Foley Hoag LLP

SUMMARY

Effective January 15, 2009, the United States Citizenship and Immigration Service (USCIS) will require federal contractors to use its E-Verify system. E-Verify is an automated system of verifying employees’ identity and authorization to work through the databases of both the Social Security Administration and the Department of Homeland Security. Enrollment will be required for most prime federal contracts with a period of performance longer than 120 days, a value above the simplified acquisition threshold ($100,000), and for work to be performed in the United States. This requirement also will apply to indefinite delivery or indefinite quantity contracts. The federal contractor and any covered subcontractors will need to enroll in E-Verify within 30 days of the contract award date.

SUMMARY

We recently informed you that Massachusetts enacted comprehensive data security regulations relating to a 2007 data security law intended to protect Massachusetts residents from identity theft. A copy of the bulleting explaining the regulations can be found here. These regulations, which had been slated to take effect on January 1, 2009, will impose a significant compliance obligation on virtually all businesses with employees or customers in Massachusetts. In light of current economic conditions, the general deadline for compliance with Massachusetts’ data security regulations has been extended to May 1, 2009, while the deadline for obtaining written certification of security compliance from third party providers, and for encrypting portable devices other than laptops, has been extended to January 1, 2010.

Foley Hoag is holding a seminar at its Boston office regarding the law and its regulations on December 10, 2008, beginning at 7:30 a.m.  Click here for more information.

SUMMARY

We know that the recent financial crisis and related economic downturn unfortunately are causing many employers to consider ways to reduce operational expenses, including through workforce restructuring and layoffs. We offer a few preliminary considerations: any such reduction-in-force (RIF) must be carefully planned and executed both to minimize exposure to liability under various employment laws and to mitigate negative effects on employee morale and operations. The following are some issues for employers to consider as they grapple with whether and how to implement a layoff.

Questions Include:

• Is a Layoff Necessary?
• Voluntary or Involuntary Program?
• Develop Uniform Selection Criteria
• Conduct a Layoff Analysis
• Is Advance Notice Required
• Severance and ERISA
• Asking for a Release
• Don't Forget Immigration Implications
• Don't Lose Sight of Termination Basics

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

On Wednesday, October 22, 2008, the Federal Trade Commission issued an Enforcement Policy Statement that it will delay some elements of enforcement of recent “Red Flags” regulations until May 1, 2009, instead of the original November 1, 2008 date.

SUMMARY

Chapter 151B, the Massachusetts anti-discrimination statute, does not apply to small employers, meaning those with fewer than six employees. However, last Friday, the Massachusetts Supreme Judicial Court (“SJC”) held that an employee may nonetheless sue a small employer for discrimination under the Massachusetts Equal Rights Act. The decision has potential ramifications for all employers -- large or small -- because it suggests that a plaintiff has a claim for discrimination under the Massachusetts Equal Rights Act whenever Chapter 151B does not apply, such as discrimination claims brought by non-employees.

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

Last year, in the wake of the TJ Maxx data security breach, Massachusetts enacted a data security law intended to protect residents from identity theft. The law provides that businesses must provide prompt notice of security breaches relating to personal information. “Personal information” means a person’s name together with either his or her Social Security Number, driver’s license number, state identification number, financial account number, credit card number or debit card number. Because all employers hold their employees’ Social Security numbers, the law applies to all employers in Massachusetts, not just those businesses that collect customer information, such as retailers. 

SUMMARY

As soon as January 1, 2009, new construction or gut renovation of a healthcare facility in Massachusetts may need to meet green building standards.

On September 24, 2008, the Massachusetts Department of Public Health ("DPH") approved new guidelines (the "Guidelines") that incorporate the Leadership in Energy and Environmental Design-Health Care ("LEED-HC") and Green Guide for Health Care ("GGHC") green building standards into the Determination of Need ("DoN") process. The Guidelines will apply to all DoN applications filed on or after January 1, 2009 (for hospitals and clinics) or July 1, 2009 (for nursing homes). [continues...]

SUMMARY

Last week, the Massachusetts Division of Health Care Finance & Policy issued new regulations defining what is “a fair and reasonable” contribution by an employer towards health insurance under the Massachusetts Health Care Reform Law. Under that law, the state is permitted to assess an annual per-employee fee called the Fair Share Contribution (FSC) against non-contributing employers with 11 or more full-time equivalent employees. The fee can be as much as $295 per employee. To avoid the fee, the law requires an employer to offer a group health insurance plan and to make a “fair and reasonable” premium contribution towards that insurance. The new regulations make this test more stringent in order to increase the number of employers who are subject to the FSC.

SUMMARY

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

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

Section 409A is an extremely broad law that covers many arrangements not generally considered deferred compensation, such as stock options, bonus plans, and severance and change in control agreements. In general, 409A governs any arrangement where an employee or consultant has a vested right to compensation in one year that will be paid in a later year, unless the arrangement fits into one of the exemptions to 409A. Arrangements subject to 409A must comply with strict rules as to the time and form of payment, and it is very difficult to make changes to an arrangement once it is in place. Any deferred compensation arrangement that does not comply with 409A will subject the employee or consultant to income tax liability at the time that the right to payment vests (even if there is no right to receive payment at that time), together with a 20% penalty tax on the deferred amount. (continues)

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

In recent months, the Massachusetts Legislature has been considering legislation to limit or ban certain marketing activities of pharmaceutical and medical device companies. On the last day of the legislative session, July 31, the House and Senate voted to accept the conference committee report concerning health care cost containment legislation, (Senate 2863.) This legislation includes the provision regulating gifts by pharmaceutical and medical device manufacturers to physicians.

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.

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.