Ibrutinib – USA

Ibrutinib – USA

On Nov. 15, 2022, Federal Circuit affirmed District court’s decision of infringement and validity.

 

Pharmacyclics LLC and Janssen Biotech (Plaintiffs) sued Alvogen, Inc., and Natco pharma (Defendants) for infringement as defendants filed ANDA to market generic version of Imbruvica (Ibrutinib). Pharmacyclics originally asserted dozens of claims across 17 patents, but by the time of trial, it had reduced the number of asserted claims to five from 4 patents: US 8,008,309 (compound); US 8,754,090 (Mantle cell lymphoma); US 9,725,455 (polymorph) and US 9,655,857 (composition). The district court held a bench trial and determined that all of the asserted claims were infringed and not invalid. You can read the detailed summary “here” on this blog.

 

On appeal, Alvogen challenged several of the district court’s determinations. First, Alvogen argues that the court erred in rejecting Alvogen’s written description and obviousness challenges to claim 2 of the ’090 patent. Second, Alvogen argues that the court erred in concluding that claim 5 of the ’455 patent was neither inherently anticipated nor obvious. Third, Alvogen argues that the court erred in rejecting Alvogen’s written description challenges to claims 30 and 37 of the ’857 patent. Fourth, Alvogen argues that the court erred in concluding that claim 10 of the ’309 patent was not anticipated by the Pan reference.

 

Federal Circuit, however, denied Alvogen’s challenges and found no clear error in district court’s decision. Court said that the dosage of “about 560 mg/day” recited in claim 2 of the ’090 patent is expressly recited by itself (rather than as part of a range) in the specification, and a 560 mg daily dose appears again in the specification’s discussion of Example 13. Therefore, claim 2 of the ’090 was adequately supported by the written description. With respect to obviousness, court held that to reach the claimed dose of about 560 mg, an artisan would need to conduct a study using pharmacodynamic endpoints,” which Alvogen’s combination of references did not disclose.

With respect to claim 5 of US’455 patent, court found no evidence that only Form A could have been used to achieve the results of the clinical study disclosed in Pollyea and Fowler. To the contrary, the court found that “a Phase I dose escalation study could be performed with amorphous ibrutinib or one of its metastable polymorphs,” and therefore that “Form A was not necessarily present in Pollyea or Fowler.”

With respect to claims 30 and 37 of the ’857 patent, court said that the precise ranges recited in the claims are found in formulations disclosed in the specification. Because the written description describes the ingredient amounts “by their respective weight concentrations,” and because the written description describes experiments conducted using BK21A at two different doses of ibrutinib, the district court correctly found that the written description “would have conveyed to [a skilled artisan] that the inventor had possession of the claimed subject matter.”

With respect to claim 10 of the ’309 patent, court said that Although Dr. Reider did not explicitly state that his students could have synthesized ibrutinib without undue experimentation, his testimony clearly conveyed that was the case. Moreover, it is clear that Intermediate 2 was not novel because it was disclosed in the WO ’829 publication. Court further said that “a skilled artisan could have synthesized Intermediate 2 and thus ibrutinib” without reference to WO ’829. Court held that patent is entitled to priority to provisional applications and therefore, claim 10 of the ’309 patent is not anticipated by the Pan article.

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