## Facts

- Navinta filed an ANDA seeking FDA approval to sell generic ropivacaine.
- Abraxis sued under 35 U.S.C. § 271(e)(2), alleging the ANDA product would infringe three patents relating to ropivacaine and its use.
- Legal title to the patents was held by Astra Lakemedel Aktiebolag (’086) and AstraZeneca AB (’524 and ’489), while a different Astra entity, AstraZeneca UK Limited (AZ-UK), executed the transaction documents with Abraxis.
- In a 2006 asset purchase agreement, AZ-UK agreed it “shall or shall cause” its affiliates to assign the patents to Abraxis; closing occurred while Astra affiliates still held legal title.
- On the closing date, AZ-UK executed an assignment purporting to transfer the patents to Abraxis even though AZ-UK did not yet own them.
- Abraxis filed the infringement complaint on March 8, 2007, when Astra affiliates still held legal title and no completed transfers to AZ-UK were in place.
- Also on March 8, 2007, Astra affiliates executed assignments transferring the patents to AZ-UK; later, AZ-UK executed a confirmatory assignment asserting Abraxis held all right, title, and interest.
- After a bench trial, the district court found infringement and entered judgment for Abraxis, including injunctive relief affecting ANDA approval/marketing.

## Issues

1. Whether Abraxis had Article III and statutory standing on the complaint’s filing date when the entity purporting to assign the patents to Abraxis did not yet hold legal title.
2. Whether contractual provisions, equitable ownership concepts, after-acquired title, or relation-back theories could cure any standing defect through later assignments.

## Decision

- The Federal Circuit vacated the district court’s judgment and remanded with instructions to dismiss for lack of subject-matter jurisdiction.
- The court held Abraxis lacked standing at filing because it did not possess legal title to the asserted patents and did not hold all substantial rights as an exclusive licensee.
- The court rejected the argument that post-filing or same-day assignments and confirmatory instruments could retroactively establish standing.
- The court did not reach infringement or validity.

## Legal Principles

- Patent standing must exist at the inception of the lawsuit; a plaintiff must hold legal title or be an exclusive licensee with all substantial rights when the complaint is filed.
- An “agreement to assign” (e.g., language that a party “shall assign” or “shall cause” affiliates to assign) generally does not effect a present transfer of patent title.
- State contract law may govern contract interpretation, but federal patent law governs whether an assignment transfers enforceable patent rights sufficient for standing.
- Later assignments, confirmatory documents, or after-acquired title theories cannot retroactively create Article III standing in a patent infringement action.

## Conclusion

Because Abraxis did not own the patents and did not hold all substantial rights when it filed suit, the Federal Circuit held the courts lacked subject-matter jurisdiction and required dismissal, regardless of later efforts to complete or confirm the chain of title.


Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359 (Fed. Cir. 2010)