News & Analysis as of

Clash Of Titans over Biosimilars at FTC Workshop

On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars. During highly informative...more

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

FDA Medical Device Regulation Update: FDA Issues Final Rule for Unique Device Identification System

On September 20, 2013, the U.S. Food and Drug Administration (“FDA”) announced the issuance of the final rule for the Unique Device Identification System (“UDI System”). The final rule sets forth the labeling and reporting...more

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

FDA Releases Draft Guidance on Medical Device Reporting - Will Supersede 1997 Guidance

On July 9, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Medical Device Reporting for Manufacturers (hereinafter “Draft Guidance”). FDA has not updated its formal...more

Medical Devices: Do Enhanced Versions Mean Your Old One Is Defective?

If you have any kind of medical device in your body, such as an artificial hip or a defibrillator, and you hear that a new and improved model is now being manufactured, does that mean that your older model device is...more

China Life Sciences Health Industry Client Briefing – May/June 2013 (July 12, 2013)

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - .. Medical Devices Regulations and News - Provincial FDAs to Approve Certain Changes to Medical Device Registration Certificates – June 21,...more

Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment

When the Second Circuit issued its December 3, 2012 decision in United States v. Caronia, the opinion was proclaimed by many to signal a sea change in the prosecution of off-label promotion....more

Pro Te Solutio - Vol. 6 No. 1 February 2013

In This Issue: - Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants? - Patent Reform for Biotech Companies - United States v. Caronia and its Implications for Off-Label...more

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1: Federal Courts Debate Safe...

Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when...more

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1

In This Issue: Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...more

FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies

The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more

Top Stories of 2012: #4 to #7

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

Path for Generic Competition Open in Biotechnology Industry

In the pharmaceutical industry, intense competition has been going on for years between "branded" drug manufacturers and "generic" competitors for the same drugs. This competition has taken place under the carefully balanced...more

FDA Issues Draft Guidelines for Biosimilars

Last Thursday, the FDA issued the first set of long-awaited draft guidelines for the regulatory approval of follow-on biologic drug products, or "biosimilars," under the Biologics Price Competition and Innovation Act of 2009...more

Follow-on Biologics and Patent Reform: Will They Discourage Venture Capital Investment in the Biotechnology Industry?

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which...more

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