Case Overview
The litigation between ACADIA Pharmaceuticals Inc. and Aurobindo Pharma Limited, filed as Case No. 1:22-cv-01387 in the US District Court for the District of Delaware, involves a complex patent dispute related to the drug Nuplazid® (pimavanserin tartrate)[2][4].
Nature of the Suit
The case is a patent infringement action under 35 U.S.C. § 271, specifically arising from Aurobindo's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Nuplazid®. ACADIA alleges that Aurobindo's generic product infringes on several of its patents[2][4].
Patents-in-Suit
The litigation involves multiple patents, including U.S. Patent No. 10,849,891 ('891 patent), U.S. Patent No. 10,646,480 ('480 patent), and U.S. Patent No. 11,321,721 ('721 patent). Additionally, there are disputes related to U.S. Patent No. 7,601,740 ('740 patent)[1][3][4].
Key Disputes and Court Rulings
Claims 1 and 4 of the '721 Patent
A significant dispute revolves around the interpretation of claims 1 and 4 of the '721 patent. The court ruled that these claims do not require the "granule" to consist solely of pimavanserin; instead, the granule can contain pimavanserin along with other pharmaceutical excipients. This ruling was based on the claim language and the specification of the patent, which explicitly contemplate the use of excipients in forming granules[1].
Blended Pimavanserin Composition
Another key issue was whether the "blended pimavanserin composition" must contain both a granular and an extra-granular component. The court determined that the composition does not require an extra-granular component, aligning with ACADIA's interpretation that the claims only necessitate a mixture of pharmaceutical ingredients, including at least one or more excipients[1].
Obvious-Type Double Patenting (OTDP)
In a related dispute involving the '740 patent, Aurobindo argued that claim 26 of this patent was invalid due to OTDP, citing a later-issued patent (the '271 patent). However, the court granted ACADIA's summary judgment motion, ruling that the '740 patent was protected under the safe harbor provision of 35 U.S.C. § 121 because it was filed as a divisional application before the issuance of the other patent[3].
Jurisdiction and Venue
The court has jurisdiction over the case pursuant to 28 U.S.C. §§ 1331 and 1338(a), and venue is proper in the District of Delaware due to Aurobindo's substantial business activities and presence in the state, including through its wholly owned subsidiary, Aurobindo USA[4].
Previous Agreements and Stipulations
Prior to the current litigation, ACADIA and Aurobindo had stipulated to noninfringement of the '480 and '891 patents under the court's construction of various terms. Aurobindo reserved the right to reassert any such defenses in the future, including in the event of an appeal[4].
Current Status and Relief Sought
ACADIA seeks various forms of relief, including a finding of infringement, an injunction against Aurobindo's generic product, monetary damages with prejudgment interest, a declaration that the case is exceptional and an award of attorneys’ fees, and reimbursement of costs and expenses incurred in prosecuting the action[4].
Key Takeaways
- Patent Interpretation: The court's rulings on the '721 patent clarify that the claims do not limit the granules to containing only pimavanserin and do not require an extra-granular component in the blended composition.
- OTDP: The court's decision on the '740 patent highlights the importance of the safe harbor provision under 35 U.S.C. § 121 in protecting divisional applications from OTDP.
- Jurisdiction and Venue: The case underscores the significance of a defendant's business activities and presence in determining jurisdiction and venue.
- Relief Sought: ACADIA's comprehensive relief seeks to protect its patent rights and compensate for any infringement.
FAQs
Q: What is the main drug product at the center of this litigation?
A: The main drug product is Nuplazid® (pimavanserin tartrate), a medication used to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
Q: Which patents are primarily involved in this case?
A: The primary patents involved include U.S. Patent No. 10,849,891, U.S. Patent No. 10,646,480, U.S. Patent No. 11,321,721, and U.S. Patent No. 7,601,740.
Q: What was the court's ruling on the composition of the granules in claims 1 and 4 of the '721 patent?
A: The court ruled that the granules do not need to consist solely of pimavanserin and can include other pharmaceutical excipients.
Q: Did the court find any of ACADIA's patents invalid due to obvious-type double patenting?
A: No, the court did not find any of ACADIA's patents invalid due to OTDP, specifically protecting the '740 patent under the safe harbor provision of 35 U.S.C. § 121.
Q: Why is the venue for this case in the District of Delaware?
A: The venue is in the District of Delaware due to Aurobindo's significant business activities and presence in the state, including through its subsidiary Aurobindo USA.
Sources Cited
- Acadia Pharm. v. Aurobindo Pharma., C. A. 22-cv-1387-GBW
- ACADIA Pharmaceuticals Inc. v. Aurobindo Pharma Limited et al
- Acadia Pharms. Inc. v. Aurobindo Pharma Ltd. - Robins Kaplan LLP
- Case 1:22-cv-01387-GBW Document 1 Filed 10/21/22
