Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (Fed. Cir. 2021)

By Kevin E. Noonan --

The Leahy-Smith America Invents Act prescribed two very different post-grant review proceedings in U.S. patent law.  The first, post-grant review (PGR), had some analogies with European opposition practice, in that petitions for PGR could be filed no later than nine months after the patent had granted and any ground of patentability was available as the basis for challenge (see 35 U.S.C. § 321 et seq.).  The other proceeding, inter partes review (IPR), was available throughout an unexpired patent term but the subject matter of challenge was limited to anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103 (see 35 U.S.C. § 311 et seq.).  However, Section 112 issues can be considered in an IPR as a part of construing the claims when questions of priority are raised, and this was the basis for the Patent Trial and Appeal Board (PTAB) to find invalid all but one of the challenged claims in Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A.

Dr. Reddy's petitioned for inter partes review (IPR) of U.S. Patent No. 9,687,454 on the grounds that all claims were anticipated by U.S. Patent Publication 2011/0033541 to Myers.  The claims are directed to therapeutic agent-containing films that can be orally dissolved as an administration route for various medicines.  The '454 patent is the latest in a series of related applications, the earliest (U.S. Patent Application 12/537,571) dating to 2009.  At issue in this IPR was whether the challenged claims were entitled to this earliest filing date, which antedated the publication of the '541 application asserted by Dr. Reddy's for anticipation.

The opinion sets forth claims 1, 7, 8, and 12 as representative of the issues before the Board.

Claim 1:

1.  An oral, self-supporting, mucoadhesive film comprising:
    (a) about 40 wt % to about 60 wt % of a water-soluble polymeric matrix;
    (b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof;
    (c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and
    (d) an acidic buffer;
    wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa;
    wherein the weight ratio of (b):(c) is about 4:1;
    wherein the weight ratio of (d):(b) is from 2:1 to 1:5;
and
    wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine Cmax from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone Cmax from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml.

7.  The film of claim 1, wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water-soluble polymeric matrix.

8.  The film of claim 7, wherein the film comprises about 48.2 wt % of the water-soluble polymeric matrix.

12.  The film of claim 1, wherein the weight ratio of (d):(b) is from about 1:1 to 1:5; wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5; and wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water-soluble polymeric matrix.

(emphasis in each instance in the opinion).  As is evident from the emphasized limitations, the distinction between claim 8 and the other claims is that this claim has a particularly specified composition of the water-soluble polymeric matrix making up the film while the other claims have a broader range of values for this parameter.

The Board considered whether the written description in the '571 priority specification had support for these features.  The Board found express disclosure for the "about 48.2 wt %" limitation in the '571 specification (albeit as the result of calculation by the skilled artisan); the Tables containing these data were reciprocated in the Federal Circuit opinion.  (While express disclosure of a claimed range can readily satisfy the written description requirement, inherent disclosure of such ranges by example is also in some cases adequate for written description purposes; see Union Oil of Cal. v. Atl. Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000)).  The ranges of water-soluble polymer in the films recited by the other claims did not find support in the '571 specification, according to the Board.  Moreover, the Board did not find Indivior's expert witness testimony to be credible on this issue.  Finally, the Board held that a person of ordinary skill in the art "would have been led away" from these ranges based on the '571 disclosure that "[t]he film may contain any desired level of self-supporting film forming polymer."  Accordingly, the Board held that the challenged claims of the '454 patent were not entitled to the priority date of the '571 application and thus claims 1-5, 7, and 9-14 were invalid for being anticipated by the teachings of the prior art '541 application while claim 8 was not anticipated.  Both parties appealed the Board's judgment.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judge Dyk and joined in part by Judge Linn, who dissented in part.  Regarding Indivior's appeal of the Board's invalidation of claims 1-5, 7, and 9-14, the panel majority agreed with the Board that the portions of the '571 specification Indivior attempted to rely upon did not disclose, expressly or inherently, the ranges recited in claims 1-5, 7, or 9-14.  Instead, there are instances in the disclosure that are "only specific, particular examples" but they are not ranges according to the opinion.  The panel majority expressly rejected Indivior's argument that written description is adequate when the skilled worker would need to "pluck[] out the polymer components and create[] a range from the percentage totals" which the opinion states "amounts to cobbling together numbers after the fact."  And "[a] written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention" because "a patent is not a hunting license," citing (with some irony) Brenner v. Manson, 383 U.S. 519, 536 (1966).  The Federal Circuit illustrated the doctrinal difficulties of applying the written description requirement consistently by rejecting Indivior's resort to its case law by stating "written description cases are intensively fact-oriented, and the cases vary, just as ranges vary."

Because Indivior did not dispute that the '541 application would anticipate claims 1-5, 7, and 9-14 if the '454 patent was not entitled to the priority date of the '721 application, the Court affirmed the Board's decision that these claims were invalid for being anticipated.

Turning to Dr. Reddy's cross-appeal, the panel understood the argument to be that the skilled worker "would not have immediately discerned that the '571 application discloses a polymer component comprising 48.2 wt % of a film because the tables do not state the total polymer weight of various formulations."  The panel agreed with Dr. Reddy's that the 48.2 wt% is not expressly disclosed but deferred to the Board's fact-finding as being supported by substantial evidence.  To the possibility that this decision be perceived as being contrary if not contradictory to the Court's decision affirming invalidity of the other claims in the '454 patent, the opinion states that "given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board's decision concerning claim 8" and accordingly affirmed.

Judge Linn's dissent illustrated the difficulties of analyzing compliance with the written description requirement.  Citing some of the same caselaw Indivior unsuccessfully relied upon, including Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019), and In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976), Judge Linn contended the majority was incorrect in failing to find written description support in the '571 specification for the '454 patent's claims 1-5, 7, and 9-14, saying the panel majority had "applie[d] an overly demanding standard for written description for ranges" contrary to this precedent.  His dissent then performs the Judge's assessment of the '571 disclosure and comes to a conclusion opposite from the panel majority.  In Judge Linn's assessment, the reason for this difference with the panel majority is that Judges Lourie and Dyk took statements in the specification out of context and considered the specification to contain "inconsistent language" that Judge Linn is at a loss to perceive.  Indeed, Judge Linn chides the panel majority for doing just what the majority opinion states should not be done, applying "strict rules" to show possession of the claimed range(s).  Judge Linn also states that in his analysis the Tables set forth in the '571 application (and reproduced in the opinion) disclose the 48.2 wt% and 58.6 wt% in the recited ranges and required no "cobbling together numbers after the fact" as the majority had asserted in support of their decision.  Finally, Judge Linn found the Wertheim and Nalpropion opinions to be "directly on point" and support his opinion that the '571 specification provided an adequate written opinion of the challenged claims of the '454 patent.

Indivior UK Ltd. v. Dr. Reddy's Laboratories S.A. (Fed. Cir. 2021)
Panel: Circuit Judges Lourie, Linn, and Dyk
Opinion by Circuit Judge Lourie; opinion concurring in part and dissenting in part by Circuit Judge Linn

Comments

[Max Drei]

Kevin, you mention EPO opposition practice. I find it interesting to compare the US WD requirement with the EPC's "no new matter" test. You report the view of the Fed Ct that "cases vary" because they are fact-intensive. Just so. But that has not prevented the EPO from deriving what is now called its "Gold Standard" as its test for WD, namely whether the post-filing amendment is free from anything that was not already "directly and unambiguously derivable" by the PHOSITA from the originally filed disclosure. The cases, thousands of them by now, flesh out what "derivable" means. The notional addressee, being skilled in the art, is quite good at deriving technical meaning from an application as filed. Perhaps that is why the European patent family member survived all "added matter" attacks advanced in opposition proceedings at the EPO

In the interests of legal certainty, and levels of confidence in writing FTO opinions, I wonder how the Fed Ct is coming along in the development of its own WD Gold Standard? I mean, now that the USA is a First to File jurisdiction, WD is going to play an ever more crucial role in determination of the validity of patents.

[skeptical]

Should we be puzzled that MaxDrei remans ever in the dark when it comes to the US Sovereign's no new matter rule?

I get that he takes every opportunity to shill for the EPO system, but that just does not excuse his lack of grasp (for SEVERAL YEARS now) that "no new matter" means exactly that.

As to what is "directly and unambiguously derivable," this too has been commented upon in that those drafting for the US Sovereign know well (or should know well) how the judicious use of what has been termed 'boilerplate' not only keeps the door open for claiming the full depth of the disclosure (which is still provided at the time of filing), but also inoculates against how the patent office will cobble together prior art (including secret prior art).

He mentions "in the interests of legal certainty" but then conflates that certainty with attempts to insert the EPO for the US Sovereign's choices. I get that he has much difficulty in understanding a viewpoint other than his own, and that operating so (for decades) likely means that he just won't "get it" no matter how many times he is led to the well of wisdom.

What to do with such willful and stubborn ignorance?

Well, this is where an application of John Maynard Keynes can at least provide a little enjoyment.

[Greg DeLassus]

“I wonder how the Fed Ct is coming along in the development of its own WD Gold Standard?… [N]ow that the USA is a First to File jurisdiction, WD is going to play an ever more crucial role… .”

As if in answer to your question, Max, the CAFC handed down Biogen v. Mylan, which moves the §112(a) WD requirement a material step in the direction of the EPO’s “directly and unambiguously derivable” standard.

[Kevin E Noonan]

More on Biogen v Mylan tonight (which of course Max didn’t have when he posted).

But I think the issue in Indivior was a little different: the claim wasn’t supported by the spec so it’s (to me) more a question of possession than new matter (although they are two sides of the same coin). Judge Linn’s dissent argues that the disputed claim scope would have been understood by the skilled artisan, while the majority seem to think the skilled worker shouldn’t have to guess what the scope is. While it’s good for Europe to have come up with a formula to use in making these determinations that just shifts the question to whether the formula fits the facts of a particular case. The benefits may be more illusory than they appear - sounds like a good law review topic to try to derive a “rule” under US law. Thanks for the comment, all

[Greg DeLassus]

Totally off-topic, Dr N, but I am very much enjoying your work on LinkedIn of late.

[MaxDrei]

Kevin, thanks. You observe that new matter and WD are two sides of the same coin. I prefer to think of i) WD, ii) new matter, iii) entitlement to priority and iv) novelty destruction as four sides of the same First to File patent law cube.

I mean, the EPO's legal test "directly and unambiguously derivable" applies with equal rigor and relevance to all four faces of that cube. It is simply a test to determine what teaching the PHOSITA will derive from any given document (whether it be the application as filed, the priority document, or D1 the alleged novelty-destroyer). It is a prerequisite of each legal situation to fix what each document teaches. You can't duck out of such a determination. If you have to do it, best I would say is to do it the same way, each time you have to do it.

As you write, each case requires the court to map the peculiar facts onto the standard legal test. We can't do anything to simplify the facts, but we can do a lot to simplify the legal test. As the poster "skeptical" would remind us, given half a chance, that test should be as simple as possible but not so simple that it over-simplifies the determination.

You muse that the benefits of the EPO Gold Standard "may" be "illusory". I wonder, what is the source of your doubts about the efficacy and effectiveness and fitness for purpose of the EPO's astonishingly simple catch-all test. Is it that, under it, your clients are being deprived of justice from the EPO? If so, do tell.

Thanks also to Greg, who perhaps also might like to add a comment. For example, if we imagine the EPO test mapped on to the Indivior facts, would Judge Linn have determined that the skilled reader would have derived the teaching in question whereas the other two judges would not.

Just think: If the advocates in Indivior had instead been directing their efforts to the EPO Gold Standard test question, would then the three judges have perhaps found it easier to agree with each other on whether the test was or was not satisfied. I mean, the easier and clearer and more ubiquitous the test to be applied to any given and unique matrix of fact, the easier it becomes for the advocates to speak to it and for the judges to adjudicate it. Is that not so?

[Kevin E Noonan]

Thanks, Greg. What surprises me most about that site is that I would expect people would know that prospective employers would look at it when vetting them for a job. It isn't the sometimes bizarre ideas and beliefs they espouse that surprises me; it is the off-the-rails vitriol and plain nuttiness about what they spout. I wouldn't hire them.