Cabazitaxel – USA

Cabazitaxel – USA

On Jul. 08, 2022, Delaware district court issued report and recommendation on res judicata and concluded that Plaintiff cannot maintain its claims against Defendants for infringement of U.S. Patent No. 8,927,592.

 

Background:

The procedural history of this product is quite complex involving decisions from PTAB, district court and CAFC. Sanofi sells the drug JEVTANA® (cabazitaxel) for metastatic castration-resistant prostate cancer. Between 2014 and 2016, several drug manufacturers, including Defendants Apotex and Sandoz filed ANDAs and Sanofi sued them in New Jersey court for US 5,847,170 (compound) and US 8,927,592 (method of use) patents. While this case was pending, Mylan filed IPR of US’592 patent in PTAB. During institution PTAB held that preamble of independent claims 1 and 27 are non-limiting. Sanofi therefore filed motion to amend claims after institution and filed new claims 31-34 which are narrower and limiting to avoid prior arts. The PTAB issued a final written decision finding that original claims 1–5 and 7–30 of the ʼ592 patent were obvious and denying Sanofi’s contingent motion to amend. Sanofi appealed the denial of its contingent motion to amend. On appeal, the CAFC ruled that PTAB erred and remanded the case. On remand, the PTAB concluded that claims 31-34 are not obvious. Mylan appealed but CAFC affirmed PTAB.

On other side, New Jersey court continued trial and found that USʼ170 patent was valid and infringed and claims 21 and 30 of US’592 patent are obvious. Sanofi did not appeal the district court’s finding regarding US’592 patent. You can read the previous decisions here, here, here, here and here.

On Aug. 30, 2021, a few days after the PTO issued the certificate of amendment for the ’592 patent, Sanofi filed a Second Amended Complaint (SAC) against Defendants that added allegations of infringement of the substitute claims of the ʼ592 patent. On Sep. 13, 2021, Defendants Apotex and Sandoz filed their motion to dismiss the SAC. Defendants argued that the doctrine of claim preclusion bars Sanofi from asserting the ʼ592 patent against Defendants a second time.

 

Court analysis:

The prime question was – under what circumstances is a patentee’s assertion of amended claims that issued out of an IPR proceeding considered the same cause of action as a prior suit involving original claims in the same patent? District court cited 2 CAFC decisions in its analysis:

1. Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335, 1339–41 (Fed. Cir. 2012):

“Federal Circuit held that claim preclusion can bar a patentee from asserting the same patent in a second suit against the same defendant, even if the claims asserted in the second suit did not exist in the same form when the patentee filed the prior suit”. It held that even though the new claims could not have been asserted in the original actions, they did not qualify as a new cause of action because they were “not materially different” from other claims that were previously available.

2. Senju Pharm. Co. v. Apotex Inc., 746 F.3d 1344, 1347 (Fed. Cir. 2014):

“Majority of Federal Circuit reiterated Aspex’s holding that “claims that emerge from reexamination do not in and of themselves create a new cause of action that did not exist before.” It held that pursuant to the statutes governing reexamination, 35 U.S.C. §§ 132(a), 305 a reexamined patent claim cannot be broader than the original claim, so it “cannot contain within its scope any product or process which would not have infringed the original claims.”

 

District court said that there is no dispute that the new ʼ592 patent claims Sanofi obtained from the IPR proceeding are essentially original patent claims with at least two additional limitation. The new claims are a “subset” of original claims, therefore, “no new cause of action [was] created” by their issuance. Federal Circuit rejected several Sanofi’s arguments and granted defendants motion to dismiss claims involving the ʼ592 patent under res judicata.

 

 

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