Due diligence is often perceived as a mundane part of the mergers & acquisitions (M&A) process, but its importance in healthcare transactions is critical. Due diligence is one of the first steps of any transaction and involves a buyer undertaking an in-depth examination of the target to evaluate the business and uncover potential issues or liabilities. In the healthcare industry, diligence is especially important considering the heavy regulation of the industry, the unique areas of risk, and the significant liabilities that could be imposed upon a buyer if issues and liabilities are not identified before the transaction closes.

It’s time to begin preparing H-1B petitions for an early April filing and Oct. 1, 2015, effective date.

Advance planning is crucial. Due to the improving economy and the backlog of demand from April 2014, the H-1B cap will likely be exceeded again this year. Employers that fail to file H-1B petitions on April 1 may lose the opportunity to employ the intended foreign national candidate.

After a protracted legal battle resolved in the favor of Teladoc, Inc. (Teladoc) on Dec. 31, 2014, (see Teladoc, Inc. v. Texas Medical Board, No. 03-13-00211-CV, Tex. App. 3rd, Austin) and clarifying that Teladoc physicians could prescribe dangerous drugs based on a telephonic evaluation, the Texas Medical Board (TMB) wasted no time in issuing an emergency rule Jan. 16, 2015, that significantly limits the use of telephones in the practice of medicine.

The new Rules (for Vending Machines and Menus) are based on changes made as the result of the Affordable Care Act. These changes were made by adding two new sections to Section 403 of the Food, Drug and Cosmetics Act, which describes Mislabeled Foods. The new sections, found under FDCA §403(q)(5)(H), enables the FDA to regulate the labeling requirements for Restaurants, Retail Food Establishments and Vending Machines.

Late last year, the U.S. Food and Drug Administration finalized a new set of Rules pursuant to the new §403 governing how and where caloric content must be displayed. As a result, beginning on Dec. 1, 2015, and Dec. 1, 2016, certain restaurants and vending machine operators, respectively, will be forced to disclose the calorie content of their products to consumers.

Recent trends in the U.S. Food and Drug Administration’s (“FDA’s”) utilization of Complete Response Letters (“CRLs”) would indicate there may be a disconnect between the intended use of CRLs and the reality of how they are actually being used by the FDA. Pharmaceutical companies seeking to acquire FDA regulatory approval for their New Drug Applications (“NDAs”) or Abbreviated New Drug Applications (“ANDAs”) will often receive a CRL from the FDA instead of an approval.

The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application now leaves resolution of patent issues for Sandoz to contend with as it prepares to launch its biosimilar filgrastim product. The lawsuit to resolve these issues, however, has just begun.

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.

Last week, Judge Richard J. Leon of the Federal District Court for the District of Columbia vacated the “third-party” regulation on the federal companionship exemption, which would have prevented third-party employers from utilizing the companionship exemption from minimum wage and overtime, as well as the “live-in” exemption from overtime.

On Dec. 31, 2014, the judge temporarily stayed the regulations that would have significantly altered the duties an exempt companion could provide. The regulations, which were set to go into effect at midnight on Dec. 31, would have prevented exempt companions from providing any “general household work” at all, and would have prevented them from engaging in any “care” of the client for more than 20 percent of their working time.

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.