Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021) | McDonnell Boehnen Hulbert & Berghoff LLP

The joint inventor has been called “one of the most confusing concepts in the muddy metaphysics of patent law” because the “exact parameters of what constitutes the joint inventor are quite difficult to define.” Mueller Brass Co. v Reading Indus., 352 F. Supp. 1357, 1372 (ED Pa. 1972), confirmed, 487 F.3d 1395 (3d Cir. 1983). The consequences of an inappropriate (or reckless) determination of inventor status (and the difficulties sometimes that can arise when a change in inventor status is delayed until a patent is claimed at trial) are illustrated in the recent non-previous decision of the Federal Circuit in Horizon Medicines LLC v. Alkem Laboratories Ltd.

The case arose in the context of a dispute with ANDA concerning Horizon’s DUEXIS® product, a formulation of NSAIDs used for administration to patients with rheumatoid arthritis and osteoarthritis. According to the opinion, the prior art recognized that chronic use of NSAIDs at doses useful for the relief of pain and inflammation (such as ibuprofen, a “non-selective” NSAID) produced ulcers. ‘stomach. (In a footnote, the opinion distinguishes between non-selective NSAIDs, which inhibit both known forms of cyclooxygenase (COX) and “selective” NSAIDs, which only recognize COX species that do not. are not present in the lining of the stomach and therefore are not associated with stomach ulcers.) However, selective NSAIDs have been shown to be disadvantageous due to the cardiovascular complications associated with their use. The non-selective NSAID formulations claimed by Horizon avoided the ulcer-producing effects of the administration of non-selective NSAIDs by co-formulation with famotidine. In the ANDA litigation, Horizon claimed U.S. Patent Nos. 8,067,033 and 8,067,451; claim 1 of each patent was presented in the notice as representative:

Patent ‘033:

1. A pharmaceutical composition comprising
a first portion which includes 800 mg of ibuprofen and a second portion which includes 26.6 mg of famotidine,
in which the area of ​​direct physical contact between ibuprofen and famotidine does not exceed 130 mm2,
wherein no more than about 1% sulfonamide 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 such that the release of both ibuprofen and famotidine occurs rapidly at about the same time,
wherein none of the composition, famotidine and ibuprofen are enterically coated or formulated for sustained or delayed release, and
wherein the composition is for use on a TID administration schedule (three times per day) to reduce the risk of developing ibuprofen-induced ulcers in a human patient requiring ibuprofen for a condition responsive to it. ‘ibuprofen.

‘451 patent:

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

Regarding the decisions of the district court, the use of the combination of a non-selective NSAID and famotidine has been known in the art to reduce stomach ulceration during prolonged use. The notice explains that this beneficial combination was also known to degrade due to the chemical incompatibility between these two compounds. The claimed formulations have achieved their greatest stability by minimizing the area of ​​direct physical contact between the incompatible ingredients; as stated in the advisory, the product contained “a famotidine core, an ibuprofen shell and an Opadry® White barrier layer in between”.

The district court concluded that the claimed claims (claims 1, 8, 11 and 14) of the ‘033 patent were invalid on the basis of obviousness and that the claimed claims (claims 1 to 3 and 8 to 10) of the’ 451 patent were not violated. Horizon appealed.

The Federal Circuit upheld the district court’s invalidity and non-violation rulings in an opinion from Judge Dyk joined by Justices O’Malley and Hughes. The district court’s decision on obviousness was based on US Patent Application Pub. n ° 2007/0043096 A1, which, according to Horizon, was not strictly speaking state of the art and the district court therefore erred in law in considering it as such. Since the relevant patents and the cited prior art patent application were filed before the enactment of the Leahy-Smith America Invents Act, the District Court and Federal Circuit applied the novelty provisions of the Act. Patent Act 1952 by finding the ‘096 application to be prior art. The ‘033 patent names the inventor Tidmarsh while the’ 096 application names Tidmarsh and a second inventor, Golombik. (In a footnote, the Federal Circuit explains that there were additional inventors named in each but their status did not need to be resolved because the resolution of Tidmarsh / Golombik’s inventor status was determinative.) At trial, Horizon moved under 35 USC § 256 to add Golombik as inventor of the ‘033 patent, a motion dismissed by the district court. Horizon’s argument on appeal was that if Tidmarsh and Golombik had invented formulations comprising 800 mg of ibuprofen and 26.6 mg of famotidine (as indicated in the ‘096 application), then the two inventors were necessarily also the inventors of the invention described and claimed in the’ 033 patent (which cites formulations comprising 800 mg of ibuprofen and 26.6 mg of famotidine). The Federal Circuit rejected this argument. The opinion notes that generally “inventors named in a granted patent are presumed correct” and this presumption can only be overcome in the face of clear and convincing evidence, citing Caterpillar Inc. v Sturman Indus., Inc., 387 F.3d 1358, 1377 (Fed. Cir. 2004). The mere testimony of an inventor is not sufficient to overcome this presumption, according to the Court, and “some form of corroboration must be shown”; see EmeraChem Holdings, LLC v Volkswagen Grp. Am., Inc., 859 F.3d 1341, 1346 (Fed. Cir. 2017) (similar considerations justify similar interference requirements; see, Medichem, SA v Rolabo, SL., 437 F.3d 1157, 1171 (Fed. Cir. 2006)). In addition, the opinion specifies that “[o]Our cases clearly show that inventing something in an earlier patent or patent application does not automatically make someone 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 not persuaded that Horizon relied 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 Pannu “[t]the only support for Golombik’s contribution to the ‘033 patent is the testimony of Tidmarsh and Golombik. “Non-specific”, “practical, unsubstantiated and not very credible”).

The Federal Circuit also rejected Horizon’s non-obviousness arguments by considering the ‘096 application to be appropriate prior art. These arguments were based on whether the skilled worker would have had a reasonable expectation of success in obtaining formulations having the stability of the claimed formulations. This expectation arose, according to the district court, as confirmed by the Federal Circuit, from another prior art reference which disclosed the use of the same “tablet-in-tablet” formulation claimed in the 033 patent. to achieve increased stability for drug combinations “similar to ibuprofen and famotidine” (as confirmed by expert testimony). The Federal Circuit also found no clear error in these district court decisions.

And the Federal Circuit rejected consideration of Horizon’s arguments regarding the non-infringement of the ‘033 patent as moot in light of their assertion of the invalidity of the claimed claims of the’ 033 patent.

Regarding the ‘451 patent, Horizon argued that the district court erred in interpreting the term “comprising” as cited in the barrier layer limitation claim to mean “consisting essentially of”. The Federal Circuit rejected this argument, first because the panel found that Horizon did not establish a detrimental error in its briefing, and second, “the prosecution history of the ‘451 patent supports the construction of the district court “. Specifically, the notice refers to “multiple discussions with the examiner” in which Horizon made changes to overcome prior art rejections that allegedly “focus on[ed] on an embodiment of the invention which uses Opadry® White (YS-1-7003) as a barrier layer. offense.

Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)
Unprecedented layout
Panel: circuit judges Dyk, O’Malley and Hughes
Opinion of Circuit Judge Dyk

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