Foley Hoag LLP

SUMMARY

The Supreme Court today affirmed the Federal Circuit’s holding that Bilski’s business method was unpatentable subject matter because it sought to claim patent protection on an abstract idea. But the Court rejected the Federal Circuit’s bright-line “machine or transformation” test as the sole test for determining whether an invention is eligible for patent protection.  [more...]

SUMMARY

An important mechanism for bringing suit against healthcare providers and pharmaceutical and medical device companies – the Qui Tam Action – has been expanded as part of the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) (the "PPACA").

SUMMARY

In a much anticipated decision that has attracted the attention of pharmaceutical and biotech companies, medical researchers, physicians, attorneys and patients concerned about their risk for breast or ovarian cancer, Judge Robert W. Sweet of the U.S. District Court for the Southern District of New York ruled in favor of the plaintiffs on March 29, 2010 in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.  [continues... ]

SUMMARY

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.

SUMMARY

In March, President Obama signed an executive order lifting the Bush Administration restrictions on federal funding for human embryonic stem cell (HE S) research. The possibility of new federal funding opportunities, in combination with more than a decade of scientific advances in both embryonic and adult stem cell research, signal that stem cell-based therapies (“SCBT”) could soon be available for patients in a clinical setting. For those wishing to commercialize such therapies, it will be important to ascertain how the U.S. Food and Drug Administration (“FDA ”), which has regulatory authority over U.S. marketing of SCBT, will exercise this oversight.

This article is not intended to be an exhaustive dissertation on all laws and regulations pertaining to stem cell research, embryonic or otherwise.1 Rather, it discusses the controversial history of federal funding for stem cell research, and then focuses on regulations and guidelines likely to govern FDA approval of clinical applications of SCBT. It also discusses some of the recent recommendations included in the International Society for Stem Cell Research Guidelines in the context of U.S. application of those recommendations.  (continues...)

SUMMARY

Included in this Issue:

• Get Your Pole Vaults Out - Mark Haddad
• The Numbers - Amanda Vendig
• Selected New England Series A Round Transactions: First Quarter 2009
• Selected New England Series B and Later Round Transactions: First Quarter 2009
• Terms of Selected New England Series A Rounds 2009
• Terms of Selected New England Series B and Later Rounds
• The Activity Level Summary
• New England Series A and First Round Transactions by Industry
• New England Series B and Later Round Transactions by Industry
• National Series A and First Round Transactions by Industry
• National Series B and Later Round Transactions by Industry
• Size of New England 2009 Series A and First Round Transactions by Industry
• Size of New England 2009 Series B and Later Round Transactions by Industry

SUMMARY

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.

SUMMARY

President Obama signed H.R. 1, the American Recovery and Reinvestment Act of 2009 (Recovery Act) into law on February 17, 2009. The bill represents the largest investment in public works since the Great Depression.

The Recovery Act allocates more than $150 billion to health related programs, and makes significant down payments on medical research, comparative effectiveness initiatives, and health information technology. The chart below describes the major health provisions in the Recovery Act.

SUMMARY

Included in this Issue:

• The End of Doom and Gloom by Dave Broadwin
  
• The Numbers by David Pierson
  
• Selected New England Series “A” Round Transactions: Fourth Quarter 2008
  
• Selected New England Series “B” and Later Round Transactions: Fourth Quarter 2008
  
• Terms of Selected New England Series A Rounds 2008
  
• Terms of Selected New England Series B and Later Rounds
  
• The Activity Level Summary
• New England Series A and First Round Transactions by Industry
• New England Series B and Later Round Transactions by Industry
• National Series A and First Round Transactions by Industry
• National Series B and Later Round Transactions by Industry
  
• Size of New England 2008 Series A and First Round Transactions by Industry
  
• Size of New England 2008 Series B and Later Round Transactions by Industry

SUMMARY

Included in this Issue:

• A Market Perspective – Justin J. Perreault, General Partner, Commonwealth Capital Ventures

• Selected New England “Series B” and Later Round Transactions
  Commentary from David Pierson

• Terms of New England Series B and Later Rounds
  Commentary from Bruce Kinn

• The Activity Level Summary - New England Series B and Later Round Transactions by Industry

• Size of New England 2008 Year to Date Series B and Later Round Transactions by Industry
  Commentary from Amanda Vendig

SUMMARY

Included in this Issue:

• A Market Perspective by Carl Stjernfeldt

• Selected New England “Series A” Round Transactions - Third Quarter 2008
  Commentary from John Hancock

• Terms of Selected New England "Series A" Rounds 2008
  Commentary from Alex Aber

• The Activity Level Summary: New England "Series A" and First Round Transactions by Industry

• National "Series A" and First Round Transactions by Industry

• Size of New England 2008 Year to Date "Series A" and First Round Transactions by Industry
  Commentary from Dave Broadwin

SUMMARY

Included in this Issue:

• A Market Perspective by Vinit Nijhawan

• Selected New England “Series B” and Later Round Transactions
  Commentary from David Pierson

• Terms of Selected New England Series B and Later Rounds
  Commentary from Amanda Vendig

• The Activity Level Summary: New England Series B and Later Round Transactions by Industry

• National Series B and Later Round Transactions by Industry

• Size of New England 2008 Year to Date Series B and Later Round Transactions by Industry
  Commentary from Jerry O’Connor

SUMMARY

The opportunity to purchase new .tel top-level domains (TLDs) is just around the corner, and trademark owners will have the first bite at the apple. During the “sunrise period” of December 3, 2008 to February 2, 2009, trademark owners will get a head start preferential period to apply for and register .tel domain names incorporating their valuable trademarks. After this period, registration opens to the general public.

SUMMARY

Last week, in In re Bilski, No. 2007-1130, the United States Court of Appeals for the Federal Circuit, sitting en banc, articulated the test for whether a process is eligible for patent protection under section 101 of the Patent Act, 35 U.S.C. § 101. The majority opinion, joined by nine of the court’s twelve judges, relies heavily on decades-old Supreme Court precedent and rejects other tests, including State Street Bank’s “useful, concrete, and tangible result” inquiry. Although this case has been closely watched as a “business methods” patent case, the decision has profound implications for protecting inventions in life sciences. At the same time, it leaves open many questions that ultimately will determine the scope of section 101. The debate over what is patent-eligible subject matter has just begun.

SUMMARY

Personalized medicine – getting the right treatment to the right patient at the right time – will be a major pillar of efforts to bring increased effectiveness and efficiency to healthcare. Today, we know far more about the molecular heterogeneity of major diseases, including cancer. It is clear that targeted and more effective medical treatments will often be unattainable unless physicians have precise molecular information about the patient’s disease. In short, is a priority that our healthcare system (both private payors and Medicare) facilitates the adoption of new molecular technologies when they are shown to be efficient and effective.

SUMMARY

Included in this Issue:

• A Market Perspective
  
• Selected New England "Series A" Round Transactions
  Commentary from Bruce Kinn
  
• Terms of Selected New England Series A Rounds 2008
  Commentary from Mark Haddad
  
• The Activity Level Summary: New England Series A and First Round Transactions by Industry
  
• Size of New England 2008 Year to Date Series A and First Round Transactions by Industry
  Commentary from Paul Sweeney

SUMMARY

Yesterday, in Broadcom Corp. v. Qualcomm Inc. (Nos. 2008-1199, -1271, -1272), the Federal Circuit held that an accused infringer’s failure to obtain an opinion of counsel may be considered as evidence to support a determination that it actively induced infringement by a third party. Specifically, the Court ruled that the presence or absence of an opinion is relevant to whether an accused infringer “‘knew or should have known’ that its actions would cause another to directly infringe.”

SUMMARY

Included in this Issue:

• A Market Perspective

  Ham Lord, Managing Director, Launchpad Ventures

  Angel financing is more than just seed round financing for future venture capital deals. In fact, angels fund 10 to 20 times more companies than venture firms do on an annual basis. This is because many angel deals will never need the type of large financing ($10M+) that is typical of most venture deals.

• Structuring a Seed Stage Investment

  David A. Broadwin, Partner, Foley Hoag LLP

  Many of the entrepreneurs who walk through our doors at the EEC are at the seed/angel stage and are looking for those kinds of investments as well as advice around how to structure the investments so as to (a) fund the early needs of the business and (b) not create barriers to a larger investment later in the life of the business.

SUMMARY

In a decision that will have far reaching implications for drug and medical device development, the Court of Appeals for the Federal Circuit held yesterday that the Hatch-Waxman safe harbor of 35 U.S.C. § 271(e)(1) is inapplicable to patented research tools that are not themselves subject to the FDA review process. While the decision is good news for the providers of research tools such as drug screening assays, it will make drug and medical device development in the United States costlier and more risky.

SUMMARY

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.