Gibbons Law Alert
Why all the buzz about biosimilars? Biosimilars, also known as follow-on biologics, are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. The evolving biosimilars landscape is of concern to companies here in the U.S. and worldwide.
This past week, Governor Christie signed into law S. 581, entitled the “New Jersey Angel Investor Tax Credit Act.” The new law is designed to stimulate investment in New Jersey’s high tech start ups by providing investment incentives for “angel investors.” The law provides credits against corporation, business and gross income taxes for investing in New Jersey’s emerging technology businesses, including: advanced computing; advanced materials; biotechnology; electronic devices; information technology; life sciences; and mobile communications, among others. Angel investors in these start-ups will be eligible for tax credits equal to 10 percent of their investments, up to a maximum allowed credit of $500,000 for the tax year. Other criteria for the start-ups require that they employ fewer than 225 employees, 75 percent of whom must work in New Jersey. The overall program has an annual cap of $25 million.
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.
As anticipated, the Supreme Court has granted certiorari in Association for Molecular Pathology v. Myriad Genetics, et al. (the “Myriad” case) to review the Circuit Court’s opinion. The Court previously granted certiorari to vacate and remand the Federal Circuit’s Myriad decision for reconsideration in view of the Court’s 2012 decision in Mayo Collaborative Services, et al. v. Prometheus Laboratories, Inc. (“Mayo”). Notwithstanding Mayo, the Federal Circuit reached the same result on remand as its initial decision.
We previously reported on developments in various United States Courts of Appeal decisions concerning reverse payments in Hatch-Waxman litigation settlements – that is, payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry of the generic product. Most recently, as we reported here, the Third Circuit in In re K-Dur Antitrust Litig. bucked prior holdings of the Eleventh, Second, and Federal Circuits, ruling that a reverse payment is prima facie evidence of an antitrust violation and, therefore, serves as evidence of unreasonable restraints of trade. In light of the Third Circuit’s divergent decision from other circuit precedent, many predicted a subsequent Petition for Certiorari.
In WM. Wrigley Jr. v. Cadbury Adams USA, a recent Court of Appeals for the Federal Circuit decision related to chewing gum patents, Wrigley brought suit against Cadbury for infringement of its U.S. Patent Number 6,627,233 (“the ‘233 patent”) claiming a chewing gum including a combination of menthol and a physiological cooling agent, WS-23. Cadbury counterclaimed against Wrigley for infringement of Cadbury’s U.S. Patent Number 5,009,893 (“the ‘893 patent”) claiming a chewing gum including menthol and a similar cooling agent entitled WS-3.
According to a press release from the Governor’s office, a recent review issued by Business Facilities magazine reported that New Jersey jumped eight positions to rank second for biotechnology strength among U.S. states. Some of the factors cited as responsible for this improvement include increases in R&D tax credits (from 50% to 100%) and the adoption of a new single sales factor formula for corporate tax liability, which will reduce company costs.
Gibbons P.C. is again proud to announce a two-day program for Pharmaceutical Management at the Rutgers University Blanche and Irwin Lerner Center for Pharmaceutical Studies in Newark, NJ. The program, which is open to the public, includes in-depth presentations relating to topics including intellectual property, regulatory, financial and marketing issues relating to the pharmaceutical industry, as well as drug development and the role of biotechnology in pharmaceutical development.
Oral argument was recently heard before the Federal Circuit in the appeal of AstraZeneca Pharms. LP. v. Aurobindo Pharma Ltd. AstraZeneca, along with IPR Pharmaceuticals, Inc., and The Brigham and Women’s Hospital, Inc., (“Plaintiffs) sued ten generic drug companies alleging infringement of US Patent Nos. 6,858,618 (“the ‘618 patent”) and 7,030,152 (“the ‘152 patent”) under the Hatch-Waxman Act. These patents claim methods of treatment using rosuvastatin calcium, which Plaintiffs market as Crestor®.
Gibbons P.C. will once again sponsor lunch at the upcoming Rutgers University/Blanche and Irwin Lerner Center for Pharmaceutical Management Studies Program on Thursday, October 27, from 12:00 – 1:00 pm at Rutgers Business School – Newark.