Supreme Court Denies Certiorari in Actavis Laboratories v. Nalproprion Pharmaceuticals

By Kevin E. Noonan --

In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed.  Indeed, avoidance of this statutory section continues a pattern that has existed since the 1952 Patent Act was enacted.  It is not for lack of petitions for certiorari, which have included during the Court's denials in Amgen v. Sanofi; Janssen Biotech, Inc. v. Abbott Laboratories; CoreValve Inc. v. Edwards Lifesciences AG; and Ariad v. Eli Lilly & Co.  Last week, the Court's refusal to consider this section recurred with its denial of certiorari in Actavis Laboratories FL, Inc. v. Nalproprion Pharmaceuticals, Inc.

To recap, the case arose in ANDA litigation over Nalproprion Pharma's Contrave® extended-release tablets of the combination of naltrexone hydrochloride and buproprion hydrochloride, for treatment of obesity, as claimed in Orange Book-listed U.S. Patent Nos. 7,375,111; 7,462,626; and 8,916,195.  The District Court found that Defendant Actavis had not established that one claim (claim 11) of the '195 patent was invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a) with regard to the claim limitation reciting USP dissolution methods ("USP1" versus "USP2"):

Claim 11 of the '195 patent:

A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is ad- ministered as a sustained release formulation, and wherein said sustained release formulation of naltrexone has an in vitro naltrexone dissolution pro- file in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of:
    a) between 39% and 70% of naltrexone re- leased in one hour;
    b) between 62% and 90% of naltrexone re- leased in two hours; and
    c) at least 99% in 8 hours;
    wherein about 16 mg of said sustained re- lease formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180 mg of said sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof is administered twice daily.

The claims expressly recited the USP 2 Paddle Method, but Actavis argued that the specification disclosed only the UPS 1 Basket Method.  The District Court based its decision on the skilled worker not having a doubt that the inventors had possession of the invention based on the nature of the dissolution method disclosed in the specification.  The Court held that disclosure of a "substantially equivalent method" was sufficient to satisfy the requirement.

The Federal Circuit, in an opinion by Judge Lourie, joined by Judge Wallach, affirmed the District Court on its written description determination over Chief Judge Prost's dissent.  The majority's written description decision was based in part on the "peculiarity" of the structure of claim 11, which is directed to a method for treating obesity using specific amounts of the two drugs and reciting the method for determining the dissolution profile of what the majority termed "resultant in vitro parameters," which were not the "operative steps to treat overweight or obesity."  The majority found no clear error in the District Court's holding that "irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it."  The majority noted that this determination by the District Court was supported by more credible testimony from Nalproprion Pharma's expert and "untrustworthy, self-serving statements by Actavis's expert."  The majority stated that it refused to disturb the District Court's weighing of witness credibility in the performance of its "fact-finding function."  The majority further recognized (in the face of the Chief Judge's dissent) that "[w]hile as a general matter written description may not be satisfied by so-called equivalent disclosure," under these facts the District Court had not clearly erred.

The Chief Judge's dissent on the written description question was based on the majority's reliance on "substantially equivalent disclosure" to support claim language not having clear and explicit support in the specification.  The Chief Judge characterized the majority's decision as "add[ing] what appears to me to be a new rule to this court's long-standing written description jurisprudence."  She set forth three reasons for her disagreement with the majority:

First, the USP 2 clause is limiting.  Second, the majority's "substantially equivalent" rule is inconsistent with this court's precedent.  Third, the district court clearly erred in finding that the '195 patent's written description includes a disclosure "substantially equivalent" to USP 2.

Important to the Chief Judge's reasoning, inter alia, were arguments from the prosecution history where the patentee appeared to rely on the dissolution profile (and the manner of determining it) to distinguish the claims from the prior art.  The Chief also disagreed with the District Court's (and the majority's) disregard for Defendant's expert testimony and found his assertion that the USP1 an USP2 methods would not have produced the same dissolution profile results to have been relevant to the written description issue before each court.

In its certiorari petition, Actavis submitted this Question Presented:

Whether § 112 requires a patent's specification to contain a written description of all of the limitations of a patent's claims, not just a "substantially equivalent" disclosure.

Actavis argued that the statutory requirement for a written description was "straightforward" and meant what it said:  that the specification was required to set forth a written description of "the invention" (emphasis on petition), which, of course, is what is claimed.  Actavis contended that the Federal Circuit majority had broken with "longstanding precedent, [and] adopted a new rule: now disclosing something 'substantially equivalent' can suffice."  This inquiry is "amorphous" and contrary to the statutory language and (of necessity) Federal Circuit precedent.  Almost pandering to Supreme Court prejudices, the petition argued that "[r]equiring a patent to contain sufficient written description support ensures that a patent-holder cannot assert a broader monopoly than what 'the inventor actually invented,'" citing Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), and that "[a]n adequate written description is also necessary 'to inform the public during the life of the patent of the limits of the monopoly asserted, so that it may be known which features may be safely used or manufactured without a license and which may not,'" citing Permutit Co. v. Graver Corp., 284 U.S. 52, 60 (1931).

According to Actavis, this decision, if permitted to stand (which is has been), overturns the certainty provided by the Federal Circuit's prior precedent on Section 112(a), substituting a "substantially equivalent" standard for one where "an obvious variant of that which is disclosed in the specification," which was previously excluded, can now suffice, citing Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).  In addition to the doctrinal error Actavis asserts, the petition also maintains that the decision "disrupt[s] the settled expectations of the inventing community" that the Supreme Court (somewhat ironically) advised against in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002).  And on a practical level, Actavis reminded the Court that this case is an excellent vehicle for review, wherein only one claim is at issue, there is no dispute on the facts, and the alternative outcome would permit Actavis to "bring its generic to market forthwith, instead of being blocked for another full decade."

The petition reminded the Court of the fundamental basis ("a bedrock principle") of the written description requirement, having been part of U.S. patent law "practically since the Founding," setting forth an explication of the history of this requirement to support its statement.  The importance of properly applying the requirement includes that "it ensures that an inventor does not claim patent protection for something broader than what he or she has invented by the time of filing the patent application, exemplified in the Court's decisions including O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1853), and Federal Circuit decisions including Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991), and Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379 (Fed. Cir. 2009).  A second benefit of the requirement is to the public, wherein "the description effectuates the patent bargain: what the inventor claims, and secures a monopoly over, he or she must describe," citing Gill v. Wells, 89 U.S. (22 Wall.) 1, 25-26 (1874) and Ariad.

"The decision below creates a new rule that hopelessly muddies what previously was clear and cannot be reconciled with the court of appeals' previous decisions" according to Actavis's petition.  These decisions cited in the petition include Lockwood; Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997); Lucent Techs., Inc. v. Gateway, Inc., 543 F.3d 710 (Fed. Cir. 2008); PowerOasis, Inc. v. TMobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008); ICU Medical, Inc. v. Alaris Medical Systems, Inc., 558 F.3d 1368 (Fed. Cir. 2009); Vas-Cath; and D Three Enters., LLC v. SunModo Corp., 890 F.3d 1042, 1052 (Fed. Cir. 2018).  This is not the same as imposing an in haec verba requirement according to Actavis; the panel majority's error Actavis emphasized that the Federal Circuit departed from years of consistent decisions to the contrary by "accepting a disclosure that was 'substantially equivalent'—i.e., different but close enough."

Actavis also challenged the basis for the majority's decision -- that the disputed, assertedly unsupported claim term -- did not related to a "operative claim step."  There is no basis in the statutory language for this distinction, Actavis argued, nor in "this Court's clear precedent," citing Supreme Court precedent in  Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915, 921 (2014); Warner-Jenkinson, Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997); and Water-Meter Co. v. Desper, 101 U.S. 332, 337 (1880), and the Federal Circuit (and its predecessor Court, the C.C.P.A.) in In re Sabatino, 480 F.2d 911, 913 (C.C.P.A. 1973); Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1557 (Fed. Cir. 1995); and Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1273 (Fed. Cir. 2017).

And yet, to no avail.  Whether the Federal Circuit's decision below will lead to the dire consequences envisioned by Petitioners or is cabined by the facts and circumstances of the case before the Federal Circuit is uncertain.  But what seems certain is that the Supreme Court has not been, and perhaps cannot be, presented with a case that has been able to overcome a seeming institutional reticence against deciding questions presented regarding Section 112(a).

Comments

[Paul F. Morgan]

One good observation here is worth repeating [and was also noted some years ago by at least one Fed. Cir. judge]: that there has been insufficient judicial interpretation or application of §112(a). Until recently it was rarely or inadequately applied in the PTO. It has also been asserted as one factor in the D.C. overuse of 101 instead. And, it cannot even be raised in an IPR except for substitute claims.

[MaxDrei]

Of course, I could check it out myself but it strikes me it is quicker and easier to ask my question here. To me, it seems decisive.

I read above, that:

"The claims expressly recited the USP 2 Paddle Method, but Actavis argued that the specification disclosed only the UPS 1 Basket Method"

So is it so, that in the patent application as filed ALL the claims were limited to the UPS1 method, ie NO claim generic to UPS1 and USP2? I mean, if the original disclosure was of generic paddle or basket, that's a bit different from a disclosure as filed of exclusively basket, with NO suggestion anywhere at all in the application as filed of any method (such as paddle) other than the basket method.

Interesting for Europeans like me is (of course) the overlap between WD in the USA and "added matter" under the EPC. I had supposed that under FItF, the WD requirement would get progressively stricter but I don't see it yet.

[skeptical]

MaxDrei,

I just do not see what you think it is that you see in regards to New Matter.

You are aware of course that the US has its own 'No New Matter' rule that applies every bit as well as the European analog.

Are you trying to make a different point than mere 'no new matter?' It is unclear from what you post.

[Kevin E Noonan]

Max: the patent uses the word "basket" exactly once, in Example 2 and recites only the paddle method in the claims.

I don't think the question is one of added matter because basket or paddle the limitation is merely a way of characterizing how the claimed formulation is made (and one step of that preparation method).

Which was the basis for the majority's decision: if the written description requirement was intended to ensure that the applicant possessed the invention at the time the application was filed, and using either basket or paddle provides the same formulation, then isn't it putting form over substance to make a distinction?

Chief Judge Prost disagreed.

I think the Supreme Court made the right decision. This is (in many ways) much ado about very little and will be cabined to its facts. This is not the hill to die on for written description.

[MaxDrei]

Thanks, both, for those replies. I see that I failed to make my question clear enough. I'll try again.

As opposed to the issued patent, let's look at the content of the patent application on its filing date. It will have a specification and a set of claims. In the specification, you report, there is Example 2 and in that Example the word "basket" appears.

Now to my question.

As to the claims, did they recite the paddle method already on the filing date of the application, or was the limitation to the paddle method added during prosecution?

If paddle was in the claims from the get go, then I can readily see that the WD attack on validity is unconvincing. But if it was added during prosecution, to an application as filed that recited no paddles and only one basket, then the WD attack on validity strikes me as weighty, more substance than mere form.

From your comments, Kevin, I presume that paddle was already in there at the filing date. In which case then, yes, form over substance.

The issue what prosecution amendments are possible is one that generates much trans-Atlantic correspondence between those who prosecute applications at Patent Offices.

[skeptical]

"The issue what prosecution amendments are possible..."

"see that I failed to make my question clear enough. I'll try again."

You are aware of course that the US has its own 'No New Matter' rule that applies every bit as well as the European analog.

I am still not seeing what point you are trying to make - are you not understanding the reply to you?

[MaxDrei]

Kevin, anon, I have now myself had a look at the US A publication and the equivalent case at the EPO EP-B-2061448. The issued claim at the EPO recites the dissolution measurement method of para [0044] of the application as filed. I continue to wonder though why claim 11 of the US '195 patent had to include the word "paddle", nowhere to be found in the application as filed.

If the restriction to "paddle" was in order to achieve patentability over the art, that for me is tantamount to a claim to an invention which Applicant, at the filing date, did not already possess.

Conversely, if "paddle" is implicit in the method stated explicitly at para [0044], that would indeed suggest that Applicant was in possession at the filing date. But, in that case, why insert into the claim the word "paddle"? What other reason could there be, other to get to patentability over the art?

[skeptical]

MaxDrei,

You ask a question that is easily answered, since the point at question is a published patent with its full prosecution history for all to read (it's called Public PAIR).

As to what POINT it is that you think that you might be making by making an intonation (what other reason?) you merely appear f00lish.

For THIS case, the amendment was made in a reply to an Office Action, but as you might gather from the reasoning provided below, this does NOT appear to be any attempt to "get patentability over the art." Certainly, the applicant plainly believed that there was NOTHING involved in the actual amendment that was needed in order to over the art, and that the art of record was simply deficient in and of itself.

The quote is part of the reply on 4/14/2014:

"The Examiner requires additional clarification on the "standard dissolution test" recited in the claims. Applicants' representatives agree to incorporate the relevant disclosure of "standard dissolution test" from the specification into the corresponding claims. Applicants' representatives maintained that Weber fails to disclose any specific sustained in the Klassen Declaration should be considered.

Note here that the amendment that you point to is basically ADMITTED prior art and has nothing to do whatsoever with patentability over the art.

Rather than throw fecal matter at the wall (while you continue to NOT address my prior questions put to you), please do at least a modest investigation to set up your 'question.'

[MaxDrei]

Well thanks, anon, for explaining how "paddle" got into the claim during prosecution.

Same objection raised in both USPTO and EPO, but claim amendment in response different.

Given that the USPTO amendment to "paddle" opened up the opportunity to run a WD argument, post-issue, whereas the EPO amendment would not, I wonder whether, given another chance, the attorney that did the prosecution at the USPTO would have avoided introducing that word "paddle" into the claim. There was no need for it at all, was there?

[skeptical]

MaxDrei,

The APPARENT need was based on the US Examiner.

Clearly here the case shows the applicant being worn down.

And no - there is NO (legitimate) WD issue - regardless of the "opportunity," as ANY amendment provides the basis of the "opportunity." Are you suggesting that applicants NEVER amend because of this ")h Noes" opportunity issue?

(but that 'wearing down' or anything remotely pro-applicant does not fit any narrative that you would espouse, does it?)