Cumberland Pharma v. Mylan (Fed. Cir. 2017) [cumberland]
Cumberland’s Patent No. 8,399,445 is listed in the Orange Book as covering Acetadote, an intravenous antidote for overdoses of acetaminophen. Following the process set out in the Hatch-Waxman Act, Generic manufacturer Mylan filed an abbreviated new drug application (ANDA) with the FDA to market its own version of the drug and Cumberland sued for infringement. While patent infringement ordinarily requires some making/using/selling of the invention, 35 U.S.C. 271(e)(2)(A) creates a form of paper-infringement – stating that “It shall be an act of infringement to submit (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent.”
The ‘445 patent (August 24, 2005 priority date) covers a non-chelating form of Acetadote. Back in 2002, Cumberland was seeking FDA approval of a form of the drug that included a chelating agent (EDTA). In a letter, to the listed inventor (Pavliv) of the ‘445 patent, the FDA requested justification for including EDTA in the formulation and later requested data proving that EDTA should be included. Shortly after that letter, the inventor Pavliv had the idea of a formulation without the EDTA.
Based upon these (and a few other) facts, Mylan argues that (1) the ’patent had been derived from someone at the FDA – and therefore the patentee was not the “inventor” as required by pre-AIA law, 35 U.S.C. 102(f); and (2) the invention would have been obvious in light of the FDA communications. On appeal, however, the Federal Circuit affirmed the lower court holding siding wholly with the patentee.
A request for justification of the inclusion of EDTA, supported by data, is not the same as a suggestion to remove it, let alone to remove it and not replace it with another chelating agent.
Further, the claim was not obvious because the defendant failed to prove “a reasonable expectation of success” if the non-EDTA version was tried. That seems to be right here (based upon the evidence presented). The inventor previously believed that EDTA (or similar agent) was needed to ensure formulation stability, but later was able to show that the non-EDTA version was still stable (and the claims expressly reflect that the formulation is stable but non-EDTA). On appeal, the Federal Circuit agreed with the patentee:
Considerable evidence supports the finding that relevant skilled artisans believed that chelating agents were necessary to sequester metal contaminants and prevent oxidative degradation of acetylcysteine and that such artisans had no reasonable expectation of stability without such an agent. . . . As late as 2011, Mylan’s own scientists expressed concern that the removal of EDTA would make the product more vulnerable to oxidation.
Judgment of Not-Invalid Affirmed.
New method for attempting to make metallic hydrogen succeeds and enables metallic hydrogen.
Question for you guys: Is the metallic hydrogen itself eligible for patenting?
6,
80 years ago, metallic hydrogen was predicted to form under extreme pressure (about half what they used), so it was obvious to try. But, leaving aside a reasonable expectation of success, could one then have received a “paper” patent on metallic hydrogen, as a composition of mater? Since it had never existed on Earth and would have been entirely artificial, I think the answer is yes.
It seems to me that metallic hydrogen should be as §101-eligible as elemental Americium, and that was patentable, even as against a §101 rejection. In theory it could exist naturally somewhere else in the universe, but it lies for the proponent of invalidity to prove as much, and good luck finding the evidence to back up that assertion, given that argument by possibility or probability is legally insufficient.
…and yet, I have provided two examples back in December of such a “good luck proving that” actually DID present themselves in nature.
The question would be, what then of a prior granted patent…?
(it’s an easy question, but hey, it’s Friday)
6, Eligible? Yes. Patentable? Probably not under 103.
“Probably not under 103.”
Why so? Prior to this it was not enabled.
Troubled, when one creates a composition, one is eligible to receive a patent on that composition. If the composition is known, but no one knows how to make it, the patentee may not receive a patent on the composition, but on the method of making it.
The hypothetical was 80 years ago before the prediction, viz. “could one then.” Does that change your view?
Lol / so the reminder to you of this point did sink in.
“If the composition is known, but no one knows how to make it, the patentee may not receive a patent on the composition, but on the method of making it.”
I have never heard of that. And further, it does seem rather odd to me if they’re the first to enable making it.
Under the AIA, my understanding is that an Examiner could make a rejection under 101 (whoever invents … may obtain a patent) based on a disclosure by a third party to a named “inventor”. This would be similar to an old 120(f) rejection.
A few thoughts about the idea of the “last inventorship case”:
(1) Remember, there is a crackpot theory out there that because the AIA did not include a severability clause, that if even one line of the AIA is ever held unconstitutional, then the whole act gets repealed in a giant whoosh of return to the immediately pre-AIA act. This seems distantly unlikely to me, but given that Pres. Trump will have a chance to name at least one and possibly more than one SCotUS justice, one cannot rule out the absurd.
(2) Even in the much more likely scenario that the AIA remains firmly in place, an inventorship challenge is called a “derivation” proceeding (Cumberland, slip op. at pgs. 7 & 8). The AIA definitely makes allowance for derivations, just not under 102(f). In other words, this is not the last invetorship case. At most it is the last 102(f) case.
(3) There are a lot of pre-AIA patents still out there, and many have a lot of patent term yet to run. I realize that 102(f) is a rare ground to assert, but I would still bet on another such case arising before the pre-AIA patents are all expired.
Lol on your “crackpot theory” Greg.
Derivation is only one possible flavor of an inventorship challenge (the set sizes for derivation and for inventorship challenges are not equal).
Greg, See post 1.
In the Madstad case, Kappos and the government argued that 101 alone provided the statutory basis for a requirement that the named inventor to have invented the subject matter of the patent.
Sure. I do not disagree. My only point is that challenges under 102(f) are called “derivations.” “Derivations” will continue under the AIA, even if they are now statutorily grounded in section 102(b)(1)(B) instead of 102(f). Therefore, this is hardly the last “inventorship case” (unless every application from here on out is filed by omniscient and morally incorruptible lawyers who never get inventorship wrong).
And Greg, we also have correction of inventorship statutes that provides that a patent is not invalid if inventorship can be corrected.
The CAFC: A request for justification of the inclusion of EDTA, supported by data, is not the same as a suggestion to remove it,
In the context of an obviousness determination, an FDA request for justification of a widely-used additive with well-known properties and functionality is pretty great evidence that the FDA, at least, didn’t believe that the additive was strictly necessary. If you can leave the additive out, you make the manufacturing easier and cheaper. There’s your motivation. Done.
The FDA approved the EDTA-containing product on January with the approval letter reminding Cumberland of its commitment to “evaluate the potential benefit of Edetate disodium on the stability of the drug product,” the study to “include a comparison of the current concentration of Edetate to a formulation with a lower concentration and no concentration of Edetate.”
The CAFC’s “finding” that this evidence somehow falls short of a suggestion to make a formulation without a chelator and test it is absolutely ridiculous. And that’s not even considering the fact that it wasn’t until it received this suggestion that the patentee contemplated a formulation without a chelator.
What. The. Heck.
I guess the reasoning is that the inventor Pavliv was acting on a mental-plane well above that of PHOSITA. Although the FDA’s suggestion triggered the gears in his mind, it would have blown right past an ordinary artisan. Further, according to the statute, the actual process of invention in this case is not relevant to whether the the patent is obvious. 35 U.S.C. § 103 (“Patentability shall not be negated by the manner in which the invention was made.”)
Dennis, I think this is covered by “obvious to try.”
Ned,
I think this case is saying that one does not get to 103 until a complete invention is made. 102(f) is pesky and was not made part of 103 analysis until ODDZON PRODUCTS, INC. v. JUST TOYS, INC., 122 F.3d 1396 (1997): “we hold that a fair reading of § 103, as amended in 1984, leads to the conclusion that § 102(f) is a prior art provision for purposes of § 103.” “Section 102(f) provides that a person shall be entitled to a patent unless ‘he did not himself invent the subject matter sought to be patented.'”
In 1984, 103 was amended to excluded 102(f) and 103(g) secret prior art if the second invention was owned by (or there was an obligation to assign) the same person as the first invention at the time the second invention was made.
102(f) was pesky because an inventor talking to third parties was at risk unless there was a common assignment before the third party made helpful suggestions. For instance, suggestions from patent agents could be unpatentable in view of the client’s invention. Moreover, the client’s improvement on that could be unpatentable.
102(f) RIP.
Prior to the invention, the FDA asked that the inventor to “Commit to evaluate the potential benefit of Edetate
disodium on the stability of the drug product.
The study shall include a comparison of the current
concentration of Edetate to a formulation
with a lower concentration and no concentration
of Edetate. Generate stability data from the new
proposed formulations including compatibility
stability with infusion bags.”
It seems to me that the drug product without Edetate simply had to be tried. Once it was tried, it worked.
It is true that the majority of the case looked to whether the FDA had actually “conceived” of the compound without Edetate. However, it is quite clear that source of the suggestion that Edetate not to be included in the final product came from the FDA. Once the request to justify was made, it was obvious to try the formulation without Edetate.
All in all, a bunch of incredible nonsense from the Federal Circuit.
‘Obvious to try’ only works where the person of ordinary skill has a reasonable expectation of success. Leo Pharma. v. Rea, 726 F.3d 1346, 1357 (Fed. Cir. 2013). As late as 2011, Mylan’s own scientists doubted that they could make a product stable enough that the FDA would approve it without a chelator. Cumberland slip op. at 17. That is about as clear evidence of a lack of a reasonable expectation of success as I can imagine.
‘Obvious to try’ only works where the person of ordinary skill has a reasonable expectation of success. Leo Pharma. v. Rea, 726 F.3d 1346, 1357 (Fed. Cir. 2013).
So the FDA’s request was unreasonable?
Mylan’s own scientists doubted that they could make a product stable enough that the FDA would approve it without a chelator.
And this where the case goes off the rails, I think. “Stable enough that the FDA would approve it without a chelator” is not the limitation recited in the claim. What’s in the claim is “stable.”
Mylan definitely could have made a “stable” formulation without EDTA. As I wrote above (and as Mylan argued) the way to do that is with careful packaging and storage (and removal of as much trace metal as possible). The reason they didn’t is that EDTA works and it’s not expensive and the FDA has approved tons of formulations with EDTA. So why bother? The answer to that question, however, was answered by the FDA’s message to the patentee: we want you to justify this because we have a reasonable belief that EDTA might not be necessary.
What’s missing from this decision — and maybe it’s in the patent — is a description of the evidence that this compound is *just as stable* without EDTA as it is with EDTA. Personally I find that difficult to believe if the claim is otherwise open-ended. It’s not like this compound somehow prevents EDTA from doing what it’s supposed to be doing.
the reasoning is that the inventor Pavliv was acting on a mental-plane well above that of PHOSITA.
This would seem to be a classic example (but definitely not the first one) of hindsight bias working in the patentee’s favor.
What evidence is there that “Pavliv was acting on mental plane well above that of PHOSITA” when he did exactly what the FDA told him to do? Is there evidence that ordinary PHOSITA’s routinely tell the FDA “No, we’re not going to bother doing that because everybody knows that EDTA is necessary?” Aren’t the FDA reviewers “ordinary skilled artisans” in this area (e.g., the field of drug stabilization)? I would hope so …
Right up until the moment when Pavliv does what the FDA asks him to do, Pavliv is perfectly ordinary. He uses the world’s most widely used drug chelator in his formulation as a stabilizer. Then Pavliv does what the Federal agency’s skilled artisan tells him to do and suddenly … he’s on some higher mental plane? Please.
the actual process of invention in this case is not relevant to whether the the patent is obvious. 35 U.S.C. § 103 (“Patentability shall not be negated by the manner in which the invention was made.”)
Whatever that passage means, it can’t possible mean that you can’t “negate” patentability by looking at what motivated the artisan to make the change. At least, it can’t mean that without chucking pretty much all of 103 jurisprudence to date.
It depends on how you go about finding that motivation.
Present example aside (i.e., a pure law discussion), hindsight cannot provide the motivation because then EVERY successful innovation would be removed from the patent sphere.
MM bro a liberal made a vid plea to ya.
link to youtube.com
This case was wrongly decided.
EDTA and other chelating agents are everywhere.
So are formulations without EDTA and other chelating agents.
Absent some bona fide teaching away that a formulation without EDTA couldn’t be stabilized (not just “we think it’s unlikely”), it’s pretty silly to be handing out patents on otherwise identical EDTA-free formulations merely because “it’s still stable”.
The FDA request for evidence supporting the need for EDTA plainly cuts away — and cuts away hard — from any such “teaching away” argument in the art. As the defendant correctly points out, the FDA provided the motivation to remove the EDTA.
Maybe Greg can tell everyone: what is the precedential holding here and why is that precedent necessary or positive for the system generally? I’m genuinely curious, especially given the palpable wrongness of the decision.
MM, EDTA and other chelating agents are everywhere. So are formulations without EDTA and other chelating agents.
Is that evidence before the court?
But I agree with you, once the agency said prove the necessity of EDTA, there was strong motivation try the formulation without EDTA. If that worked, is that invention? I think not.
It seems rather odd that the court would require a traditional test for nonobviousness (lack of expectation of success) in this circumstance. That to me is the height of … – need I complete the sentence?
EDTA and other chelating agents are everywhere. So are formulations without EDTA and other chelating agents.
Is that evidence before the court?
I have to assume so as both parties and the FDA were certainly aware of it.
To me, this is the exact kind of pharma patent decision that benefits literally nobody except the patent holder and the attorneys.
[O]nce the agency said prove the necessity of EDTA, there was strong motivation try the formulation without EDTA. If that worked, is that invention? I think not.
Let us be clear what was suggested and what was claimed. The agency suggested testing a formulation without EDTA. The patentee claimed a formulation without a chelator>. In other words, the FDA was suggesting that they try replacing EDTA with a different chelator. The FDA did not suggest that one could, by altering other parameters, dispense with chelators altogether. No one at the time believed that it was possible to omit chelators altogether (as claimed). Even the defendant’s own scientists did not believe that this would work at first, even after Cumberland’s patent had published with data showing it.
It seems rather odd that the court would require a… lack of expectation of success… in this circumstance.
Why should the legal test applied change according to the circumstances of the invention. The law is not one thing for one applicant and another thing for another applicant. The essence of a system of laws is that we apply the same rules and standards to each party who appears before the court.
In other words, the FDA was suggesting that they try replacing EDTA with a different chelator.
The FDA said to compare a formulation with “the current concentration of Edetate to a formulation with a lower concentration and no concentration of Edetate.”
There’s nothing there that says “use a different chelator.”
EDTA is a very popular and extensively studied chelator. The above choice of language seems very odd, to say the least, if the FDA wanted the applicant to substitute EDTA with a different chelator.
The other major problem with the court’s analysis is that “stability” is a relative term that depends on a whole lot of other factors.
If someone had asked me to make a “stable” formulation of Acetadote without EDTA, my first questions would be “what do you mean by ‘stable’ ” and “what are my storage options”?
If the answer is “whatever works”, then I’m putting the compound in an oxygen free, metal free environment at freezing temperatures. There: stable. Also: not inventive.
This is an interesting case. It is also a precedential decision. The other two decisions issued today (Schweichert and Securus Tech.) are also interesting cases that deal with relevant issues, but they are both designated non-precedential. Why? It really is a scandal that on most days, there are more non-precedential decisions delivered than there are precedents delivered. This is not how a common-law system is supposed to work.
Greg, consider yourself a member of the Federal Circuit and you see a decision circulated for consideration as to whether it should become precedential. You believe that the result might be right but you disagree with the reasoning. How do you vote?
I think that the idea of considering whether it should be precedential is strange and silly. All written decisions should precedential by default. It should require an affirmative decision to make it otherwise. I would like to see the rule be that the whole CAFC, not just the panel, has to agree to make it non-precedential.
Non-precedential decisions by circuit courts of appeal should be rare events, not the ordinary course of business. If you look at the CADC, for example, you will see that almost all of their opinions are precedential. That is how it should be.
Dennis, I have come to believe that 101 is sufficient to deny a patent to one who claims to have invented something when he has not. The source of my authority here are cases like Myriad which effectively held that patents are awarded to those who create something “new,” not to those who discover that which already exists, such as a product of nature or the invention of another, albeit such product of nature or invention of another are not otherwise prior art – publicly known etc.
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