Litigation Details for Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2015)

Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2015)

Docket		Date Filed	2015-09-08
Court	District Court, D. Delaware	Date Terminated	2017-07-28
Cause	35:0145	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Parties	MEDA PHARMACEUTICALS INC.
Patents	6,759,398; 7,629,335; 8,071,073; 8,163,723; 8,168,620; 9,259,428
Attorneys	Steven J. Balick
Firms	Shaw Keller LLP, I.M. Pei Building
Link to Docket	External link to docket

Details for Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (D. Del. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-09-08				External link to document
2015-09-08	101	Exhibit A	’428 Patent PH U.S. Patent No. 6,759,398 (see, e.g., Col. …00001339. U.S. Patent No. 6,759,398 (see, e.g., Col. … The ’620, 723, and ’428 patents arise from the same patent family and share substantially similar… ’723, and ’428 patents contain many of the same references. For citations to patents, the parties incorporate… MEDA_TEVA_00000733 (Non-Patent U.S. Patent No. 5,889,015 (see, e.g., Col.	External link to document
2015-09-08	104		("CoC") for U.S. Patent No. 9,259,428 ('" 428 patent") into this case. (D.I…inadvertent typographical errors" in the '428 patent. (D.I. 62 at 1) "On May 3, 2016, the PTO issued…requested Certificate of Correction for the '428 patent." (Id.) Plaintiffs explain that thereafter…indefiniteness arguments regarding claim 28 of '_428 patent, arguments that would be affected by introduction…litigating the uncorrected version of the '428 patent. (See D.I. 65 at 5) (discussing litigation that	External link to document
2015-09-08	113		of U.S. Patent Nos. 8,163,723; 8,168,620; and 9,259,428. With respect to the '428 patent, the PTO… claims 28-30 of the '428 patent, which, in the uncorrected patent, contain a typographical error…addressing construction of claims 28-30 of the '428 patent, within one week of the date of this order. Signed…additional exhibits are documents from the '428 patent's prosecution history, including a listing…in the,context of claims 28-30 of the '428 patent. 3. D~fendant opposes Plaintiffs	External link to document
2015-09-08	123		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,163,723; 8,168,620. (etg) (…2015 28 July 2017 1:15-cv-00785 830 Patent None District Court, D. Delaware	External link to document
2015-09-08	124		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,163,723; 8,168,620; 9,259,428…2015 28 July 2017 1:15-cv-00785 830 Patent None District Court, D. Delaware	External link to document

Litigation Summary and Analysis for Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.

Introduction

The litigation between Meda Pharmaceuticals Inc. and Teva Pharmaceuticals USA, Inc., while not the primary focus of the provided sources, is closely related to broader legal issues involving Teva Pharmaceuticals. To provide a comprehensive analysis, we will delve into the relevant aspects of Teva's legal challenges, particularly those involving patent infringement, antitrust violations, and regulatory compliance.

Background on Teva Pharmaceuticals

Teva Pharmaceuticals is a global pharmaceutical company that has been involved in numerous high-profile legal cases. Here, we will focus on the key litigation points that are relevant to understanding the broader legal landscape.

Patent Infringement: GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.

Overview of the Case

One of the significant cases involving Teva is the patent infringement dispute with GlaxoSmithKline (GSK) over the drug Coreg (carvedilol). This case, GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., revolves around Teva's generic version of Coreg and whether Teva's "skinny label" encouraged physicians to use the drug in a way that infringed on GSK's patent[4].

Key Findings

• The Federal Circuit court upheld the jury verdict that Teva was liable for induced infringement of GSK's patent. The court found that Teva's skinny label, along with its press releases and marketing materials, encouraged physicians to use the drug in a patented method[4].
• The majority opinion emphasized that substantial evidence supported the jury's finding that Teva intended to infringe on the patent. This decision was crucial as it reaffirmed the standard of review for induced infringement in the context of skinny label cases[4].

Implications

The decision in GSK v. Teva has significant implications for the pharmaceutical industry, particularly regarding the use of skinny labels by generic manufacturers. It sets a precedent that generic manufacturers must carefully carve out patented indications from their labels to avoid liability for induced infringement[4].

Antitrust and Regulatory Violations

False Claims Act (FCA) and Anti-Kickback Statute (AKS) Violations

Teva has also faced significant legal challenges related to antitrust and regulatory violations. In a recent settlement, Teva agreed to pay $450 million to resolve claims that it violated the FCA and AKS. The allegations included paying Medicare patients' copays for the multiple sclerosis drug Copaxone through third-party charitable foundations, which is prohibited by the AKS[5].

Price Fixing Allegations

Additionally, Teva was involved in a price-fixing scheme with other generic drug manufacturers. This led to a deferred prosecution agreement with the DOJ's Antitrust Division, resulting in a criminal penalty of $225 million and a civil settlement of $25 million[5].

Implications

These cases highlight the importance of compliance with antitrust laws and regulatory requirements. The settlements underscore the severe financial and reputational consequences that pharmaceutical companies can face for engaging in illegal practices.

Opioid Litigation

New York Opioid Trial

Teva has also been a defendant in opioid-related litigation. In a significant settlement, Teva agreed to pay up to $4.2 billion nationwide to settle opioid claims, with $523 million specifically secured by New York Attorney General James. This settlement included critical injunctive relief, such as bans on high-dose opioids, prohibitions on opioid marketing, and restrictions on political lobbying[1].

Implications

The opioid litigation against Teva and other pharmaceutical companies reflects the broader societal and legal response to the opioid epidemic. The settlements and injunctive relief aim to address the root causes of the crisis and prevent future abuses.

Conclusion

The litigation involving Teva Pharmaceuticals USA, Inc., particularly in the contexts of patent infringement, antitrust violations, and regulatory compliance, highlights several key points:

• Patent Infringement: The GSK v. Teva case sets a critical precedent for generic manufacturers regarding the use of skinny labels and the need to avoid inducing infringement of patented methods.
• Antitrust and Regulatory Compliance: Teva's settlements related to FCA and AKS violations, as well as price-fixing allegations, emphasize the importance of adhering to antitrust laws and regulatory requirements.
• Opioid Litigation: The opioid settlements underscore the legal and financial consequences for pharmaceutical companies implicated in the opioid epidemic.

Key Takeaways

• Generic manufacturers must carefully navigate patent laws to avoid induced infringement liability.
• Compliance with antitrust laws and regulatory requirements is crucial to avoid severe penalties.
• Pharmaceutical companies face significant legal and financial risks for their role in public health crises like the opioid epidemic.
• Injunctive relief can be a powerful tool in addressing systemic issues within the pharmaceutical industry.

FAQs

Q: What was the outcome of the GSK v. Teva patent infringement case? A: The Federal Circuit court upheld the jury verdict that Teva was liable for induced infringement of GSK's patent, affirming the decision that Teva's skinny label and marketing materials encouraged physicians to use the drug in a patented method[4].

Q: Why did Teva agree to pay $450 million in the FCA and AKS settlement? A: Teva agreed to pay $450 million to resolve allegations that it violated the FCA and AKS by paying Medicare patients' copays for the drug Copaxone through third-party charitable foundations and by conspiring to fix prices for certain generic drugs[5].

Q: What were the terms of Teva's settlement in the New York opioid trial? A: Teva agreed to pay up to $4.2 billion nationwide, with $523 million secured by New York Attorney General James. The settlement included critical injunctive relief such as bans on high-dose opioids and prohibitions on opioid marketing[1].

Q: What are the implications of Teva's legal challenges for the pharmaceutical industry? A: The cases highlight the importance of compliance with patent laws, antitrust regulations, and public health standards. They also underscore the severe financial and reputational consequences for non-compliance.

Q: How do these cases reflect broader societal and legal trends? A: These cases reflect a broader trend of increased scrutiny and legal action against pharmaceutical companies for their roles in public health crises and regulatory violations, emphasizing the need for strict compliance and ethical practices within the industry.

Sources

1. Attorney General James Secures $523 Million from Top Opioid Manufacturer Teva, Bringing Settlement Concludes New York Opioid Trial. New York State Attorney General. November 3, 2022.
2. JUDICIAL WATCH, INC. v. KERRY, No. 1:2015cv00785 - Document 58 (D.D.C. 2017). Justia.
3. in the united states district court for the district of delaware meda .... Insight.RPXcorp.com.
4. GSK v. Teva: Federal Circuit Opinion After Rehearing Confirms Induced Infringement Liability. Cooley. August 17, 2021.
5. Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims. AFSLaw. October 18, 2024.