Litigation Details for Astellas US LLC v. Wockhardt Bio AG (D. Del. 2018)

Astellas US LLC v. Wockhardt Bio AG (D. Del. 2018)

Docket		Date Filed	2018-10-25
Court	District Court, D. Delaware	Date Terminated	2020-03-23
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	Defendant	Referred To
Patents	8,106,183; 9,085,601
Attorneys	Kevin M. Yurkerwich
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Astellas US LLC v. Wockhardt Bio AG (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-10-25				External link to document
2018-10-25	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,106,183 ;9,085,601. (nmg) (…2018 23 March 2020 1:18-cv-01678 835 Patent - Abbreviated New Drug Application(ANDA) Defendant	External link to document

Litigation summary and analysis for: Astellas US LLC v. Wockhardt Bio AG (D. Del. 2018)

Based on the search results provided, here is a summary and analysis of the litigation between Astellas US LLC and Wockhardt Bio AG:

Key Facts:

• Case number: 1:18-cv-01678 in the U.S. District Court for the District of Delaware
• Plaintiffs: Astellas US LLC, Astellas Pharma US, Inc., and Gilead Sciences, Inc.
• Defendant: Wockhardt Bio AG (along with other Wockhardt entities)
• Filed in 2018
• Patent infringement case related to Abbreviated New Drug Application (ANDA)

Case Background: This case arose from Wockhardt's submission of an ANDA to the FDA seeking approval to market a generic version of Astellas/Gilead's drug Lexiscan (regadenoson). Astellas and Gilead alleged that Wockhardt's proposed generic product would infringe patents covering Lexiscan.

Key Issues:

1. Patent infringement of Lexiscan patents
2. Validity of the asserted patents
3. Whether Astellas LLC (as exclusive licensee) was a required party to the litigation

Key Rulings:

• The court ruled that Astellas LLC, as the exclusive licensee, was an indispensable party that needed to be joined to the case under Federal Rule of Civil Procedure 19.
• The court found that Astellas LLC would be prejudiced if not joined, as an adverse judgment could severely impact its exclusive license rights.
• The case was dismissed for failure to join Astellas LLC as a required party.

Analysis: This case highlights the complexities that can arise in pharmaceutical patent litigation, particularly regarding standing and necessary parties. As the exclusive licensee, Astellas LLC had significant interests at stake, even though it was not the patent owner. The court's ruling emphasizes the importance of joining all parties with substantial rights in the patents-in-suit.

The dismissal likely forced Astellas/Gilead to refile the case with Astellas LLC properly joined. This procedural hurdle may have delayed the litigation, potentially benefiting Wockhardt by pushing back any potential generic entry date.

More broadly, the case demonstrates how ANDA filers like Wockhardt can use procedural tactics to try to gain advantages in Hatch-Waxman patent litigation. Careful attention must be paid to ensuring all necessary parties are included from the outset of such cases.