PATENT CASE OF THE WEEK

Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories, FL, Inc., Appeal No. 2018-1221 (Fed. Cir. Aug. 15, 2019)

This week’s Case of the Week focuses on issues relating to written description and obviousness in a Hatch-Waxman litigation involving three patents covering extended-release tablets for the weight management drug Contrave®.

In this appeal from the U.S. District Court for the District of Delaware, Actavis challenged the district court’s opinion that the claims at issue were not invalid and would be infringed by Actavis’s ANDA product. Three patents were at issue in this appeal: the first, US Patent No. 8,916,195 (“the ’195 patent”) covers a method for treating obesity using a sustained-release formulation of bupropion and naltrexone, and requires that the claimed formulation have a specific in vitro dissolution profile; the second and third, US Patent Nos. 7,462,626 (“the ’626 patent”) and 7,375,111 (“the ’111 patent”) cover a method for treating obesity comprising diagnosing an individual, administering bupropion in an amount effective to induce weight loss, and administering naltrexone in an amount effective to enhance the activity of bupropion, and the sustained-release composition for same, respectively. The Court held that the district court did not err in finding the written description of the ’195 patent sufficient, but did err in finding that the claims at issue of the ’111 and ’626 patents would not have been obvious over the prior art.

As to written description, at the district court, Actavis argued that because the dissolution profile claimed by the ’195 patent was achieved using the USP Apparatus 2 Paddle Method (“USP 2”) but the specification disclosed data obtained using a different method—the USP Apparatus 1 Basket Method (“USP 1”)—the claim was invalid for lack of written description. The district court disagreed, finding the method used to achieve the claimed dissolution profile to be irrelevant to whether the inventors had possession of the invention, in part because a person of ordinary skill in the art would understand that the inventors possessed the invention, regardless of whether USP 2 or a “substantially equivalent method” was used to measure it. The Federal Circuit agreed.

In its analysis, the Court noted the “peculiarity” of the claim at issue in the ’195 patent, explaining that it begins by reciting a method of treating obesity by carrying out the specific, positive steps of administering a formulation of specific amounts of two drugs twice a day, and that the claim then records the dissolution data resulting from that formulation. The Court found that while as a general matter, written description may not be satisfied by an equivalent disclosure, in this case it was sufficient because it was buttressed by the district court’s fact finding, especially where, as here, the equivalence relates only to the resultant dissolution parameters rather than operative claim steps of administering the formulation. Thus, there was no clear error.

Chief Judge Prost dissented in part, disagreeing with the majority’s written description decision, finding that in holding so, the majority added a new rule that a “substantially equivalent” disclosure can satisfy written description when the relevant claim limitation “recites only ‘resultant dissolution parameters rather than operative claim steps.’”  Judge Prost explained that the written description requirement was not satisfied here first because the USP 2 clause is limiting since it does not merely state the inherent result of performing the manipulative steps, but rather, is part of the process itself. Indeed, the parties did not dispute that the USP 2 clause was limiting, and the original patent disclosure fails to literally or inherently disclose it. Judge Prost then explained that, while the inquiry should have ended there, the majority was further incorrect because the “substantially equivalent” rule is inconsistent with precedent—a substantially equivalent disclosure, even if it would render a claim limitation obvious, cannot satisfy the written description requirement. Finally, Judge Prost explained that the district court erred in finding the ’195 patent written description even includes such a “substantially equivalent” disclosure because the record contains no evidence of such, and instead, includes evidence that the two methods do not produce the same results.

As to obviousness, the Court, in reviewing the prior art asserted, held that every limitation of the claims at issue in the ’111 and ’626 patents was met by two references and that a person of ordinary skill in the art would have been motivated to combine two drugs that were well-known to affect weight loss. Further, as to secondary considerations, the Court held that the result of the inventors’ efforts—a combination drug that affected weight loss—could not have been unexpected. Thus, the district court clearly erred in holding the claims were not invalid.

The opinion can be found here.

ALSO THIS WEEK

Anza Technology, Inc. v. Mushkin, Inc., Appeal No. 2019-1045 (Fed. Cir. Aug. 16, 2019)

The Federal Circuit reversed a district court decision barring suit based on the statute of limitations, declining to apply the relation-back doctrine codified in Federal Rule 15. Anza had filed suit in March 2017 for infringement of the ’927 patent. Through the process of infringement contentions and mediation, Anza learned that defendant did not practice the ’927 patent. The court granted the motion to dismiss with leave to file an amended complaint. In June 2018, Anza filed an amended complaint alleging two different patents, dropped some of the accused products, and added two new accused products. The district court dismissed the amended complaint finding that the relation-back doctrine under Rule 15 did not apply because the allegations were not sufficiently related to each other. Because all accused infringing activity occurred more than 6 years prior to the filing of the amended complaint, the district court dismissed the case pursuant to the statute of limitations. The Federal Circuit reversed, finding this to be an “overly restrictive” application of the relation-back doctrine under Rule 15. It also held as a matter of first impression that the question was to be handled as a matter of Federal Circuit law, as opposed to the law of the regional circuit, and was subject to de novo review.

The opinion can be found here.

Iridescent Networks, Inc. v. AT&T Mobility, LLC, Appeal No. 2018-1449 (Fed. Cir. Aug. 12, 2019)

In an appeal from the United States District Court for the Eastern District of Texas on the ground that the District Court erred in its construction of the term “high quality of service connection,” the Federal Circuit affirmed the claim construction was proper. The Federal Circuit agreed that “high quality of service connection” was a term of degree that was not a known term of art, but rather a term coined by the patentee. Because the disputed term was a coined term, the specification and prosecution history are to be considered. In particular, the Federal Circuit found when the term was coined it was proper to look at the prosecution history for guidance without having to first find a clear and unmistakable disavowal.

The opinion can be found here.

Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Laboratories., Inc., Appeal Nos. 2018-1804, -1808, -1809 (Fed. Cir. Aug. 14, 2019)

The Federal Circuit vacated a district court’s declaratory judgment that certain pharmaceutical patent claims were obvious, because there was no case or controversy with respect to those claims when the district court issued its decision. At that time, the patent owner had filed a statutory disclaimer of the claims, following a parallel inter partes review decision finding them unpatentable. The patent owner had appealed the Patent Trial and Appeal Board’s denial of its motion to amend the claims, but not the decision finding the original claims invalid as obvious. The Federal Circuit vacated PTAB’s denial of the motion to amend, and in the instant appeal, rejected defendants’ argument that a potential issue preclusion defense as to any amended claims had preserved a case or controversy as to the disclaimed claims. The Court found that once the claims were disclaimed, the declaratory relief sought by defendants became both speculative and immaterial to any future preclusion defense. The Court also affirmed the district court’s judgment that another asserted patent was not obvious.

The opinion can be found here.

MTD Products, Inc. v. Iancu, Appeal No. 2017-2292 (Fed. Cir. Aug. 12, 2019)

In an appeal from an inter partes review, the Court addressed whether the Board erred in its conclusion that the claim term “mechanical control assembly … configured to” perform certain functions is not a means-plus-function term subject to 35 U.S.C. § 112, ¶ 6. The Court held that the Board erred by concluding that the term “mechanical control assembly” connotes specific structure to one of ordinary skill in the art in view of a Board finding that patentee’s specification described a specific structure for the “mechanical control assembly.” Given that claim scope may be different under 35 U.S.C. § 112, ¶ 6, on remand it may be possible for the Board to reach a different conclusion with respect to obviousness if the Board concludes on remand that the claim term is subject to 35 U.S.C. § 112, ¶ 6.

The opinion can be found here.

MyMail v. ooVoo, LLC, et al., Appeal Nos. 2018-1758 et al. (Fed. Cir. Aug. 16, 2019)

In this case arising from a district court’s judgment on the pleadings that patents were invalid as ineligible under Section 101, the Federal Circuit reversed. In rendering its decision, the district court had declined to construe one of the claim terms that MyMail had requested—a term that had previously been construed by the Eastern District of Texas in disputes concerning the patents there. The Federal Circuit found that to be error and remanded for the district court to consider the claim term and the parties’ opposing arguments on construction and the impact of the construction on its Section 101 analysis. Judge Lourie dissented. He would have held that the claims were ineligible for patenting. He opined that the claim construction dispute was “little more than a mirage.”

The opinion can be found here.