News & Analysis as of

Biotechnology Life Sciences

How Washington Can Help Biotechs

by Mark Mansour on

Biotechnology companies are making daily breakthroughs in understanding genetic and biomolecular causes of disease, and are committed to developing the next generation of medicines to transform patient care. It has been...more

Relocation of the EU Medicines Agency – Germany

by Hogan Lovells on

"EMA" and "gErMAny" – far more in common than mere letters - The European Medicines Agency (the "EMA"/"Agency") has reached celebrity-style status in the aftermath of the Brexit vote, and is being wooed by most European...more

Is there a legislative fix for biotech patents?

by Morrison & Foerster LLP on

By some accounts, we have entered a golden age for innovation in personalised medicine. Through scientific advancements in the study of genetic coding and molecular analysis, it is now possible to screen an individual for...more

Boom Predicted in Biodegradable Stent Market

Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

Preparing Biotech Patent Applications - Ten Strategies for Success

Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

Relocation of the EU Medicines Agency - The Netherlands: Tulips & EMA, a Gouda combination

by Hogan Lovells on

The EMA is looking for a new home. According to the Dutch Minister of Foreign Affairs and the Minister of Health, Welfare and Sports' formal bid, this home is where the heart of the Netherlands is. It might not have the food,...more

Supreme Court Limits Foreign Reach of the U.S. Patent Act

The supply from the United States of a single component of an invention, for assembly of the invention abroad, is not patent infringement under Section 271(f)(1) of the Patent Act. This is according to a unanimous ruling this...more

Top 5 Patent Red Flags in Life Sciences Due Diligence

by JD Supra Perspectives on

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Don’t Miss These 2017 J.P. Morgan Healthcare Conference Events in San Francisco

If your work involves life sciences dealmaking, you know it’s the time of year to start firming up your plans for the week of the J.P. Morgan Healthcare Conference. In the last 10 years, the second week of January in San...more

EPO Stays Proceedings Over Patentability Of Plants And Animals

by Foley & Lardner LLP on

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

21st Century Cures: Modernizing Public and Private Research

by McDermott Will & Emery on

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

by Morgan Lewis on

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

by McDermott Will & Emery on

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

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

Second Quarter Venture Funding Increases 20% from First Quarter

Earlier this year, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the second quarter of...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

by Ropes & Gray LLP on

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

Investment in Biotechnology Companies -- Nature Biotechnology Report

Despite an understandable amount of gloom and doom in patenting circles regarding the effects of the recent Supreme Court and Federal Circuit jurisprudence on life sciences patents (Mayo v. Prometheus; AMP v. Myriad Genetics;...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

Federal Circuit Offers Path Through Section 101 Thicket for Biotech Method Patents

by Foley Hoag LLP on

In its July 5, 2016 decision in Rapid Litigation Management Ltd and In Vitro, Inc. v. CellzDirect, Inc. and Invitrogen Corp., the Federal Circuit held that patent claims directed to an improved method of cryopreserving...more

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