In a previous article published, we discussed the role of written description and how written description should be contextualized within the meaning of the Section 112(a) of the patent laws. [Click HERE:] There we wrote that the Supreme Court has steadfastly refused to take any case about whether Section 112(a) requires a “full” written description of the invention and if the invention is broadly claimed, should the specification include a full written description. In this article, we discuss the recent Supreme Court ruling involving the full scope of enablement in the patent specification. That is, the Supreme Court was asked to resolve that if the claim is very broad, must the specification have a correspondingly broad enablement? This article, as usual, concludes with some practical tips for both patentees and challengers.
Section 112(a) of the patent law describes various requirements of the patent specification:
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 which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Embedded in the statute are three requirements: a written description, the enablement, and the best mode. As with written description, the same conceptual questions about claim breadth and specification details exist concerning enablement. Said another way, if the claims are very broad and thus encompass lots of different ways to do what is claimed, does the specification need to recite every example of each different way? Or what if the claimed invention is to “any” (or as lawyers like to say, “any and all”) of doing something, does giving a few examples in the specification enable the broad claim? This question is important because patent attorneys, acting on behalf of the named inventors, draft broad claims that attempt to cover “any and all” ways of doing something even though the inventors didn’t invent all ways of doing it.
For a plain English example, suppose an inventor invented a doorknob that is made of a special combination of vibranium (a metal only mined in Wakanda) and adamantium (a metal developed in a secret lab at Alkali Lake). The special mixture of the metals makes this special doorknob. This doorknob resists all fingerprints, is never hot, never cold, never gets dull, always stay shiny, but more importantly, it functions super smoothly, the parts slide nicely, and never gets jammed. As such, this new doorknob can keep a door closed. Woe be upon the patent attorney that drafts a patent claim just to this super specific doorknob by claiming the special metals in the unique mixture ratios!
Rather this patent attorney may claim “any mechanism for keeping a door closed” in the patent. (Let’s ignore for the moment whether such as claim is unpatentable for other reasons.) The patent attorney only includes a detailed enablement of the vibranium + adamantium mixture and the way to melt these metals together and pour into a mold to make a doorknob. The alleged infringer, however, makes a ceramic doorknob with ceramic parts and pieces. It has all the attributes of the vibranium + admanatium doorknob, but is much cheaper, much more available in stores, and easier to install. Now assume that the ceramic doorknob is infringing a claim because after all, it is a “mechanism for keeping a door shut.” But the patented doorknob claim includes all mechanisms for for keeping the door shut. It could conceivably include any other type of doorknob, latches, chains & slides, bolts, Velcro straps, strings and hooks, etc. It may even cover a simple heavy brick propped up against the door. The specification didn’t laundry list any other example of mechanisms. Is this claim too broad because it functionally covers every type of mechanism that functionally keeps the door closed? [Again we ignore the unpatentability of the claim based on other reasons.] Is a claim invalid because it preempts every mechanism but only provides limited examples of the mechanisms? So, the tension is whether the full scope of the claim must have an equally valid enablement.
In Re Wands and Undue Experimentation in Enablement
And because of the tension, the Courts have been called in to help. The Court of Appeals for the Federal Circuit (CAFC) is often called the supreme court of patent law because the actual Supreme Court rarely takes patent cases and that the CAFC is the sole appellate court. The CAFC has slowly been moving the patent law to require more synchronicity between what is claimed and what is detailed in the specification. The CAFC has been using the so-called In Re Wands factors to determine if the specification is enabled for the claims. The Federal Circuit generally requires that the specification teach those in the art to make and use the invention without undue experimentation. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). And the devil is in the details of how much detail is needed in the specification and for omitted details, then is there undue experimentation needed to determine the full scope of enablement. And when lawyers see words like “undue” the litigation will often devolve into whether any experimentation is due or undue. 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. For a fuller discussion of enablement, see Chapter 9 of my book: Shashank Upadhye, Generic Pharmaceutical Patent and FDA Law (2022 Ed.)(available on Westlaw in GENPHARMA database or HERE:
Sanofi vs Amgen – Enablement of the Full Scope
The Sanofi vs. Amgen case concerned antibodies that bind to a protein. Briefly, the offending PCSK9 protein interacted with an LDL receptor, which interaction affected the LDL receptor’s ability to sweep up LDL from the blood. Scientists looked at blocking the PCSK9 protein itself so that the PCSK9 protein would not interfere with the LDL receptor. Amgen developed an antibody that bound to a segment of the PCSK9 that essentially gummed it up, and got FDA approval for its PCSK9-inhibitor drug called Repatha®. Sanofi developed another antibody drug called Praluent® that used a different mechanism to gum up the PCSK9 protein. Amgen had patents on its specific amino acid sequence for Repatha that gummed up the PCSK9 protein. But those specific amino acid sequence patents couldn’t be asserted against Sanofi because Sanofi’s Praluent® drug was different. But Amgen also got a patent on “the entire genus” of antibodies that: (1) bind to specific amino acid residues on the PCSK9 protein, and (2) block PCSK9 from binding to [LDL receptors]. In other words, it claimed any mechanism that gummed up the PCSK9 protein. Amgen’s patent taught 26 antibody sequences that could work on the PCSK9 protein itself. Amgen sued Sanofi. The Supreme Court ruling doesn’t talk about the underlying procedure. In jury trial #1, the jury found the patent valid and infringed. The Federal Circuit in appeal #1 reversed and remanded back to the trial court. In jury trial #2, the jury found the patent valid and infringed. But the trial judge entered a JMOL to overturn the jury verdict and thereby invalidated the patent based on enablement. The Federal Circuit appeal #2, the Federal Circuit affirmed the invalidity based on a lack of enablement. The CAFC’s decision recapped that a broad functional claim, like here, required sufficient enablement and recapped that under the Wands factors, there was undue experimentation in play. The CAFC’s decision did not delve too deeply into prior Supreme Court case law, and only discussed its own cases.
The Supreme Court affirmed 9-0 that the patent was invalid. See, 2023 WL 3511533. Whereas the CAFC’s decision was predicated on the In Re Wands case, other CAFC cases, and with no discussion of prior Supreme Court cases, the Supreme Court’s opinion only discussed its own Supreme Court decisions and didn’t touch In Re Wands at all. In effect, the Supreme Court leaves standing the body of case law on enablement as it has existed for 100+ years. And despite the typical parade of horrors trotted out by Amgen that the pharmaceutical industry will die out if the decision is not reversed, the Court didn’t touch this. As has been stated before, in the pharmaceutical patent field, appellants will often characterize the issue as life or death to the industry to curry favor with the Court. This Court didn’t bite.
The Court did drop a few nuggets for practitioners though. First, undoubtedly patentees will likely cite to this statement, “Despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody’s structure and function.” 2023 WL 3511533, at *4. We envision citation to this in rebutting arguments about obviousness and predictability of the art. But this statement from the Court is not a holding that antibody science is unpredictable and is just background dicta.
Second, in discussing prior Supreme Court cases, the Court reiterated that one cannot claim broadly but enable little. It was not enough to preempt nearly every way of doing something but disclosing only one or just a few ways of doing it. The Court reminded that the patentee needs to describe the various ways, and the commonalities between them. It stated:
If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. 2023 WL 3511533, at *4.
Third, the Court reminded that the enablement discussion is not a function of the time and effort needed to vet out different embodiments or all embodiments within the claim.
Finally, what the Court taketh in requiring full scope enablement, the Court giveth by not requiring that the specification describe each and every embodiment of the invention; that a sufficient recitation of representative species may be enough if the species have “some general quality … running through the class that gives it a peculiar fitness for the particular purpose”; and that a specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.
Be Careful What You Wish For – It May Come True
Here, Amgen candidly admitted that it wanted its patent to claim the entire universe of useable antibodies. But in being that greedy, the patent claim was invalid.
There are other areas in which grabbing for more may result in the invalidity. For example, often times in claim construction a patentee will seek a broad claim construction to ensnare the infringement. But the claim breadth may now implicate invalidity based on classic prior art and for Section 112 issues.
Practical Considerations
Section 112(a) requires, as affirmed by the Supreme Court, a synchronicity between the full scope of the claim and the claim breadth. And whether the Supreme Court’s affirmance of the Federal Circuit’s enablement law implicates a policy battle between patents, innovation, and competition is a function for Congress to decide.
Because the Court’s ruling affirmed the Federal Circuit’s existing precedent on enablement, patentees may continue to act in the manner they have been. Obviously the pharmaceutical industry has continued to innovate over the decades. But patentees should consider the implications of the Court’s ruling. First, we recommend that pharmaceutical companies continue to obtain narrower claims. Yes, one can and should consider broad independent claims. But narrower, dependent claims may survive invalidity challenges. And narrower claims need not go directly from the very broad functional to the ridiculously narrow claim. Rather, patentees should strive for differing scopes of sub-genus claims. And while patentees will need to pay for additional but narrower claims, that is a relatively marginal price to pay.
Further, while it may sound cheeky to suggest, nothing stops the pioneer pharmaceutical company from doing the additional R&D needed to develop the alternative embodiments. For example, Amgen could have continued to research and develop the very embodiments that Sanofi discovered as Praluent®. In other words, nothing stops the original pioneer from continuing R&D to find other embodiments, even if the originator has developed its first drug.
Patentees can still avail themselves of the doctrine of equivalents, if applicable. For example, Amgen’s problem was that it discovered little but claimed a lot. Here Amgen could have relied on narrower but enabled claims and argued that infringement existed under the DOE versus direct literal infringement.
We may see the USPTO examiners clamp down on broad functional claims, by arguing that the enablement just isn’t there and/or that undue experimentation exists. Because patent applications are very case specific, in the right circumstances, applicants may choose to file Rule 132 affidavits from experts that help rebut the outstanding rejection. Now while Rule 132 affidavits come with their own potential problems, those problems may not erupt until later after patent issuance and later litigation. For the sake of obtaining the patent issuance in the first place, a Rule 132 affidavit may be helpful.
Finally, patentees can consider reexamination and reissue proceedings to obtain narrower claims to different species or narrower sub-genus claims. Even if the two-year period post issuance has passed, a narrowing reissue is available.
For challengers, the Court’s ruling was rather undramatic. It leaves open typical enablement challenges. A challenger can continue arguing that the amount of experimentation is undue and use expert testimony to prove it.
Another area to explore is whether inoperative embodiments impact claim validity. Normally, the existence of some inoperative embodiments is not a per se grounds for enablement invalidity. But if the challenger can show that the full scope of the claims includes inoperative embodiments, there may be an argument. This is because when the number of inoperative embodiments is large, they tend to obscure the invention versus distinctly point out the invention (see e.g., Crown Operations Intern., Ltd. v. Solutia Inc., 289 F.3d 1367, 1380 (Fed. Cir. 2002)) or they lend credence to the undue experimentation argument. But there is no numerical threshold as to when the number of inoperative embodiments becomes enough.
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About Upadhye Tang LLP
Upadhye Tang LLP is an IP and FDA boutique firm concentrating on the pharmaceutical, life sciences, and medical device spaces. We help clients with navigating the legal landscape by helping on counseling and litigation. Clients call us to help move drug and device approvals along and to represent them in IP and commercial litigation. Call Shashank Upadhye, 312-327-3326, or by email: shashank@ipfdalaw.com, for more information. Read more about our firm at www.ipfdalaw.com.
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