Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

Joint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define."  Mueller Brass Co. v. Reading Indus., 352 F. Supp. 1357, 1372 (E.D. Pa. 1972), aff'd, 487 F.3d 1395 (3d Cir. 1983).  The consequences of an improper (or improvident) determination of inventorship (and the sometime difficulties that can arise when a change of inventorship is delayed until a patent is being asserted at trial) is illustrated in the Federal Circuit's recent non-precedential decision in Horizon Medicines LLC v. Alkem Laboratories Ltd.

The matter arose in ANDA litigation over Horizon's DUEXIS® product, an NSAID formulation used for administration to rheumatoid arthritis and osteoarthritis patients.  According to the opinion, the prior art recognized that chronic use of NSAIDs at dosages useful for pain relief and inflammation (such as ibuprofen, a "non-selective" NSAID) produced stomach ulcers.  (In a footnote the opinion sets forth a distinction between non-selective NSAIDs, which inhibit both known forms of cyclooxygenase (COX), and "selective" NSAIDs, which only recognize the COX species that are not present in the mucus lining of the stomach and thus are not associated with stomach ulcers.)  However, selective NSAIDs were found to be disadvantageous due to cardiovascular complications associated with their use.  Horizon's claimed non-selective NSAID formulations avoided the ulcer-producing effects of non-selective NSAID administration by co-formulation with famotidine.  In ANDA litigation Horizon asserted U.S. Patent Nos. 8,067,033 and 8,067,451; claim 1 of each patent was set forth in the opinion as being representative:

'033 patent:

1.  A pharmaceutical composition comprising
    a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine,
    wherein the surface area of direct physical contact between ibuprofen and famotidine does not exceed 130 mm2,
    wherein no more than about 1% sulfamide is present when the composition is stored at 40°C and 75% relative humidity for a period of one month,
    wherein the composition is formulated so that release of both the ibuprofen and the famotidine occurs rapidly at about the same time,
    wherein none of the composition, the famotidine, and the ibuprofen is enterically coated or formulated for sustained or delayed release, and
    wherein the composition is for use according to a TID (three times per day) administration schedule for reducing the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for an ibuprofen-responsive condition.

'451 patent:

1.  An oral dosage in tablet form comprising
    a first portion that comprises 800 mg ibuprofen and a second portion that comprises 26.6 mg famotidine,
    wherein a barrier layer comprising hydroxyl propyl methyl cellulose 2910, polyoxyethylene glycol 400, polysorbate 80, and titanium dioxide surrounds the second portion completely separating it from the first portion . . .

Relevant to the District Court's determinations, use of the combination of a non-selective NSAID and famotidine was known in the art to reduce stomach ulceration upon prolonged use.  The opinion explains that this advantageous combination was also known to degrade due to chemical incompatibility between these two compounds.  The claimed formulations achieved their greater stability by minimizing the surface area of direct physical contact between the incompatible ingredients; as set forth in the opinion the product contained "a famotidine core, an ibuprofen shell, and an Opadry® White barrier layer in between."

The District Court found the asserted claims (claims 1, 8, 11, and 14) of the '033 patent to be invalid for obviousness and the asserted claims (claims 1–3 and 8–10) of the '451 patent not to be infringed.  Horizon appealed.

The Federal Circuit affirmed the District Court's invalidity and non-infringement determinations in an opinion by Judge Dyk joined by Judges O'Malley and Hughes.  The District Court's obviousness determination was based on U.S. Patent Application Pub. No. 2007/0043096 A1, which Horizon argued was not properly prior art and thus the District Court had committed legal error in considering it to be so.  Because the patents-in-suit and the cited prior art patent application were filed prior to enactment of the Leahy-Smith America Invents Act, the District Court and Federal Circuit applied the novelty provisions of the 1952 Patent Act in finding the '096 application to be prior art.  The '033 patent names Inventor Tidmarsh while the '096 application names Tidmarsh and a second inventor, Golombik.  (In a footnote the Federal Circuit explains there were additional inventors named in each but that their status did not need to be resolved because resolution of the Tidmarsh/Golombik inventorship status was outcome determinative.)  At trial Horizon moved under 35 U.S.C. § 256 to add Golombik as an inventor on the '033 patent, a motion the district court denied.  Horizon's argument on appeal was that if Tidmarsh and Golombik had invented formulations comprising 800 mg ibuprofen and 26.6 mg famotidine (as set forth in the '096 application) then both inventors perforce were also inventors of the invention described and claimed in the '033 patent (which recites formulations comprising 800 mg ibuprofen and 26.6 mg famotidine).  The Federal Circuit rejected this argument.  The opinion notes that generally "the inventors named in an issued patent are presumed to be correct" and this presumption can be overcome only in the face of clear and convincing evidence, citing Caterpillar Inc. v. Sturman Indus., Inc., 387 F.3d 1358, 1377 (Fed. Cir. 2004).  Mere inventor testimony is not enough to overcome this presumption, according to the Court, and "some form of corroboration must be shown"; see EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 1346 (Fed. Cir. 2017) (similar considerations provide the rationale for like requirements in interferences; see, Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1171 (Fed. Cir. 2006)).  Moreover, the opinion states that "[o]ur cases are clear that inventing something in an earlier patent or patent application does not automatically make one an inventor of patents that incorporate the earlier invention," citing Eli Lilly and Co. v. Aradigm Corp., 376 F.3d 1352, 1358, 1362 (Fed. Cir. 2004).  The Court was unpersuaded by Horizon's reliance on Pannu v. Iolab Corp., 155 F.3d 1344 (Fed. Cir. 1998), to the effect that Tidmarsh and Golombik were engaged in a "collaborative enterprise," on the grounds that unlike in Pannu "[t]he only support for Golombik's contribution to the '033 patent is testimony by Tidmarsh and Golombik."  The Federal Circuit found no clear error by the District Court based on the totality of the evidence, including putative inventor testimony (which the District Court had characterized as "non-specific," "convenient, uncorroborated, and not very credible").

The Federal Circuit also rejected Horizon's non-obviousness arguments taking the '096 application as proper prior art.  These arguments were grounded on whether the skilled worker would have had a reasonable expectation of success in achieving formulations having the stability of the claimed formulations.  This expectation arose, according to the District Court as affirmed by the Federal Circuit, from another prior art reference that disclosed using the same "tablet-in-tablet" formulation claimed in the '033 patent to achieve increased stability for combinations of drugs "similar to ibuprofen and famotidine" (as supported by expert witness testimony).  The Federal Circuit found no clear error in these District Court determinations either.

And the Federal Circuit dismissed consideration of Horizon's arguments regarding non-infringement of the '033 patent as moot in view of their affirmance of the invalidity of the '033 patent's asserted claims.

Regarding the '451 patent, Horizon argued that the District Court erred in construing the term "comprising" as recited in the claim with regard to the barrier layer limitation to mean "consisting essentially of."  The Federal Circuit rejected this argument, first, because the panel held that Horizon had not established harmful error in its briefing, and second, "the prosecution history of the '451 patent supports the district court's construction."  Specifically, the opinion points to "multiple exchanges with the Examiner" where Horizon made amendments to overcome rejections over the prior art that purportedly "focus[ed] on an embodiment of the invention that uses Opadry® White (YS-1-7003) as a barrier layer."  In view of this history the panel found no clear error in the District Court's construction nor the factual basis for its finding of non-infringement.

Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)
Nonprecedential disposition
Panel: Circuit Judges Dyk, O'Malley, and Hughes
Opinion by Circuit Judge Dyk

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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