The case: Polansky v Executive Health Resources
Health care providers who dislike the FCA may find solace this Term in this second FCA case.11
The legal claim. Polansky, a physician employed by a medical billing company, became an “intervenor” in a suit claiming the company assisted hospitals in false billing (inpatient claims for outpatient services). The government sought to dismiss the case, but Polansky refused.
Decision. The case eventually reached the Supreme Court, which held that the government may enter an FCA case at any time and move to dismiss the case even over the objection of a whistleblower. The government does not seek to enter a case in order to file dismissal motions often. When it does so, whistleblowers are protected by the fact that the dismissal motion requires a hearing before the federal court.
An important part of this case has escaped much attention. Justices Thomas, Kavanaugh, and Barrett invited litigation to determine if allowing private whistleblowers to represent the government’s interest is consistent with Article II of the Constitution.11 The invitation will likely be accepted. We expect to see cases challenging the place of “intervenors” pursuing claims when the government has declined to take up the case. The private intervenor is a crucial provision of the current FCA, and if such a challenge were successful, it could substantially reduce FCA cases.
Criminal false claims
Another case this Term is cautionary about the consequences of health care misbilling. It resulted in a criminal charge. More importantly, in addition to a basic fraud charge, the government added a charge of aggravated identity theft,12 which carries a mandatory 2-year prison sentence.
Dubin overbilled Medicaid for psychological testing by saying the testing was done by a licensed psychologist rather than an assistant. The government claimed the “identity theft” was using the patient’s (actual) Medicaid number in submitting the bill.12 The Court unanimously held the overbilling was not aggravated identity theft as defined in federal law. Dubin could be convicted of fraudulent billing but not aggravated identity theft, thereby avoiding the mandatory prison term.
Patents of “genus” targets
The case: Amgen v Sanofi
This case, which corrected an error of the patent office, received little attention but was likely a turning point in the next generation of pharmaceuticals.13
Background. “Genus” patents allow a single pharmaceutical company to patent every antibody that binds to a specific amino acid on a naturally occurring protein. In this case, the patent office had granted a “genus” patent on “all antibodies” that bind to the naturally occurring protein PCSK9 and block it from hindering the body’s mechanism for removing low-density lipoprotein (LDL) cholesterol from the bloodstream,13 helping to reduce LDL cholesterol levels. These patents could involve millions of antibodies—and Amgen was claiming a patent on all of them. Amgen and Sanofi marketed their products, each with their own unique amino acid sequence.13 Amgen sued Sanofi for violating its patent rights.
Decision. The Court unanimously held that Amgen did not have a valid patent on all antibodies targeting PCSK9, only those that it had explicitly described in its patent application—a ruling based on a 150-year-old technical requirement for receiving a patent. An applicant for a patent must include “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the same.”13 Amgen’s patent provided the description for only a few of the antibodies, but from the description in its application others could not “make and use” all of the antibodies targeting PCSK9.
While the decision was vital for future pharmaceuticals, the patent principle on which it was based has an interesting history. The Court noted that it affected the telegraph (Morse lost part of his patent), electric lights (Edison won his case against other inventors), and the glue for wood veneering (Perkins Glue Company lost).13
Continue to: Other notable decisions...