Category Archives: Legislation

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Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. … Continue Reading

New California Commission Contract Rules – It is Not Too Early To Get Ready!

By Jennifer Redmond, Morgan Forsey, and Bram Hanono  Employers with sales teams in California need to get ready. California has a new commission contract law, AB 1396, which takes effect January 1, 2013. Under AB 1396, which amends California Labor Code section 2751, employers who pay commissions to their employees are required to enter into … Continue Reading

FDA Announces Proposals for Biosimilars User Fees and Performance Review Goals

By Peter Reichertz FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees for "generic" copies of biologics, called biosimilars in the BPCI Act. A biosimilar is a product approved under Section 351(k) … Continue Reading

Rights to Compensation for use of Biospecimens: OHRP and FDA Clarify that Waivers of Rights in Informed Consents are not “Exculpatory”

By Peter S. Reichertz In a Federal Register notice of September 7, 2011,[1] the Office of Human Research Protection (“OHRP”) and the Food and Drug Administration have clarified that a waiver by an individual in an informed consent to compensation for use of his/her biospecimens is not “exculpatory”, and permissible, if worded properly. This Guidance – … Continue Reading

A MATRIXX Revolution, Part II: Supreme Court affirms Ninth Circuit’s holding that life science companies cannot rely on a statistical significance standard when deciding whether adverse event reports are material for the purpose of securities disclosures

By Peter S. Reichertz and Allie Frumin On March 22, the U.S. Supreme Court affirmed the Ninth Circuit’s ruling in Matrixx Initiatives, Inc. v. Siracusano, 09-1156. See our prior blog article from November 18, 2010.  … Continue Reading

Going Back to Risk Basics for Clinical Work: Beware of Overly Broad Indemnification Clauses, Lack of Clarity on Third-Party Loss Clauses, and Incomplete Insurance Coverages

By Blaine Templeman and Sarah E. Aberg 1. You May Get What You Drafted. Broad indemnification provisions, once played out, can sometimes result in surprising applications. For example, in Mass Transit Administration v. CSX Transportation, Inc., 708 A.2d 298 (Md. 1998), the court considered an indemnification clause in a procurement contract between the Maryland Transit Authority (MTA) … Continue Reading

IRS Guidance On New Excise Tax On Branded Pharmaceutical Companies: Filing Due January 21, 2011

By Peter S. Reichertz In a prior article dated May 25, 2010, we advised of a new excise tax on branded pharmaceutical manufacturers. We indicated that the Patient Protection and Affordable Care Act ("PPACA") required the Internal Revenue Service ("IRS") to publish guidance "necessary to carry out the purpose" of the section in which the tax … Continue Reading

A MATRIXX Revolution? Is there a need to describe all adverse event reports in SEC filings of life sciences companies?

By Peter S. Reichertz The U.S. Supreme Court has scheduled oral argument for January 10, 2011, in the case of Matrixx Initiatives et al v. Siracusano, Case Number 09-1156, on appeal from the decision of the Ninth Circuit in Siracusano v. Matrixx Initiatives, Inc., 585 F3d 1167 (9th Cir. 2008).  The court granted certiorari on … Continue Reading

Proposed Tax Incentives for Life Sciences Research

By Matthew Richardson A bill was recently introduced in the House of Representatives that would provide significant tax incentives for life sciences research. Under current law, a 20% tax credit is available for spending on qualified research in excess of a specified base amount, subject to a number of limitations and special rules. Under H.R. 6165, which was introduced last week, … Continue Reading

User Fees for Generic Drugs – What are the Issues?

By Peter S. Reichertz On August 9, 2010, the Food and Drug Administration (“FDA”) published a notice announcing a public meeting to be held September 17, 2010, “to gather stakeholder input on the development of a generic drug user fee program.” See 75 Fed. Reg. 47,820-21. FDA also requested submission of written comments on issues relating to … Continue Reading

Has the Time Come for “Total Recall” of Medical Products?

By Peter Reichertz On July 14, 2010, Congressman Edolphus Towns introduced legislation to provide for the mandatory recall of adulterated or misbranded drugs. The legislation, H.R. 5740, has been referred to the Committee on Energy Commerce. Congressman Towns was the chair of the subcommittee that held hearings about Johnson & Johnson/McNeil and its handling of adulterated children’s drug … Continue Reading
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