Foley Hoag LLP

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

A year and a half has passed since Congress sought to make document productions and associated pre-production privilege review less costly and less burdensome with the passage of Federal Rule of Evidence 502. In this column, we examine the new rule, describe what parties can do to maximize their protection under the rule, and highlight the potential risks the rule has left unaddressed.

SUMMARY

This morning, Friday, May 28, 2010, the Federal Trade Commission (FTC) announced that it was extending the deadline for enforcement of the Red Flags Rule through December 31, 2010, in order to give Congress sufficient time to amend the law to exclude certain businesses from application of the Rule.  [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

Businesses that have not adopted written information security programs to comply with the Massachusetts information security regulations have little more than a week to wrap up their compliance efforts. Monday, March 1, 2010 is the deadline set by the Massachusetts Office of Consumer Affairs and Business Regulation (OCABR) for businesses around the world that handle the personal information of Massachusetts residents to comply with the strict Massachusetts regulations.

SUMMARY

A retrospective review of the cases brought by the Massachusetts U.S. Attorney’s Office Health Care Fraud Unit between September 2008 and September 2009 reveals a high number of cases involving medical devices as compared to drugs or other medical products. Medical devices include a wide range of products, such as implants, stents, heart pacemakers, fetal monitors, x-ray equipment, and thermometers. They are used in patients for the purposes of diagnosis, therapy or surgery. By definition, medical devices do not achieve their primary intended purposes through “chemical action” and are not “dependent upon being mobilized” to achieve their primary intended purposes. Medical devices often require approval by the Food & Drug Administration (“FDA”) before they may be legally distributed and marketed.

The gamut of products that may be considered medical devices are reflected in the cases brought by the Health Care Fraud Unit over this past year.

SUMMARY

On Thursday, April 30, 2009, just 24 hours before the Federal Trade Commission (FTC) was set to begin enforcement of federal Red Flags Rules, the FTC announced that it was giving businesses three additional months, until August 1, 2009, to comply with the new identity theft regulations.  The FTC also promises to provide a “template” for compliance directed to “entities that have a low risk of identity theft.”  This announcement is welcome news for businesses that have been struggling to develop a compliant program by the end of the day today.

SUMMARY

On March 5, 2009, both the House and the Senate proposed legislation amending the Federal Food, Drug, and Cosmetic Act to reverse the 2008 Supreme Court decision in Medtronic v. Riegel H.R. 1346; S. 540. The law, if passed, would permit plaintiffs to bring state law liability suits against medical device companies with respect to devices approved by the federal Food and Drug Administration ("the FDA") under the premarket approval ("PMA") process, a longer, more complicated evaluation process undertaken by the FDA in approving a device.

SUMMARY

Somewhat lost in the American Recovery and Reinvestment Act of 2009 (“ARRA”), among the hundreds of pages describing billions in stimulus spending and tax relief, are significant new health information privacy and security provisions. These provisions have the potential to impact every “covered entity” under HIPAA, including hospitals, physicians and health plans, as well as “business associates” who were not previously covered by HIPAA.

SUMMARY

In this Issue:

• Reversing the district court’s dismissal, the First Circuit reinstated the SEC’s civil enforcement action against two mutual fund underwriters
• The First Circuit held that, under Section 17(a), a person may be held liable for “using” another person’s material false statement to obtain money in the offer or sale of securities
• The First Circuit held that, under Section 10(b) and Rule 10b-5, a person may be held liable for “impliedly making” a material false statement in connection with the purchase or sale of securities
• Ultimately, the Supreme Court may have to resolve the growing circuit split regarding the scope of liability under the federal securities laws

SUMMARY

On Thursday, February 12, 2009, the Massachusetts Office of Consumer Affairs and Business Regulation (OCABR) issued a public statement indicating that it is extending the May 1, 2009 deadline to comply with recent Massachusetts identity theft regulations until January 1, 2010.

SUMMARY

Excerpt:

The American Lawyer (January 2009) - On October 17 the International Court of Justice ordered Georgia and Russia to refrain from ethnic cleansing in Russian-occupied Abkhazia and South Ossetia while Georgia’s complaint against Russia is being heard. It was the first invocation of the 1965 U.N. Convention on the Elimination of All Forms of Racial Discrimination by the World Court, which usually concerns itself with mundane border disputes.

But it was not the first ICJ case that Foley Hoag’s Paul Reichler helped to bring against a present or former superpower. Reichler catapulted to fame in 1984 at age 36, when he launched a suit—on behalf of Nicaragua—against the United States for its paramilitary activities in Central America. As Reichler says, “I’m surely the only lawyer to have sued both the U.S. and Russia in the International Court of Justice.” And, he might have added, won. While the World Court enjoined violence on both sides in the Caucasus—and some observers blame Georgia for provoking the confrontation—Georgia sought the injunction, and it is Georgians who most need its protection.  (continues...)

SUMMARY

Within days of news of the alleged Ponzi scheme perpetrated by Bernard Madoff, the Massachusetts Secretary of State, William F. Galvin, acting through his Securities Division, issued subpoenas ordering Bernard Madoff and his related funds to turn over all records related to money he managed for Massachusetts residents. A separate subpoena was issued to Cohmad Securities Corporation, a firm that marketed Madoff’s investment products and is located in the same building in Manhattan as Madoff’s firm. Specifically, Galvin is asking for all names and addresses of Massachusetts-based investors and any notes, emails, meeting agendas and telephone records that relate to investments Madoff made on their behalf from 2000 onwards.

SUMMARY

In this Issue:

• Criminal investigations on the rise
  
• DOJ has revised corporate charging guidelines again
  
• Will Filip Memorandum be cast aside in 2009?

SUMMARY

Excerpt:

Q: Has the current economic crisis altered the regulatory environment? If so, how?

A: The current economic crisis has altered the regulatory environment in two important and related respects.

First, the law has changed. Congress enacted the Emergency Economic Stabilization Act of 2008 (“EESA”), which requires all federal financial regulatory agencies to cooperate with the Federal Bureau of Investigation (“FBI”) and all “other law enforcement agencies,” including state regulatory agencies, that are “investigating fraud, misrepresentation, and malfeasance with respect to development, advertising, and sale of financial products.” As a practical matter, this requires financial regulatory agencies, such as the Securities and Exchange Commission (“SEC”) and Financial Industry Regulatory Authority (“FINRA,” formerly the NYSE), to provide support to the FBI’s and state law enforcement’s criminal investigations of financial fraud. As a result of this broad mandate, more criminal investigations concerning the current economic crisis should be expected. The EESA also creates new civil liabilities (e.g., for misrepresenting or falsely advertising the insured status of bank deposits) and new disclosure obligations (e.g., for those financial institutions participating in the Troubled Asset Relief Program (“TARP”)).

Second, the climate has also changed. The public desire to assign blame for the financial crisis and the attendant political pressure to prosecute entities or individuals who may be responsible will likely lead to more vigorous enforcement of familiar criminal laws and financial regulations, such as prohibitions on securities fraud and insider trading as well as wire, mail, bank and bankruptcy fraud. In addition, pending investigations may lead to high-profile prosecutions that press novel theories under more general laws, such as New York’s Martin Act. For example, New York Attorney General Andrew Cuomo is currently investigating executive compensation and corporate spending at major financial institutions that have received federal bailout funds, and he has threatened to “seek appropriate sanctions and remedies” against any company that “wastes” taxpayer funds—for example, by deeming employee bonuses to be fraudulent conveyances in violation of New York law. Massachusetts Secretary of State William Galvin has already charged investment banks with violating state securities laws by defrauding investors who purchased collateralized debt obligations and auction rate securities.

Other questions include: 

• Which government agencies are investigating activities relevant to the current economic crisis? And who is under investigation?
• What types of activities will investigators be looking at? Can you give some examples?
• What steps should we take if our company receives the proverbial “knock on the door”?
• Our best client/joint venture partner is under investigation. What steps should our company take?

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

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

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