Foley Hoag LLP

SUMMARY

The Prescription Drug Marketing Act was enacted in 1988 to establish, among other things, a system for tracking drugs through the manufacturing and marketing processes. implementing regulations regarding these pedigree provisions for prescription drugs have been delayed for years. The Food and Drug Administration has issued it’s own stay on implementation, and a recent lawsuit by prescription drug distributors over the scope of the pedigree requirements has contributed to the delay as well.

The resulting lack of clear of federal criteria for prescription drug pedigrees has created an opportunity for states to pass their own pedigree laws, leading to a patchwork of diverse, often conflicting, state standards. Prescription drug distributors find it increasingly difficult to comply with the multitude of state laws, thus the time is ripe for federal action to create uniform pedigree requirements.

SUMMARY

While marking products to indicate that they are patented is necessary to maximize your patent rights, a recent case highlights the importance of marking the products accurately.

SUMMARY

Health Canada released a draft guidance this week which would allow approval of “subsequent entry biologics” (SEB) based on an abbreviated complement of clinical data, provided the SEB is shown to be “similar” to a reference, approved biologic product.[1] While the U.S. continues to heatedly debate legislation which would create a pathway for abbreviated approval of biosimilars, or follow-on biologics, by the U.S. Food and Drug Administration (FDA), Canada is advancing its implementation of such a pathway with the release of the SEB draft guidance. The European Union has permitted approval of biosimilar products since 2005.

Like FDA guidance documents in the U.S., Health Canada guidance documents do not have the force of law in Canada. However, the draft guidance indicates that the Canadian Food and Drug Regulations will be amended to provide “a comprehensive legal basis” for the regulation of SEBs and that in the interim, the draft guidance will provide a flexible SEB regulatory framework. The Canadian Minister of Health also plans to publish additional guidance documents that will further elaborate information and data requirements for specific classes of SEBs. Public comments on the SEB draft guidance are due April 16. 

SUMMARY

Key Members of the House Committee on Energy & Commerce have introduced bipartisan legislation which would create an abbreviated approval pathway for biosimilars or follow-on-biologics (FOBs). The Pathway for Biosimilars Act, H.R. 5629 introduced by Congresswoman Anna Eshoo (D-CA) and committee ranking member Joe Barton (R-TX), enhances the prospects for congressional action in 2008, following Senate HELP Committee action last year on S. 1695, a comparable bipartisan bill introduced by Senators Kennedy, Enzi, Clinton and Hatch. 

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

Foley Hoag provides side-by-side analysis of House and Senate versions of Patent Law Reform Bill.

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

As the clean energy sector continues to evolve,successful decision makers must rely on counsel tohelp them anticipate where this dynamic industry isheading and respond quickly to take advantage ofthe right opportunities. Investors and lenders inclean energy companies and projects needadvisers familiar with the potential risks and rewardsthat such investments can present. At Foley Hoag,we have the knowledge, experience and resourcesto deliver solutions-oriented advice to entitiesinvolved in all aspects of this increasingly importantclean energy sector.

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

The goal of the private equity fund practice is to provide our clients with superior expertise, problem solving, and service.

Our clients include both traditional and SBIC venture capital, buy-out, mezzanine and other private equity funds, both domestic and international, for whom we provide a full range of services, including fund formation, management organization, and portfolio transactions. The firm has represented SBICs for 30 years. We have the requisite depth of experience, both SBIC and non-SBIC, to be closely familiar with market and regulatory norms and trends.

Although most fund terms are necessarily guided by market and regulatory conditions, we believe that a “one size fits all” approach does a disservice to clients that may be facing unique circumstances. Our experience is that sophisticated investors, including institutional investors, are typically more open to well crafted solutions to understandable problems than they are typically given credit for. Although our clients closely follow “market” in the vast majority of cases, some have found ample room for creativity when necessary, such as the creation of multiple investor classes, the re-opening of a fund’s fundraising, the opening of offices in more than one country, resolving conflicts to mutual benefit, and the in-house “incubation” of start-up portfolio companies, to name just a few examples.

We seek to distinguish ourselves in a highly competitive legal service industry by offering a superior level of service. Appreciating that this is easier said than done, we take pride in the fact that most new clients are referred to us by existing clients. When this is not the case, we encourage reference checks to back our claim of service that is available, responsive and timely.

SUMMARY

Foley Hoag client Dr. Margaret Shipp and her colleagues at Dana-Farber Cancer Institute have discovered that Galectin-1, a carbohydrate-binding protein, is useful for the prognosis, diagnosis, and treatment of Hodgkin's Lymphoma.  Philip Choi, Hathaway Russell and DeAnn Smith, of Foley Hoag's Intellectual Property Group handled the IP matters for the work described in the attached article in Focus Online, the newsletter of Harvard Medical, Dental and Public Health Schools.

The full article is available here: http://focus.hms.harvard.edu/2007/091407/oncology.shtml.

SUMMARY

The Origin of Patents and Trademarks -- Intellectual property protection originated in medieval Europe. Members of medieval guilds would share their knowledge with each other but guard it from disclosure to outsiders. Their closely guarded techniques and skills are precursors of today’s trade secrets. Partly in response to the closed societies arising from the guilds, governments passed laws to encourage dissemination of inventions and ideas by granting exclusive rights – a patent or copyright – for a limited period of time to anyone who disclosed a new and useful item, process, or creative work into the public domain. The early guilds also used symbols and pictures to identify services performed or products made by guild members. Those guild symbols are the precursors of today’s trademarks.

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

The concept of creativity should be irrelevant in determining the scope of copyright protection for factual works, which is explained by the purpose of such works: the communication of information. Repetition of the Feist formulation confuses copyright law in critical respects and hinders progress as copyright law seeks to address new forms of communication and new areas of technology.

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

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

Xerox tops list of N.E. patent awardees in Q1

The big patent winners in New England during the first quarter are also some of the region's largest companies - such as Connecticut-based Xerox Corp., which topped the list by garnering 111 patent approvals.

SUMMARY

Welcome to the first installment of a quarterly series monitoring New England patent activity. 2006 closed with a quarter marked by consistent patent issuance in high technology and the life sciences, particularly in companies native to the region such as EMC and Raytheon, which may point to the overall health of the technology sector.

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.