Pharmaceutical Industry Biotechnology

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Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

IBioIC Announces Recipients Of £3 Million In Funding For Synthetic Biology Projects

On October 17, 2016, the Industrial Biotechnology Innovation Centre (IBioIC) announced over £3 million in investments over six synthetic biology projects. IBioIC was founded by Ingenza Ltd, GlaxoSmithKline plc (GSK), and...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

Medical Device Investor Forum - Oct. 27-28 in Irvine, CA - Knobbe Medical

OCTANe, an Orange County-based non-profit life sciences and technology accelerator organization, has announced the agenda for its 11th Annual Medical Device & Investor Forum (MDIF), which will be held on October 27-28, 2016,...more

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

Economic Times of India: Report Suggests that Indian Biosimilars Market May Reach $40 Billion USD by 2030

The Economic Times of India has reported on a study of the Indian biosimilars market conducted by the Jawaharlal Nehru Institute of Advanced Studies (JNIAS). The study reports that the Indian biosimilars industry was...more

Freedom to Utilize Genetic Resources? The Nagoya Protocol Two Years Later

Two years ago today, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization to the Convention on Biological Diversity (“Protocol”) entered into international...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Donations and Grants in China: Compliance Controls Beyond T&E

While travel and entertainment expenses have presented significant compliance challenges for life sciences companies operating in China, donations and grants can also pose notable compliance risks. China’s escalated...more

Double Patenting Decision Delivers Bitter Pill To Antibody Patent

In a recent decision on obviousness-type double patenting, Judge Wolf shortened the shelf life of a dispute between Janssen Biotech, Inc. (“Janssen”) and Celltrion Healthcare Co. Inc. (“Celltrion”), relating to a...more

Bad Science Makes Bad Patent Law—No Science Makes It Worse (Part II)

In Part I, I explained some general criteria for laws of nature, considering the prototypes of Newton's laws and Einstein's E=mc2. Now I'll turn to whether there are laws of nature in biology. Biological generalizations,...more

Oxford Immunotec Ltd. v. Qiagen, Inc. (D. Mass. 2016)

Magistrate Recommends That Defendants' Motion to Dismiss Be Allowed for Kit Claims and Denied for Method Claims - Last month, in Oxford Immunotec Ltd. v. Qiagen, Inc., Magistrate Judge Donald L. Cabell of the U.S....more

Court Report - September 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey...more

Court Report - August 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Elizabeth LLC et al. 1:16-cv-00603l; filed July 12, 2016 in the District Court of...more

Your daily dose of financial news - The Brief – 8.22.16

The SEC’s opened an inquiry into Hampton Creek in response to a Bloomberg report that the Just Mayo maker used undercover contractors to purchase its non-egg mayonnaise product in bulk not long before HC raised $90 million...more

Court Report - August 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Takeda Pharmaceutical Co. Ltd. v. Lee - 1:16-cv-00852; filed July 1, 2016 in the Eastern District of...more

PTAB Denies Priority Claim, Has No Affinity for “Antibody Rule”

Addressing enablement and written description issues in the context of a priority challenge, the Patent Trial and Appeal Board (PTAB or Board) found that the challenged claims were not entitled to the benefit of the parent...more

States’ Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry

As we previously reported, in 2015 and early 2016, bills and voter initiatives were introduced in several states that would impose drug pricing controls and transparency requirements on pharmaceutical manufacturers. Of...more

PhRMA and BIO Take Off-Label Communication Into Their Own Hands with New Guidelines

Industry for years has sought clarity on off-label communications. Numerous meetings on the topic have taken place between the U.S. Food and Drug Administration (FDA) and industry, citizen petitions have been filed,...more

Court Report - July 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Genzyme Corp. et al. v. Zydus Pharmaceuticals (USA) Inc. 1:16-cv-00540; filed June 29, 2016 in the District Court of...more

Cipla to Open Biotech Facility in South Africa

Cipla has announced that it is investing 1.3 billion South African Rand (approximately 91 million USD) to open a biotech plant in South Africa. According to Cipla’s press release, this will be South Africa’s first...more

Court Report - July 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Eli Lilly and Company et al. v. Apotex Inc. et al. 1:16-cv-00475; filed June 22, 2016 in the District Court of...more

Full Federal Circuit Curbs On Sale Bar's Threat to Patents

Biotech and pharmaceutical companies received critical guidance from the Federal Circuit yesterday, when the en banc court exempted a broad category of common manufacturing and supply arrangements from the reach of the patent...more

New Patent Office Initiative Provides a Boost to Cancer Immunotherapy Patent Applications

On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This...more

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