Foley Hoag LLP

SUMMARY

Effective tomorrow, January 10, 2012, applicants filing international patent applications under the Patent Cooperation Treaty (PCT) in the U.S. Patent and Trademark Office (USPTO) will be able to designate the Russian Federal Service for Intellectual Property (Rospatent) as the International Search Authority (ISA) and pay a Search Fee of only $415.  [more...]

SUMMARY

The last decade has seen the creation of complex genomic tests, sometimes as the outcome of tens of millions of dollars of research, designed from ground up to solve a recognized clinical problem. These tests, which range in price from $500 to $3000, are the “poster child” for the potential as well as the challenges when genomics and advanced bioinformatics are brought together and enter the clinic. According to a number of published studies, at least some tests in these categories can be net cost-saving in real-world scenarios, in addition to improving medical decision-making.

In March 2012, the local Medicare contractor for all California-based laboratories plans to launch an elaborate program for genomic test evaluation, coding, and pricing. This essay discusses major features of the program, as they have been released up to November 2011. The program is likely one of the most distinctive strategic policy efforts proposed by a Medicare contractor in the forty-five year history of the Medicare program. 

SUMMARY

Insurance companies consistently assert that Commercial General Liability (“CGL”) insurance, routinely purchased by most businesses, provides no coverage for patent infringement lawsuits. An October 17, 2011 decision of a federal appeals court in Colorado has rejected that view, however, holding that CGL insurers may be bound at least to fund an insured company’s defense of patent litigation where the invention at issue has potential promotional uses.  [more...]

SUMMARY

On September 16, 2011, President Obama signed into law the Leahy-Smith America Invents Act (the "AIA"). The law makes the most sweeping reform of the United States patent system in at least 60 years. The changes under the AIA will be phased in over the next eighteen months. While a number of significant changes will not take effect until late 2012 and early 2013, patent applicants can optimize their positions under the new law by taking certain steps now:  [more...]

SUMMARY

Today President Obama signed into law the Leahy-Smith America Invents Act, considered by many to be the most sweeping reform of the United States patent system in 60 years. Among many changes, one which takes immediate effect is the creation of a new “Micro-entity” status which offers qualified applicants a 75% reduction in many Patent Office fees. The Micro-entity status is available to universities as well as to some very early stage companies and individual inventors.  [more...]

SUMMARY

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...]

SUMMARY

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.”

SUMMARY

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.

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