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Amgen’s Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

On Friday, September 23, the FDA approved its fourth biosimilar, Amgen’s biosimilar version of AbbVie’s Humira®. Amgen’s biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic...more

Health Alert (Australia) 26 September 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland - 10 September 2016 - Inquest into the death of C - C was a 14 year old girl with multiple physical and...more

Precarious steps: patent eligibility for healthcare IT

The healthcare IT market, comprising electronic medical records, diagnostic systems and medical devices, is expected to top $100 billion this year. But this growth is tempered by an often hostile landscape for patenting,...more

Stop them in their tracks: key points in seeking a preliminary injunction against medical device infringers

In 2006, the US Supreme Court reversed years of jurisprudence by eliminating the presumption of irreparable harm in patent litigations,1 which previously had resulted in virtually automatic grants of injunctions to prevailing...more

Amgen v. Hospira: Amgen Files Appeal Brief at Federal Circuit

As we reported in August, the Federal Circuit denied Hospira’s motion to dismiss Amgen’s interlocutory appeal from the district court (D.Del., J. Andrews) regarding a discovery dispute. The court ordered the parties to brief...more

Samsung Bioepis Biosimilars Update

According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel®...more

District Court Upholds Eligibility Of Personalized Medicine Method Claims For FANAPT

In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Stark of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT®...more

Mylan Files Two Petitions for IPR on Genentech’s Herceptin Patent

Yesterday, Mylan filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According the petitions, the patent is directed to humanized antibodies, and Mylan expects that Genentech will rely on...more

BREAKING NEWS: FDA Approves Sandoz’s Erelzi, biosimilar to Enbrel (etanercept)

The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept). Sandoz’s biosimilar is called Erelzi. It is the first biosimilar etanercept approved by FDA, and the third...more

Celltrion Files Petition for IPR on Genentech’s Rituximab Patent

Yesterday, Celltrion filed a petition for inter partes review of Genentech’s U.S. Patent No. 7,976,838, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on...more

Australia Allows Substitution of Biosimliar for Etanercept Brand

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) announced that Brenzys, an etanercept biosimilar, “could be marked as equivalent” to the branded antibody Enbrel on the Australian Pharmaceutical Benefits Scheme...more

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

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

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

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

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

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

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