Posts Tagged: "ANDA"

Novartis Pharmaceuticals announced today that it will appeal the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) June decision invalidating its patent for a dosing regimen for its multiple sclerosis drug Gilenya to the U.S. Supreme Court, after the CAFC denied its request to rehear the case. The CAFC in June vacated a different three-judge panel’s January opinion upholding Novartis’ U.S. Patent No. 9,187,405. In the original ruling, Chief Judge Moore had dissented from the majority; in the rehearing, Moore authored the opinion vacating the January decision, with Judge Linn dissenting.

Last week, Patexia released its second annual ANDA Litigation Intelligence Report in which we covered the rankings, statistics and comprehensive analysis of abbreviated new drug application (ANDA) and Hatch-Waxman stakeholders. We couldn’t help but notice the decline in ANDA filing activity that has begun, after reaching its peak in 2018. Year-over-year comparison of the ANDA data, as seen in the following chart, shows the trend in the last four years. We observe a considerable decline from 2018 to 2019 (a decline of 4.2 cases/month) followed by a smaller decline from 2019 to 2020 (2.7 cases/month) and the sharpest decline from 2020 to 2021 (5.3 cases/month) indicated by the data analyzed for the first half of 2021. In total, this represents a decline in ANDA case filings of about 36% from 2017 to 2021. The same trend is noticed with the number of the patents involved in these cases.

Last week, the U.S. Court of Appeals for the Federal Circuit addressed a question of first impression regarding whether an act of patent infringement occurs in a Hatch-Waxman case “only when and where an ANDA-filer submits its ANDA to the FDA [Food and Drug Administration] or occurs wherever future distribution of the generic is contemplated.” Valeant Pharmaceuticals v. Mylan Pharmaceuticals. The court ultimately determined the answer to be the former; however, in the case of a foreign defendant, venue is proper in any judicial district. The court ultimately determined the answer to be the former; however, in the case of a foreign defendant, venue is proper in any judicial district. It was the first time the court has had a chance to address the question of where infringement occurs in an ANDA case since TC Heartland v. Kraft Food Group Brands.

Patent challenges are an indispensable part of the drug approval process under the provisions of the Hatch-Waxman Act (Hatch-Waxman). To gain early market access, multiple types of invention claims, ranging from compositions to method of use and from combinations to “kits”, are frequently challenged under the Hatch-Waxman provisions by abbreviated new drug application (ANDA) filers. However, challenges to claims for chemical compounds are quite rare compared to claims for other types of inventions. Though the overall approach for challenging any patent/claim remains broadly similar, a compound claim challenge involves a relatively different approach compare to other types of invention claims involved in the Hatch-Waxman context. The chief difference is the types of art that may be available for citation.

This week’s District Court filings were robust, with a dip in Patent Trial and Appeal Board (PTAB) filings–a big chunk of which were related to a dispute over robot vacuum cleaners. A few new (or renewed) assertion campaigns, a few small inter-company disputes, and a number of pharmaceutical disputes led the charge. I say Robot, you say vacuum:  Call it the great robot vacuum wars of 2020: industry leader iRobot sued SharkNinja for infringement of three patents (as well as false advertising)—seeking a preliminary injunction of a competing product right before the lucrative holiday season.  iRobot contended that SharkNinja had “brazenly ripped off” their Roomba robotic vacuum cleaners with their much less expensive IQ Robot competitor product.  That bid failed, and the case continued; now SharkNinja has filed multiple IPRs seeking to invalidate the asserted patents.

On October 9, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. affirming the U.S. District Court for the District of New Jersey’s findings of invalidity and noninfringement of certain claims of some of the asserted HZNP (Horizon) patents, as well as the district court’s finding of nonobviousness of one claim of another Horizon patent. The finding of nonobviousness means that Actavis, owned by generic drug maker Teva Pharmaceuticals, is enjoined from engaging in the commercial use, offer for sale, or sale of its product covered in its Abbreviated New Drug Application (ANDA) until the expiration of U.S. Patent No. 9,066,913 (the ‘913 patent) in 2027.

The Federal Circuit recently vacated a district court decision which found a patent for the antipsychotic drug “Saphris,” belonging to Forest Laboratories (Forest), valid as nonobvious, but not infringed by ANDA filers Alembic Pharmaceuticals Ltd. (Alembic) and Breckenridge Pharmaceuticals, Inc. (Breckenridge). See Forest Labs., LLC v. Sigmapharm Labs., LLC, Nos. 2017-2369, 2017-2370, 2017-2372, 2017-2373, 2017-2374, 2017-2375, 2017-2376, 2017-2389, 2017-2412, 2017-2436, 2017-2438, 2017-2440, 2017-2441, 2019 U.S. App. LEXIS 7485 (Fed. Cir. Mar. 14, 2019) (Before Prost, Dyk, and Moore, J.) (Opinion for the court, Moore, J.). The Court highlighted an unanswered question that the district court skimmed over at trial and took issue with a claim construction. The Court vacated and remanded for further proceedings on this basis. Alembic and Breckenridge were among a number of drug manufacturers that filed Abbreviated New Drug Applications (ANDA) to market generic versions of Saphris. Saphris is an antipsychotic containing asenapine maleate. Saphris is administered sublingually, meaning under the tongue. Forest sued the ANDA filers for patent infringement. At trial, the district court held that the relevant claims of asserted Patent No. 5,763,476 (“the ’476 patent”) were not invalid as obvious, and that Forest had not established infringement by Alembic or Breckenridge. Alembic and Breckenridge appealed the invalidity determination, and Forest cross-appealed the non-infringement decision as clearly erroneous. On appeal, the Federal Circuit vacated and remanded both the validity and infringement determinations for reconsideration under a correct claim construction of the term “excitation.”

The ‘650 patent covers a compound called fesoterodine, which is an antimuscarinic drug marketed as Toviaz® and used to treat urinary incontinence. Mylan Pharmaceuticals petitioned for IPR of the ‘650 patent alleging certain claims were obvious. After institution of the IPR, Amerigen and two other companies joined as parties to the proceeding. After the PTAB’s finding that the challenged claims were not unpatentable, Amerigen—but not Mylan—appealed the decision.

On appeal, UCB asserted Amerigen lacked standing. Specifically, UCB argued that, based on the Paragraph III certification accompanying Amerigen’s abbreviated new drug application (ANDA), the FDA will not approve Amerigen’s ANDA until the expiration of the ‘650 patent, previously upheld in a separate suit in the District of Delaware, in 2022. Consequently, UCB contends Amerigen is foreclosed from infringing the ‘650 patent, and without a possibility of infringement there can be no justiciable dispute.

The Federal Circuit rejected UCB’s argument for several reasons. First, this case did not arise under the Hatch-Waxman Act. Second, Amerigen did not rely a risk of infringement liability as a basis for injury. Rather, Amerigen pointed to a concrete commercial injury that it incurred from the listing of the ’650 patent in the Orange Book, which was only possible so long as the ’650 patent was not found invalid. Specifically, the listing of the ‘650 patent blocked the launch of Amerigen’s tentatively approved ANDA, and invalidation of the patent would advance its drug’s launch.

How the likelihood of success on the merits should (or should not) be determined and the four factors balanced in a patent infringement case, are areas in which there has been significant disagreement among the judges of the Federal Circuit… Whether or not to grant the extraordinary relief of preliminary injunction to a patentee is a matter largely within the discretion of the trial court. This discretion is to be exercised in consistence with traditional principles of equity, grounded on well-articulated principles, and based on long-held precedents.  Grant or denial of a preliminary injunction by a trial court may be overturned only upon a showing of abuse of discretion by the trial court.  Failing to consider the totality of the preliminary injunction factors during review can lead to an outcome inconsistent with the requirements of equity.

The United States Court of Appeals for the Federal Circuit recently affirmed a district court decision finding the ‘229 patent valid, unexpired, enforceable, and infringed, and granting an injunction until February 2019. Specifically, the Federal Circuit held that the ‘229 patent’s five-year term extension pursuant to 35 U.S.C. § 156 was valid, even though it effectively extended the term of a related patent. The Court also held that the ‘229 patent was not invalid based on obviousness-type double patenting because obviousness-type double patenting cannot invalidate a patent which has received a valid term extension. Novartis AG v. Ezra Ventures LLC, No. 2017-2284, (Fed. Cir. Dec. 7, 2018) (Before Moore, Chen, and Hughes, Circuit Judges) (Opinion for the court by Chen, Circuit Judge).

Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive available to the first generic manufacturer to file a paragraph IV challenge when the Orange Book drug patent is successfully invalidated in a subsequent district court proceeding. Therefore, the IPR process has provided generic manufacturers a dual track option for challenging Orange Book patents by initiating Hatch-Waxman litigation and also pursuing IPRs. Overall, because the rate of settlement in IPRs is much lower than in Hatch-Waxman litigation, both generic manufacturers and patent owners obtain more favorable final decisions in IPRs as compared to their Hatch-Waxman litigation outcomes.

The sole question on appeal was whether it would have been obvious to make zolmitriptan into a nasal spray. The Federal Circuit agreed with the district court that the prior art taught away from formulating zolmitriptan for intranasal administration.

Appellants were generic drug manufacturers who filed Abbreviated New Drug Applications (“ANDAs”), seeking approval for generic versions of Vimpat®. As a result, the Federal Circuit affirmed the district court’s ultimate conclusion that the asserted claims were not invalid.

Of the many lingering issues left in TC Heartland’s wake for domestic corporations, a Federal Circuit panel resolved several of them recently. In In re ZTE (USA), No. 2018-113, the court addressed two of the most common issues dogging appeals over the application of § 1400(b): whose law governs burden, and where does that burden lie. In In re Bigcommerce, No. 2018-120, the court addressed the territorial bounds mapped by the phrase “judicial district” in § 1400(b). Judge Linn authored both.