by Dennis Crouch
Mylan Pharms. Inc. v. Research Corp. Techs., Inc. (Fed. Cir. 2019)
This post begins with an obviousness discussion, then moves to IPR standing, and finally talks about SAS.
Obviousness: In Mylan, the Federal Circuit affirms a PTAB decision siding with the patentee and holding that RCT’s pharmaceutical compound patent claims were not proven unpatentable (i.e., confirming patentability).
The patent at issue is directed toward an enantiomeric isomer (R configuration) of lacosamide. The dependent claims at issue are directed to the use of the drug for anticonvulsant effective (treating epilepsy symptoms).
As with most Inter Partes Review (IPR) decisions, the focus is obviousness. The listed inventor – Harold Kohn – is also the author of the lead prior art reference.
Harold Kohn et al., Preparation and Anticonvulsant Activity of a Series of Functionalized α-Heteroatom-Substituted Amino Acids, 34 J. Medicinal Chemistry 2444 (1991); J.A. 2404–12.
The article identifies a particular compound as the “most active” as a potential anticonvulsant whose structure is shown below.
Although the Board decided that there was sufficient similarity to institute the IPR, it ultimately ruled that the modification of the 1991 compound to create lacosamide was beyond ordinary skill in the art.
On appeal, the Federal Circuit affirmed — holding that even if the 1991 compound was an appropriate lead compound the challenger “failed to meet their burden to establish a motivation to modify.” Here, the challenger relied upon an organic chemistry drug design text for the principle that a developer would be motivated to replace an amine in the 1991 compound with a methylene link to form lacosamide.
According to Appellants, a person of skill in the art would then have been motivated to modify compound 3l by replacing the amine of its methoxyamino group with a methylene link to yield a more stable, synthetically accessible, pharmaceutically common and acceptable moiety.
On appeal, however, the Federal Circuit rejected this approach — holding that the PTAB decision was based upon substantial evidence. In particular, the Board looked at contemporaneous evidence that such a modification would have reduced therapeutic activity.
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The case includes an important discussion regarding standing to appeal and the one-year bar under 5 U.S.C. § 319. Here, Argentum filed the IPR petition in November 2015. Argentum had not ever been sued under the patent and arguably would not have Article III standing to challenge the patent in court. However, the IPR statute allows anyone to petition.
After institution, Mylan, Brekenridge, and Alembic all filed their own IPR petitions as well as petitions for joinder under 35 U.S.C. § 315(c).
(c) Joinder.— If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314.
The joinder petitions were granted. One quirk here is that the Mylan, Brekenridge, and Alembic IPR petitions would not have been granted on their own since they were all time-barred under 35 U.S.C. § 315(b). Joinder, however, is a different matter — since the statute expressly indicates that “The time limitation set forth in [§ 315(b)] shall not apply to a request for joinder under subsection (c).”
In the appeal, the original petitioner Argentum dropped-out and did not appeal — and arguably could not have appealed. Only the newcomers, Mylan, Brekenridge, and Alembic, appealed.
On appeal, RCT called foul — on the challengers approach of cobbling together rights.
- Argentum able to file IPR, but no right to appeal.
- Mylan, et al., not able to file IPR on its own, but standing to appeal.
In the end though, the Federal Circuit found the approach proper under the statute. Once Mylan was joined as a petitioner, it had a statutory right to appeal.
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Final point to discuss here involves SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018). In that case, the Supreme Court held that the PTAB must either institute as to either (1) all challenged claims or (2) no claims. The Federal Circuit has expanded that holding to now include a requirement of instituting as to either (1) all grounds for challenge or (2) no grounds at all.
Here, the PTAB instituted as to all challenged claims, but only some grounds for challenge. In oral arguments (rebuttal), Mylan’s counsel requested, in the “alternative,” that the case be remanded for consideration of all grounds. On appeal, the Federal Circuit held that the right to remand had been waived. In particular, applicant waited more than 6-months until the rebuttal portion of oral arguments to request the remand. “Given the circumstances in this case, we find that Appellants have waived their request for remand.”
Speaking about standing…
link to cafc.uscourts.gov
(no advisory opinions from Article III courts, as such is beyond the proper authority of the Legislative branch – the AIA does not get to bootstrap the first part of the dual fora into a proper and legitimate place in the second part of the dual fora).
Ah, the case now has its own thread.
To be sure, we are certain to now hear from the AIA post grant mechanism cheerleaders, eh?
Let’s all bootstrap away.
(now where did I put my Sheldon sign…)
I think Judges Prost, Moore, and Reyna are going to make short and precedential work on the “untimely filed petition being “timely joined” when their ruling comes out on Mangrove vs. VirnetX. Judge Moore made it QUITE clear that her “plain language reading” say “a properly filed petition may be joined” and the rest simply doesn’t matter. If you are time barred you can NEVER “properly” file a petition. Neither Prost nor Reyna seemed to have any problem with that line of thinking and Moore seemed to have gotten it in her head to take the bull by the horns and put the nonsense to rest once and for all.
But then in 2017, in Town of Chester v. Laroe Estates, Inc., 137 S. Ct. 1645, 1651
(2017), the Court ruled that an additional plaintiff whose standing is uncertain “must have Article III standing in order to pursue relief that is different from that which is sought by a party with standing.” If the same remedy/same relief test under FRCP 24 (a) is current law, then the FC should have applied in Mylan said test; although again it appears that the same remedy/same relief test is dicta in Town of Chester (2017).
Are you suggesting that Mylan et al. lack Article III standing? Please elaborate.
I think the Federal Circuit should have discussed (at least) the same remedy/same relief test as proposed in Town of Chester (2017) since the FC should have followed USSC dicata.
And here are the other two USSC cases: Dir., Office of Workers’ Comp. Program v. Perini N. River Assocs., 459 U.S. 297, 302–05 (1983) (holding that it was unnecessary to decide whether a government official had Article III standing to seek appellate review where an injured individual was also a party before the Court); and Diamond v. Charles, 476 U.S. 54, 64 (1986) (stating that a party found
to lack standing to appeal could “ride ‘piggyback’” on another party’s standing, if that other party had appealed); the latter was again dicta.
Not sure those fit because the “riding piggyback” could not change the point of the matter being in the Article III forum.
The situation is a bit different if there is no piggy already IN that Article III forum.
The only case I’m familiar with is Clinton v. City of New York, 524 U.S. 417, 431 n.19 (1998) (“Because both the City of New York and the health care [plaintiffs] appellees have standing, we need not consider whether the [plaintiff-]appellee unions also have standing to sue.”); again this is dicta.
I do not think the Federal Circuit got this right; although it is an open question if under FRCP 24 (a) a joining party needs to proof independently Art. III standing; I think there is a case pending before the USSC regarding the Art. III requirement on this very same question right now.
Doubtful, seems like just a play on two meanings of standing
Also, the original expression “standing on the shoulders of giants” doesn’t refer to an undeserved benefit, it just means leveraging current knowledge to discover new knowledge, without any moral judgment involved.
It’s the “without standing” that provides the negative connotation.
Yes, the play on words is clear – the negative part also seems clear – but I wanted to make sure that negativity was intended.
What’s the intended connotation of the title here?
I’m picking up a sense of “obtaining something undeservedly”
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