By Chris Holman
Sun Pharmaceutical v. Incyte, 2023 WL 5370639, Not Reported in Fed. Rptr. (Fed. Cir. Aug. 22, 2023)
Bald Girls Do Lunch (“BDGL”) is a nonprofit organization dedicated to improving the quality of life for females living with alopecia areata (“AA”). AA has been described as “an autoimmune skin disease resulting in partial to complete hair loss on all hair-bearing areas of the body, including, for example, on the face, resulting in loss of eyebrows and eyelashes.” According to BDGL, “AA is not a simple cosmetic problem—it is a chronic, often devastating condition that has substantial and wideranging implications, affecting patient’s physical, mental, and emotional health. Indeed, in severe cases, AA can lead to chronic depression.”
On August 22, the Federal Circuit issued a nonprecedential opinion in the case of Sun Pharmaceutical v. Incyte affirming an IPR decision that struck down as obvious all the claims in a patent directed towards a promising new treatment option for AA. The patent is directed towards certain deuterated derivatives of ruxolitinib. Ruxolitinib is a JAK1/JAK2 inhibitor “currently approved for the treatment of patients with intermediate or high-risk myelofibrosis.” Deuteration involves replacing one or more hydrogen atoms of a drug with deuterium, an isotope of hydrogen, to slow the CYP-mediated metabolism of a drug or to reduce the formation of undesirable metabolites, which can result in improved safety, tolerability, or efficacy. The claims encompass an octo-deuterated ruxolitinib analog identified as “CTP-543,” a potential treatment for AA that has been granted “Fast Track” and “Breakthrough Therapy” designations, which means that FDA will expedite its review as a new drug.
BDGL filed an amicus curiae brief in support of the patent owner, Sun Pharmaceutical, which focuses on one specific aspect of the Patent Trial and Appeal Board’s decision, i.e., the Board’s evaluation of one of the objective indicia of nonobviousness, “long-felt but unsolved need.” The Board found that while CTP-543 has the “potential” and “likelihood” of satisfying the need for an effective treatment for AA, as of now it has not actually satisfied the need for an FDA-approved treatment for AA, because it has yet to receive FDA marketing approval.
In its brief, BDGL argues that in 2012, at the time of the patent’s effective filing date, there was a long-felt, unmet need for a new treatment option for AA. No FDA-approved AA treatment existed, and off-label treatments were ineffective or not tolerable long-term, or both, and many caused unwanted side effects, ranging from unpleasant or undesirable to potentially serious. BDGL argues in its brief that the proper time for assessing the presence of a long-felt, unmet need is at the time of patent filing, and that the determination of whether that need has been satisfied should be based on the treatment as claimed in the as-filed patent application, not upon a marketed product embodying the patented invention. The organization points to the FDA’s decision to grant CTP-543 expedited review status as evidence of the long-felt, unmet need for treatment for AA patients, as well as positive results in completed Phase 3 clinical trials.
BDGL’s brief concludes by warning that the Board’s approach “threatens to upend the well-established obviousness analysis – solely with respect to patents on technology that requires premarket regulatory approval such as pharmaceutical patents – and threatens to impede the development of innovative pharmaceutical treatment necessary to care for patients, particularly for patients suffering from conditions for which no treatment otherwise exists.”
A unanimous panel of the Federal Circuit was not persuaded, however, upholding the Board’s determination with respect to objective indicia as well as its ultimate conclusion that all of the claims were obvious. The Federal Circuit explained:
Assuming, without deciding, that the need for an effective and safe alopecia areata treatment existed, the Board had substantial evidence for its finding that CTP-543 had not actually satisfied this long-felt need, but only had the “potential” and “likelihood” to do so. While we agree with Sun (and amicus Bald Girls Do Lunch) that FDA approval is not a prerequisite to showing that a long-felt need has been met, and FDA’s designation of CTP-543 for “Breakthrough Therapy” and “Fast-Track” approval are probative of nonobviousness, here Sun expressly framed its objective indicia argument as “CTP-543 satisfies the long-felt need for an FDA-approved, evidence-based alopecia areata treatment,” (emphasis added), and the Board reasonably found that CTP-543 had not met this need because it lacked FDA approval. Thus, substantial evidence supports the Board’s conclusion that Sun did not prove that CTP-543 has satisfied this long-felt need.
Note the emphasis that the Federal Circuit places on Sun Pharmaceutical’s decision to frame the issue on appeal as whether CTP-543 had satisfied the need for an “FDA-approved” AA treatment, seeming to suggest that the outcome might have been different if Sun Pharmaceutical had simply argued that the drug had satisfied the need for a new treatment option for AA, without any explicit mention of FDA approval. In a footnote, the court specifically notes that “evidence provided by the amicus, Bald Girls Do Lunch, but not otherwise in the record cannot be considered on appeal.”
Sun Pharmaceutical v. Incyte raises the question of whether deuterated analogs of prior art compounds will generally be found obvious. I suspect that the answer is no, and as is the case with claims directed towards enantiomers, the determination will be fact-dependent and made on a case-by-case basis. In this particular case, the Board found that the prior art references of record (which included a marketing publication issued by Concert Pharmaceuticals, the original owner of the patent) disclosed (1) that ruxolitinib is a promising drug candidate; (2) that deuteration of compounds provides the potential for improved safety, better tolerability, and enhanced efficacy; and (3) the specific locations of certain metabolic “hotspots” on ruxolitinib, which are the sites on a compound were oxidative metabolism occurs during in vivo metabolism. These “hotspots” correspond to the locations where the compounds claimed in the patent are deuterated.
I can imagine scenarios in which a deuterated analog of a prior art compound might be deemed nonobvious. For example, if the prior art did not provide sufficient motivation to deuterate the particular compound at issue, or did not identify specific metabolic “hotspots” as likely locations for deuteration. Or in some cases a court might find that there was not a reasonable likelihood of success in creating or using a particular deuterated compound.
Fortunately, this was a nonprecedential decision. Given the length of time that generally elapses between the filing and issuance of a patent and FDA approval of the corresponding patented compound, a determination of obviousness will often occur prior to FDA marketing approval. Would the outcome in this case have been different if FDA had approved CTP-543 during the intervening time between the Board decision and the Federal Circuit’s decision? If the FDA does eventually approve CTP-543, will Sun Pharmaceuticals have any avenue to revisit the issue in the courts or the PTO?
In the amicus brief, “Bald Girls Do Lunch” is abbreviated “BGDL’, not “BDGL”.
“The Board found that while CTP-543 has the “potential” and “likelihood” of satisfying the need for an effective treatment for AA, as of now it has not actually satisfied the need for an FDA-approved treatment for AA, because it has yet to receive FDA marketing approval.”
Hughes, Linn and Stark: [derogatory term that the filter won’t let through]. There is no other word for it. You can never, ever wait until you’ve gotten FDA approval to file your patent application, and for that reason the CAFC has never (until now) required FDA approval to show non-obviousness.
No wonder they want Newman out: she’d have made mincemeat of these clowns.
If this is the state of patent law in the US, the future looks very, very dim.
Having prosecuted many deuterated drug claims, I can say from experience that these are a hard lift. The drug itself is usually already prior art, and deuteration is a known technique to improve the pharmacokinetics. You are, in other words, using a known technique to alter a known compound to achieve an expected improvement. Unless there is some really “wow” unexpected additional result, the obviousness rejection practically writes itself.
I do not blame Sun for arguing long-felt-but-unmet need as a pitch for nonobviousness. You have to argue something. Still, when you argue “unmet need” as your pitch for patentability, part of your case is that you have met the need. The need, at this point, has not been met.
I agree with Old Curmudgeon down below that it looks a bit like bad luck for Sun here. If the FDA had moved faster or if the IPR had been brought later, the outcome might have been different. But if my grandmother had wheels, she would have rolled.
On this record, I am not sure that the Fed. Cir. got this one wrong. I am not convinced that Judge Newman would have seen this any differently than her colleagues did here.
St. John: “ You are, in other words, using a known technique to alter a known compound to achieve an expected improvement. Unless there is some really “wow” unexpected additional result, the obviousness rejection practically writes itself.”
My thoughts exactly. This is always a tough row to hoe.
Sure on current precedent…but the more fair/logical way to handle these, err, “Schrödinger’s facts,” is to construe them in the light most favorable to the defendant (i.e., the accused in an infringment action, the patentee in an IPA). After all, they voluntarily choose the timing of the lawsuit.
Now, does this mean IPA plaintiffs might have have a bit of pause* before filing their lawsuit pre-FDA decision? Sure. But that’s probably a good thing. If the FDA doesn’t approve the drug, then nobody is likely to care about the patent in the first place #JudicialEconomy.
*one secondary factor isn’t outcome-determinent in most cases, but I’ll admit it would be a consideration.
“The Board found that while CTP-543 has the “potential” and “likelihood” of satisfying the need for an effective treatment for AA, as of now it has not actually satisfied the need for an FDA-approved treatment for AA, because it has yet to receive FDA marketing approval.”
Hughes, Linn and Stark: idiots. There is no other word for it. You can never, ever wait until you’ve gotten FDA approval to file your patent application, and for that reason the CAFC has never (until now) required FDA approval to show non-obviousness.
No wonder they want Newman out: she’d have made mincemeat of these clowns.
If this is the state of patent law in the US, the future looks very, very dim.
Fantastic to see a patient group advocating for new treatments rather than just discounts on old treatments.
This is a simple one – along a different patent metric:
At the time of filing, they simply cannot say that they possess the utility of the (putative – as this may change when I see the) claim.
THAT is something that must be there at time of filing.
As to, “Fortunately, this was a nonprecedential decision., not certain what the point being asserted is, as “nonprecedential” typically (and only) that the panel did not feel that this changed the law (i.e., nothing new here, move along)
Strange idea. Written description and enablement are as the of the time of the filing. But utility? Either something has utility or it doesn’t. Whether or not one is allowed to market the invention because of regulatory issues is (or should be) irrelevant in the utility analysis.
We’ve been over this: the utility (claimed) MUST meet that standard (as any PHOSITA could attest).
You want a lower level of utility in your claim?
No problem – you are the master of how you claim.
You want the Pharma Big Bucks? Well, that’s quite a different story now, isn’t it?
And yes – possession of utility is necessary at time of filing (research projects simply do not qualify).
Written description and enablement are as the of the time of the filing. But utility? Either something has utility or it doesn’t.
Indeed, it is hard to know what “at the time of filing” might mean with regard to utility. As you say, if the drug described in the application has utility, then it “has utility at the time of filing,” regardless of whether the tests that prove that utility are done by the time of filing. The invention must have utility, but there has never been a requirement that the utility be proven.
Of course, if the invention does not have utility at the time of filing, then it will never have utility any other time. If the drug genuinely does not work today, it is not going to work any better tomorrow, nor the next day. Therefore, if one fails to describe an invention with bona fide utility, then your claims should fail.
But, of course, at the point where you have filed an application that does not describe an invention that possesses utility, the lack of utility is almost superfluous. The claims will fail on written description grounds in any event, which is almost always going to be easier to prove than would a utility challenge. Why would the challenger want to make it harder on themselves by going after the utility challenge, when a perfectly simple written description challenge is sitting right there?
I expect nothing less than “Big Pharma” shilling of patent narratives from Greg, and this one:
“Indeed, it is hard to know what “at the time of filing” might mean with regard to utility.”
falls right in place.
Possessing utility at time of filing is very easy to understand.
If you want to claim an item that (as PHOSITA would recognize as passing FDA), then you must possess that utility at the time of filing.
Patents are not research projects. Greg should be well aware of cases that reinforce the notion that one is not allowed to file on a substance merely with some hope that a few years later it MAY have a desired utility.
“Utility” is a low bar. While a drug at the time of filing may not yet have proven utility as a drug, it likely has utility in modulating some pathway in a cell or in a rodent.
Utility is supposed to be a low bar.
On that, we would likely agree.
But the Court’s we@ap0niz@t10n of 35 USC 101 has changed that.
Further, and not withstanding any such change (as I have repeatedly pointed out), the patentee, as master of the claims, can easily choose claim language of a different scope from that which is sought the passing of the (PHOSITA) standard of FDA approved Pharma world (where the Big Bucks reside).
You want that level of utility protected by your claims? You must possess that level of utility at the time of filing.
I am certain that even most all patent agents can understand this.
>THAT is something that must be there at time of filing.
IDK. Most of the secondary factors aren’t there at time of filing e.g., commercial success, praise by others, copying, etc.
The sad thing about this one is that FDA delays + the IPR process (i.e., the patentee didn’t pick the timing of the suit) might have cost the patentee the patent.
Utility is most definitely not a “secondary factor.”
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