Supreme Court Reduces Patent Protection for Medical Diagnosis and Analysis

On March 20, 2012, the U.S. Supreme Court released its long-awaited decision in the case of Mayo Collaborative Services v. Prometheus Laboratories, Inc. slip. op., Case No. 10-1150 (March 20, 2012). This decision resolves a...more

"Skadden's 2012 Insights, January 2012: Global Litigation"

In This Issue: - 58 U.S. Supreme Court Cases to Watch - 59 Securities Litigation: Recent Supreme Court Decisions and Future Trends - 66 Continued Step-up in Government Investigations and White Collar Crime...more

ANDA Automatic Stay of FDA Approval Does Not Defeat Standing in Sham Litigation Antitrust Counterclaim

The District of Delaware recently denied a motion to dismiss an antitrust counterclaim in a patent infringement action in the wake of defendant Mylan, Inc. ("Mylan") having filed an Abbreviated New Drug Application ("ANDA")...more

Clinical Method Claims Dodge a Bullet: Prometheus v. Mayo

On December 17, 2010, the U.S. Court of Appeals for the Federal Circuit confirmed that claims to clinical and diagnostic methods can constitute patent-eligible subject matter in its Prometheus II,1 decision. This was one of...more

An Unclear Diagnosis

What constitutes patentable subject matter? The tension between the broad language of 35 U.S.C. Section 101 and the limitations of its scope by the courts is playing out in the context of patent eligibility of process...more

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