IP Tech Knowledgy

The Supreme Court held that under U.S. patent law, it remains a requirement that for a patent to be awarded, the disclosure must enable others in the field to understand how to practice the patented invention. In reaffirming the “enablement requirement” in a unanimous opinion, Amgen v. Sanofi reaffirmed that it is part of the patent “bargain” that a patent application must include enough detail for others to understand how to practice the invention being patented.

The case addressed Amgen’s attempt to patent an entire genus of antibodies useful in reducing levels of low-density lipoprotein, which is associated with cardiovascular disease, heart attacks and strokes. Initially, Amgen received patents for antibodies having specific amino acid sequences. Later, Amgen obtained patents covering a broader genus of antibodies that bound to the same biological receptor without disclosing specific amino acid sequences. Amgen sued Sanofi for infringement, and Sanofi in turn argued that the later patent filings did not include enough detail for a scientist working in the field to understand how to produce the antibodies, and were therefore not valid patents.

In Amgen’s case, the earlier-filed patents disclosed the antibody sequences necessary to recreate them, but the later-filed applications did not, and thus did not enable scientists in the field to reproduce them, which is a requirement under U.S. patent law. The Court ruled that all the patents needed enabling descriptions.

This is something for inventors and companies interested in obtaining patents to keep in mind, and it sometimes goes overlooked. There can be reluctance to make such a full disclosure that would enable competitors to copy inventions when patent applications become public. However, full disclosure is required, as the Supreme Court noted in this case. Without full disclosure, the patents do not enable others to understand how to practice the invention patented. The expectation of the public is that once a patent expires, others should understand how to practice the patented invention and be free to do so.

If inventors or companies are not prepared to provide enabling language, for fear of copies once the patents expire, they should consider whether a better option might be to maintain their competitive advantage by treating the inventions as trade secrets, and not disclose them at all.

The Amgen decision reassures drug and biologics companies operating independently and utilizing different platforms that they can continue to pursue developments that may compete with existing patented therapies if they are not directly infringing on the patent rights of others. The Court held that those rights should be clearly defined to carry out this purpose.

The Constitution understood the importance of laws that “promote the progress of science and useful arts, by securing for limited times to … inventors the exclusive right to their respective … discoveries.” The modern application is that there should exist room for development by competing companies of therapies that treat diseases that burden our healthcare system. This decision supports that notion.

S. Scott Lloyd
410-576-4249 • slloyd@gfrlaw.com