PATENT CASE OF THE WEEK 

Grunenthal GMBH v. Alkem Labs., Ltd., Appeal Nos. 2017-1153, -2048, -2049, -2050 (Fed. Cir. Mar. 28, 2019)

This week the Federal Circuit issued a rare decision concerning the utility doctrine in patent law. In general, patents are issued for inventions that are new, useful, and nonobvious. Sections 102 and 103, respectively, cover the “new” and “nonobvious” requirements, whereas the “useful” requirement is subsumed within Section 101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor …”

As the Court noted this week, however, “[t]he bar for utility is not high.” “A patent fails to satisfy the utility requirement under 35 U.S.C. § 101 only if the invention is ‘totally incapable of achieving a useful result.’” Id. (citing Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F2d 1555, 1571 (Fed. Cir. 1992)).

The utility requirement involves two prongs—“specific and substantial utility.” The specific utility prong is satisfied when the claimed invention “provide[s] a well-defined and particular benefit to the public.” Id. (citing In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005)). The substantial utility requirement, also known as “practical utility,” “is satisfied when ‘the claimed invention has a significant and presently available benefit to the public.’” Id. The issue of utility is a question of fact. Courts have found the utility prong to be not satisfied in only rare cases.

In the instant case, the patent at issue claimed a pharmaceutical—the “Form A polymorph of the chemical compound tapentadol hydrochloride and a method of treating pain and/or urinary incontinence.” The Form B polymorph was known in the art, and was known “to have an analgesic effect suitable for the treatment of pain.” The patent specification states that “Crystalline Form A … has the same pharmacological activity as Form B but is more stable under ambient conditions.” The defendants argued that this failed to provide “a well-defined and particular benefit to the public” over Form B.

The Federal Circuit held that this argument was without merit, noting that the patent discloses the crystalline Form A is used for the treatment of pain or the treatment of urinary incontinence, and therefore fulfills a benefit to the public.

The defendants argued that to show substantial utility, there had to be a benefit over Form B, and that it had to be proven by test data. The Court disagreed, saying that this would “set too high a bar” for purposes of utility. The Court noted that test data may be useful, but that they are not required. “All that is necessary is evidence that a POSA would accept the claimed utility as correct.” In this case, such evidence was presented: expert testimony confirmed that Form A was more stable at room temperature than Form B. The Court held that “it is sufficient that Form A is shown to be stable at room temperature and useful for pain relief.”

The Court also heard decided issues relating to obviousness, including reasonable expectations of success and the “obvious to try” doctrine, in addition to induced infringement in the context of ANDA cases and method claims concerning instructions for use of the pharmaceutical in question. In sum, the Court affirmed the district court.

The opinion can be found here.

ALSO THIS WEEK

Endo Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2017-1240, -1455, -1887 (Fed. Cir. Mar. 28, 2019)

In this appeal from the United States District Court for the District of Delaware, the Federal Circuit addressed issues relating to 35 U.S.C. § 101 and whether the patent claims at issue were directed to natural law. The district court held that the claims were ineligible because they were directed to the “reaction of the human body of a renally impaired individual to oxymorphone, which is unquestionably a natural law.” The Federal Circuit reversed, however, because under the Alice/Mayo test, claims that recite a “specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome” are not directed to a patent-ineligible concept, i.e., claims that merely “embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” The Court emphasized that the claims at issue were directed to “more than just reciting the natural relationship” between oxymorphone and patients with renal impairment—rather, they were directed to an application of that relationship, requiring specific steps to adjust or lower the dose. And further, the result of the claims here is not simply “an observation or detection”; rather, the result is a new and useful method of treating pain in patients with impaired renal function.

The Court held that the claims were “legally indistinguishable” from other claims that have subsequently been found eligible for patenting in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018). See our write-up of that case here.

See also Natural Alternatives Int’l v. Creative Compounds, LLC, 2019 WL 1216226 (Fed. Cir. Mar. 15, 2019), which we covered as our Case of the Week two weeks ago, here.

The opinion can be found here.

ChargePoint, Inc. v. SemaConnect, Inc., Appeal No. 2018-1739 (Fed. Cir. Mar. 28, 2019)

In a third Section 101 case issued this week, the Federal Circuit affirmed dismissal of a complaint for infringement of four patents concerning the “Internet of Things,” finding the asserted claims were patent-ineligible under 35 U.S.C. § 101. The patents generally described electric vehicle charging stations connected to a network. The Court explained that while “reliance on the specification must always yield to the claim language in identifying th[e] focus” of the claims, the shared specification of the asserted patents illuminated that the problem addressed by the invention was a “need for a communication network which facilitates finding the recharging facility, controlling the facility, and paying for the electricity consumed.” Notwithstanding other technical details recited in the specification, the Court found the broad claims of the patents, reciting, e.g., communicating requests to and from a remote server, including doing so “as part of the demand response system,” were directed to “nothing more than the abstract idea of communication over a network for interacting with a device, applied to the context of electric vehicle charging stations,” and that such communications are a “building block of the modern economy” as described in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014).

The Court also applied Fourth Circuit regional law to find that the Court did not err in dismissing the complaint with prejudice and entering judgment without providing an opportunity to amend, or an express analysis of why amendment would be futile, where appellant did not seek leave to amend.

The opinion can be found here.

Artic Cat Inc. v. GEP Power Products, Inc., Appeal Nos. 2018-1520, -1521 (Fed. Cir. Mar. 26, 2019).

In an appeal from an inter partes review of patents concerning power distribution modules for personal recreational vehicles, the Federal Circuit addressed three arguments raised by the Patent Owner that the PTAB erred by: (a) expunging from the record the full transcript of the inventor’s deposition, (b) finding that certain preamble language was not limiting, and (c) finding an earlier filed patent was prior art to the patents at issue. For arguments (a) and (b), the Federal Circuit agreed with the PTAB. However, the Court found that the PTAB erred in finding the earlier filed patent was prior art because it applied too rigid of a standard for diligence. Here, even though the prior art patent was filed seven months before the priority date, the inventor conceived the invention and diligently reduced it to practice prior to the filing date of the prior art patent. Consequently, the earlier filed patent was not prior art. Therefore, with respect to one of the patents in issue, the Court reversed in part, vacated in part, and remanded for further proceedings consistent with its opinion. The Court affirmed the PTAB’s decision with respect to the second patent at issue.

The opinion can be found here.

Tek Global, S.R.L. v. Sealant Sys. Int’l, Inc., Appeal No. 2017-2507 (Fed. Cir. Mar. 29, 2019)

In an appeal following a jury trial, the Court addressed appeals concerning claim construction, motions for new trial, judgment as a matter of law on invalidity, non-infringement and damages, and the district court’s issuance of a permanent injunction. This is the second appeal in this case. See 616 F. App’x 987 (Fed. Cir. 2015). In the first appeal, the Court reversed the Court’s claim construction and provided guidance concerning how that construction was to be applied to the invalidity case. The district court apparently misunderstood the Federal Circuit’s mandate, and excluded a particular combination from trial. The Federal Circuit remanded for the limited purposes of trying the additional obviousness combinations.

The Court affirmed the district court’s other decisions, in the event the claims are found valid. The term “conduit” was held not to be a nonce term because it described sufficiently definite structure. The Court also addressed when a comparison between the accused product and a product embodying the patent may be appropriate. The Court also held lost profit damages to be supported by substantial evidence, and affirmed the permanent injunction.

The opinion can be found here.