Supreme Court Grants Cert in Two IP Cases

The US Supreme Court has recently granted petitions for certiorari in two intellectual property (IP) cases. A writ of certiorari is a request that a lower court send a record of a case for review by the Supreme Court. The Supreme Court is asked to review more than 7,000 cases per year and only accepts about 100-150 of these, when the case could have national significance, might harmonize conflicting decisions in the federal Circuit courts, and/or could have precedential value. In Amgen v. Sanofi, involving life science patents, the Court granted cert only on question two of the petition:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “ ‘time and effort,’….

The US Solicitor General filed an amicus (“friend of the court”) https://www.supremecourt.gov/DocketPDF/21/21-757/238447/20220921145309411_21-757 Amgen v. Sanofi.pdf in which it recommended that the Supreme Court deny the petition. In February 2022, the Federal Circuit held that claims of two Amgen patents related to its Repatha cholesterol medication are not enabled because practicing their full scope would require "undue experimentation." The patent claims are directed to antibodies that bind to amino acids of the PCSK9 protein and block PCSK9 from binding to LDL receptors. As the Federal Circuit noted,

To prove that a claim is invalid for lack of enablement, a challenger must show by clear and convincing evidence that a person of ordinary skill in the art would not be able to practice the claimed invention without ‘undue experimentation.’ Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.

Those factual considerations, which have come to be known as the “Wands factors,” are:

(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.

The second IP case, Abitron Austria GmbH v. Hetronic International, Inc. is a trademark case in which the 10th Circuit affirmed a damage award of $90 million for infringement taking place almost entirely outside the US. As the Circuit Court explained,

Hetronic International, Inc., a U.S. company, manufactures radio remote controls —the kind used to remotely operate heavy-duty construction equipment (think cranes). Defendants, none of whom are U.S. citizens, distributed Hetronic's products, mostly in Europe. That relationship worked well for nearly a decade. But then one of Defendants' employees stumbled across an old research-and-development agreement between the parties. Embracing a creative legal interpretation of the agreement endorsed by Defendants' lawyers, Defendants concluded that they—not Hetronic—owned the rights to Hetronic's trademarks and other intellectual property.

As a result of this,

Defendants began manufacturing their own products—identical to Hetronic's—and selling them under the Hetronic brand, mostly in Europe. They even kept the same product names. Hetronic terminated the parties' distribution agreements, but that didn't stop Defendants from making tens of millions of dollars selling their copycat products (which they continue to sell today). Defendants attempted a brief foray into the U.S. market but backed off after Hetronic sued them.

The US Solicitor General filed a brief asking the Supreme Court to grant cert in order to limit the application of the Lanham Act (which governs trademarks) so that damages are only awarded when the alleged infringement is likely to cause confusion among US consumers – rather than foreign buyers.