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How is Graphene Currently Used and What is the Hope for the Future? [Video]

In the second video of a three-part series, Fenwick attorney Paul Smith talks about the growing anticipation surrounding this strong, conductive and flexible material. Why the excitement? Simply put, graphene is easy. It’s...more

What is Graphene? Fenwick Patent Attorney Has the Answer [Video]

The technology and life sciences communities alike have been raving about new "wonder material" graphene for the past year. From applications for wearable devices to the creation of lightweight, bendable televisions and...more

Two Tips for Inventors Filing Patent Applications [Video]

The intense patent activity in graphene stems from its enormous technological and commercial potential. But because much of the territory underlying the graphene cross-roads has already been claimed, patenting graphene poses...more

High Court Will Take Up Standard of Review of Factual Findings in Claim Construction

Teva Pharmaceuticals USA Inc. et al. v. Sandoz Inc. et al. - In a case that will likely determine the standard of review used by the U.S. Court of Appeals for the Federal Circuit over lower court claim constructions,...more

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

The Life Sciences Report - Spring 2014

In this issue: - A New Accelerator Takes Digital Health Start-Ups to the Next Level - The Return of the MedTech IPO Market - Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters -...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

Personalized Medicine and Patent Eligibility under 35 U.S.C. § 101

Double-digit growth is predicted for the molecular diagnostic market in the next several years, driven in part by an increased demand for personalized medicine—medical decisions and therapeutic products tailored to address...more

Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

The State of Vaccines Under the USPTO 101 Guidelines

In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

Five Things You Should Know About the USPTO Patent Subject Matter Eligibility Guidelines

The new USPTO patent subject matter eligibility guidelines set forth a detailed analytical framework for evaluating whether claims satisfy the patent subject matter eligibility requirement of 35 USC § 101. If you are an...more

HSR Act Allows Pharmaceutical Licensing Transactions To Be Subject to Unique Reporting Requirements, FTC Tells Court

The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more

TransCardiac's State Court Complaint Avoids Raising Federal Question

Judge Totenberg remanded the case brought by TransCardiac Therapeutics, Inc. (“TransCardiac”), against Ajit Yoganathan, Ph.D, Jorge H. Jiminez, Ph.D., Vinod H. Thourani, M.D., Emory University, Georgia Tech Research...more

The USPTO Announces New Guidelines for Determining Subject Matter Eligibility Under 35 U.S.C. §101 in View of Myriad, Prometheus...

March 10, 2014 – On March 4, 2014, the United States Patent & Trademark Office issued guidelines for the examination of “all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of...more

USPTO Guidance for Examiners Takes Expansive View of Myriad and Prometheus Decisions

On March 4, 2014, the U.S. Patent and Trademark Office (“USPTO”) issued a memorandum to the Patent Examining Corps with guidance for determining the patent eligibility of claims relating to products of nature and laws of...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

Patent Profile: VM Institute of Research Receives Patent for Method of Treating Triple Negative Breast Cancer

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,642,270, which is entitled "Prognostic biomarkers to predict overall survival and metastatic disease in patients with triple negative breast cancer." The...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...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

Patent Profile: Patent Issued for Method of Differentiating Pancreatic Cancer from Benign Pancreatic Disease

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,632,983, which is entitled "Biomarkers for pancreatic cancer and diagnostic methods." The '983 patent, which is assigned to the Van Andel Research...more

No Patent for You

Patent eligibility restrictions hit life sciences and tech - After years of issuing rulings limiting what can be patented, the Supreme Court turned its attention squarely toward patent eligibility in the life sciences...more

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

mHealth Stakeholders: Updated Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...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

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