DCT

2:10-cv-02272

Baker v. Novartis Pharma Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:10-cv-02272, W.D. Tenn., 06/16/2011
  • Venue Allegations: Venue is alleged to be proper in the Western District of Tennessee because the accused products were advertised, offered for sale, and sold within the district.
  • Core Dispute: Plaintiff brings a qui tam action alleging that Defendants violated 35 U.S.C. § 292 by marking various pharmaceutical and veterinary products with patent numbers after those patents had expired, with the intent to deceive the public.
  • Technical Context: The patents at issue cover a range of pharmaceutical technologies, including antibiotics, antiparasitic compounds for veterinary use, glaucoma treatments, and chemotherapy drugs.
  • Key Procedural History: No significant procedural events are mentioned in the complaint.

Case Timeline

Date Event
1972-04-13 U.S. Patent No. 3,910,924 Priority Date
1972-05-25 U.S. Patent No. 4,748,234 Priority Date
1975-10-07 U.S. Patent No. 3,910,924 Issued
1979-11-29 U.S. Patent No. 4,278,674 Priority Date
1980-01-02 U.S. Patent No. 4,309,432 Priority Date
1981-07-14 U.S. Patent No. 4,278,674 Issued
1982-01-05 U.S. Patent No. 4,309,432 Issued
1983-11-25 U.S. Patent No. 4,547,520 Priority Date
1984-03-28 U.S. Patent No. 4,569,790 Priority Date
1984-10-17 U.S. Patent No. 4,530,787 Priority Date
1984-12-06 U.S. Patent No. 4,572,798 Priority Date
1984-12-21 U.S. Patent No. 4,853,332 Priority Date
1985-02-07 U.S. Patent No. 4,959,314 Priority Date
1985-03-21 U.S. Patent No. 4,604,377 Priority Date
1985-07-23 U.S. Patent No. 4,530,787 Issued
1985-10-15 U.S. Patent No. 4,547,520 Issued
1986-02-11 U.S. Patent No. 4,569,790 Issued
1986-02-25 U.S. Patent No. 4,572,798 Issued
1986-08-05 U.S. Patent No. 4,604,377 Issued
1988-05-31 U.S. Patent No. 4,748,234 Issued
1989-08-01 U.S. Patent No. 4,853,332 Issued
1990-09-25 U.S. Patent No. 4,959,314 Issued
1993-01-19 U.S. Patent No. 3,910,924 Expired (alleged)
1999-11-29 U.S. Patent No. 4,278,674 Expired (alleged)
2000-01-02 U.S. Patent No. 4,309,432 Expired (alleged)
2004-03-17 U.S. Patent No. 4,530,787 Expired (alleged)
2004-03-21 U.S. Patent No. 4,604,377 Expired (alleged)
2004-03-28 U.S. Patent No. 4,569,790 Expired (alleged)
2004-12-06 U.S. Patent No. 4,572,798 Expired (alleged)
2005-07-02 U.S. Patent No. 4,547,520 Expired (alleged)
2006-03-25 U.S. Patent No. 4,748,234 Expired (alleged)
2006-08-01 U.S. Patent No. 4,853,332 Expired (alleged)
2007-09-25 U.S. Patent No. 4,959,314 Expired (alleged)
2011-06-16 Second Amended Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 4,278,674 - "Substituted 14-desoxy-mutilin compositions," issued July 14, 1981

The Invention Explained

  • Problem Addressed: The patent does not explicitly state a problem in its background section but describes the general field of pleuromutilins, a class of chemical compounds known for their antibiotic effects (’674 Patent, col. 1:12-14).
  • The Patented Solution: The invention provides new pleuromutilin derivatives and their salts, which are described as having an antibacterial effect (’674 Patent, Abstract; col. 8:60-65). The patent claims compositions of matter based on a core chemical formula for these new antibiotic compounds (’674 Patent, col. 21:1-6).
  • Technical Importance: The invention relates to the development of new antibiotic compounds, a field of significant importance for treating bacterial infections in both humans and animals (’674 Patent, col. 8:60-65).

Key Claims at a Glance

  • The complaint does not assert specific claims for infringement, as the action is for false marking under 35 U.S.C. § 292. The action concerns the marking of a product with the patent number itself after the patent's expiration (Compl. ¶¶ 35-38).

U.S. Patent No. 4,547,520 - "5-oxime derivatives of milbemycins and veterinary and agricultural use thereof," issued October 15, 1985

The Invention Explained

  • Problem Addressed: The patent background identifies a class of compounds known as milbemycins, which have anthelmintic and acaricidal activities, and notes the discovery of new derivatives with improved properties (’520 Patent, col. 1:8-13, 54-62).
  • The Patented Solution: The invention discloses novel 5-oxime derivatives of milbemycins, which are described as having valuable anthelmintic, acaricidal, and insecticidal activity (’520 Patent, Abstract; col. 2:35-43). The invention is directed to new chemical compounds and compositions useful for treating parasites in animals and plants (’520 Patent, col. 2:28-48).
  • Technical Importance: The patented compounds provide new tools for veterinary and agricultural parasite control, addressing a significant market need for effective treatments against helminths, acarids, and insects (’520 Patent, col. 7:5-8:2).

Key Claims at a Glance

  • The complaint does not assert specific claims for infringement, as the action is for false marking under 35 U.S.C. § 292. The action concerns the marking of a product with the patent number itself after the patent's expiration (Compl. ¶¶ 47-50).

Multi-Patent Capsule: U.S. Patent No. 3,910,924 - "3,4-Dihydrocarbostyril derivatives and a process for preparing the same," issued October 7, 1975

Technology Synopsis

The patent describes novel 3,4-dihydrocarbostyril derivatives that exhibit a blocking activity on β-adrenergic nerves (’924 Patent, Abstract). These compounds are presented as useful pharmaceuticals for treating conditions such as arrhythmia and coronary sclerosis (’924 Patent, col. 2:25-44).

Asserted Claims

No specific claims asserted for infringement; action is for false marking (Compl. ¶¶ 59-62).

Accused Features

The product "Ocupress®" is alleged to have been marked with the ’924 Patent number after its expiration (Compl. ¶¶ 17, 61-62).

Multi-Patent Capsule: U.S. Patent No. 4,309,432 - "Compositions for treating glaucoma containing a carbostyril," issued January 5, 1982

Technology Synopsis

The patent discloses compositions for treating glaucoma that contain carbostyril derivatives (’432 Patent, Abstract). The invention is based on the finding that these compounds are effective for reducing intraocular pressure (’432 Patent, col. 2:22-33).

Asserted Claims

No specific claims asserted for infringement; action is for false marking (Compl. ¶¶ 71-74).

Accused Features

The product "Ocupress®" is alleged to have been marked with the ’432 Patent number after its expiration (Compl. ¶¶ 17, 73-74).

Multi-Patent Capsule: U.S. Patent No. 4,530,787; 4,569,790; 4,604,377; 4,748,234; 4,572,798; 4,853,332; and 4,959,314

Technology Synopsis

This group of seven patents relates to recombinant DNA technology for producing proteins, specifically interferons and interleukin-2 (IL-2), and methods for their purification and formulation (’787 Patent, Abstract; ’790 Patent, Abstract). These proteins are used in immunotherapy and chemotherapy for treating cancers and other diseases (’234 Patent, col. 4:10-15; Compl. ¶12).

Asserted Claims

No specific claims asserted for infringement; action is for false marking (Compl. ¶¶ 19-20).

Accused Features

The chemotherapy drug "Proleukin®" is alleged to have been marked with all seven of these patent numbers after their respective expirations (Compl. ¶19).

III. The Accused Instrumentality

Product Identification

"Denagard®", "Milbemite®", "Ocupress®", and "Proleukin®" (Compl. ¶11).

Functionality and Market Context

  • "Denagard®" is described as a broad-spectrum antibiotic for the control and treatment of certain swine bacterial diseases (Compl. ¶12).
  • "Milbemite®" is a veterinary product described as a solution for the treatment of feline ear mites (Compl. ¶12).
  • "Ocupress®" is an eye drop used to treat open-angle glaucoma and elevated eye pressure in humans (Compl. ¶12). The complaint alleges that the product's packaging and/or labeling has been marked with expired patents (Compl. ¶¶ 62, 74).
  • "Proleukin®" is a chemotherapy drug used for advanced renal cell cancer or advanced melanoma (Compl. ¶12). The complaint alleges the product's packaging and labeling has been marked with seven different expired patents (Compl. ¶19). A reference is made to the "Proleukin®" label as evidence of this marking (Compl. ¶86).

IV. Analysis of False Marking Allegations

The complaint does not allege patent infringement but rather false marking under 35 U.S.C. § 292, based on the marking of products with expired patents. The central factual allegation for each product is that the marking continued after the patent's statutory term ended.

Accused Product Marked With Patent Alleged Patent Expiration Date Core Allegation (Violation of 35 U.S.C. § 292) Complaint Citation
"Denagard®" U.S. Pat. No. 4,278,674 November 29, 1999 Continued use of improper patent markings after expiration with the intent to deceive the public. ¶¶ 13, 14, 36
"Milbemite®" U.S. Pat. No. 4,547,520 July 2, 2005 Continued use of improper patent markings after expiration with the intent to deceive the public. ¶¶ 15, 16, 48
"Ocupress®" U.S. Pat. No. 3,910,924 January 19, 1993 Continued use of improper patent markings after expiration with the intent to deceive the public. ¶¶ 17, 18, 60
"Ocupress®" U.S. Pat. No. 4,309,432 January 2, 2000 Continued use of improper patent markings after expiration with the intent to deceive the public. ¶¶ 17, 18, 72
"Proleukin®" U.S. Pat. Nos. 4,530,787; 4,569,790; 4,604,377; 4,748,234; 4,572,798; 4,853,332; 4,959,314 Various dates in 2004, 2006, 2007 Continued use of improper patent markings after expiration with the intent to deceive the public. ¶¶ 19, 20
  • Identified Points of Contention:
    • Factual Question: The primary factual question will be whether Defendant Novartis continued to mark, or cause to be marked, the identified products with the specified patent numbers after the alleged expiration dates.
    • Legal Question (Intent): The central legal question will be whether the alleged marking was done "with the intent of counterfeiting or imitating the mark of the patentee, or of deceiving the public" as required by 35 U.S.C. § 292(a). The dispute will likely focus on what evidence exists to establish this specific intent.

VI. Other Allegations

  • Intent to Deceive Allegations: The complaint alleges that the false marking was committed with the intent to deceive competitors and the public, and to gain a competitive advantage (Compl. ¶¶ 2, 14, 16, 18, 20). The factual basis for this allegation of intent includes:
    • Defendant Novartis is a "sophisticated company with many decades of experience applying for and obtaining patents" and therefore knows that patents expire (Compl. ¶¶ 23, 41, 53).
    • Defendant allegedly employs an in-house legal department responsible for intellectual property and marketing law, and is therefore aware of the requirements of 35 U.S.C. § 292 (Compl. ¶¶ 24, 25, 41).
    • The complaint alleges that Defendant "knew" that the patents had expired at the time it was marking the products (Compl. ¶¶ 27, 39, 51, 63).
    • The alleged effect of the marking was to discourage or deter competitors from commercializing competing products, thereby quelling innovation and price competition (Compl. ¶22).

VII. Analyst’s Conclusion: Key Questions for the Case

This case appears to turn on two central questions for the court, one factual and one concerning the defendant's state of mind:

  • A core factual question will be one of timing: Can the plaintiff produce evidence demonstrating that specific articles (e.g., individual boxes of "Denagard®") were marked with the expired patent numbers after the dates on which those patents are alleged to have expired?
  • A key legal question will be one of culpability: Assuming the marking of expired patents is proven, can the plaintiff establish that Novartis acted with the specific "intent to deceive the public" required by 35 U.S.C. § 292, as opposed to the marking being the result of an oversight, administrative error, or reliance on a mistaken belief about patent term?