Rutgers Business School’s MBA in Pharmaceutical Management was recently ranked as one of the top 10 MBA programs for Health Care/Pharmaceuticals/Biotechnology in the world, based on a survey done by Find-MBA.com. According to a press release from Rutgers, the program earned its ranking due to its success in assisting MBA grads to earn internships and jobs focused in the health care, pharmaceuticals and biotechnology industries. This was a function of the quality of the program, complemented by Rutgers Business School’s proximity to, and relationship with, top tier pharmaceutical companies and several large hospitals in the region.
The generic pharmaceutical industry faced a Catch-22 when a serious adverse reaction arose from use of a generic drug product, and the manufacturer was restrained from unilaterally amending the product label to conform to state requirements, due to the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). PLIVA held that state requirements to change a label are pre-empted by the Federal Food, Drug and Cosmetic Act’s prohibition of changing labeling without authorization by the FDA.
For years, the average person who heard the phrase “knock offs” would immediately think of counterfeit versions of brand name luxury goods. While counterfeiters continue to target those types of goods, they are by no means the most nefarious or sophisticated category of counterfeiters. Counterfeiters have effectively targeted almost every type of consumer product imaginable, including the drugs and medical diagnostic devices that consumers rely on for their health and safety.
Pharmaceutical counterfeiting poses a threat to consumers and harms both the reputation and financial condition of pharmaceutical companies. On Tuesday, June 18, the Gibbons Institute of Law, Science & Technology will be hosting “Managing Counterfeiting Issues in the Pharmaceutical Industry,” from 5:00 – 7:00 pm at Seton Hall Law School in Newark, NJ.
Gibbons Institute of Law, Science & Technology Files Amicus Brief in “Pay-for-Delay” Case Before Supreme Court
We previously reported on the battle over so-called “pay-for-delay” settlements, which puts the pharmaceutical industry versus the Federal Trade Commission (“FTC”) before the Supreme Court, to decide the legality of reverse payments in Hatch-Waxman cases. The case is FTC v. Actavis, Inc., et al. Last week, the Gibbons Institute of Law, Science & Technology, among 16 other amici, filed briefs in support of respondents and the lawfulness of these payments. The other amici included: Antitrust Economists; Bayer AG and Bayer Corp.; Health Economics and Law Professors; Mediation and Negotiation Professionals; Law Professors Gregory Dolin, Kent Bernard, et al.; The American Intellectual Property Law Association; Enavail, LLC; The Generic Pharmaceutical Association]; Intellectual Property Owners Association; Merck & Co., Inc.; National Association of Manufacturers; Pharmaceutical Research and Manufacturers of America (Phrma); New York Intellectual Property Law Association; Shire plc; Washington Legal Foundation; Generic Manufacturers Upsher-Smith Laboratories, Inc.; Teva Pharmaceuticals USA, Inc.; Ranbaxy Pharmaceuticals, Inc.; Mylan Pharmaceuticals Inc.; and Impax Laboratories, Inc.
As the so-called pay for-delay case is ripening for Supreme Court oral argument on March 25, 2013, on Tuesday a bi-partisan group of senators introduced legislation meant to strongly deter such arrangements. The introduction of the bill, known as the “Preserve Access to Affordable Generics Act,” follows an annual FTC report disclosing 40 potential pay-for-delay deals struck in the 2012 fiscal year — a jump from 28 such deals in 2011. The goal of the bill is “to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.” Such reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry) are considered lawful by some, and anti-competitive by others, including the FTC.
On Monday, the Supreme Court denied the petition for writ of certiorari filed by Apotex seeking review of the Federal Circuit’s May 7, 2012, ruling that affirmed the District Court of New Jersey’s judgment that Otsuka’s patents covering its blockbuster drug Abilify© are valid and not obvious. In that ruling, the Federal Circuit found no error in the District Court’s application of the so-called lead compound test; an analytical framework in chemical art cases that seeks — in an obviousness inquiry under 35 U.S.C. § 103 — to determine whether a POSA (“person of ordinary skill in the art”) would select the proffered prior art as a “lead compound.” Specifically, in a lead compound analysis, the Court will consider: the hypothetical person of skill in the art’s identification of a lead compound, structural differences between the proposed lead compound and the claimed invention, motivation or teachings in the prior art to make the necessary changes to arrive at the claimed invention, and whether the person of skill in the art would have a reasonable expectation of success in making such structural changes.
We recently reported that during the August doldrums the Federal Trade Commission (FTC) proposed for comment amendments to the Hart-Scott-Rodino rules that would require reporting of licensing agreements under which a patent holder grants an “exclusive” license, but retains the limited right to manufacture solely for the recipient of the patent rights, or a right to assist in developing and commercializing the product covered by the patent (“co-rights”) and the value of the license exceeds the HSR minimum (currently $68.2 million).
In a recent “not for publication” Memorandum Opinion and Order relating to Reckitt Benckiser’s (“RB”) over-the-counter cough syrup, Delsym® (dextromethorphan polistirex), United States Magistrate Judge Douglas E. Arpert of the District of New Jersey found that RB failed to establish trade secret misappropriation, unfair competition, and tortious interference with business expectations claimed against Tris Pharma, following a four-day bench trial.
FTC Proposes Rules to Codify Reporting of Exclusive Patent Right Transfers in the Pharmaceutical Industry
Is the sale or assignment of a patent reportable? The Hart-Scott Rodino Antitrust Improvements Act of 1976 (“HSR”) and related rules require that all acquisitions of voting securities or assets exceeding a threshold amount be reported to the Federal Trade Commission (“FTC”), as well as the Antitrust Division of the Department of Justice. The current threshold is $68.2 million.