Can You Patent Human Genes? ACLU Says No
Going on the Offense: Proactive Strategies to Reduce Uncertainty
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
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
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
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
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guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more
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
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
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
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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