Here in Washington, D.C., the Trans-Pacific Partnership (TPP) is the latest talk of the town. The TPP is a proposed trade agreement among twelve Asia-Pacific countries concerning a variety of economic policy matters, including intellectual property. TPP’s membership includes several of the U.S.’s largest trading partners, e.g., Canada, Japan, and Mexico. The membership countries reached agreement in early October after years of negotiation. Congress is expected to vote on the agreement in 2016. The full text released on November 15, 2015; the whole of Chapter 18 relates to intellectual property. Overall, it appears that the patent-related provisions in the TPP reflect well-established U.S. patent practice. If ratified, the TPP would likely benefit U.S. companies as it would simplify worldwide patent procurement.
Continue Reading Trans-Pacific Partnership: What does it say about patents?

On July 21, 2015, the Federal Circuit issued its decision in Amgen v. Sandoz in-terpreting two key provisions in the Biologics Price Competition and Innovation Act (BPCIA).1 The case involved Sandoz’s Zarxio, a biosimilar drug to Amgen’s Neupogen and the first approved abbreviated biologics license application (ABLA) under the provisions of the BPCIA. Judges Newman, Lourie, and Chen were on the panel.
Continue Reading Amgen v. Sandoz: What “Shall” Biosimilar Applicants Do?

In a case involving Google’s “very cool”1 Street View technology, Google convinced the district court that its technology did not infringe four Verderi’s patents.2 But Google’s victory was short lived. The Federal Circuit disagreed with the district court on claim construction, and remanded the case to the district court to determine infringement based on the Federal Circuit’s own claim construction. Google applied for, and was recently denied, Supreme Court review.3
Continue Reading During Claim Construction, Claim Amendments Need Not Be Strictly Construed Against Applicant

On June 12, 2015, the Federal Circuit invalidated Sequenom’s patent on fetal DNA testing (U.S. Patent No. 6,258,540; “the ’540 patent”) holding that the subject matter was not eligible for patent protection under 35 U.S.C. § 101. This is the first time that a lower court applied the Supreme Court’s ruling in Mayo Collaborative Services v. Prometheus Laboratories.
Continue Reading Federal Circuit Deals Blow to Biotech Industry and Diagnostic Method Patents

On May 7, 2015, the California Supreme Court revived a class-action lawsuit against pharmaceutical giant, Bayer AG, in which it was accused of violating the state’s antitrust law.1 A settlement agreement between Bayer and generic pharmaceutical, Barr Laboratories, is central to the dispute. In a 1997 agreement, Bayer paid Barr almost $400 million in cash, and Barr in turn withdrew its challenge on the validity of Bayer’s ciprofloxacin patent (i.e., U.S. Patent No. 4,670,444) and agreed to postpone marketing a generic version of Cipro until the patent expired. Ciprofloxacin was Bayer’s bestselling antibiotic, generating $6 billion in gross sales between 1997 and 2003. The 1997 settlement between Bayer and Barr produced a wave of state and federal antitrust suits. This appeal arose from nine such coordinated class action suits brought by indirect purchasers of Cipro in California against Bayer and Barr.2
Continue Reading Reverse Settlement Payments in Patent Disputes Come Under Scrutiny Under Both Federal Law and State Antitrust Law