A bullet dodged or the bomb-throwing Supreme Court declines to destroy the patent system… for once.
The Supreme Court does not take a patent case unless it can screw up the patent system and make things worse for inventors. That’s why Your Faithful Correspondent was alarmed when the Court accepted the case of Amgen v Sanofi, which opinion issued this month. To YFC’s shock and surprise, the Supreme Court acted like an appellate court (which it is) and not like a legislature (which it would like to be). The unanimous Supreme Court opinion reviews the facts and the precedent and AFFIRMS the decision of the Federal Circuit Court of Appeals. The Supreme Court actually complemented the Federal Circuit Court, saying how the lower court’s decision complied with the law and with earlier decisions.
That happens, like, NEVER. Usually the Supremes beat up the Federal Circuit and leave it for dead.
Why the judicial restraint? Could it be the intense scrutiny on the Court from all sides due to the Justice Thomas scandal, or the pushback (court packing, anyone?) due to the naked partisanship of the majority? …Hmm.
On to the decision, but first a little background:
The claims of a patent determine the scope of protection of an invention and the value of the patent. As we have pointed out before, a particular type of claim – the functional claim – is directed to a result to be achieved rather than to a specific apparatus or method to achieve that result. Functional claims are everywhere in patenting. Consider the following hypothetical claim element:
“… two or more table legs configured to support a table top above a floor.”
The legs are defined by what they do, not by their shape, material, length, or how they’re attached – it’s a functional claim. All claims, including functional claims, must meet the ‘enablement’ requirement; namely, the application must have enough information to teach a knowledgeable person how to make and use the invention ‘without undue experimentation.’ Our functional example claim prevents us from having to spell out every one of the ways for a table leg to support a table.
A related claim is the ‘genus’ claim; that is, a claim not to a single invention, but to an entire category of inventions. One way to define a ‘genus’ is to claim the common function that each of the members of the category accomplishes. That’s what Amgen did in this situation – it described an entire class of drugs by what the drugs did rather than by the structure of the drugs or how the drugs are made. The drugs in this case were artificial antibodies. There are literally millions of artificial antibodies that might or might not have the claimed function and hence fall under the scope of the claim. The only way to find out would be by trial and error – to synthesize each of the artificial antibodies and check for the function. The lower courts and the Supreme Court concluded that this claim required ‘undue experimentation’ and did not meet the enablement requirement. Of interest, the lower court applied the ‘Wands factors’ in determining whether the claims were enabled. The Supreme Court’s endorsement of the lower court decision was an implied endorsement of the Wands factors:
- Quantity of experimentation. The more experimentation needed, the more likely that the claim is not enabled.
- Amount of guidance in the application. The less guidance, the more likely the claim is not enabled.
- Working examples. The existence of working examples makes enablement more likely.
- State of the art. If the claimed invention is a leap forward in the art, the less likely that a claim is enabled. If an incremental change, the more likely that the claim is enabled.
- Breadth of the claims. If the claims are broad, the less likely that the claims are enabled. If the claims are narrow, the more likely the claims are enabled.
The Supreme Court could have worked all kinds of mischief, such as upending patent law by outlawing functional claims altogether. The Court did not do so. We can breathe a sigh of relief.
— Robert Yarbrough, Esq.