Foley Hoag LLP

SUMMARY

Included in this Issue:

• Activity Level of New England Series A Transactions
• Activity Level of New England Series B and Later Round Transactions
• Size of New England Q3 2011 Series A Transactions by Industry
• Size of New England Q3 2011 Series B and Later Round Transactions by Industry
• The Numbers: by Dave Broadwin
• Selected New England Series A Round Transactions:
  • Third Quarter 2011
• Selected New England Series B and Later Round Transactions:
  • Third Quarter 2011
• Terms of Selected New England Series A Round Transactions 2010-2011
• Terms of Selected New England Series B and Later Round Transactions 2010-2011
• The National Activity Level Summary
  • National Series A Deals by Industry
  • National Series B and Later Round Deals by Industry

SUMMARY

On December 14, 2011, the Centers for Medicare & Medicaid Services (“CMS”) released the long-awaited Proposed Rule for implementing the so-called “Sunshine Act” physician payment reporting requirements. These proposed regulations provide some additional clarity regarding the reporting obligations for most drug and device manufacturers, contained in Section 6002 of the Affordable Care Act (“the Act”). The Act will require most drug and device manufacturers to file annual disclosure reports detailing their financial relationships with physicians and teaching hospitals.  [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

Overview

Yesterday, the United States Supreme Court granted certiorari (meaning it has agreed to hear an appeal) on three petitions concerning the constitutionality of the Affordable Care Act (“ACA”). Given the Supreme Court’s timeline for the filing of briefs, oral argument will likely be scheduled for the end of March or beginning of April 2012. The Supreme Court has set aside five and a half hours for oral arguments on four different issues. Under this timeline, the Court’s final ruling will likely be handed down at the end of June 2012, just before the Court recesses for the summer.

Key Points About The Decision

The Supreme Court has complete discretion to decide which cases (and which issues raised by those cases) it will hear. Each year the Court receives approximately 10,000 certiorari petitions, of which it hears between 80 and 100. A petition must receive the vote of four Justices to be granted certiorari. [continues...]

SUMMARY

Introduction

The core set of genetic test codes used by U.S. insurers and Medicare date to 1993. Only general information is conveyed by these codes to insurers – “DNA probe x 2.” They lead to payment for genetic tests based on a fixed price per genetic test step (such as “DNA probe x 2” or “DNA amplification x 3”). The payment was set using rules for the Medicare clinical laboratory fee schedule, rules which date to 1984. [more... ]

SUMMARY

Included in this Issue:

• Activity Level of New England Series A Transactions
• Activity Level of New England Series B and Later Round Transactions
• Size of New England Q2 2011 Series A Transactions by Industry
• Size of New England Q2 2011 Series B and Later Round Transactions by Industry
• The Numbers: byDave Pierson
• Selected New England Series A Round Transactions:
  • Second Quarter 2011
• Selected New England Series B and Later Round Transactions:
  • Second Quarter 2011
• Terms of Selected New England Series A Round Transactions 2010-2011
• Terms of Selected New England Series B and Later Round Transactions 2010-2011
• The National Activity Level Summary
  • National Series A Deals by Industry
  • National Series B and Later Round Deals by Industry

SUMMARY

On Thursday, June 23, the United States Supreme Court voted 6-3 to strike down a Vermont statute that sought to impose significant restrictions on pharmaceutical detailing and “data mining” activities. Justice Kennedy’s opinion in the closely-watched case of Sorrell v. IMS Health Inc. held that the Vermont statute was an unconstitutional regulation of commercial speech. In so doing, the Court found that the sale, disclosure, and use of redacted pharmacy records containing physician prescribing information constituted “speech in aid of pharmaceutical marketing” and therefore enjoyed First Amendment protection. This case is an important victory for the pharmaceutical, medical device, biotechnology, and related sectors, The following summarizes this ruling and its potential consequences to those involved in these industries. 

[more... ]

SUMMARY

Included in this Issue:

• Activity Level of New England Series A Transactions
• Activity Level of New England Series B and Later Round Transactions
• Size of New England Q1 2011 Series A Transactions by Industry
• Size of New England Q1 2011 Series B Transactions by Industry
• The Numbers: byDave Pierson
• Selected New England Series A Round Transactions:
  • First Quarter 2011
• Selected New England Series B and Later Round Transactions:
  • First Quarter 2011
• Terms of Selected New England Series A Rounds 2010-2011
• Terms of Selected New England Series B and Later Rounds 2010-2011
• The National Activity Level Summary
  • National Series A Deals by Industry
  • National Series B and Later Round Deals by Industry

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

Included in this Issue:

• Activity Level of New England Series A Transactions 
• Activity Level of New England Series B and Later Round Transactions 
• Size of New England Q4 2010 Series A Transactions by Industry 
• Size of New England Q4 2010 Series B Transactions by Industry 
• The Numbers:Dave Pierson
• Selected New England Series A Round Transactions:
  • Fourth Quarter 2010
• Selected New England Series B and Later Round Transactions:
  • Fourth Quarter 2010
• Terms of Selected New England Series A Rounds 2009-2010
• Terms of Selected New England Series B and Later Rounds 2009-2010 
• The National Activity Level Summary 
  • National Series A Deals by Industry 
  • National Series B and Later Round Deals by Industry

 

SUMMARY

CDRH Hopes to Increase “Predictability, Reliability, and Efficiency”

In response to protracted public and political criticism of the Food and Drug Administration’s (FDA or Agency) regulation and review of medical devices under the premarket notification, or 510(k), process, the FDA’s Center for Devices and Radiological Health (CDRH or Center) today released a set of proposed reforms to better “foster medical device innovation and assure the safety and effectiveness of medical technology.” [more...]

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 Affordable Care Act (§ 9008, as amended by § 1404 of the Reconciliation Act), established an annual fee that will be imposed on covered entities that manufacturer or import branded prescription drugs.

The Department of Treasury recently issued guidance on this new annual fee, available at http://www.irs.gov/pub/irs-drop/n-10-71.pdf . The guidance describes a proposed methodology for calculating the fee, how the IRS will use the methodology to provide covered entities with a preliminary 2011 fee calculation, and solicits public comments. Comments must be submitted by June 2, 2011.

IRS Form 8947, which is referenced in the guidance, is available at http://www.irs.gov/pub/irs-pdf/f8947.pdf

SUMMARY

Included in this Issue:

• New England Series A Deal Activity
• New England Series B and Later Round Deal Activity
• Size of New England Q3 2010 Series A Transactions by Industry
• Size of New England Q3 2010 Series B Transactions by Industry
• The Numbers:Dave Pierson
• Selected New England Series A Deals: Third Quarter 2010
• Selected New England Series B and Later Round Deals: Third Quarter 2010
• Selected New England Series A Deal Terms 2009-2010
• Selected New England Series B and Later Round Deal Terms 2009-2010
• The Activity Level Summary
  • National Series A Deals by Industry
  • National Series B and Later Round Deals by Industry

SUMMARY

The Affordable Care Act (also known as the ACA) was enacted earlier this year culminating over a year of intense political negotiations, legislative drafting and numerous Congressional hearings over whether, and how, to comprehensively reform the nation's health care system.

SUMMARY

Included in this Issue:

• New England Series A Deal Activity
• New England Series B and Later Round Deal Activity
• Size of New England Q2 2010 Series A Transactions by Industry
• Size of New England Q2 2010 Series B Transactions by Industry
• The Numbers:Dave Pierson
• Selected New England Series A Deals: Second Quarter 2010
• Selected New England Series B and Later Round Deals: Second Quarter 2010
• Selected New England Series A Deal Terms 2009-2010
• Selected New England Series B and Later Round Deal Terms 2009-2010
• The Activity Level Summary
  • National Series A Deals by Industry
  • National Series B and Later Round Deals by Industry

SUMMARY

On Wednesday, August 4, 2010, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released for public comment two preliminary reports recommending steps to: (1) foster medical device innovation; (2) enhance regulatory predictability; and (3) improve patient safety. According to CDRH Director Jeffrey Shuren, MD, JD, the actions proposed in the reports represent “a blueprint for smarter medical device oversight” and are intended to advance CDRH’s responsibility to both protect and promote public health. The reports were prepared by two separate internal groups within CDRH, both convened in September 2009.  [continues... ]

SUMMARY

On July 8, 2010, the Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking (“NPRM” or “proposed rule”) modifying the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy, Security, and Enforcement Rules pursuant to the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which was enacted February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5.  [more...]

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

Transparency Initiative

In June 2009, Dr. Margaret Hamburg, the newly appointed Commissioner of Food and Drugs, announced the Food and Drug Administration (“FDA” or “Agency”) Transparency Initiative and created the FDA Transparency Task Force to carry out the Initiative. The goals of the initiative were in keeping with President Obama’s January 2009 memorandum calling for “creating an unprecedented level of openness in Government” to “promote accountability and provide information for citizens about what their Government is doing.”    [continues...]