Posts Tagged: "Pharma & Chemical"

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.

Legal Threats to Strong Returns on Pharmaceutical Patents Grow, Threatening Innovation

Pharmaceuticals is the industry sector where a strong patent system, promising substantial returns to successful innovation, is of paramount importance. Regrettably, the weakening of pharmaceutical patent rights through legislative means and antitrust lawsuits is symptomatic of a broader and more general policy attack that antitrust enforcers have directed against patents in recent years. Antitrust enforcers and legislators clearly need a few remedial lessons in the economics of innovation before their myopic meddling cripples the (up-to-now) highly successful American pharmaceutical sector and other key U.S. industries, which have stood as a testament to the value of strong patent rights.

Innovation A, B, C’s: Amazon, Boehringer and Chevron Disrupt World’s Top Innovator List

According to Thomson Reuters 2015 list of Top 100 Global Innovators, Amazon and several other established players in mature markets are proving that it’s not just start-ups that have the potential to upend traditional business models and reinvent our world. In fact, several of the companies new to this year’s ranking of top innovators have been around a lot longer than Amazon, among them: Boehringer Ingelheim, Chevron, Exxon Mobil, Johnson Controls, Thales, and Yamaha.

Merger of Dow and DuPont set to make huge waves in agriculture, materials and plastics sectors

No one should get too used to seeing the name DowDuPont, however. Company executives plan on splitting DowDuPont into three separate companies, each with a specific industry focus. One will be a $19 billion company focused on the corporation’s combined properties in agricultural products, including fungicides, genetically modified seeds and herbicides. A $13 billion specialty products company will also be spun off to produce electronics materials, Kevlar, Tyvek, food additives and other biological products. The largest of the new companies, however, will be a $51 billion firm with a focus on construction materials, vinyl, packaging plastics and specialized chemicals for the automotive and pharmaceutical industries.

Distorting Innovation: Fixed Patent Terms and Underinvestment in Long-term Research

Drugs for the treatment of late-stage cancers are less expensive to develop, in part because late-stage drugs extend patients’ lives for a shorter period of time such that clinical trials are concluded more quickly. This means that such drugs require less time to research, develop, test and bring to market than drugs that treat earlier stage cancers, providing the innovator with a longer effective patent life. In essence, less research and development investment is directed toward drugs that treat patient groups requiring lengthy clinical trials, those with longer commercialization lags… It’s worthwhile to ask whether a ‘one-size-fits-all’ patent policy is optimal. How we can think creatively about patent protection in an effort to incentivize the innovation we want and push the frontiers of modern medicine.