Konstantin Linnik, JD, PhD – Nutter McClennen & Fish LLP

FDA Issues Draft Guidance on Regulatory Exclusivity for Biologics

August 13, 2014 Advisory On August 4, 2014, the US Food and Drug Administration (FDA) released Draft Guidance on determining eligibility of a biological drug for regulatory exclusivity. Under the Public Health Service Act…more

Consumer Watchdog Puts a Leash on Appealing USPTO Decisions to Federal Court

Despite being dismissed by the Federal Circuit before reaching its highly anticipated substantive issues regarding patent eligibility, the ruling in Consumer Watchdog v. Wisconsin Alumni Research Foundation nonetheless…more

Whose Invention Is It Anyway? Or, “Should I Throw Away My Lab Notebook?”

On July 17, 2014, MassBio will host an expert panel “Best Practices in Protecting and Exploiting Intellectual Property.” Among other topics, the panel will discuss the new US patent system, the first inventor to file (“FITF”)…more

FDA Issues Draft Guidance on How to Demonstrate Biosimilarity

New draft guidance released by the FDA on May 13, 2014 will assist drug companies in determining whether a proposed therapeutic biological product is “biosimilar” to its reference product. “Biosimilarity” under Section 351(k) of…more

USPTO Issues Guidance in View of Myriad and Prometheus

On March 4, 2014, the U.S. Patent and Trademark Office (USPTO) published the long-awaited Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products…more

The Myriad Decision: Has the Dust Settled Yet?

Six months ago, the United States Supreme Court shook up the biotechnology industry by ruling that genetic sequences are not patent eligible “simply because they have been isolated.” AMP v. Myriad Genetics, 569 U.S. 12-398 (June…more

Are Combination Drugs in Danger After the Federal Circuit’s Novo Nordisk Decision?

The Federal Circuit rendered a decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. on June 18, 2013, finding that a Novo Nordisk diabetes treatment patent involving the combination of the drugs metformin and…more
| Intellectual Property

The Myriad Ruling: 6 Points Every Biotech CEO Must Consider

Last week, the US Supreme Court issued a long-awaited decision in Myriad Genetics, which sent shockwaves through the very foundation of the biotech industry. The decision invalidated one of Myriad’s patents on mutated BRCA-gene …more
| Constitutional Law, Health, Intellectual Property, Privacy

Supreme Court Unanimously Rules That “Gene Patents” Are Invalid

In a highly anticipated decision issued today in Association for Molecular Pathology v. Myriad Genetics, the Supreme Court unanimously ruled that isolated DNA sequences are not eligible for patent protection. The Court…more
| Intellectual Property

The Perils of Claiming Open-Ended Ranges – A Reminder Courtesy of the Federal Circuit

Patent prosecutors drafting claims that recite open-ended ranges (e.g., at least 10%, greater than 5 units) were again warned of the perils of claiming more than has been disclosed. In a recent decision by the Federal Circuit,…more
| Intellectual Property

Lighting the Path to More Valuable Method Claims: Inducement with Divided Infringement

Inducement with Divided Infringement after Akamai Tech. v. Limelight Networks and McKesson Tech. v. Epic Systems September 18, 2012 Legal Update As diagnostics, end-user sophistication, and mobile and web-based technologies…more
| Intellectual Property

Who Owns My Invention?

In a July 12, 2012 order, Suffolk Superior Court Justice Lauriat dismissed a lawsuit by urologist Dr. Grocela, asserting that his employer’s Intellectual Property (IP) policy as applied to him was an unfair restraint on trade…more
| Intellectual Property, Labor & Employment Law

Myriad Genetics Notches Another Legal Victory

Sept 6, 2012, Cancer Discover--Myriad Genetics of Salt Lake City, UT, can check off another legal victory on its BRCA1 and BRCA2 patent claims. On August 16, 2012, the U.S. Court of Appeals for the Federal Circuit in…more
| Health, Intellectual Property

PPACA: What’s Next For Life Sciences Companies

Law360, New York (August 24, 2012, 12:57 PM ET) -- Life sciences companies breathed a sigh of relief when the U.S. Supreme Court largely upheld the Patient Protection and Affordable Care Act (PPACA). After all, the PPACA will…more
| Antitrust & Trade Regulation, Health, Insurance, Intellectual Property

Federal Circuit Reaffirms (Again) Gene Patents in Myriad

On August 16, 2012, biotechnology patent owners breathed a short sigh of relief, as the US Court of Appeals for the Federal Circuit issued the highly anticipated decision in Association for Molecular Pathology v. Myriad…more
| Intellectual Property
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