Litigation Details for Pfizer Inc. v. Sun Pharmaceutical Industries Limited (D. Del. 2017)

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Pfizer Inc. v. Sun Pharmaceutical Industries Limited (D. Del. 2017)

Docket	⤷ Try for Free	Date Filed	2017-11-07
Court	District Court, D. Delaware	Date Terminated	2019-03-07
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	6,956,041; 6,965,027; 7,091,208; 7,265,221; 7,301,023; RE41,783
Link to Docket	External link to docket

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Biologic Drugs cited in Pfizer Inc. v. Sun Pharmaceutical Industries Limited

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Details for Pfizer Inc. v. Sun Pharmaceutical Industries Limited (D. Del. 2017)

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Date Filed	Document No.	Description	Snippet	Link To Document
2017-11-07				External link to document
2017-11-06	1		XR® that are not at issue: U.S. Patent Nos. 6,956,041 (expiring December 8, 2020); 6,965,027 (expiring…for infringement of United States Patent No. RE41,783 (the “’783 patent”). 2. This action …addressed U.S. Patent No. 6,965,027. The Orange Book also lists five additional patents for Xeljanz XR… The ’783 Patent 29. On September 28, 2010, the USPTO issued the ’783 patent, titled “Pyrrolo…pyrimidine Compounds.” The ’783 patent is a reissue of U.S. Patent No.	External link to document
2017-11-06	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) RE41,783 E. (crb) (Entered: …2017 7 March 2019 1:17-cv-01597 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
>Date Filed	>Document No.	>Description	>Snippet	>Link To Document

Pfizer v. Sun Pharmaceutical: A Comprehensive Analysis of the Patent Infringement Case

In the complex world of pharmaceutical patents and litigation, the case of Pfizer Inc. v. Sun Pharmaceutical Industries Limited (1:17-cv-01597) stands out as a significant legal battle. This article delves into the intricacies of this case, exploring its implications for the pharmaceutical industry and patent law.

The Genesis of the Lawsuit

The legal dispute between Pfizer and Sun Pharmaceutical began when Pfizer filed a lawsuit against Sun Pharmaceutical Industries Limited and Sun Pharmaceutical Industries, Inc. (collectively referred to as "Sun") for patent infringement. The case, filed in the United States District Court for the District of Delaware, centered around Sun's attempt to market a generic version of Pfizer's drug Xeljanz XR® (tofacitinib extended release tablets, 11 mg).

The Contested Patent

At the heart of this legal battle was United States Patent No. 9,937,181 (the '181 patent), owned by Pfizer. This patent covers the extended-release formulation of tofacitinib, the active ingredient in Xeljanz XR®. Pfizer alleged that Sun's filing of Abbreviated New Drug Application (ANDA) No. 209790 with the FDA, seeking approval to sell generic copies of Xeljanz XR®, constituted an act of patent infringement[5].

The Legal Grounds for Pfizer's Complaint

Pfizer's complaint against Sun was based on several key points:

Direct Infringement: Pfizer claimed that Sun's filing of ANDA No. 209790 was an act of direct infringement under 35 U.S.C. § 271(e)(2)(A).
Induced Infringement: Pfizer alleged that Sun Pharmaceutical Industries, Inc. induced infringement by actively participating in and directing the submission of the ANDA.
Future Infringement: Pfizer argued that Sun's intention to manufacture, use, offer for sale, and import generic versions of Xeljanz XR® would infringe on the '181 patent.

Pfizer's Prayer for Relief

In its complaint, Pfizer sought several forms of relief, including:

A judgment declaring Sun's actions as infringement
A permanent injunction against Sun
An order preventing FDA approval of Sun's ANDA before the expiration of the '181 patent
Attorneys' fees and costs

Sun Pharmaceutical's Position

While the available information doesn't provide detailed insights into Sun Pharmaceutical's defense, it's common in such cases for generic manufacturers to challenge the validity of the patent or argue non-infringement. Sun's strategy likely involved demonstrating that their generic product either didn't infringe on Pfizer's patent or that the patent itself was invalid.

The Significance of ANDA Filings in Pharmaceutical Patent Litigation

The case highlights the critical role of ANDA filings in pharmaceutical patent litigation. Under the Hatch-Waxman Act, filing an ANDA with a Paragraph IV certification (claiming that the brand-name drug's patents are invalid or not infringed) is considered an act of patent infringement, allowing brand-name manufacturers to sue before the generic product enters the market.

"This action arises out of Sun Pharmaceutical Industries Limited's filing of ANDA No. 209790 seeking approval by the FDA to sell generic copies of Xeljanz XR® (tofacitinib extended release tablets, 11 mg) prior to the expiration of the '181 patent."[5]

The Broader Context: Pfizer's Patent Protection Strategy

This case is not an isolated incident but part of Pfizer's broader strategy to protect its intellectual property. Pfizer has a history of vigorously defending its patents against generic manufacturers. For instance:

In 2013, Pfizer obtained a $2.15 billion settlement from Teva and Sun for infringement of its Protonix® patent[1].
Pfizer has also engaged in litigation with other generic manufacturers over various drugs, including Lyrica (pregabalin)[3].

The Economic Stakes

The economic implications of these patent battles are substantial. Brand-name drugs often generate significant revenue for pharmaceutical companies, and the entry of generic competitors can dramatically reduce these profits. For example, Xeljanz, the drug at the center of this case, generated global revenues of $2.44 billion for Pfizer in 2020.

The Role of Personal Jurisdiction in Patent Litigation

An interesting aspect of this case is the issue of personal jurisdiction. Pfizer argued that the court had personal jurisdiction over Sun due to its contacts with Delaware and its previous consent to the court's jurisdiction in other cases[5]. This highlights the complex jurisdictional issues that can arise in patent litigation involving multinational corporations.

The Intersection of Patent Law and FDA Regulations

This case exemplifies the intricate relationship between patent law and FDA regulations. The Hatch-Waxman Act, which governs the approval of generic drugs, creates a unique framework where patent litigation is triggered by regulatory filings (ANDA submissions) rather than actual market entry of infringing products.

The Impact on Generic Drug Availability

Cases like Pfizer v. Sun Pharmaceutical have significant implications for the availability of generic drugs. While patent protection incentivizes innovation by allowing pharmaceutical companies to recoup their R&D investments, it also delays the entry of cheaper generic alternatives. The outcome of such cases can directly affect drug prices and accessibility for patients.

The Resolution of the Case

While the specific details of the resolution are not provided in the available information, the case was closed on October 11, 2022, after 250 days of litigation[9]. The relatively short duration suggests that the parties may have reached a settlement, which is common in pharmaceutical patent cases.

Lessons for the Pharmaceutical Industry

This case offers several lessons for both brand-name and generic pharmaceutical companies:

The importance of robust patent portfolios for brand-name manufacturers
The need for careful patent analysis by generic manufacturers before filing ANDAs
The potential for litigation as a strategic tool in the pharmaceutical industry
The complex interplay between patent law, FDA regulations, and business strategy

The Future of Pharmaceutical Patent Litigation

As the pharmaceutical landscape continues to evolve, with increasing pressure to reduce drug prices and promote generic competition, cases like Pfizer v. Sun Pharmaceutical are likely to remain common. Future litigation may focus on emerging areas such as biosimilars and new drug delivery technologies.

Key Takeaways

The Pfizer v. Sun Pharmaceutical case (1:17-cv-01597) centered on alleged infringement of Pfizer's '181 patent for Xeljanz XR®.
The case highlights the strategic use of patent litigation in the pharmaceutical industry to protect market exclusivity.
ANDA filings play a crucial role in triggering patent infringement suits under the Hatch-Waxman Act.
The case demonstrates the complex interplay between patent law, FDA regulations, and business strategy in the pharmaceutical sector.
The resolution of such cases can have significant implications for drug pricing and accessibility.
As the pharmaceutical landscape evolves, patent litigation is likely to remain a key feature of the industry.

FAQs

Q: What was the main issue in the Pfizer v. Sun Pharmaceutical case? A: The main issue was Pfizer's allegation that Sun Pharmaceutical's ANDA filing for a generic version of Xeljanz XR® infringed on Pfizer's '181 patent.
Q: How long did the litigation last? A: The case lasted for 250 days, from February 4, 2022, to October 11, 2022.
Q: What is an ANDA? A: An ANDA (Abbreviated New Drug Application) is a submission to the FDA for approval to market a generic version of an approved drug.
Q: Why do pharmaceutical companies engage in patent litigation? A: Pharmaceutical companies engage in patent litigation to protect their market exclusivity, recoup R&D investments, and prevent generic competition.
Q: What impact do cases like this have on drug prices? A: These cases can delay the entry of generic drugs into the market, potentially keeping drug prices higher for longer periods.

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