DCT

1:16-cv-01114

Allergan Sales LLC v. Teva Pharma USA Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-01114, D. Del., 11/30/2016
  • Venue Allegations: Venue is asserted based on Defendants being incorporated in Delaware, having consented to jurisdiction in Delaware through registration or prior litigation conduct, or having systematic and continuous contacts with the district.
  • Core Dispute: Plaintiffs allege that Defendants' filing of Abbreviated New Drug Applications (ANDAs) to market generic versions of Plaintiffs' Linzess® (linaclotide) capsules constitutes an act of infringement of nine U.S. patents.
  • Technical Context: The patents relate to linaclotide, a peptide agonist of the guanylate cyclase C (GC-C) receptor, used for treating gastrointestinal disorders such as irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
  • Key Procedural History: The asserted patents are listed in the U.S. Food and Drug Administration's publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book") for Linzess®. The complaint notes that U.S. Patent No. 7,704,947 underwent an inter partes reexamination, with a certificate issued on April 3, 2014, which may suggest that the claims of this patent have been scrutinized and confirmed over prior art challenges.

Case Timeline

Date Event
2003-01-28 Earliest Priority Date (’036, ’727, ’947, ’409, ’526, ’553, ’030 Patents)
2007-12-04 U.S. Patent No. 7,304,036 Issued
2008-05-13 U.S. Patent No. 7,371,727 Issued
2010-04-27 U.S. Patent No. 7,704,947 Issued
2010-06-29 U.S. Patent No. 7,745,409 Issued
2011-12-20 U.S. Patent No. 8,080,526 Issued
2012-02-07 U.S. Patent No. 8,110,553 Issued
2012-08-23 Earliest Priority Date (’573, ’628 Patents)
2014-04-03 Inter Partes Reexamination Certificate Issued for '947 Patent
2014-06-10 U.S. Patent No. 8,748,573 Issued
2014-08-12 U.S. Patent No. 8,802,628 Issued
2015-01-13 U.S. Patent No. 8,933,030 Issued
2016-10-17 Aurobindo Submitted ANDA No. 209611 (on or before this date)
2016-10-21 Teva Submitted ANDA No. 209568 (on or before this date)
2016-11-01 Sandoz Submitted ANDA No. 209630 (on or before this date)
2016-11-02 Mylan Submitted ANDA No. 209564 (on or before this date)
2016-11-30 Complaint Filed

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

No probative visual evidence provided in complaint.

U.S. Patent No. 7,304,036 - "Methods And Compositions For The Treatment Of Gastrointestinal Disorders," Issued Dec. 4, 2007

The Invention Explained

  • Problem Addressed: The patent addresses Irritable Bowel Syndrome (IBS), a common chronic intestinal disorder characterized by abdominal pain and disturbed bowel patterns, for which there was a "tremendous unmet medical need" due to a lack of prescription treatment options at the time of invention (U.S. Pat. No. 7,304,036, col. 1:26-44).
  • The Patented Solution: The invention provides peptides that activate the guanylate cyclase C (GC-C) receptor in the intestine. This activation is described as increasing intestinal motility and decreasing visceral pain, thereby treating IBS and other gastrointestinal disorders (U.S. Pat. No. 7,304,036, col. 2:12-41, Abstract). The core of the invention is the identification and use of specific peptide sequences, such as linaclotide, to achieve this therapeutic effect.
  • Technical Importance: This approach provided a targeted mechanism for treating the complex symptoms of IBS, moving beyond general laxatives or antispasmodics to a receptor-specific therapy.

Key Claims at a Glance

  • Asserted Independent Claim: Claim 1
  • Essential Elements of Claim 1:
    • A purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31)
    • or a pharmacologically acceptable salt thereof.
  • The complaint asserts infringement of Claims 1-70 against Defendants Teva, Mylan, and Sandoz (Compl. ¶32, ¶41, ¶50).

U.S. Patent No. 7,371,727 - "Methods And Compositions For The Treatment Of Gastrointestinal Disorders," Issued May 13, 2008

The Invention Explained

  • Problem Addressed: Similar to the ’036 Patent, this patent addresses the need for effective treatments for IBS and other gastrointestinal disorders, which are described as being among the most common disorders diagnosed by gastroenterologists and primary care physicians (U.S. Pat. No. 7,371,727, col. 1:16-24).
  • The Patented Solution: This patent claims methods of treating gastrointestinal disorders by administering a pharmaceutical composition containing specific peptides that activate the GC-C receptor. The claimed method provides a therapeutic application for the peptide compositions, focusing on the act of administration to a patient to alleviate GI disorder symptoms (U.S. Pat. No. 7,371,727, Abstract, col. 2:13-24).
  • Technical Importance: This patent secures protection not just for the compound itself, but for the specific medical use of the compound, a critical aspect of pharmaceutical patent strategy.

Key Claims at a Glance

  • Asserted Independent Claim: Claim 1
  • Essential Elements of Claim 1:
    • A method of treating a patient for a gastrointestinal disorder.
    • The method comprises administering to the patient a pharmaceutical composition.
    • The composition comprises a purified polypeptide which comprises a specific amino acid sequence with several variable positions (Xaa), including a core structure of six cysteine residues.
  • The complaint asserts infringement of Claims 1-6 against Defendants Teva, Mylan, and Sandoz (Compl. ¶32, ¶41, ¶50).

U.S. Patent No. 7,704,947 - "Methods And Compositions For The Treatment Of Gastrointestinal Disorders," Issued Apr. 27, 2010

Technology Synopsis

This patent relates to compositions and methods for treating gastrointestinal disorders by administering peptides, such as linaclotide, that activate the GC-C receptor. The claims are directed to specific peptide sequences and their use (U.S. Pat. No. 7,704,947, Abstract). The complaint notes this patent survived an inter partes reexamination (Compl. ¶21).

Asserted Claims

Claims 1-16, including independent claims 1 and 9 (Compl. ¶32, ¶41, ¶50).

Accused Features

The generic linaclotide capsules described in Defendants' ANDAs (Compl. ¶30, ¶39, ¶48).

U.S. Patent No. 7,745,409 - "Methods And Compositions For The Treatment Of Gastrointestinal Disorders," Issued June 29, 2010

Technology Synopsis

The patent claims methods of treating gastrointestinal disorders by administering pharmaceutical compositions containing specific GC-C receptor agonist peptides. The claims focus on the method of use for specific peptide sequences (U.S. Pat. No. 7,745,409, Abstract).

Asserted Claims

Claims 1-7, including independent claim 1 (Compl. ¶32, ¶41, ¶50).

Accused Features

The generic linaclotide capsules described in Defendants' ANDAs (Compl. ¶30, ¶39, ¶48).

U.S. Patent No. 8,080,526 - "Methods And Compositions For The Treatment Of Gastrointestinal Disorders," Issued Dec. 20, 2011

Technology Synopsis

This patent claims methods of treating gastrointestinal disorders by administering compositions that include specific peptide sequences acting as GC-C receptor agonists. The claims are directed to methods of treatment utilizing these peptides (U.S. Pat. No. 8,080,526, Abstract).

Asserted Claims

Claims 1-2, including independent claim 1 (Compl. ¶32, ¶41, ¶50).

Accused Features

The generic linaclotide capsules described in Defendants' ANDAs (Compl. ¶30, ¶39, ¶48).

U.S. Patent No. 8,110,553 - "Methods And Compositions For The Treatment Of Gastrointestinal Disorders," Issued Feb. 7, 2012

Technology Synopsis

The patent relates to methods of treating various gastrointestinal disorders by administering peptides that activate the GC-C receptor. The claims are directed to specific methods of treatment using pharmaceutical compositions containing these peptides (U.S. Pat. No. 8,110,553, Abstract).

Asserted Claims

Claims 1-11, including independent claims 1 and 10 (Compl. ¶32, ¶41, ¶50).

Accused Features

The generic linaclotide capsules described in Defendants' ANDAs (Compl. ¶30, ¶39, ¶48).

U.S. Patent No. 8,748,573 - "Formulations Comprising Linaclotide," Issued June 10, 2014

Technology Synopsis

This patent describes stable pharmaceutical formulations of linaclotide suitable for oral administration. The invention focuses on compositions that include stabilizing agents such as a polymer, a sterically hindered primary amine, and/or a cation to prevent degradation of the linaclotide peptide (U.S. Pat. No. 8,748,573, Abstract).

Asserted Claims

Claims 1-10, including independent claims 1 and 3 (Compl. ¶32, ¶41, ¶50).

Accused Features

The generic linaclotide capsule formulations described in Defendants' ANDAs (Compl. ¶30, ¶39, ¶48).

U.S. Patent No. 8,802,628 - "Stable Solid Formulation Of A GC-C Receptor Agonist Polypeptide Suitable For Oral Administration," Issued Aug. 12, 2014

Technology Synopsis

This patent covers stable, solid formulations of linaclotide for oral administration, focusing on compositions that provide a sufficient shelf life for manufacturing and distribution. The claims are directed to specific formulations comprising linaclotide, a cation, and a sterically hindered primary amine (U.S. Pat. No. 8,802,628, Abstract).

Asserted Claims

Claims 1-26, including independent claims 1, 13, and 16 (Compl. ¶32, ¶41, ¶50).

Accused Features

The generic linaclotide capsule formulations described in Defendants' ANDAs (Compl. ¶30, ¶39, ¶48).

U.S. Patent No. 8,933,030 - "Treatments For Gastrointestinal Disorders," Issued Jan. 13, 2015

Technology Synopsis

This patent relates to modified linaclotide peptides, including alkyl esters or imidazolidinone derivatives, and their use in treating gastrointestinal disorders. The modifications are designed to alter the peptide's properties while retaining its ability to activate the GC-C receptor (U.S. Pat. No. 8,933,030, Abstract).

Asserted Claims

Claims 6, 18, and 19 against Teva, Mylan, and Sandoz; Claims 6, 18, and 19 against Aurobindo (Compl. ¶32, ¶41, ¶50, ¶59). All asserted claims are dependent.

Accused Features

The generic linaclotide capsules described in Defendants' ANDAs (Compl. ¶30, ¶39, ¶48, ¶57).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the "generic capsule products containing 145 µg and 290 µg of linaclotide as the active ingredient" that are the subject of ANDA No. 209568 (Teva), ANDA No. 209564 (Mylan), ANDA No. 209630 (Sandoz), and ANDA No. 209611 (Aurobindo) (Compl. ¶30, ¶39, ¶48, ¶57).

Functionality and Market Context

  • The complaint alleges that these generic products are versions of Plaintiffs' Linzess® brand linaclotide capsules, which are approved for the treatment of IBS-C and chronic idiopathic constipation (CIC) (Compl. ¶10, ¶28). The core functionality is the oral delivery of linaclotide to activate GC-C receptors in the gastrointestinal tract, thereby increasing intestinal motility and reducing visceral pain (U.S. Pat. No. 7,304,036, col. 2:12-41).
  • The filing of the ANDAs containing Paragraph IV certifications is the statutory act of infringement under 35 U.S.C. § 271(e)(2), intended to allow for the resolution of patent disputes before the generic products enter the market (Compl. ¶10).

IV. Analysis of Infringement Allegations

'036 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A purified peptide consisting of the amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:31) The accused Teva, Mylan, and Sandoz Generic Products are alleged to contain linaclotide as the active ingredient, which has the claimed amino acid sequence. ¶30, ¶39, ¶48 col. 25:31
or a pharmacologically acceptable salt thereof. The complaint does not specify whether the accused products use a salt form, but this element would be met if they do. ¶30, ¶39, ¶48 col. 25:31

'727 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of treating a patient for a gastrointestinal disorder, the method comprising administering to the patient a pharmaceutical composition The proposed package inserts for the accused generic products will allegedly instruct doctors, pharmacists, and patients to administer the products to treat GI disorders such as IBS-C and CIC, thereby inducing infringement. ¶33, ¶42, ¶51 col. 1:16-19
comprising a purified polypeptide comprising the amino acid sequence: [Xaa...Cys Cys Glu Xaa...Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr] The active ingredient in the accused products, linaclotide, is a polypeptide alleged to fall within the scope of the claimed sequences. ¶30, ¶39, ¶48 col. 4:30

Identified Points of Contention

  • Scope Questions: The primary dispute in this ANDA litigation, as framed by the complaint, will not be whether the generic products literally meet the claim limitations, but whether the asserted patent claims are valid and enforceable. The Defendants' Paragraph IV certifications allege the patents are "invalid, unenforceable, and/or will not be infringed" (Compl. ¶31, ¶40, ¶49, ¶58). A central question for the court will be whether Defendants can prove by clear and convincing evidence that the claims are invalid over the prior art.
  • Technical Questions: A potential point of contention for composition claims (e.g., in the '036, '573, and '628 patents) could relate to the term "purified" or specific formulation elements. The question may arise as to whether the defendants' manufacturing processes and final formulations result in a product that meets the specific purity, stability, or compositional limitations defined or implied by the patents, particularly the later-issued formulation patents.

V. Key Claim Terms for Construction

The Term: "purified peptide" (’036 Patent, Claim 1)

  • Context and Importance: This term's construction is central because the scope of the composition claim hinges on the required level of purity. Practitioners may focus on this term because a defendant could argue that its generic product does not meet the claimed purity level, or alternatively, that if the term is construed broadly, the claim is rendered invalid by prior art that disclosed the peptide in a less pure form.
  • Intrinsic Evidence for a Broader Interpretation: The specification does not appear to provide an explicit numerical percentage for "purified," which may support a construction consistent with its plain and ordinary meaning, i.e., separated from at least some other components with which it is naturally associated.
  • Evidence for a Narrower Interpretation: The patent's detailed description discloses specific purification methods, such as using reverse-phase chromatography (U.S. Pat. No. 7,304,036, col. 29:46-54). A party could argue that these specific embodiments implicitly define "purified" as the level of purity achievable by these advanced techniques.

The Term: "treating" (’727 Patent, Claim 1)

  • Context and Importance: The scope of this term defines the infringing act for the method-of-use claims. Its construction is critical for assessing both infringement (what the proposed label must instruct) and validity (whether prior art discloses the same method).
  • Intrinsic Evidence for a Broader Interpretation: The patent's background section broadly describes treating IBS and other gastrointestinal disorders by alleviating symptoms like "abdominal pain and a disturbed bowel pattern" (U.S. Pat. No. 7,371,727, col. 1:16-24), supporting a broad therapeutic meaning.
  • Evidence for a Narrower Interpretation: A party might argue that the specific outcomes detailed in clinical data or examples within the patent family could be used to narrow the definition of "treating" to achieving a specific, quantifiable clinical endpoint, potentially distinguishing it from prior art that disclosed more general effects.

VI. Other Allegations

Indirect Infringement

  • The complaint alleges induced infringement under 35 U.S.C. § 271(b) for the asserted method claims. The basis for this allegation is that the Defendants' proposed product labels and package inserts will instruct physicians and patients to administer the generic linaclotide products for the patented methods of treating gastrointestinal disorders (Compl. ¶33, ¶36, ¶42, ¶45, ¶51, ¶54, ¶60, ¶63).

Willful Infringement

  • The complaint alleges that Defendants had knowledge of the patents-in-suit prior to filing their ANDAs (Compl. ¶36, ¶45, ¶54, ¶63). Plaintiffs also request a finding that the case is "exceptional" under 35 U.S.C. § 285, which is a predicate for an award of attorneys' fees and can be related to findings of willful infringement or litigation misconduct (Compl. ¶37, ¶46, ¶55, ¶64).

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

  • A core issue will be one of patent validity: can the Defendants prove by clear and convincing evidence that the asserted claims, which cover the linaclotide compound, its medical uses, and specific formulations, are invalid as anticipated or obvious in light of prior art that existed before the patents' priority dates? The reexamination of the '947 patent will be a significant factor in this analysis.
  • A second key question will be one of infringement scope, particularly concerning the later-issued formulation patents ('573 and '628 patents). The dispute may focus on whether the specific excipients, stabilizing agents, and manufacturing processes used by the Defendants for their generic products fall within the scope of claims directed to stable oral formulations of linaclotide.
  • A final evidentiary question will relate to induced infringement: will the language of the Defendants' final, FDA-approved labels be found to actively encourage, recommend, or promote the specific methods of treatment claimed in the patents, thereby satisfying the intent requirement for inducement?