DataCloud Tech LLC v. Western Digital Corp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: AbbVie Inc. (Delaware)
  • Defendant: Sun Pharmaceutical Industries Limited (India)
  • Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
• Case Identification: 1:24-cv-00156, D. Del., 02/05/2024
• Venue Allegations: Venue is asserted on the basis that the defendant is a foreign corporation and may be sued in any judicial district.
• Core Dispute: Plaintiff alleges that Defendant's Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's ORILISSA® product constitutes an act of infringement of two patents covering methods of administering elagolix.
• Technical Context: The dispute is in the field of pharmaceutical treatments for gynecological disorders, specifically focusing on methods of using elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist.
• Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by Defendant’s submission of an ANDA with a Paragraph IV certification. The complaint notes that this is the third lawsuit Plaintiff has filed against Defendant concerning the same ANDA; two prior suits asserted different patents. This action was commenced within 45 days of Plaintiff receiving Defendant’s "Third Notice Letter," which provided notice of the Paragraph IV certification for the patents-in-suit.

Case Timeline

Date	Event
2018-04-19	U.S. Patent No. 11,690,854 Priority Date
2018-07-23	FDA approves ORILISSA® New Drug Application (NDA)
2020-03-05	U.S. Patent No. 11,690,845 Priority Date
2023-07-04	U.S. Patent Nos. 11,690,845 and 11,690,854 issue
2023-12-22	Plaintiff receives Defendant's "Third Notice Letter"
2024-02-05	Complaint filed

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

U.S. Patent No. 11,690,845: Methods of Administering Elagolix

• Patent Identification: U.S. Patent No. 11,690,845, "Methods of Administering Elagolix," issued July 4, 2023.

The Invention Explained

• Problem Addressed: The patent identifies a potential for drug interactions when elagolix, which is used to treat conditions like endometriosis, is co-administered with drugs metabolized by the CYP2B6 enzyme, such as the antidepressant bupropion ('845 Patent, col. 1:20-33). The background notes a potential link between high peak plasma concentrations of bupropion and certain adverse events, creating a need to understand this specific drug interaction ('845 Patent, col. 1:34-36).
• The Patented Solution: The patent discloses methods of treating gynecological disorders by co-administering elagolix and a CYP2B6 substrate. The inventors discovered, contrary to expectations from in vitro data, that co-administration with elagolix increased the peak plasma concentration (Cmax) of bupropion and its primary metabolite but did not produce a clinically significant change in overall exposure (AUC) ('845 Patent, col. 8:50-59; Fig. 3). The patent claims specific dosing regimens that result in defined pharmacokinetic outcomes, providing a predictable safety and efficacy profile for patients taking both medications ('845 Patent, col. 2:50-col. 3:4).
• Technical Importance: The invention provides critical clinical data clarifying the drug-drug interaction profile of elagolix, enabling physicians to safely co-prescribe it with bupropion, a commonly used medication, without needing dose adjustments ('845 Patent, col. 9:10-14).

Key Claims at a Glance

• The complaint asserts infringement of one or more unspecified claims (Compl. ¶54). Independent claim 1 is representative of the core invention.
• Independent Claim 1 recites a method for treating a gynecological disorder with essential elements comprising:
  • Orally administering to a patient elagolix sodium in an amount equivalent to 300 mg of elagolix free acid twice daily;
  • The patient receives a once daily dose of 150 mg of bupropion; and
  • The co-administration results in specific pharmacokinetic ratios for bupropion and its metabolite, hydroxybupropion, including a Cmax ratio for bupropion between about 1.104 and 1.407 and a Cmax ratio for hydroxybupropion between about 1.216 and 1.427.
• The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶54).

U.S. Patent No. 11,690,854: Methods of Treating Heavy Menstrual Bleeding

• Patent Identification: U.S. Patent No. 11,690,854, "Methods of Treating Heavy Menstrual Bleeding," issued July 4, 2023.

The Invention Explained

• Problem Addressed: The patent addresses heavy menstrual bleeding (HMB), a common symptom of conditions like uterine fibroids and endometriosis, which can lead to iron-deficiency anemia and necessitate surgical interventions ('854 Patent, col. 1:31-43). While GnRH antagonists can reduce bleeding, their use alone can cause significant side effects from low estrogen levels, such as bone density loss ('854 Patent, col. 2:5-10).
• The Patented Solution: The invention is a method for treating HMB by administering elagolix in combination with an estrogen and a progestogen ('854 Patent, Abstract). This "add-back" therapy is intended to manage the bleeding while simultaneously providing enough estrogen to mitigate the side effects of GnRH antagonism, particularly bone loss, creating a more favorable long-term treatment profile ('854 Patent, col. 4:20-34).
• Technical Importance: This approach provides an oral, non-surgical treatment option that balances the therapeutic effect of reducing HMB with the need to maintain patient safety over longer treatment durations.

Key Claims at a Glance

• The complaint asserts infringement of one or more unspecified claims (Compl. ¶67). Independent claim 1 is representative of the core invention.
• Independent Claim 1 recites a method for reducing the volume of menstrual blood loss with essential elements comprising:
  • Administering to a subject with uterine fibroids 300 to 600 mg per day of elagolix or a salt thereof;
  • In combination with an estrogen and a progestogen;
  • Wherein the estrogen is estradiol and the progestogens are norethindrone acetate and progesterone.
• The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶67).

III. The Accused Instrumentality

Product Identification

• Defendant’s proposed generic version of ORILISSA® (elagolix sodium oral tablets), for which it seeks FDA approval via ANDA No. 215804 ("Sun's Generic Product") (Compl. ¶1, ¶44).

Functionality and Market Context

• Sun's Generic Product is alleged to contain elagolix sodium and to be pharmaceutically and therapeutically equivalent to Plaintiff's ORILISSA® (Compl. ¶52, ¶65). ORILISSA® is a GnRH receptor antagonist approved for the management of moderate to severe pain associated with endometriosis (Compl. ¶6). The infringement alleged is not based on the composition of the drug itself, but on its intended use by patients and physicians as will be instructed by the product's proposed labeling and other promotional activities (Compl. ¶57, ¶70).
• The complaint alleges that Defendant is a major global generic pharmaceutical company and that its entry into the market for ORILISSA®, a product prescribed to over 80,000 women, would cause Plaintiff irreparable harm (Compl. ¶6, ¶23, ¶61).

IV. Analysis of Infringement Allegations

The complaint does not provide the proposed package insert for Sun's Generic Product or a detailed claim chart. The infringement analysis is therefore based on Plaintiff's allegations about the intended use of the product.

The infringement theory for both patents is primarily based on inducement under 35 U.S.C. § 271(b) (Compl. ¶56, ¶69). Plaintiff alleges that Defendant, through its proposed package insert and promotional activities, will instruct and encourage healthcare providers and patients to use Sun's Generic Product in a manner that directly infringes the asserted method claims (Compl. ¶57, ¶70).

• ’845 Patent Infringement Allegations: The complaint alleges that upon approval, Sun's Generic Product will be prescribed and used by patients, some of whom will also be taking a CYP2B6 substrate like bupropion. This co-administration, guided by Defendant's label, is alleged to result in the pharmacokinetic profile claimed in the patent, thus infringing the method claims (Compl. ¶55-58). A central question is what evidence exists that Defendant's label will encourage or lead to the specific co-administration regimen required by the claims.
• ’854 Patent Infringement Allegations: The complaint alleges that Defendant knows or should know that its product will be prescribed and used for treating HMB, and that its proposed label will instruct users to take the product in a way that infringes (Compl. ¶68-70). Since GnRH antagonists are often prescribed with "add-back" therapy to manage side effects, the alleged infringement relies on the combination of Sun's product with separately prescribed estrogens and progestogens, as guided by Defendant's instructions (Compl. ¶69). The complaint also pleads contributory infringement, alleging the product is especially adapted for this infringing use and has no substantial non-infringing use (Compl. ¶73-74).

No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • Evidentiary Question: What specific instructions or language in Defendant’s proposed package insert support the allegation that it will induce infringement of the specific methods claimed in the ’845 and ’854 patents? The contents of the ANDA's proposed label will be a focal point of discovery.
  • Technical Question (’845 Patent): Does the complaint provide evidence that the co-administration of Sun's Generic Product with bupropion would necessarily result in the specific pharmacokinetic ratios recited in claim 1?
  • Scope Question (’854 Patent): Does the use of Sun's product, prescribed for an FDA-approved indication (endometriosis pain), to treat a related condition (HMB) constitute infringement of a method claim for treating HMB, and what level of encouragement from the defendant is required to prove inducement for such use?

V. Key Claim Terms for Construction

• Term: "in combination with" (’854 Patent, Claim 1)

  • Context and Importance: This term is critical for determining whether infringement can occur when elagolix is administered from one product and the "add-back" therapy (estrogen and progestogen) is administered separately. The definition will determine whether co-packaging or co-formulation is required, or if instruction for concomitant use is sufficient.
  • Evidence for a Broader Interpretation: The patent repeatedly describes administering elagolix "in combination with" the other components without requiring they be in the same dosage form, which may support an interpretation covering separate administrations pursuant to a common therapeutic plan ('854 Patent, col. 2:42-45, col. 3:1-4).
  • Evidence for a Narrower Interpretation: A defendant might argue that without an explicit instruction on its label to combine its product with specific estrogens and progestogens, there can be no infringement. The use of the open-ended term may be argued to be indefinite if the full combination is not taught or enabled for all permutations.

• Term: "wherein [a specific pharmacokinetic ratio] is between [X and Y]" (’845 Patent, Claim 1)

  • Context and Importance: This limitation defines the invention by its result. The infringement analysis will depend on whether this pharmacokinetic outcome is an inevitable result of the claimed administration steps or if it is a characteristic that distinguishes the patented method from the prior art.
  • Evidence for a Broader Interpretation: Plaintiff may argue that because its studies showed this specific PK outcome results from the claimed dosing regimen, any administration following that regimen necessarily meets this limitation ('845 Patent, col. 8:50-col. 9:8).
  • Evidence for a Narrower Interpretation: Defendant may argue that patient variability could lead to PK outcomes outside the claimed ranges, meaning infringement is not guaranteed. Further, practitioners may focus on whether this limitation renders the claim invalid as an improper attempt to claim a natural phenomenon (the metabolic interaction) rather than a new method of treatment.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendant will actively induce infringement of both patents by providing a package insert and promotional materials that instruct and encourage infringing uses (Compl. ¶56-58, ¶69-71). For the ’854 patent, the complaint also alleges contributory infringement, stating that Sun's product is not a staple article of commerce and is especially made or adapted for an infringing use (Compl. ¶67, ¶73-74).
• Willful Infringement: The complaint does not explicitly plead willfulness. However, it alleges that Defendant has had knowledge of the patents since at least December 22, 2023, via a "Third Notice Letter" (Compl. ¶46). This allegation establishes pre-suit knowledge, which could form the basis for a later claim of willfulness or a request for enhanced damages.

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

• A central issue will be one of induced infringement: Can Plaintiff prove, based on the contents of Defendant’s proposed drug label and other evidence, that Defendant possessed the specific intent to encourage physicians to prescribe, and patients to use, its generic product in the exact manner claimed in the asserted method patents?
• A key evidentiary question will be one of label interpretation: Does the language in Defendant's proposed label for its generic elagolix product, which is formally indicated for endometriosis pain, nevertheless provide instructions or suggestions that would lead a physician to use it for treating heavy menstrual bleeding or to co-administer it with bupropion in a way that falls within the scope of the patent claims?
• The case may also turn on questions of claim validity: Will Defendant be able to demonstrate, by clear and convincing evidence, that the asserted method claims are invalid as obvious, for instance, by arguing that the claimed combination therapies or their resulting effects were predictable applications of known pharmacological principles at the time of the invention?