Newcomer to the luxury cosmetics marketplace, Tatcha LLC (“Tatcha”), recently made a splash by filing a trade dress infringement lawsuit in the Northern District of California against Too Faced Cosmetics LLC (“Too Faced”), a division of Estee Lauder. The trade dress claim is based on alleged similarities in the appearance of the two companies’ lipstick packaging.
For opponents of the 2.3 percent medical device tax, it looked like the repeal/replacement of the Affordable Care Act would alleviate their concerns. However, following the failure of repeal legislation that would have killed off, or delayed, the tax, the tax is on pace to be reinstated on January 1st, 2018 after a two-year gap.
On August 7, 2017, after nearly two-and-a-half years of litigation, an East Texas jury awarded just over $21,000,000 to Elbit Systems of America and its affiliate (“Elbit”). Elbit, an international defense electronics company, sued Hughes Network Systems, LLC (“Hughes”) and several of its customers on January 21, 2015 for infringement of two of its patents.
On August 4, 2017, after five-and-a-half years of litigation over patent infringement, a Federal Claims judge ordered the United States (“the Government”) to pay Advanced Aerospace Technologies, Inc. (“AATI”) a lump sum of $12,500,000. This is only a portion of the compensation that AATI will receive to resolve this patent dispute.
On July 14, 2017, the International Trade Commission determined that financial services company Diebold Nixdorf, Inc. (“Diebold”) violated Section 337 of the Tariff Act by importing ATMs and ATM components that infringe a patent belonging to Nautilus Hyosung America’s (“Hyosung”).
In March 2014, Regeneron Pharmaceuticals, Inc. sued Merus B.V. for allegedly infringing U.S. Patent No. 8,502,018 (“the ’018 Patent”). The ’018 Patent generally relates to using vectors to modify genes and chromosomal loci in eukaryotic cells.
K2M Group Holdings, Inc. recently announced its acquisition of a portfolio of 17 issued and pending patents for expandable interbody technology. According to K2M, the company is a global leader in the medical device industry and provides complex spine and minimally invasive solutions to help patients with difficult spinal pathologies achieve three-dimensional (i.e., axial, coronal, and sagittal) Total Body Balance™. K2M explains that the acquisition of the “comprehensive patent portfolio” allows the company to expand its portfolio of 3D-printed spinal solutions.
Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.
On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals for streamlined development of certain antibacterial drugs.
The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to submit a report within 30 days of a problem. Under the current version of the Reauthorization Act, companies will be able to submit reports once every three months instead. Additionally, these reports will be able to “summarize previously reported product malfunctions, rather than filing detailed reports on each case” as reported by the StarTribune. However, this does not affect the 30-day reporting requirement for medical device companies to report “adverse events” or anything that result in actual injury to consumers.
