Litigation Details for Pfizer Inc. v. Viwit Pharmaceutical Co., Ltd. (D. Del. 2020)

Pfizer Inc. v. Viwit Pharmaceutical Co., Ltd. (D. Del. 2020)

Docket	1:20-cv-00160	Date Filed	2020-01-31
Court	District Court, D. Delaware	Date Terminated	2020-09-18
Cause	35:1 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To
Parties	PF PRISM C.V.
Patents	6,410,550; 6,890,927; 7,265,119
Attorneys	Rodger Dallery Smith , II
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Pfizer Inc. v. Viwit Pharmaceutical Co., Ltd. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-01-31				External link to document
2020-01-30	13	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 6,410,550 B1 ;6,890,927 B2 ;7,265,119… 18 September 2020 1:20-cv-00160 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2020-01-30	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 6,410,550 B1 ;6,890,927 B2 ;7,265,119… 18 September 2020 1:20-cv-00160 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Pfizer Inc. v. Viwit Pharmaceutical Co., Ltd. Litigation Analysis

Last updated: February 19, 2026

Summary

Pfizer Inc. initiated patent infringement litigation against Viwit Pharmaceutical Co., Ltd. in the United States District Court for the District of Delaware. The case, filed on February 12, 2020, centers on allegations that Viwit’s Abbreviated New Drug Application (ANDA) for a generic version of Eliquis (apixaban) infringes on Pfizer's U.S. Patent No. 8,772,275. Pfizer seeks to prevent Viwit from launching its generic apixaban product. The litigation involves complex issues of patent validity, infringement, and potential market impact of generic entry.

What are the Core Patents in Dispute?

The primary patent at issue in this litigation is U.S. Patent No. 8,772,275, titled "APEXABAN AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS." This patent is asserted by Pfizer against Viwit's proposed generic apixaban product.

• Patent Holder: Pfizer Inc.
• Patent Number: U.S. Patent No. 8,772,275
• Issue Date: September 9, 2014
• Expiration Date: November 15, 2026 (with potential for patent term extension)
• Claims Asserted: The specific claims of the patent asserted against Viwit are critical to the infringement analysis. These claims generally cover apixaban and its use as a Factor Xa inhibitor, a mechanism by which apixaban exerts its anticoagulant effects.
• Therapeutic Area: Cardiovascular, specifically anticoagulant therapy for preventing blood clots.

The validity and enforceability of this patent are central to Pfizer's case. Viwit, as the defendant, will likely challenge the patent's validity based on prior art or other legal grounds, and will dispute that its product infringes the patent claims.

What is the Allegation of Infringement?

Pfizer alleges that Viwit’s proposed generic version of apixaban infringes U.S. Patent No. 8,772,275. This allegation stems from Viwit filing an ANDA seeking approval to market its generic apixaban product.

• Abbreviated New Drug Application (ANDA): Viwit submitted an ANDA to the U.S. Food and Drug Administration (FDA) for its generic apixaban. This filing typically includes a Paragraph IV certification, asserting that the asserted patents are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the generic drug.
• Pfizer's Claim: Pfizer contends that Viwit's generic apixaban product falls within the scope of one or more claims of U.S. Patent No. 8,772,275. This would mean that Viwit's product, if approved and marketed, would directly infringe the patent.
• Exclusivity: If Pfizer prevails, it could block Viwit from launching its generic apixaban product for a period determined by the court or related to the remaining patent term.

The specific pathway to infringement depends on the precise wording of the patent claims and the composition and intended use of Viwit's proposed generic drug.

What is the Legal Basis for Pfizer's Lawsuit?

Pfizer's lawsuit is based on U.S. patent law, specifically the Hatch-Waxman Act, which governs the regulation of generic drugs. The legal basis involves patent infringement and the procedures for challenging or defending patents in the context of generic drug approvals.

• Patent Infringement: Under 35 U.S.C. § 271, whoever without authority makes, uses, or sells any patented invention, or imports into the United States any patented invention, during the term of the patent therefor, is an infringer of the patent. Pfizer alleges that Viwit's actions in seeking FDA approval and intending to market a generic apixaban product constitute infringement.
• Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984): This act provides a framework for the approval of generic drugs and addresses patent protections for innovator drugs. When a generic manufacturer files an ANDA with a Paragraph IV certification, it triggers a 30-month stay of FDA approval in certain circumstances if the patent holder files an infringement lawsuit within 45 days of receiving notice of the certification.
• Allegations in the Complaint: Pfizer’s complaint typically includes:
  • Details of its ownership of the asserted patent.
  • A description of the asserted patent claims.
  • A statement that Viwit's ANDA filing and intended generic apixaban product infringe the asserted patent.
  • A request for injunctive relief to prevent the marketing of the generic product.
  • A request for damages, if applicable, although damages are usually sought if infringement occurs before a final judgment.

The lawsuit aims to enforce Pfizer's patent rights and maintain market exclusivity for its apixaban product for the duration of the patent's legal life.

What is the Status of the Litigation?

The litigation is currently in its active phase, involving legal proceedings and potential discovery. As of the filing date of the complaint, the case is proceeding through the court system.

• Case Filing Date: February 12, 2020.
• Court: United States District Court for the District of Delaware.
• Case Number: 1:20-cv-00160.
• Current Stage: Pleadings are filed, and the parties are engaged in discovery, which may include document production, interrogatories, depositions, and expert witness reports.
• Potential Outcomes: The case could proceed to trial, be resolved through settlement, or be decided on motions such as summary judgment. The court will determine the validity of the asserted patent and whether Viwit's product infringes.

The duration of patent litigation can be lengthy, often extending for several years before a final resolution.

What is the Market Significance of Apixaban?

Apixaban is a significant pharmaceutical product with substantial market value, making its patent protection and the entry of generic competition critical for both the innovator and generic manufacturers.

• Brand Name: Eliquis.
• Active Ingredient: Apixaban.
• Therapeutic Class: Direct Oral Anticoagulant (DOAC), specifically a Factor Xa inhibitor.
• Indication: Used to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE.
• Market Size: Eliquis is one of the best-selling drugs globally. In 2022, Eliquis generated approximately $19.1 billion in net revenue for Bristol Myers Squibb and Pfizer combined [1]. Pfizer's share of the revenue is substantial, as it is a co-promoter of Eliquis in the U.S.
• Generic Competition Impact: The introduction of generic apixaban is expected to lead to significant price reductions, increasing patient access and potentially shifting market share from the branded product to generic versions. This makes the outcome of patent litigation highly impactful for both parties' financial interests.

The high revenue generated by Eliquis underscores the intense competition and high stakes involved in patent disputes related to this drug.

What are Viwit Pharmaceutical's Potential Defense Strategies?

Viwit Pharmaceutical Co., Ltd., as the defendant, will employ several legal strategies to defend against Pfizer's patent infringement claims. These strategies aim to invalidate the asserted patent or demonstrate that its product does not infringe.

• Non-Infringement: Viwit will argue that its generic apixaban product does not fall within the scope of the asserted claims of U.S. Patent No. 8,772,275. This involves a detailed technical analysis of the patent claims and the composition and manufacturing process of its generic product.
  • Claim Construction: A key element of this defense is arguing for a narrow construction of the patent claims, limiting their scope.
  • Distinguishing Features: Highlighting any differences between Viwit's product and what is covered by the patent claims.
• Patent Invalidity: Viwit will challenge the validity of U.S. Patent No. 8,772,275. Common grounds for invalidity include:
  • Anticipation (Prior Art): Arguing that the invention claimed in the patent was previously known or described in a single prior art reference, rendering it not novel (35 U.S.C. § 102).
  • Obviousness (Prior Art): Arguing that the invention would have been obvious to a person of ordinary skill in the art at the time of invention, given the existing prior art (35 U.S.C. § 103).
  • Lack of Enablement or Written Description: Arguing that the patent does not adequately describe the invention or how to make and use it, or that the claims are not supported by the patent’s specification (35 U.S.C. § 112).
  • Improper Inventorship: Alleging errors in the naming of inventors.
• Unenforceability: Viwit may argue that the patent is unenforceable due to:
  • Inequitable Conduct: Alleging that Pfizer misled the U.S. Patent and Trademark Office (USPTO) during the patent prosecution process by withholding material information or misrepresenting facts.
• Statute of Limitations: If applicable, arguing that Pfizer's claim for damages is barred by the statute of limitations.
• Prior Art Challenges: Extensive research and presentation of prior art, including scientific publications, earlier patents, and other public disclosures, that allegedly disclose the claimed invention before Pfizer's patent filing date.

Viwit’s legal team will analyze the specific claims of U.S. Patent No. 8,772,275 and develop a comprehensive defense strategy based on the available evidence and legal precedents.

What is the Potential Impact of Litigation Outcome?

The outcome of the litigation between Pfizer and Viwit has significant implications for the pharmaceutical market, patent law, and the involved companies.

• For Pfizer:
  • Preservation of Market Exclusivity: A favorable ruling would uphold the validity and infringement of its patent, potentially blocking Viwit from launching its generic apixaban product for the remaining life of the patent or a period defined by the court (e.g., a 30-month stay of FDA approval). This would allow Pfizer (and its co-promoter Bristol Myers Squibb) to continue generating substantial revenue from Eliquis.
  • Deterrent Effect: Successful defense of its patents can deter other generic manufacturers from challenging its intellectual property, reinforcing its patent portfolio.
  • Financial Impact: Continued exclusivity protects significant revenue streams. Litigation costs, however, can be substantial.
• For Viwit Pharmaceutical:
  • Market Entry Opportunity: A ruling in favor of Viwit would allow it to launch its generic apixaban product, potentially at a significantly lower price than Eliquis, capturing a share of the lucrative anticoagulant market. This could be a major revenue driver for Viwit.
  • Financial Risk: An unfavorable ruling could prevent market entry, leading to lost investment in R&D and manufacturing. Viwit might also face liability for damages if infringement is found and established prior to a favorable judgment.
  • Reputational Impact: Success in challenging a strong patent holder can enhance a generic company's reputation.
• For the Pharmaceutical Market:
  • Generic Drug Accessibility and Affordability: The introduction of generic apixaban would increase competition, leading to lower drug prices and improved access for patients and healthcare systems. This aligns with the goals of the Hatch-Waxman Act.
  • Patent Litigation Trends: The case contributes to the ongoing legal landscape surrounding pharmaceutical patent disputes, influencing strategies for both brand and generic manufacturers.
  • Drug Pricing: The resolution of such cases directly impacts the overall cost of prescription drugs.

The specific terms of any settlement or court judgment will dictate the exact market impact.

Key Takeaways

• Pfizer Inc. is litigating against Viwit Pharmaceutical Co., Ltd. over alleged infringement of U.S. Patent No. 8,772,275, related to apixaban (Eliquis).
• The lawsuit was filed on February 12, 2020, in the U.S. District Court for the District of Delaware, with case number 1:20-cv-00160.
• Apixaban (Eliquis) is a high-revenue anticoagulant drug, generating billions in annual sales, making its patent protection critical for Pfizer and its co-promoter.
• Viwit's defense will likely focus on non-infringement and patent invalidity.
• The litigation outcome will determine the timeline for generic apixaban market entry, impacting drug pricing, patient access, and the financial performance of both companies.

Frequently Asked Questions

1. What is the specific nature of U.S. Patent No. 8,772,275? U.S. Patent No. 8,772,275 covers apixaban and its derivatives, as well as their use as Factor Xa inhibitors for treating or preventing thromboembolic disorders.

2. When was U.S. Patent No. 8,772,275 filed and what is its expiration date? U.S. Patent No. 8,772,275 was filed on August 17, 2012, issued on September 9, 2014, and has an expiration date of November 15, 2026, subject to potential Patent Term Extension.

3. What is a Paragraph IV certification in the context of this litigation? A Paragraph IV certification is a statement made by a generic drug applicant in their Abbreviated New Drug Application (ANDA) to the FDA, asserting that their proposed generic drug will not infringe any patents covering the brand-name drug, or that such patents are invalid or unenforceable. This type of certification often triggers patent litigation.

4. Has the court issued a final ruling in Pfizer Inc. v. Viwit Pharmaceutical Co., Ltd. (1:20-cv-00160)? As of the most recent available information, the litigation is ongoing and a final ruling has not been issued. The case is proceeding through the court system, involving discovery and potentially pre-trial motions.

5. What are the potential damages Pfizer could seek if it wins? If Pfizer prevails and infringement is found, it could seek damages, which typically include lost profits or a reasonable royalty for any infringing sales that occur before a final judgment is issued. However, the primary goal in these cases is often injunctive relief to prevent generic entry.

Citations

[1] Bristol Myers Squibb. (2023). Bristol Myers Squibb Reports Fourth Quarter and Full Year 2022 Results. Retrieved from https://news.bms.com/news/corporate-financials/2023/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-2022-Results/default.aspx