Posts Tagged: "Patented Drug"

India’s booming $26 billion generic drug industry and public health sector rejoiced over the Indian Supreme Court’s recent decision to reject a patent filed by the Swiss pharmaceutical giant, Novartis for their landmark leukemia drug, Gleevec. Novartis received a patent for an earlier variation of Gleevec in 40 countries including Russia, China, and Taiwan. However, India’s troubled IP regime applies an ambiguous standard to patentability, the so-called “enhanced efficacy” for new forms of known substances. India only applies their “efficacy” requirement to the chemical and pharmaceutical drug industry as a protectionist measure. India codified the efficacy requirement in section 3(d) of their patent code and this may contravene with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) as set forth by the World Trade Organization (WTO).

In a moment of extreme weakness, I agreed to Gene’s request to doing a primer on Paragraph IV Certifications under the Drug Price Competition and Patent Term Restoration Act, commonly referred to as Hatch-Waxman. I don’t know if you would call me an expert, but I’ve studied many, many cases involving Paragraph IV Certifications under Hatch-Waxman. The courts have found Hatch-Waxman to be a hydra-like monster with a labyrinth of sections that are frequently confusing (or worse yet, conflicting). Paragraph IV Certifications are a particular trouble spot in Hatch-Waxman. So if you’re up to diving into the “belly of this beast,” let’s examine the characteristics of this most infamous of the Hatch-Waxman monsters. To understand Paragraph IV Certifications, you must first address what an Abbreviated New Drug Application (ANDA) is. ANDAs are how generic drug manufactures expedite the approval of their generic drugs.

In response to the scandal over a fungal meningitis outbreak, the FDA has begun a crackdown on compounding pharmacies and targeting about 30 ‘high risk’ operations in nearly a dozen states. San Francisco officials approved a referendum that will allow residents to decide whether to require city officials to hold talks with drug makers about pricing for ‘essential medicines.’ A federal appeals court upheld the conviction of a former biotech chief executive, who argued that federal prosecutors violated his First Amendment and commercial speech rights. The Federal Trade Commission filed a brief siding with generic drug makers in dispute with brand-name drug makers. At issue is whether a brand-name drug maker should be required to sell samples of its medicine to an aspiring generic rival when its medicine was approved with a Risk Evaluation and Mitigation Strategy.