Litigation Details for Indivior Inc. v. Biodelivery Sciences International, Inc. (E.D.N.C. 2015)

Indivior Inc. v. Biodelivery Sciences International, Inc. (E.D.N.C. 2015)

Docket		Date Filed	2015-07-21
Court	District Court, E.D. North Carolina	Date Terminated	2023-03-09
Cause	35:271 Patent Infringement	Assigned To	James C. Dever III
Jury Demand	Both	Referred To
Parties	INDIVIOR INC.
Patents	6,159,498; 7,579,019; 8,147,866; 8,603,514; 8,703,177; 8,765,167; 9,522,188; 9,655,843; 9,931,305
Attorneys	AURORA CASSIRER
Firms	McCarter & English, LLP
Link to Docket	External link to docket

Details for Indivior Inc. v. Biodelivery Sciences International, Inc. (E.D.N.C. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-07-21				External link to document
2015-07-21	101	Opening Claim Construction Brief	Indivior Inc.. (Attachments: # 1 Exhibit A - Patent 8,765,167, # 2 Exhibit B - Pather Declaration, # 3 Exhibit… Exhibit E - Patent 5,881,476, # 6 Exhibit F - Rounds Declaration, # 7 Exhibit G - Patent 5,393,528, #…2010 Response to Office Action, # 9 Exhibit I - Patent 7,425,292) (Evans, E.) (Entered: 11/18/2021) … 21 July 2015 5:15-cv-00350 830 Patent Both District Court, E.D. North Carolina	External link to document
2015-07-21	103	Responsive Claim Construction Brief	U.S. Patent 8,603,514 B2, # 4 Exhibit M - U.S. Patent 8,900,497 B2, # 5 Exhibit N - U.S. Patent 9,931,305…2015 9 March 2023 5:15-cv-00350 830 Patent Both District Court, E.D. North Carolina	External link to document

Litigation Summary and Analysis for Indivior Inc. v. BioDelivery Sciences International, Inc.

Introduction

The litigation involving Indivior Inc. and BioDelivery Sciences International, Inc. is complex and involves multiple layers of patent disputes, particularly in the context of pharmaceutical products. Here, we will focus on the key aspects of the case, including the patents in question, the legal proceedings, and the outcomes.

Background on the Parties and Products

• Indivior Inc.: Indivior is known for its opioid addiction treatment product, Suboxone, which is available in both tablet and sublingual film forms. The sublingual film combines buprenorphine and naloxone and was the first such product to gain FDA approval in 2010[1].
• BioDelivery Sciences International, Inc.: BioDelivery Sciences is another pharmaceutical company involved in the development and marketing of various drug delivery systems.

Patent Disputes

The litigation primarily revolves around patent disputes related to pharmaceutical films and methods of making them.

Patents in Question

• The case involves several patents owned by Indivior, particularly those listed in the Orange Book as covering Suboxone Film. These patents pertain to pharmaceutical films and their manufacturing processes[1][4].

Infringement and Invalidity Claims

• Dr. Reddy's Laboratories, among other generic manufacturers, was involved in challenging the validity of Indivior's patents. These challenges were part of broader litigation that included BioDelivery Sciences International, Inc., although the specific case mentioned (5:15-cv-00350) does not directly involve Indivior vs. BioDelivery Sciences International, Inc.[1][4].

Legal Proceedings

The legal proceedings in these cases are multifaceted and involve various stages and forums.

District Court Decisions

• In the district court, decisions were made regarding the validity and infringement of Indivior's patents. For instance, the court found that certain claims were not invalid as obvious and that some defendants did not infringe on specific patents[1].

Inter Partes Review (IPR)

• The Patent Trial and Appeal Board (PTAB) played a significant role in these disputes through inter partes review proceedings. In one such proceeding, the PTAB held that certain claims of Indivior's patents were unpatentable as anticipated or obvious[4].

Federal Circuit Appeals

• The Federal Circuit Court of Appeals reviewed the decisions from both the district court and the PTAB. For example, in the appeal related to U.S. Patent 9,687,454, the Federal Circuit reviewed the PTAB's decision that certain claims were unpatentable and upheld some of these findings while reversing others[4].

Key Rulings and Outcomes

Several key rulings and outcomes are noteworthy in these cases.

SAS Institute v. Iancu Impact

• The Supreme Court's decision in SAS Institute v. Iancu (2018) had a significant impact on the proceedings. This decision clarified that if the Director institutes an inter partes review, the PTAB must review all claims challenged in the petition, not just a subset[3].

Patent Validity

• The PTAB and the Federal Circuit made detailed determinations on the patentability of various claims. For instance, in the case involving U.S. Patent 9,687,454, the PTAB found that claims 1–5, 7, and 9–14 were unpatentable as anticipated, while claim 8 was not found to be anticipated[4].

Infringement Findings

• The district court and Federal Circuit also addressed infringement claims. For example, Watson was found to infringe one of Indivior's patents, while other defendants were found not to infringe certain patents[1].

Analysis

The litigation highlights several important aspects of patent law and pharmaceutical industry disputes.

Patent Litigation Complexity

• The cases demonstrate the complexity of patent litigation, involving multiple patents, defendants, and legal forums. The interplay between district court decisions, PTAB reviews, and Federal Circuit appeals underscores the layered nature of these disputes.

Impact of SAS Institute v. Iancu

• The SAS Institute v. Iancu decision has had a profound impact on how inter partes reviews are conducted, ensuring that all challenged claims are reviewed, which can significantly affect the strategy and outcomes of patent disputes.

Market Implications

• The outcomes of these cases have significant implications for the market, particularly in the context of generic competition. The validity and infringement status of patents can delay or facilitate the entry of generic products, affecting both the innovator companies and generic manufacturers.

Key Takeaways

• Patent Validity and Infringement: The cases emphasize the importance of thorough patent validity and infringement analyses, involving both legal and technical expertise.
• Inter Partes Review: The role of the PTAB in inter partes review is crucial, and the SAS Institute v. Iancu decision has standardized the process to ensure all challenged claims are reviewed.
• Market Impact: The outcomes of these patent disputes can significantly impact the pharmaceutical market, influencing the availability and pricing of critical medications.

FAQs

Q: What is the main product involved in the Indivior Inc. patent disputes? A: The main product is Suboxone, a sublingual film used for opioid addiction treatment, combining buprenorphine and naloxone.

Q: What is the significance of the SAS Institute v. Iancu decision in these cases? A: The decision ensures that the PTAB must review all claims challenged in an inter partes review petition, not just a subset, which affects the strategy and outcomes of patent disputes.

Q: Which court has jurisdiction over appeals from PTAB decisions? A: The Federal Circuit Court of Appeals has jurisdiction over appeals from PTAB decisions.

Q: What is the role of the PTAB in inter partes review proceedings? A: The PTAB reviews the patentability of challenged claims and makes determinations on their validity.

Q: How do the outcomes of these patent disputes affect the pharmaceutical market? A: The outcomes can delay or facilitate the entry of generic products, affecting both innovator companies and generic manufacturers, and ultimately impacting the availability and pricing of medications.

Cited Sources

1. Indivior Inc. v. Dr. Reddy's Laboratories, S.A., No. 17-2587 (Fed. Cir. 2019)
2. Case 5:15-cv-06325-WB Document 137-2 Filed 05/06/20
3. United States Court of Appeals for the Federal Circuit, BIODELIVERY SCIS. INTL. v. AQUESTIVE THERAPEUTICS, INC.
4. Indivior UK Limited v. Dr. Reddy's Laboratories S.A., No. 20-2073 (Fed. Cir. 2021)