Litigation Details for ACADIA Pharmaceuticals Inc. v. Aurobindo Pharma Limited (D. Del. 2020)

ACADIA Pharmaceuticals Inc. v. Aurobindo Pharma Limited (D. Del. 2020)

Docket		Date Filed	2020-07-24
Court	District Court, D. Delaware	Date Terminated	2024-05-07
Cause	35:271 Patent Infringement	Assigned To	Gregory B. Williams
Jury Demand	None	Referred To
Parties	HETERO LABS LIMITED
Patents	10,028,944; 10,188,632; 10,449,185; 10,517,860; 10,646,480; 10,849,891; 10,953,000; 11,007,179; 11,090,291; 11,160,792; 11,229,627; 11,452,721; 6,756,393; 6,815,458; 7,115,634; 7,601,740; 7,659,285; 7,732,615; 7,741,356; 7,786,158; 7,863,296; 7,923,564; 8,344,011; 8,618,130; 8,691,860; 8,921,393; 9,115,091; 9,296,694; 9,364,489; 9,566,271; 9,675,587; 9,789,125
Attorneys	Kenneth Laurence Dorsney
Firms	Saul Ewing Arnstein & Lehr LLP
Link to Docket	External link to docket

Details for ACADIA Pharmaceuticals Inc. v. Aurobindo Pharma Limited (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-07-24				External link to document
2020-07-24	1	Complaint	States Patent Nos. 7,601,740 (“the ’740 patent”), 7,732,615 (“the ’615 patent”), 10,449,185 (“the ’185…’185 patent”), and 10,646,480 (“the ’480 patent”) (collectively “the patents-in-suit”). This action arises… of the ’740 patent is attached as Exhibit A. 26. ACADIA owns the ’740 patent. 27.…of the ’615 patent is attached as Exhibit B. 28. ACADIA owns the ’615 patent. 29.… of the ’185 patent is attached as Exhibit C. 30. ACADIA owns the ’185 patent.	External link to document
2020-07-24	12	Patent/Trademark Report to Commissioner of Patents	,923,564 ;8,618,130 ;8,921,393 ;9,566,271 ;10,028,944 . (Dorsney, Kenneth) (Entered: 09/01/2020) 1… Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,659,285 ;7,923,564…July 2020 7 May 2024 1:20-cv-00985 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-07-24	117	Stipulation-General (See Motion List for Stipulation to Extend Time)	16 of U.S. Patent No. 10,646,480, Claim 3 of U.S. Patent No. 10,449,185, and Claims…8 of U.S. Patent No. 10,646,480 and Claim 1 of U.S. Patent No. 10,449,185; and … of the ’480 patent, the ’185 patent, and the ’891 patent with respect to … lubricant” appearing in Claims 1 and 6 of U.S. Patent No. 10,849,891; • “a D90 particle…Claims 7 and 11 of U.S. Patent No. 10,849,891; 38842524.2 Case 1:20-cv-00985-RGA Document	External link to document
2020-07-24	122	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,601,740 ;7,732,615 ;10,449,185 ;10,517,860…July 2020 7 May 2024 1:20-cv-00985 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-07-24	125	Claim Construction Chart	United States Patent Nos. 10,449,185 (“the ’185 patent”); 10,646,480 (“the ’480 patent”); and 10,849,…U.S. Patent No. 10,449,185 B U.S. Patent No. 10,646,480 C U.S. Patent No. …for certain terms of the ’185 patent, the ’480 patent, and the ’891 patent. In addition to their proposed… Copies of the ’185 patent, the ’480 patent, and the ’891 patent, and portions of the intrinsic…construction ’480 patent specification: pimavanserin tartrate ’480 patent specification:	External link to document

Acadia Pharmaceuticals Inc. v. Aurobindo Pharma Limited: A Comprehensive Litigation Summary and Analysis

Case Overview

The litigation between Acadia Pharmaceuticals Inc. and Aurobindo Pharma Limited, et al., involves a complex series of patent disputes related to Acadia's drug product Nuplazid® (pimavanserin tartrate). Here is a detailed summary and analysis of the key aspects of this case.

Background and Context

Nuplazid® is a drug used for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. Acadia Pharmaceuticals Inc. holds several patents related to this drug, which are listed in the FDA's "Orange Book."[2][3][4]

Nature of the Case

The case, filed under the Hatch-Waxman Act, revolves around Aurobindo Pharma Limited's filing of an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Nuplazid® before the expiration of Acadia's listed patents. This led to a patent infringement lawsuit in the United States District Court for the District of Delaware[2][3][5].

Key Patents and Claims in Dispute

U.S. Patent No. 7,601,740 ('740 patent)

This patent, issued on October 13, 2009, is crucial in the litigation. It includes claim 26, which recites a tartrate salt of pimavanserin. The defendants argued that this claim was invalid due to obvious-type double patenting (OTDP) in light of claim 5 of U.S. Patent No. 9,566,271 ('271 patent)[2][4].

U.S. Patent No. 9,566,271 ('271 patent)

This patent, issued on February 14, 2017, includes a method for treating hallucinations by administering the tartrate salt of pimavanserin. The defendants contended that this patent rendered claim 26 of the '740 patent invalid for OTDP[2][4].

U.S. Patent No. 11,452,721 ('721 patent)

In a related dispute, the court was asked to construe claims 1 and 4 of this patent, which pertains to granulated pimavanserin compositions. The defendants argued that previous rulings on predecessor patents should apply to this patent, while Acadia argued that the '721 patent has a broader claim scope[1].

Legal Issues and Rulings

Obvious-Type Double Patenting (OTDP)

The central issue was whether claim 26 of the '740 patent was invalid due to OTDP in light of claim 5 of the '271 patent. The court had to interpret 35 U.S.C. § 121, which provides a safe harbor for divisional applications to protect against OTDP.

• Safe Harbor Protection: The court ruled in favor of Acadia, finding that the '271 patent was filed "as a result of" the original '740 patent application. This meant that the safe harbor of § 121 applied, protecting the '740 patent from OTDP invalidity[2][4].

Claim Construction of the '721 Patent

The court was tasked with construing claims 1 and 4 of the '721 patent. The key points included:

• Granules with Excipients: The court found that claim 1 of the '721 patent explicitly contemplates pimavanserin granulated with pharmaceutically acceptable excipients, unlike the predecessor patents[1].
• Blended Composition: The court determined that a "blended pimavanserin composition" does not require an "extra-granular" component, aligning with Acadia's argument[1].

Patent Term Adjustments and Extensions

The '740 patent had significant patent term adjustments (PTA) and extensions (PTE) due to USPTO and FDA delays. It received 1,249 days of PTA and 1,315 days of PTE, extending its patent term substantially[3].

Contingent Terminal Disclaimer

In a separate development, the USPTO rejected a "contingent" terminal disclaimer filed by Acadia Pharmaceuticals Inc. The USPTO stated that conditional disclaimers, whether terminal or statutory, are not allowed under the relevant statutes[3][4].

Conclusion and Implications

The litigation highlights the complexities of patent law, particularly in the pharmaceutical industry. Acadia's success in defending its patents against generic challenges underscores the importance of careful patent drafting, claim construction, and the strategic use of safe harbor provisions.

Key Takeaways

• Safe Harbor Protection: The safe harbor provision under 35 U.S.C. § 121 can protect original and divisional patents from OTDP if filed before the issuance of the other patent.
• Claim Construction: The language of the claims is crucial in determining the scope of patent protection.
• Patent Term Adjustments: Delays by the USPTO and FDA can significantly extend the life of a patent.
• Conditional Disclaimers: The USPTO does not allow contingent or conditional disclaimers.

Frequently Asked Questions

1. What is the main issue in the litigation between Acadia Pharmaceuticals Inc. and Aurobindo Pharma Limited?

The main issue is whether Aurobindo Pharma Limited's ANDA filing infringes on Acadia's patents for Nuplazid®, specifically focusing on the validity of certain claims under obvious-type double patenting.

2. What is the significance of 35 U.S.C. § 121 in this case?

Section 121 provides a safe harbor that protects divisional applications from obvious-type double patenting, which was crucial in the court's decision to uphold the validity of Acadia's '740 patent.

3. How did the court construe claims 1 and 4 of the '721 patent?

The court found that claim 1 of the '721 patent includes pimavanserin granulated with excipients, and a "blended composition" does not require an extra-granular component.

4. What is the impact of patent term adjustments and extensions on the '740 patent?

The '740 patent received significant extensions due to USPTO and FDA delays, extending its patent term by 1,249 days (PTA) and 1,315 days (PTE).

5. Why did the USPTO reject Acadia's contingent terminal disclaimer?

The USPTO rejected the disclaimer because the statute does not allow for conditional disclaimers, whether they are terminal or statutory.

Cited Sources:

1. Acadia Pharm. v. Aurobindo Pharma., C. A. 22-cv-1387-GBW (D. Del. Dec. 13, 2023)
2. Acadia Pharms. Inc. v. Aurobindo Pharma Ltd. | Robins Kaplan LLP
3. USPTO Rejects "Contingent" Terminal Disclaimer - JD Supra
4. Safe Harbor Protection: Acadia Pharms., Inc. v. Aurobindo Pharma Ltd.
5. ACADIA Pharmaceuticals Inc. v. Aurobindo Pharma Limited et al