Litigation

The U.S. Court of Appeals for the 9th Circuit affirmed a lower court’s findings Feb. 10, 2015, that the acquisition by St. Luke’s Health System (“St. Luke’s”) of Saltzer Medical Group (“Saltzer”), a physician group consisting mostly of primary care physicians, violated Section 7 of the Clayton Act. This is the first case in which the Federal Trade Commission (“FTC”) litigated through trial a challenge to a physician acquisition.

Despite getting a rare Writ of Mandamus from the D.C. Circuit Court of Appeals establishing that its internal investigations were covered by the attorney-client privilege, Kellogg Brown & Root must still turn them over. As predicted in our earlier posts on Barko v. Halliburton, Judge James Gwin has ruled that KBR waived the attorney-client privilege that would otherwise have shielded KBR’s internal investigation documents from discovery. His rationale is reflected in three opinions published in November and December 2014.

Case law regarding written description is in a state of flux so it is beneficial for the patent practitioner to understand some key Federal Circuit decisions involving the written description requirement.

One might ask why a separate written description of the invention is needed in the specification when the claims are there to define the subject matter of the invention. The reason is historical.

The U.S. District Court for the Eastern District of Tennessee answered what it acknowledged was a novel question: whether statistical sampling and extrapolation are appropriate to establish liability under the False Claims Act (FCA). The court found the government could extrapolate from a sample of patient records to prove FCA liability. While the court’s decision approved the use of sampling, it emphasized the defendant could challenge the government’s methodology and that the government was not using sampling to prove all of the elements of the alleged FCA violations.

Husch Blackwell received significant recognition as a top litigation firm in the 2015 edition of Benchmark Litigation’s annual nationwide rankings. The list includes 8 healthcare attorneys from the firm’s Illinois and Missouri offices. Husch Blackwell had 22 attorneys total named on the list.

Husch Blackwell’s Litigation practice received the commendable “Recommended” ranking in Missouri and Nebraska, and the firm was reputed to have “one of the strongest toxic and mass tort practices in the country.”

Dietary supplements represent a huge sector of the consumer market and changes in both intellectual property law and the regulations governing the market entry and advertising of these products is changing.

The new America Invents Act allows anyone to challenge the validity of patents under the inter partes review (IPR) process. In a Sept. 9 webinar, Husch Blackwell Partner Joseph Cwik, who recently won the first pharmaceutical IPR case, will provide an overview of this new process and explain how it is more cost-effective, efficient and successful than the traditional litigation.

The Kentucky Supreme Court issued an opinion Aug. 21, 2014, (Tibbs v. Bunnell, Ky., No. 2012-SC-000603-MR)  in which it held that the incident report developed by the University of Kentucky Hospital (“hospital”), through the hospital’s Patient Safety Evaluation System (“PSES”), following the death of a patient, was not protected as patient safety work product (“PSWP”) under the Patient Safety and Quality Improvement Act of 2005 (the “Act”).

The attorney-client privilege applies with equal force to internal investigations today as it did 30 years ago thanks to the D.C. Circuit’s recent decision in In re: Kellogg Brown & Root, Inc., No. 14-5055 (D.C. Cir. June 27, 2014). The appeals court decision vacates the March 6, 2014, district court decision in the same case. At the district court, Judge James Gwin ruled that the attorney-client privilege did not protect documents developed during KBR’s internal investigations of potential fraud relating to its LOGCAP III contract. According to Judge Gwin, KBR’s investigations were not privileged because they were conducted “pursuant to regulatory law and corporate policy rather than for the purpose of obtaining legal advice.”

Several parts of the America Invents Act (the “AIA”) became law on Sept. 16, 2012, sparking some of the most meaningful changes to patent law seen in decades. One hot provision in the new law is the ability for one to challenge a patent’s validity in a new inter partes review (“IPR”) process. This legal tool could prove to be very valuable in solving some of the biggest business challenges facing generic pharma. This post addresses the business case for generic pharma using the IPR process.