MBBP’s Life Sciences Vector, Summer 2016 07/14/2016

2016 LIFE SCIENCES PANEL SERIES

At the second of our Life Sciences panel Series: “Laying the Foundation for Growth: Entity & Equity”, experts discussed whether a corporation or a limited liability company is the “Right Stuff ” for building an emerging company, and how to structure and optimize the equity compensation of the team. MBBP’s John Hession moderated the panel, which included Marc Cote of Accellient and Jeff Solomon of Katz Nannis + Solomon. Stay tuned for details on Panel 3 in the fall.

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MBBP ADDS TWO ATTORNEYS

Weatherly Ralph Emans, Corporate Senior Attorney – As a member of the firm’s PIFA team in the corporate group, Weatherly focuses her practice primarily on private investment funds, including private equity funds, venture funds, hedge funds and funds of funds. Weatherly’s practice also includes venture capital transactions and providing general corporate advice to early stage companies.

Amanda R. Phillips, Litigation Associate – As a member of the firm’s litigation practice, Amanda focuses her practice on commercial civil disputes and securities litigation, and has broad experience working with clients under investigation by federal and state government agencies.

WAIT A MINUTE MR. POSTMAN…

Sooner or later many companies with a successful product or service will receive an overture from a patent holder. Some are almost friendly, proposing a potential mutually beneficial business relationship involving the patent. Others are decidedly less so, leveling claims of patent infringement and seeking immediate termination of the activity or product sales and/or significant financial compensation. This entire range of written communications is commonly referred to as “demand letters.” So – what’s the next step if your company receives a demand letter?

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SUPREME COURT DENIES SEQUENOM’ PETITION TO CLARIFY SCOPE OF MAYO IN SEQUENOM V. ARIOSA

On June 27, 2016, the United States Supreme Court denied a Petition for Writ of Certiorari filed by Sequenom, Inc. requesting the Supreme Court to clarify the scope of its Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) decision, as applied to Sequenom’s claimed inventions. The Mayo decision, which held that a method correlating a drug dosage regimen and levels of the drug in the blood was an unpatentable law of nature, has had the profound effect of narrowing the scope of patent-eligible subject matter in the United States and has cast doubt on the validity and enforceability of previously issued United States patents.

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CLIENT SPOTLIGHT: iSpecimen 

iSpecimen is a trusted, one-stop source of customized human biospecimen collections. Compliantly sourced from our diverse
partner network of hospitals, labs, biobanks, blood centers, and other healthcare organizations, our solid tissues, biofluids, and cells are delivered directly into the hands of biomedical researchers using our unique, turnkey technology. Scientists gain access to a ready supply of the high-quality, richly-annotated specimens they need from the patients they want. Supply partners gain an opportunity to further contribute to biomedical discovery as well as their bottom line.

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MBBP’s Life Sciences Vector, Fall 2015 11/30/2015

U.S. INTRODUCTION TO THE HAGUE SYSTEM

For many years, non-U.S. parties have taken advantage of the Hague System to register their design patents, an important part of strengthening and differentiating your product and brand. On May 13, 2015, the Hague Agreement Implementation of the Patent Law Treaties Implementation Act of 2012 (PLT) went into effect in the U.S. As a result, the U.S. became a member of the Hague System, an international system of registration for design patents (also referred to as “industrial designs” internationally). Now, U.S. applicants wishing to register a design patent in the U.S. and abroad may submit a single application and pay a single fee to register such design patent in all or some of the 63 other Contracting Parties that participate in the Hague Agreement.

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4,500 COMPANIES REELING AS EU’S HIGHEST COURT INVALIDATES SAFE HARBOR

On October 6, the Court of Justice of the European Union (“CJEU”) issued a binding judgment invalidating the European Commission Decision (Commission Decision 2000/520, the “Safe Harbor Decision”) that authorized the EU-U.S. Safe Harbor arrangement. For the past fifteen years, this arrangement has been relied upon by many businesses to transfer personal data from the European Union to the United States in compliance with the EU Data Protection Directive (Commission Decision 95/46, the “Directive”). As a result of the CJEU’s judgment, self-certification under the Safe Harbor framework is no longer sufficient to comply with the Directive.

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CONTROLLING THE DEBATE: ANTICIPATORY SELF-DILIGENCE IN BIOTECH BUSINESS DEVELOPMENT

By: Jonathan P. Gertler, Back Bay Life Science Advisors

Business development is the lifeblood of the biotech industry. This article focuses on internal decision making regarding portfolio prioritization, and external anticipatory diligence to maintain optimal control over negotiation dynamics (i.e. “controlling the debate”).

Read more on Page 3.

MBBP ADDS TWO ASSOCIATES

Registered Patent Attorney Erin E. Bryan handles a broad range of intellectual property issues in a number of technical areas. She currently works with a variety of clients, including universities, research organizations and start-ups in the chemical, pharmaceutical and biotechnology areas. She is also proficient in patent prosecution and provides assistance with various phases of IP litigation and counseling.

Corporate Attorney Erik S. Thompson provides services to a range of clients, including emerging businesses and private investment funds, and advises them on mergers and acquisitions, issuances of ISOs and equity options, and regulatory compliance. He also serves as outside counsel to numerous companies, attending Board meetings and advising them on corporate actions.

MBBP ATTORNEYS PRESENT “CONSTRUCTING A SOLID PROVISIONAL PATENT”

In October, Registered Patent Attorneys Sean D. Detweiler and Dr. Stanley F. Chalvire spoke at a program hosted by TechSandBox for its Life Sciences SIG. Joining Sean and Stan were two Life Science CEOs. The panel provided attendees with guidance on how to do a provisional patent, on your own, or on a low budget.

RECENT FINANCINGS IN HEALTHCARE / LIFE SCIENCES

• NED Biosystems closed a $1.5 million Series B Preferred financing with First Round Capital and angel investors. NED Biosystems provides a adjunct therapy of natural supplements designed to enhance chemotherapy with less toxic side effects.

• Criscot Inc. closed an $800,000 extension of its Series A-2 Preferred Stock financing. Criscot provides a novel, proprietary applicator for delivery of drug compounds, resulting in more exact dosage without toxicity effects.

• First Light Biosciences Inc. closed a $3.0 million Series B Preferred Stock financing. First Light Biosciences provides a patented instrument for early and swift detection of pathogens during the hospital admissions process, reducing the risk of hospital-acquired infections.

SELVITA ESTABLISHES FIRST U.S. OPERATIONS  IN GREATER BOSTON AREA

MBBP client, Selvita, recently announced an expansion into the Boston-area biotechnology and pharmaceutical market, as they open a fully-owned US subsidiary, Selvita Inc., headquartered in Cambridge, Massachusetts. Selvita is a leading global drug discovery company and the largest drug discovery company in Central and Eastern Europe. The new office, located at 485 Massachusetts Ave., will focus largely on expanding the company’s existing clients for its drug discovery services, as well as exploring and developing partnering opportunities.

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HENKE-SASS, WOLF A SO-CALLED “HIDDEN CHAMPION”

Every day, people all over the world use products and solutions produced by Henke-Sass, Wolf – often without even realizing it, as most of our products have the brand and label of our customers and not ours. As a medium-sized international company, and a technological leader in the medical endoscopy sector, we are sometimes considered a “hidden champion” – but certainly not “hidden” from our longstanding business partners and loyal customers.

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