Tag Archives: Apotex

Federal Circuit Affirms Tygacil Formulation Patent

In a non-precedential decision in Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline were invalid as obvious. Both the PTAB and Federal Circuit decisions show that while the … Continue reading this entry

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that 42 USC § 262(l)(8)(A) is a mandatory, stand-alone requirement. … Continue reading this entry

Biosimilar Pre-Marketing Notice Always Required

Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the statute requires a biosimilar applicant to give 180 days’ pre-marketing notice after FDA approval even if it has engaged in the BPCIA’s patent … Continue reading this entry

Amgen And Apotex Do The Biosimilar Patent Dance

Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have invoked the BPCIA, this may be the first one in which the patent dance provisions have been followed.… Continue reading this entry

Apotex Has Standing Despite Benicar Patent Disclaimer

In Apotex Inc. v. Daiichi Sankyo, Inc., the Federal Circuit held that Apotex has standing to seek a declaratory judgment that it does not infringe Daiichi Sankyo’s patent, even though Daiichi Sankyo has disclaimed the patent such that there can be no infringement as a matter of law. The court reached this decision because only … Continue reading this entry

Federal Circuit Finds Apotex ANDAs Do Not Infringe Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either Apotex’s or Watson’s Abbreviated New Drug Applications (ANDAs). In this article, I focus on the decision relating to the Apotex ANDAs, and … Continue reading this entry

Federal Circuit Upholds Inequitable Conduct Defense Against Apotex Patent

In Apotex Inc. v. UCB, Inc., the Federal Circuit upheld the district court’s finding that Apotex’s patent is unenforceable due to inequitable conduct. While affirming on the ground of “but-for materiality,” the Federal Circuit noted that the inventor’s conduct “at a minimum, come[s] close to the type of affirmative misconduct” that can “justify finding inequitable … Continue reading this entry

Federal Circuit Uses Dependent Claims To Construe "Therapeutically Effective Amount"

In Alcon Research, Ltd. v. Apotex Inc., the Federal Circuit held that most claims of Alcon’s patent were obvious in view of prior art that suggested the use of the recited active agent to treat the recited condition, but not by the recited mechanism of action, because the prior art used a concentration of active … Continue reading this entry

When Words Matter: Drug Labels vs. Kit Labels

The Federal Circuit decision in AstraZeneca LP v. Apotex, Inc. reveals an interesting dichotomy in the role of printed material in pharmaceutical patent disputes. On the one hand, the court found that proposed labeling for Apotex’s drug product supported a claim of induced infringement, while on the other it confirmed that the labeling included in AstraZeneca’s kit … Continue reading this entry