Health Intellectual Property

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Celltrion Begins Shipping Remsima to the U.S.

As we reported last week, the district court granted Celltrion’s Motion for Summary Judgment of Invalidity for one of the two patents-at-issue in Janssen v. Celltrion. The Korea Times reports that Celltrion shipped its...more

IPR Petition Filed on Genentech Patent Directed to Method of Producing Polypeptides

On August 16, bioeq filed a petition for inter partes review of U.S. Patent No. 6,716,602, titled “Metabolic rate shifts in fermentations expressing recombinant proteins.” The patent is owned by Genentech and is directed to...more

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events...more

USPTO Offers a Fast Track to Cancer Immunotherapy Patents

The United States Patent Office (USPTO) is implementing a new program that provides prioritized examination of patent applications relating to cancer immunotherapy (Cancer Immunotherapy Pilot Program or Program). The new...more

Health Tech Podcast - Episode 2: Best Practices for Health App Development [Video]

Ian O’Neill, a shareholder in the firm’s Intellectual Property Department focusing on technology transactions, licensing, advanced media and privacy issues, and Emily Weber, a shareholder in the firm’s Health Care Group...more

Letter to Colombian President Encourages Grant of Compulsory License for Imatinib

Last month, we reported on letters sent by two Senators and fifteen Representatives to the U.S. Trade Representative, seeking clarification regarding the Administration's position on compulsory licenses. The letters were...more

A Few Things To Avoid When Drafting A North Carolina Covenant Not To Compete

The Business Court closely examined a set of restrictive covenants last week in Sandhills Home Care,, LLC v. Companion Home Care-Unimed, Inc., 2016 NCBC 59. This decision collects a number of North Carolina Court of Appeals...more

GSK and Verily Partnering to Form New Bioelectronic Medicine Firm

GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million...more

Hudson Institute Report Refutes UN Panel Stance on Impact of Patents on Access to Medicines

In June, the Hudson Institute released a research report that analyzes several positions taken by the United Nations (UN) High Level Panel on Access to Medicines (HLP) on the impact of patents on global access to medicines. ...more

Health Tech Podcast – Episode 1 [Video]

With Denver’s new presence in the health-technology market and Denver’s own digital-health business generator 10.10.10 celebrating the completion of its 10 day journey to have a group of 10 CEOs confront 10 health problems,...more

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

Not What the Doctor Ordered: Injunction Ruled Too Narrow in Trademark Infringement Case

Addressing the scope of injunctive relief awarded in a trademark infringement case, the US Court of Appeals for the Second Circuit affirmed a district court’s finding of a likelihood of confusion, but vacated, reversed and...more

Intellectual Property in Medicine: Tailoring your Patent Strategy

In last week’s post, we covered initial considerations for physicians considering patent protection. At this point, you may be wondering why we haven’t talked about the actual patent application process. That’s because it...more

Basic Contract Issues for New Physician Contracts

When physicians have finally completed the medical education journey, many are confronted with a “physician employment contract,” usually from a hospital or medical practice, which could define the essential terms of their...more

New EU framework for foods for specific groups as of 20 July 2016

Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control (foods for specific groups – “FSG Regulation”) applies as of 20...more

Federal Circuit Holds Claims to Cell Freezing Methods to Be Patent-Eligible

On July 5, 2016, the Federal Circuit held that claims reciting methods for cryopreserving hepatocytes in U.S. Patent No. 7,604,929 ("the '929 patent") are eligible for patenting. The decision vacated a lower court's holding...more

It’s Time to Update Physician Noncompete Agreements in Connecticut

There have been a number of recent legislative developments that will impact physician noncompete agreements entered into in Connecticut. First, any physician noncompete agreement entered into on or after July 1, 2016, must...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

USPTO Joins Cancer Moonshot Effort, Expedites Immunotherapy Patent Applications

On January 12, 2016, President Obama announced a "National Cancer Moonshot" in his State of the Union Address. The Moonshot aims to achieve ten years of progress in cancer research within the next five years. The U.S. Patent...more

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications...more

For Purposes of an On-Sale Bar, Sale of Manufacturing Services by a Contract Manufacturer Does Not Necessarily Constitute a...

On July 11, 2016, the United States Court of Appeals for the Federal Circuit issued a decision in The Medicines Co. v. Hospira, Inc., No. 2014-1469. The decision was by the Federal Circuit sitting en banc (the entire court),...more

Federal Circuit Holds Again That BPCIA's 180-day Notice Is Mandatory

On July 5, 2016, the Federal Circuit affirmed a district court's preliminary injunction against proposed biosimilar manufacturer Apotex, holding that Apotex was enjoined from entering the market until Apotex: (1) provides...more

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this...more

USPTO Fast-Tracks Cancer Immunotherapy Patent Applications

Effective June 29, 2016, the United States Patent and Trademark Office (USPTO) implemented a pilot program to provide for earlier review of patent applications pertaining to cancer immunotherapy. The Cancer Immunotherapy...more

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