Med tech patents have been especially vulnerable to litigation in recent years, and a new decision by the Court of Appeals for the Federal Circuit affirms yet again the vulnerability of patents undergoing litigation. The Federal Circuit said nine claims found in two patents held by Becon Medical Ltd., of Batavia, Ill., were invalid due to obviousness, presenting the company a significant loss in its infringement litigation with Talexmedical LLC, of Malvern, Pa.
Drug and device makers that offer health care professionals opportunities to earn continuing medical education (CME) points have a fine line to walk when sponsoring those programs, but a new advisory opinion by the Office of Inspector General at the Department of Health and Human Services seems to draw a very clear line around those programs.
For companies in the life sciences, patent subject matter eligibility has acquired a bad reputation, but the U.S. Patent and Trademark Office (PTO) has attempted to provide administrative workarounds to the problem. PTO director Kathi Vidal said recently, however, that the agency intends to revisit its guidance, just one of several steps the PTO is taking to eliminate some of the drag on patent applications in the U.S.
The U.S. FDA’s guidance for unique device identifiers (UDIs) is heavily adjusted to account for a device’s inherent risk class, and many class I devices are now going to enjoy another reprieve from UDI requirements per an updated FDA guidance.
A committee of the U.S. House of Representatives is moving forward with a bill that would extend Medicare telehealth provisions for two years after the end of the COVID-19 public health emergency, but the legislation lacks features to deal with fraud and abuse.
For companies in the life sciences, patent subject matter eligibility has acquired a bad reputation, but the U.S. Patent and Trademark Office (PTO) has attempted to provide administrative workarounds to the problem. PTO director Kathi Vidal said recently, however, that the agency intends to revisit its guidance, just one of several steps the PTO is taking to eliminate some of the drag on patent applications in the U.S.
The shortage of semiconductor products has plagued the U.S. medical device industry for better than a year, but there is legislation in play in Washington that might bring some relief. The White House held a July 25 briefing during which President Joseph Biden promised his support for the CHIPS Plus Act of 2022, a development that could break a legislative logjam.
The U.S. Department of Justice (DOJ) reported that Biotronik Inc., of Lake Oswego, Ore., agreed to pay $12.95 million to settle allegations that the company induced cardiologists to use the company’s devices to treat their patients. Among the allegations is that the company paid for physicians’ holiday parties and winery tours that could not be tied to a legitimate business expense.
The U.S. Department of Justice has been intensely focused on illicit billings to federal government agencies, so much so that the agency reclaimed more than $500 million in the first half of calendar year 2022 under the False Claims Act. However, 80% of that amount came from companies in the life sciences, a fact which combines with pending federal and state legislation to amplify the risk for these companies in the coming years, according to a new report by the law firm of Gibson Dunn & Crutcher, LLP.
Several U.S. government agencies have been involved in the enforcement action directed toward Medifirst Solutions Inc., of Freehold, N.J., including the Department of Justice, but the Securities and Exchange Commission (SEC) has had its say as well. The SEC recently announced that a final consent judgment has been entered against a former Medifirst stock promoter, although there is still no word as to the fate of the company’s former CEO.
