Friday, the U.S. Supreme Court issued its anticipated ruling in Amgen Inc. v. Sanofi and affirmed the Federal Circuit's prior decision that Amgen's patent was invalid for lack of enablement. A copy of the Court's Opinion is available here.
At issue in the case was a dispute over the scope of several Amgen patents relating to monoclonal antibodies used to treat high cholesterol. Shortly after obtaining the patents at issue, Amgen sued Sanofi claiming Sanofi's competing high cholesterol medication infringed its patents. Specifically, Amgen's patents went beyond claiming the functionality relating to specific antibodies; rather, Agmen's patents sought to claim the entire genus of antibodies that performed the same claimed function. In other words, Amgen was seeking to claim a monopoly over all antibodies that performed the same function described in the patents. Amgen's justification for such broad patent protection was the fact its patents provided two methods on how to make and identify other antibodies that perform the same function.
In response, Sanofi argued there was no infringement on the grounds the claims at issue were invalid because the methods outlined in the patent failed to enable a person skilled in the art to do so reliably; rather, the methods offered little more than advising other scientists to engage the trial and error process of discovery. Thus, Sanofi argued the patents failed to comply with 35 U.S.C. §§ 111 and 112, which requires a patent specification to 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." The trial court agreed with Sanofi's arguments and concluded that Amgen's patents had failed to adequately enable all that was claimed, and the Federal Circuit agreed.
The U.S. Supreme Court's opinion affirmed those rulings and made clear that the fundamental purpose of the Patent Act has not changed since 1790. The Patent Act is a bargain between the inventor and the public. An inventor is provided a monopoly on its patented invention for a limited time in exchange "upon the expiration of [the patent], the knowledge of the invention [i]nures to the people, who are thus enabled without restriction to practice it." Thus, the Court held:
"For if our [prior enablement] cases teach anything, it is that the more a party claims, the broader the monopoly it demands, the more it must enable. That holds true whether the case involves telegraphs devised in the 19th century, glues invented in the 20th, or antibody treatments developed in the 21st."
Amgen attempted to argue that its broad claims did provide sufficient enablement for every undisclosed but functional antibody given the methodologies provided in its patents. But the Court still disagreed, explaining that those "two approaches amount to little more than two research assignments" that require other scientists "to engage in 'painstaking experimentation' to see what works." Nonetheless, the Court did not go so far as to cast doubt on all genus-type claims. Rather, in this instance, the Court agreed with the lower court's rulings relating to Amgen's patents and left us with this important reminder:
Section 112 of the Patent Act reflects Congress’s judgment that if an inventor claims a lot, but enables only a little, the public does not receive its benefit of the bargain. For more than 150 years, this Court has enforced the statutory enablement requirement according to its terms. If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark. Today’s case may involve a new technology, but the legal principle is the same. The judgment is Affirmed.
