Foley Hoag LLP

SUMMARY

Understanding Medicare coverage and payment policy is critical to the successful launch of any new life sciences technology. Foley Hoag’s Medicare Coverage & Payment Practice provides regulatory and legislative advice to a broad array of leading life sciences companies, including:

• global pharmaceutical and biotechnology firms,
• trade associations,
• venture capital and investment funds,
• patient associations and advocacy groups, and
• early-stage companies.

SUMMARY

Foley Hoag’s Food and Drug Practice provides regulatory and legislative advice to leading biotechnology, pharmaceutical, medical device, and health care companies regulated by the Food and Drug Administration (FDA). Lawyers at Foley Hoag understand the critical regulations and policies affecting product development schedules, regulatory compliance, and timely product approvals. In representing clients, our lawyers work with senior agency managers, congressional staff, and Members of Congress to shape agency interpretations, clarify regulatory guidance, challenge adverse decisions, develop effective compliance plans, and enact legislation into law.

SUMMARY

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which includes biotechnology and medical devices, accounted for 28% of VC money invested, the largest investment sector in 2006.

As Life Sciences venture capital investing has risen, the biotechnology industry has become increasingly dependent on such funding. This is particularly true for start-up companies that cannot rely on revenue from marketed biologics to fund their research and development pipeline. To cover the nearly $1 billion capital investment required to bring a biologic drug to market (from discovery through clinical trials and FDA approval), early-stage companies rely on VC investing. Investing in emerging companies, however, is risky for a venture capitalist: only 1 in 10 drugs discovered actually makes it to market, and despite the more than $50 billion spent on biotech drugs in 2006, the great majority of early-stage companies never reach the point of net profitability.

SUMMARY

Legislative and regulatory matters are critically important for life sciences companies. The lawyers in Foley Hoag’s Government Strategies Practice have extensive experience in the development and implementation of legislation and regulations affecting the biotechnology, pharmaceutical, medical device, and health care provider industries. The regulatory environment can pose significant burdens to life sciences companies, but intelligent strategic advocacy in Congress and before federal regulatory agencies can also open up new markets and opportunities for innovative products. Lawyers at Foley Hoag work directly with Congressional staff and federal agencies, including the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), on a variety of matters relating to the life sciences.

Focuses include:

• Biotechnology, Pharmaceuticals and Medical Devices
• Legislative
• Coverage and Reimbursement
• Food and Drug
• Bioterrorism and Pandemic Preparedness

SUMMARY

Preface:

Patenting generally offers a superior means for legally protecting most inventions, particularly since:

• copyright, when available, does not provide a broad scope of protection; and
• the ability to effectively protect an invention as a trade secret is in constant jeopardy, due to publication or oral disclosure.

Unfortunately, the patenting process can be complicated, time-intensive and costly. However, costs can often be minimized and opportunities for establishing value in products and technology maximized if scientists and business professionals with an understanding of the patenting process are actively involved throughout.

This publication was prepared to provide an overview of patenting, particularly as it pertains to innovative technologies such as biotechnology and information technology.

SUMMARY

Established in December 1980 by the partners of law firm Foley Hoag, The Foley Hoag Foundation is a private foundation that seeks to combat racism, especially among youth, in the City of Boston. The Foundation awards grants to organizations working to improve the racial climate in Boston by addressing issues of diversity and racism. Grantee organizations achieve their goals through a variety of means, including arts and cultural activities, youth leadership and recreational programs. Other grantees provide advocacy assistance, enabling individuals to confront racism through legal or political action. Some grantee organizations work to prepare young children to live in the reality of a multicultural society, others engage teens, and a few target a primarily adult constituency.

The Foley Hoag Foundation was the first—and remains the only— foundation to focus exclusively on the improvement of race relations in Boston. The trustees are fortunate to have the unqualified endorsement of Foley Hoag, which has provided an enormous amount of financial, administrative and moral support.

SUMMARY

On February 20, in an 8-1 decision, the United States Supreme Court held that state common law tort claims against medical device manufacturers are preempted by FDA’s approval under the Premarket Approval (PMA) process. The decision dramatically enhances the regulatory compliance defense for Class III medical devices that receive Premarket Approval (PMA) from the Food and Drug Administration (FDA).

SUMMARY

Originally published in Drug Discovery News, November 2007.

Affymetrix Inc. filed a second wave of patent infringement lawsuits against San Diego-based Illumina Inc. in late October. The three cases—in the United States, the United Kingdom and Germany—claim that all of Illumina’s BeadArray products, as well as the genome-analysis and array technologies Illumina acquired when it bought Solexa, infringe various Affymetrix patents.

SUMMARY

To succeed in today’s technology-driven world, every companymust maximize the strategic value of its intellectual property.At Foley Hoag, we use our technical expertise and deepexperience to enhance the power of your technology globally.Claims to exclusive ownership of a process, design or productraise complex issues. In today’s global marketplace, conflictshave increased—making intellectual property managementa top priority for successful companies. We will help you:

• Implement a strategy to protect and expand your intellectual property assets
• Proactively protect your assets to keep your success on track
• Evaluate the validity of conflicting claims, and if necessary, take action to defeat those claims
• Resolve conflicts through commercial agreements

We can help you manage your current intellectual property assetsand build value for your new technologies or other inventions.Our intellectual property lawyers have earned a reputation forcreatively handling the full range of intellectual property, includingpatent, trademark, copyright, trade secrets, due diligence, andlitigation throughout the United States and internationally for largeand small businesses, universities, individuals, venture capitalfirms and institutional investors.

SUMMARY

Organizations succeeding in today’s global life sciences marketplacework hard to develop and introduce new products andtechnologies. Competitive, regulatory and litigation challengescan arise at any point and Foley Hoag lawyers are ready to guidecompanies in overcoming these obstacles. From initial conceptionto commercial viability, from market success to expansion, weprovide our clients with strategic and practical legal advice.

We are former scientists, engineers, researchers, physicians, andpolitical advisors. We bring a diversity and depth of knowledgeto clients ranging from manufacturers of medical devices andbiotech or pharmaceutical products to leading research institutionsand major industry advocacy organizations. We can help youfocus on your priorities including:

• Protection and Enforcement of Intellectual Property
• Corporate Finance and Partnering Arrangements
• Regulatory and Government Strategies
• Product Liability Defense

SUMMARY

Successful dispute resolution requires perspective, from all vantage points. At Foley Hoag, we offer you clear insight into when to go to the mat and when to settle. If litigation becomes necessary, we focus on helping you make prudent upfront decisions that best represent your interests and aim to reach a prompt, cost-effective and viable solution.

SUMMARY

This guide is intended to provide foreign businesspeople with an introduction to the basic kinds of laws and regulations that affect the conduct of business in the United States, and particularly in the Commonwealth of Massachusetts. The level of detail is varied, reflecting the nature of the legal areas discussed. For example, environmental law and taxation are subjects of detailed and technical regulation, while labor relations are governed as much by custom and practice as by direct regulation.

SUMMARY

Chambers and Partners, a leading U.K.-based research and publishing company, has again included Foley Hoag and its individual lawyers in its popular Chambers USA: The Client's Guide. This year, eleven practice areas and 22 lawyers are represented.

A digital reprint is avalable for download (.pdf).

SUMMARY

Research collaborations offer institutions the opportunity to achieve goals they might not accomplish on their own: breakthrough discoveries with manageable costs.  Such collaborations permit the sharing of resources and ideas, but they can also bring with them risks concerning the intellectual property that grows out of collaborative work.  These risks are rooted in patent law governing inventorship and ownership of jointly created inventions.

SUMMARY

On September 29, Congressman Henry Waxman (D-CA-30), the co-author of the 1984 Hatch-Waxman amendments, introduced H.R. 6257, “The Access to Life-Saving Medicine Act” – the first major legislation authorizing a new abbreviated approval pathway for biological products licensed under the Public Health Service (PHS) Act. The Senate companion to the Waxman bill, S. 4016, was introduced by Senators Charles Schumer and Hillary Clinton (D-NY), Patrick Leahy (D-VT) and Debbie Stabenow (D-MI).

SUMMARY

At the end of each year, many of us become preoccupied for a while with countdowns and top 10 listings. We like to hear what the pundits list as significant and feel like geniuses when we guess what’s on a list.

SUMMARY

Passed in 1995, the Private Securities Litigation Reform Act (“PSLRA”) was designed to curb abuses occurring in private securities class action litigation. Among the enacted measures were provisions for appointment by the court of a lead plaintiff (or, in some instances, a lead plaintiff group or two or more co-lead plaintiffs), and approval by the court of lead plaintiff’s selection of lead counsel (or, again, in some instances, two or more co-lead counsel or lead or co-lead counsel and liaison counsel). The intent of these provisions was to have injured shareholders themselves, and not their lawyers, actually control securities class action litigation, so that there would be fewer baseless lawsuits brought and controlled by lawyers with the goal of simply extracting settlements. Courts have generally taken seriously the lead plaintiff and lead counsel requirements, and have carefully reviewed lead plaintiff applications and lead counsel selections to ensure that those requirements are being met.

SUMMARY

Businesses have long understood that an advertisement can serve as an opening to connect the viewer to information and materials not included in the advertisement. Simple, traditional means of making this connection or link include: references to 800 numbers, tear-out sheets and postcards, and invitations to visit showrooms or to order printed materials or samples.

SUMMARY

Following the Federal Circuit's important ruling in Festo Corp. v.Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000), a team of Foley Hoag attorneys led by Claire Laporte filed two amicus curiae briefs in the United States Supreme Court on behalf of the Federal Circuit BarAssociation (FCBA).

• The Federal Circuit's opinion in Festo cut back on certain protections traditionally granted to patent-holders, thus reducing the value of hundreds of thousands of existing patents.
• The first brief, filed on May 9, 2001, supported Festo's successful petition for certiorari. The brief argued that the Federal Circuit's opinion unfairly eroded the value of existing patents and raised questions regarding the Federal Circuit's approach to appellate decision making.
• After the Supreme Court granted certiorari on June 18, 2001, the Foley Hoag team filed a second brief, dated August 31, 2001. This brief argues that the new rules the Federal Circuit established in Festo should be abandoned and the older rules, with some minor changes, restored.
• The briefs were co-authored by Foley Hoag patent litigators Claire Laporte, Mitchell J. Matorin, Robert L. Bocchino, Jr., Megan H. Mack, and Mark A. Reilly.
• The FCBA, the organization for which Foley Hoag prepared these briefs, is a national organization comprising approximately 2,400 attorneys whose practice concerns the United States Court of Appeals for the Federal Circuit in all aspects of its jurisdiction.

The original amicus curiae brief is available here (.pdf): Brief of Amicus Curiae Federal Circuit Bar Association in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. on Writ of Certiorari