By David Hricik, Mercer University School of Law. (Note – this is an update of the essay posted last week on the Patent Ethics site.)
I forget when I first thought about this, but it's been a while. With all the discussion of Prometheus (sadly, the case, not the film, which was great), I figured this was a good time to raise it. At minimum, there's a litigable question here, and assumptions that a patent issued on non-patentable subject matter is invalid need examination. I'd love to be wrong about this, but I don't think I am.
I have not scorched the earth, but from what I can tell no court has squarely addressed the question of whether the Patent Act allows a court to deny enforcement (on any ground) of a patent granted on subject matter that is not within Section 101. Instead, what the cases showed me was that law developed in the context of challenges to the USPTO's denial of a patent have been used to invalidate issued patents – without analyzing the statutory authority to do so.
Let's take a look at what most people assume is the law and see if we can get there: does the Patent Act allow a court to invalidate a patent that does not claim patentable subject matter?
The starting point is 35 USC 282. It provides in pertinent part:
The following shall be defenses in any action involving the validity or infringement of a patent and shall be pleaded:
(1) Noninfringement, absence of liability for infringement, or unenforceability,
(2) Invalidity of the patent or any claim in suit on any ground specified in part II of this title as a condition for patentability,
(3) Invalidity of the patent or any claim in suit for failure to comply with any requirement of sections 112 or 251 of this title,
(4) Any other fact or act made a defense by this title.
Federico's commentary, often relied on to indicate Congressional intent, doesn't help at all, but here it is:
The defenses which may be raised in an action involving the validity or infringement of a patent are specified in general terms, by the second paragraph of section 282, in five numbered items. Item 1 specifies "Noninfringement, absence of liability for infringement, or unenforceability" (the last word was added by amendment in the Senate for greater clarity); this would include the defenses such as that the patented invention has not been made, used or sold by the defendant; license; and equitable defenses such as laches, estoppel and unclean hands. The second item specifies "Invalidity of the patent or any claim in suit on any ground specified in Part II of this title as a condition for patentability"; this would include most of the usual defenses such as lack of novelty, prior publication, prior public use, lack of invention. The third item specifies "Invalidity of the patent or any claim in suit for failure to comply with any requirement of section 112 or 251 of this title"; the first section mentioned would include the defense of insufficient disclosure, and the second sentence mentioned would include reissue defenses. The fourth item merely specifies "Any other fact or act made a defense by this title." All the defenses usually listed in textbooks on patent law may be placed in one or another of the enumerated categories, except a few which are no longer applicable in view of changes in the new statute.
Section 101 is relied upon as the basis for invalidating patents. It states: "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title."
While clearly granting power to the USPTO to issue patents on "new and useful" processes, it obviously also limits the USPTO's power to do so.
The question here is not patentability, but validity. Simply, suppose the USPTO makes a mistake, and issues a patent on non-patentable subject matter. Is this a defense to infringement?
In my view, the answer is "no."
Let's start with the two specific subsections, because they make us focus on the text and show some very deliberate choices by Congress that easily could have gone the other way had Congress intended 101 to be a defense.
The second subsection of 282 is probably the most important: "Invalidity of the patent or any claim in suit on any ground specified in part II of this title as a condition for patentability."
Section 102 and 103 are "conditions of patentability." They say so in their titles, and they are substantive legal conditions (technically, I'd call them "conditions of unpatentability" given the burdens of proof, but this works). The fact that 101 is not a condition of patentability is to me is very important: Congress chose in 282(2) to specify that only those things denominated as "conditions of patentability" are bases for invalidity. It then chose to label 102 and 103 as conditions, but not 101. Those are deliberate choices. In my view, a patent issued on non-patentable subject matter is not "invalid" under the second provision.
Subsection 3 of Section 282 is easy to apply to this question, but it is important because it also adds to the evidence that 101 is not a defense. Patentable subject matter is in 101, not 251 or 112. So that part's easy: 282(3) doesn't list 101.
But the important point, again, is that Congress deliberately thought about what should be invalidity defenses, and what should not, and left out 101 not just as a "condition of patentability," but also in this specific paragraph, where it "caught" some strays. It left out 101. That says a lot.
Two down, two to go.
Now we're left with arguing that, although it thought about what should be invalidity defenses in two different places, nonetheless we should imply that Congress meant to include it in some amorphous language in the other two subsections. We're fighting uphill.
Let's go to the first catch-all type subsection: "Noninfringement, absence of liability for infringement, or unenforceability." Logically, I can't make patentable subject matter fit, at all. Before explaining why, let's be clear on the consequences of saying that Section 101 is within this section: it would be that the patent is valid but there would be no infringement.
"Unenforceability" is the easy one. The cases and legislative history I've read show this was designed to capture equitable doctrines like patent misuse and, arguably, inequitable conduct (long diversionary story there). We'd be straining to put 101 there.
Federico's statements that the defendant hadn't made the product, or had a license to do so, show that "infringement" means what we think it means. A licensed patent is valid, but "not infringed." A patent that the defendant never violated is valid, but not infringed. So, I can't make "noninfringement" logically work or work without giving words a very unnatural meaning.
Now the only arguable catch-all, subsection 4: "Any other fact or act made a defense by this title." Here we are, trying to read it into the catch-all that, even Federico says, "merely" specifies things in the statute that are made defenses. But, section 101 is not made a defense by this title. Instead, it specifically points to other requirements and conditions. Again, if this were easy and clear, Congress would have put in 101 "it shall be a defense to patent infringement that…" or put 101 in Section 282.
So, tell me why I am wrong.
Let me get rid of some easy ones: no court I've found has ever addressed this issue. I think it's pretty simple, but there you go. Second, don't conflate patentability with infringement defenses. There are lots of things that can affect patentability that aren't in 282. Third, 282 is exclusive: if you want so suggest that it's not, you (a) have to say "Congress enacted a specific statute laying out defenses, but it's just a guide" which is not in my view defensible; and (b) it says "shall be defenses," not "may include" or some-such. Third, this is a relatively new "defense." I can't say I've scorched the earth, but in looking at CAFC cases it has only been raised a few times.