Foley Hoag LLP

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Foley Hoag’s Trademark, Copyright & Unfair Competition group releases “The Best of the Blog Trademark Posts - 2011 Edition.”

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In Microsoft Corp. v. i4i Limited Partnership, a unanimous Supreme Court held last week that an accused infringer must prove the facts underlying any challenge to the validity of a United States patent by clear and convincing evidence.

Under 35 U.S.C. § 282, “[a] patent shall be presumed valid” and “[t]he burden of establishing invalidity . . . rest[s] upon the party asserting” such invalidity. Writing for the Court, Justice Sotomayor interpreted this language as codifying not only the burden of proof to establish invalidity, but also a heightened standard of proof rooted in the common law and recognized in Supreme Court jurisprudence dating back to the 19th century. [more...]

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After a lengthy and contentious approval process, the Internet Corporation for Assigned Names and Numbers (ICANN) recently entered into an agreement with ICM Registry to delegate the new .xxx top-level domain (TLD). The .xxx domain, intended to serve as an Internet "red light district" (despite being strongly opposed by many in the adult entertainment community itself), will likely go live later this year. In the meantime, ICM Registry has opened a "pre-reservation period" for interested members of adult entertainment industry, and for trademark owners in other industries.

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The Federal Circuit yesterday issued a ruling in In re BP Lubricants USA, Inc., available here, that is likely to have a significant impact on the recent spate of lawsuits claiming “false marking.” In these lawsuits, a plaintiff alleges that the defendant is marking a product with a patent that does not, in fact, cover the product, and that the defendant is doing so “for the purpose of deceiving the public.”

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Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 08-1403, (December 17, 2010), available here.

In the first case to consider the patentability of a life sciences invention since the U.S. Supreme Court decided Bilski v. Kappos, the Federal Circuit held that medical treatment claims asserted by Prometheus Laboratories were eligible for patent protection.

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On March 8, 2010, the Federal Circuit affirmed a ruling of the International Trade Commission invalidating the asserted claims of two U.S. patents for failure to meet the best mode requirement. Ajinomoto Co., Inc. v. ITC, available here. Foley Hoag represented the prevailing party, Global Bio-Chem Technology Group Company Limited (GBT), a Chinese biotechnology company. The patents covered the production of lysine using genetically modified bacteria.

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Trade secrets can be a valuable component of an intellectual property (IP) portfolio, whether as a complement to patents or as an alternative. Companies benefit from an IP portfolio that matches the unique benefits of trade secrets and patents to the types of information they seek to protect. Trade secret protection can be available immediately, without going through a government agent, whereas a patent is available only after an application to and approval by the government. And unlike patents, trade secrets provide IP protection of potentially infinite duration. Trade secret protection is also available for a broad array of information for which patents are not available.

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Foley Hoag LLP’s interdisciplinary team counsels and protects the interests of its clients facing new realities, challenges and risks framed by today’s tumultuous economic and market conditions. By maintaining an active and engaged dialogue with our clients during this period of economic distress, our lawyers are better able to adapt to the changing legal needs of clients affected in the short term. More importantly, our immersion in their businesses and industries enables our lawyers to provide sound, strategic counsel to protect our clients’ interests in the longer term. The Economic Crisis Team delivers forward-thinking advice, focusing on long-standing core, integrated strengths of the firm.

Topics include:

• Financial investigations, enforcement proceedings and litigation
• Federal and state securities regulation
• Deal-making, corporate finance and investment restructuring
• Bankruptcy, corporate reorganization and financial disputes

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Global Bio-Chem Technology Group Company Limited (GBT), a Chinese biotechnology company, has prevailed in a patent litigation brought by Ajinomoto Co., Inc in the International Trade Commission.

A Foley Hoag patent litigation team, including Claire Laporte, DeAnn Smith, and Jeremy Younkin, invalidated the asserted claims of two US patents. The Administrative Law Judge of the International Trade Commission also found both patents unenforceable because Ajinomoto committed inequitable conduct.

The decision represents an important victory for the Chinese biotechnology industry. Li Weigang, Assistant General Manager of GBT, said, "We are pleased that the Administrative Law Judge has determined there was no violation of Section 337. This ruling maintains continued competition in the marketplace, which will benefit American consumers during this time of rising food prices."

The Washington, DC firm Adduci, Mastriani & Schaumberg LLP are co-counsel with Foley Hoag LLP. 

The full Press Release is available here.

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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.

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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.

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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.

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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

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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.

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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).

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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.

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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.

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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

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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.

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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).