Posts Tagged: "Abbreviated New Drug Application"

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.

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.

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. 

The Federal Circuit’s decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, No. 2016-2707, addresses the complicated topic of patent eligibility in the pharmaceutical space. Much of the decision compares Vanda’s claims to those found ineligible for patent protection in the U.S. Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, 132 S. Ct. 1289 (2012). While the ultimate patentability conclusions are opposite, the claims in Vanda and Mayo are very similar, highlighting the thin—and often unpredictable—line that divides eligible and ineligible subject matter. Generic drug manufacturers must account for this unpredictability in gauging their litigation risks.

In 2017, U.S. district courts saw a total of 417 patent infringement suits related to ANDA filings made by drugmakers with the U.S. Food and Drug Administration (FDA) seeking to bring generic versions of brand-name pharmaceuticals to the U.S. market. This total number of ANDA cases was below recent highs set in 2014 (437 cases) and 2015 (475 cases) but it was also a significant increase over the 324 ANDA cases filed in 2016. Going back to 2009, 2017 saw the third-highest number of ANDA cases in a single year. The fact that ANDA litigation is rising is pretty consistent with the number of ANDA applications being received by the FDA. In 2017, the FDA approved a record number of ANDAs with 763 such approvals that year; the agency attributed this uptick to an increased number of agency hires.

35 U.S.C. § 271(e)(2) provides that it shall be an act of infringement to submit an Abbreviated New Drug Application (“ANDA”) “if the purpose of such submission is to obtain approval … to engage in the commercial manufacture, use, or sale of a drug … claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.” 35 U.S.C. § 271(e)(2). The statute requires that the infringement analysis focus on what is likely to be sold following FDA approval. Bayer AG v. Biovail Corp., 279 F.3d 1340, 1346 (Fed. Cir. 2002). The governing case law holds that this hypothetical inquiry is grounded in the ANDA application itself, the materials submitted in support thereof, as well as any other relevant evidence submitted by the applicant or patent holder. However, as reflected in the below discussion of key Federal Circuit case law examining the appropriate analytical approach, and the sorts of evidence properly considered, when assessing infringement in the ANDA context, these seemingly bedrock legal principles in reality fall by the way side and, therefore, neither patentees nor ANDA applicants should allow themselves to be lulled into a false sense of security through reliance on such verbiage.

Competitors like Mylan and Teva, rather than inventing better treatments or cures for dry eyes chose the shortcut. They attacked Allergan’s patent in the PTAB. Allergan responded by assigning their patent to the Saint Regis Mohawk Tribe who in turn invoked sovereign immunity at the PTAB, and demanded their rights in a real court with a real judge and jury. Mylan, Teva, the PTAB, Congress, and class action lawyers have formed a mob to gang up on Allergan for defending their intellectual property rights. They filed hundreds of suits accusing Allergan and the Tribe of fraud, conspiracy, and sham transactions stemming from an “invalid” patent. The attackers are mistakenly focusing on the patent as the problem. The problem is not the patent, but rather all of the incentives that reward copying instead of innovating.

Inherent obviousness cannot be based on what the inventor thought, and, in addition, the results in a particular case may not be inherently obvious depending on what was expected by a person of ordinary skill. The court pointed out “’the mere fact that a certain thing may result from a given set of circumstances is not sufficient’ to render the results inherent.” Millennium Pharmaceuticals, 2017 WL 3013204, at *6 (citations omitted by author). The court also held that it is never appropriate to consider “what the inventor intended when the experiment was performed,” even though Millennium “conceded as a matter of law that the ester is a ‘natural result’ of freeze-drying bortezomib with mannitol.” Id. Thus, hindsight reasoning should never be applied and, obviousness is “measured objectively in light of the prior art, as viewed by a person of ordinary skill in the invention.”

Lex Machina recently released a Hatch-Waxman/ANDA litigation report detailing trends and key findings from pharmaceutical cases filed in U.S. district courts between January 1st, 2009, and March 31st, 2017. More than eight years worth of data shows that patent infringement case filings in response to abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) declined in 2016 for the first time in three years.

A claim term can be limited to an embodiment described in the specification, if the claim would otherwise be found invalid and the embodiment was not disclaimed. Thus, a claim term with no ordinary meaning can be defined according to a single example in the specification, if the example provides “a clear objective standard” for that term.

American drugmakers Bristol Myers Squibb Co. (NYSE:BMY) and Pfizer, Inc. (NYSE:PFE) fired off a series of nine lawsuits to prevent generic versions of Eliquis, a treatment that helps reduce the risk of stroke in patients with atrial fibrillation. The lawsuits stem from abbreviated new drug applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) to market generic versions of apixaban, the anticoagulant agent used in Eliquis. The suits have all been filed in the U.S. District Court for the District of Delaware (D. Del.).

On April 6, 2017, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in The Medicines Company v. Mylan, Inc. (2015-1113, 2015-1151, and 2015-1181) that imports certain subject matter from the specification into the claims… This case provides some key takeaways for patent practitioners, some more obvious than others. First, as has been known for some time, referring to the “invention” in a patent’s specification can hurt, as can indicating that a particular process “includes all” of the embodiments the specification describes. This is why patents for inventions in the U.S. now curiously, if understandably, usually avoid using the word “invention”. Also, setting forth definitions in a specification can have unintended consequences not just for the term being defined but also for terms that are not explicitly defined even if unequivocally characterized in some other way. Prosecution history also matters too, particularly where an applicant distinguishes its invention during prosecution by explicitly characterizing “the invention” in terms divorced from the language of the claims themselves.

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.