Under the recently passed Leahy-Smith America Invents Act (“AIA”), generic drug manufacturers will be able to use post grant review (“PGR”) to effectively invalidate or constrain pharmaceutical patents. The efficiency of PGR and the lower burden of proof for the PGR process in comparison to patent litigation makes PGR an attractive new tool for generic drug manufacturers. Furthermore, generic drug manufacturers can effectively avoid estoppel under a counterclaim exception for PGR. The primary constraint on PGR, with respect to pharmaceutical litigation, is that patents must be challenged under PGR within nine months of their issuance. At that early stage, it could be uncertain if a particular pharmaceutical patent is valuable and worth challenging, as the compounds and treatment methods described in the patent may only be in the early stages of clinical trials.
The Post Grant Review Process
PGR is a process where a third party can challenge patent claims within nine months of their issuance using evidence on a broad range of grounds, such as subject matter, novelty, nonobviousness, enablement and written description. 35 USC § 321(b),(c). Continue reading
On February 23, 2012 President Obama’s administration (“the Administration”) released an important new report entitled “Consumer Data Privacy In A Networked World: A Framework For Protecting Privacy And Promoting Innovation In The Global Digital Economy.” President Obama situates the new report as a mechanism that encourages the further development of online enterprises by protecting, enlightening, and enabling consumers’ privacy choices. “For businesses to succeed online,” President Obama asserts, “consumers must feel secure.”
The report announced the Administration’s new four-element online privacy framework, which is designed to augment already existing privacy protection laws. The first, and perhaps most critical, element of the new framework is a Consumer Privacy Bill of Rights (“CPBR”). The framework also consists of a multistakeholder process “to specify how the principles in the [CPBR] apply in particular business contexts, recommendations for effective enforcement, and a commitment to increase interoperability with international privacy protections.”
This post includes a dissection of each of the four elements of the Administration’s new framework, followed by a discussion of initial reactions to the framework.
On January 23, 2012, the United States Supreme Court handed down its decision on United States v. Jones, No. 10-1259, 2012 BL 14420 (U.S. Jan. 23, 2012), regarding the warrantless use of a GPS tracking device by law enforcement to track the actions of a suspected criminal. This author previously covered the D.C. Circuit’s decision and the oral arguments heard by the Supreme Court last November. After oral argument, this author predicted that the Court would find that GPS tracking without a warrant violates the Fourth Amendment. While the Court found that in this case the Government had violated Jones’s Fourth Amendment rights, the ambiguous majority opinion and concurrences have left the public questioning the implications of the decision beyond the facts of this case.
The Opinion: Justice Scalia
Delivering the opinion of the court, Scalia holds that the law enforcement’s placement of a GPS device on a vehicle and then using that device to track the vehicle’s movements constituted a “search.” Id. at *3. Notably, Scalia — joined by Chief Justice Roberts and Justices Kennedy and Thomas as well as Justice Sotomayor in part through her concurrence — found that by using the GPS tracking device, the Government had “physically occupied private property for the purpose of obtaining information” such that the “physical intrusion would have been considered a ‘search’ within the meaning of the Fourth Amendment when it was adopted.” Id. at *4. Scalia’s majority focuses its analysis on the jurisprudence of common-law trespass and takes an originalism approach to the Fourth Amendment — focusing on what the authors of the Amendment intended to protect against. Id. Continue reading