Gibbons Law Alert
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.
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.
Gibbons is proud to once again sponsor lunch at the Rutgers Business School’s Blanche and Irwin Lerner Center for Pharmaceutical Management Studies Program on Thursday, April 26, and Friday, April 27, at Rutgers Business School – Newark, One Washington Park, Room 1027, 10th Floor.
In AstraZeneca Pharms. LP. v. Apotex Corp., the Federal Circuit ruled that an Abbreviated New Drug Application (“ANDA”), filed under § 355(j)(2)(B)(ii) and limited to FDA approved, but unpatented uses of a medication, is not an act of infringement of Orange Book-listed patents covering approved but different uses of the same medication. The Court did find that Plaintiff’s allegation that its listed patents are infringed was sufficient to establish subject matter jurisdiction over the generic Defendants.
Coming off a year that included the Smith-Leahy “America Invents Act,” 2012 portends to have some significant developments in IP law. Decisions for IP practitioners and industry to watch for include: the Supreme Court’s decision in Caraco Pharm. Labs. Ltd. v. Novo Nordisk A/S, regarding “use codes” and section viii carve-outs under the Hatch-Waxman Act; the Supreme Court’s decision in Mayo v. Prometheus, regarding patentable subject matter, post-Bilski; and the Federal Circuit’s upcoming en banc decisions in McKesson and Akamai, regarding joint infringement liability.
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.
The Federal Circuit’s Myriad Genetics decision, Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office, 99 U.S.P.Q. 2d 1938 (Fed. Cir. 2011), which invalidated most of the method claims in the patents at issue, brings to mind a concern about the value of method claims, particularly to the pharmaceutical industry. The Myriad Genetics patents at issue included two types of method claims relating to human genetics: one involved determining whether a female patient had abnormal BRCA1/2 genes by comparison of BRCA1/2 gene and BRCA 1/2 RNA from the patient’s tumor sample to those from a non-tumor sample; the second was an activity screening method for anticancer drugs that compared the growth of a host cell transformed with a cancer-causing BRCA gene in the presence and absence, respectively, of the test compound.
The Federal Circuit recently found that intervening rights can apply to a claim that has been narrowed by argument only during a reexamination. In Marine Polymer Technologies, Inc. v. HemCon, the Federal Circuit recently found that narrowing a claim by argument only changes the substantive scope of the claim for purposes of intervening rights. Specifically, a claim term that is changed during reexamination without changing a word in the claim can still substantively narrow the scope of a claim. Therefore, upon reissue of the patent, an infringer would have “… absolute intervening rights with respect to products manufactured before the date of reissue.”
On Tuesday, September 6, 2011, the Senate invoked cloture on H.R. 1249, also known as the America Invents Act, making it almost a done deal for passage of this Act. One reason that this bill has succeeded over its predecessors is that, with one major exception, there is little difference between the House and Senate versions. The passage of H.R. 1249 will mark the culmination of a 6-year process to pass patent reform legislation that started with H.R. 2795