Litigation Details for Pfizer Inc. v. Aurobindo Pharma, Ltd. (D. Del. 2019)

Pfizer Inc. v. Aurobindo Pharma, Ltd. (D. Del. 2019)

Docket		Date Filed	2019-04-25
Court	District Court, D. Delaware	Date Terminated	2021-06-08
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Patents	6,936,612; 7,208,489; 7,456,168
Link to Docket	External link to docket

Details for Pfizer Inc. v. Aurobindo Pharma, Ltd. (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-04-25				External link to document
2019-04-25	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 6,936,612 B2 ;7,208,489 B2 ;7,456,168… 2019 8 June 2021 1:19-cv-00748 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation summary and analysis for: Pfizer Inc. v. Aurobindo Pharma, Ltd. (D. Del. 2019)

Based on the available search results, here is a summary and analysis of the patent litigation between Pfizer Inc. and Aurobindo Pharma:

Key Points:

1. Pfizer has filed multiple patent infringement lawsuits against Aurobindo Pharma and other generic drug manufacturers related to Pfizer's cancer drug Ibrance (palbociclib).

2. The lawsuits allege that Aurobindo and others are seeking FDA approval to market generic versions of Ibrance before Pfizer's patents expire.

3. Pfizer is asserting patents covering the composition and method of use for palbociclib that expire in 2023.

4. The cases have been filed in U.S. District Courts, primarily in Delaware.

5. Pfizer is seeking injunctions to prevent Aurobindo from commercially manufacturing or selling generic palbociclib until after patent expiration.

Analysis:

• These lawsuits are typical Hatch-Waxman patent litigation cases filed by brand-name drug companies against generic manufacturers seeking early market entry.

• Pfizer is trying to protect its blockbuster cancer drug Ibrance, which had nearly $5 billion in global sales in 2019.

• By filing the lawsuits, Pfizer triggers an automatic 30-month stay on FDA approval of the generic versions, buying time to assert its patent rights.

• The outcome will likely depend on whether Aurobindo can successfully challenge the validity of Pfizer's patents or prove non-infringement.

• Even if Pfizer prevails, its patent protection only extends to 2023, after which generic competition is expected to significantly impact Ibrance sales.

• For Aurobindo, successfully challenging the patents could allow earlier market entry and a potentially lucrative first-to-file exclusivity period for its generic version.

• The cases highlight the ongoing tensions between brand-name and generic drug companies in the pharmaceutical industry over patent protection and market exclusivity.

In summary, this litigation represents Pfizer's efforts to defend its patent rights and market exclusivity for a major cancer drug against generic competition from Aurobindo and others. The outcome could have significant financial implications for both companies.