DCT

1:22-md-03038

In re: Ozempic (Semaglutide) Patent Litigation

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-md-03038 (related to C.A. No. 22-1040), D. Del., 03/21/2023
  • Venue Allegations: The action was originally filed in the Northern District of West Virginia, where Mylan is incorporated and has its principal place of business. It was subsequently transferred to the District of Delaware for consolidated pretrial proceedings as part of a Multi-District Litigation (MDL).
  • Core Dispute: Plaintiff alleges that Defendant's proposed generic versions of the Ozempic® (semaglutide) injectable drug product, as described in two Abbreviated New Drug Applications (ANDAs), infringe twenty U.S. patents covering the drug's active ingredient, formulation, methods of use, and delivery device technology.
  • Technical Context: The dispute centers on semaglutide, a long-acting GLP-1 receptor agonist for the treatment of type 2 diabetes, which has achieved significant commercial success, and the associated injection pen delivery systems.
  • Key Procedural History: This First Amended Complaint was filed within a broader MDL concerning Ozempic patents. The amendment adds allegations relating to Defendant's second ANDA and narrows the patents asserted against Defendant's first ANDA. The action arises under the Hatch-Waxman Act, triggered by Defendant’s Paragraph IV certifications asserting that the patents-in-suit are invalid, unenforceable, and/or will not be infringed.

Case Timeline

Date Event
1999-02-12 Priority Date for U.S. Patent No. 9,775,953
2003-01-24 Priority Date for U.S. Patent No. 9,132,239 and RE46,363
2003-11-20 Priority Date for U.S. Patent No. 8,114,833
2004-10-21 Priority Date for U.S. Patent Nos. 8,684,969, 9,687,611, and 11,446,443
2005-01-21 Priority Date for U.S. Patent Nos. 9,108,002, 9,616,180, 10,376,652, and 11,311,679
2005-01-25 Priority Date for U.S. Patent Nos. 9,457,154, 9,861,757, and 10,357,616
2005-03-23 Priority Date for U.S. Patent Nos. 8,129,343 and 8,536,122
2005-07-27 Priority Date for U.S. Patent Nos. 8,920,383, 10,220,155, and 11,097,063
2012-02-14 U.S. Patent No. 8,114,833 Issued
2012-03-06 U.S. Patent No. 8,129,343 Issued
2012-07-01 Priority Date for U.S. Patent No. 10,335,462
2013-09-17 U.S. Patent No. 8,536,122 Issued
2014-04-01 U.S. Patent No. 8,684,969 Issued
2014-12-30 U.S. Patent No. 8,920,383 Issued
2015-08-18 U.S. Patent No. 9,108,002 Issued
2015-09-15 U.S. Patent No. 9,132,239 Issued
2016-10-04 U.S. Patent No. 9,457,154 Issued
2017-04-11 U.S. Patent Nos. 9,616,180 and RE46,363 Issued
2017-06-27 U.S. Patent No. 9,687,611 Issued
2017-10-03 U.S. Patent No. 9,775,953 Issued
2018-01-09 U.S. Patent No. 9,861,757 Issued
2019-03-05 U.S. Patent No. 10,220,155 Issued
2019-07-02 U.S. Patent No. 10,335,462 Issued
2019-07-23 U.S. Patent No. 10,357,616 Issued
2019-08-13 U.S. Patent No. 10,376,652 Issued
2021-08-24 U.S. Patent No. 11,097,063 Issued
2022-02-04 Date of First Notice Letter for Mylan's First ANDA
2022-03-18 Original Complaint Filed
2022-04-26 U.S. Patent No. 11,311,679 Issued
2022-09-20 U.S. Patent No. 11,446,443 Issued
2023-02-10 Date of Second Notice Letter for Mylan's Second ANDA
2023-03-21 First Amended Complaint Filed

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

U.S. Patent No. 8,114,833 - Propylene Glycol-Containing Peptide Formulations Which Are Optimal for Production and for Use in Injection Devices

  • Patent Identification: U.S. Patent No. 8,114,833, issued on February 14, 2012 (the "’833 Patent"). (Compl. ¶11).

The Invention Explained

  • Problem Addressed: The patent's background section describes that common isotonicity agents, such as mannitol, can cause problems during the production of peptide drug formulations by crystallizing and creating deposits on manufacturing equipment and in the final drug product. These deposits can also lead to the clogging of injection devices. (’833 Patent, col. 1:30-44).
  • The Patented Solution: The invention is a pharmaceutical formulation that uses propylene glycol as an alternative isotonicity agent instead of mannitol. This substitution is described as reducing deposits during production and minimizing the clogging of injection devices, while maintaining the physical and chemical stability of the peptide formulation. (’833 Patent, col. 1:51-67; Abstract).
  • Technical Importance: This approach aimed to improve the efficiency and reliability of manufacturing injectable peptide drugs and to enhance the performance and safety of the final product for patient administration. (Compl. ¶42).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-31. (Compl. ¶42).
  • Independent claim 1, a composition claim, includes the following essential elements:
    • A pharmaceutical formulation comprising a peptide and propylene glycol,
    • wherein the propylene glycol is present in a concentration of 1-100 mg/ml,
    • and the pH of the formulation is from 7.0-10.
  • Independent claim 16 is a method claim for preparing a peptide formulation by replacing an isotonicity agent with propylene glycol.

U.S. Patent No. 8,129,343 - Acylated GLP-1 Compounds

  • Patent Identification: U.S. Patent No. 8,129,343, issued on March 6, 2012 (the "’343 Patent"). (Compl. ¶12).

The Invention Explained

  • Problem Addressed: The technical field relates to the need for glucagon-like peptide-1 (GLP-1) compounds with a longer duration of action, which are more suitable for treating conditions like type 2 diabetes than native GLP-1. (Compl. ¶54; ’343 Patent, col. 1:18-24).
  • The Patented Solution: The patent discloses specific derivatives of GLP-1 analogues that have been chemically modified (acylated) to exhibit a protracted profile of action. This modification allows the compound to bind to albumin in the bloodstream, which significantly slows its clearance from the body and extends its therapeutic effect. The compound known as semaglutide is described in Example 4 of the patent. (’343 Patent, col. 3:6-14; Abstract).
  • Technical Importance: This technology enables less frequent dosing regimens (e.g., once-weekly), which can improve patient adherence and convenience in managing chronic diseases like diabetes. (Compl. ¶¶31-32, 54).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1-2 and 4-5. (Compl. ¶54).
  • Independent claim 4 claims a specific chemical structure, including the following essential elements:
    • A derivative of a GLP-1 analogue, which has specific amino acid substitutions relative to native GLP-1(7-37), including Aib at position 8.
    • The analogue has a lysine (K) residue at a position corresponding to position 34 of GLP-1(7-37).
    • This lysine residue is derivatized with a specific acyl group: N-epsilon-(17-carboxyheptadecanoyl)-L-y-glutamyl.

U.S. Patent No. 8,536,122 - Acylated GLP-1 Compounds

  • Patent Identification: U.S. Patent No. 8,536,122, issued on September 17, 2013. (Compl. ¶13).
  • Technology Synopsis: This patent, like the ’343 Patent, is directed to GLP-1 compound derivatives designed for a protracted therapeutic effect. The claims cover specific chemical structures of GLP-1 compounds. (Compl. ¶¶66, 72).
  • Asserted Claims: Claims 10 and 11 are asserted. (Compl. ¶¶66, 72).
  • Accused Features: The complaint alleges that Mylan's proposed generic products, by containing semaglutide, will infringe these claims. (Compl. ¶¶66, 72).

U.S. Patent No. 8,684,969 - Injection Device with Torsion Spring and Rotatable Display

  • Patent Identification: U.S. Patent No. 8,684,969, issued on April 1, 2014. (Compl. ¶14).
  • Technology Synopsis: The patent is directed to the mechanical design of an injection pen. It claims a device comprising a torsion spring connected to a dose setting member and a rotatable display, allowing for a dose scale that can rotate more than one full revolution. (Compl. ¶78). This design facilitates a higher resolution and more accurate dose setting.
  • Asserted Claims: Claims 1-26 are asserted. (Compl. ¶78).
  • Accused Features: The complaint alleges that the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶78).

U.S. Patent No. 8,920,383 - Dose Mechanism for an Injection Device for Limiting a Dose Setting Corresponding to the Amount of Medicament Left

  • Patent Identification: U.S. Patent No. 8,920,383, issued on December 30, 2014. (Compl. ¶15).
  • Technology Synopsis: This patent describes a dose-limiting mechanism for an injection device. The mechanism is designed to prevent a user from setting a dose that exceeds the amount of medicament remaining in the device's reservoir. (Compl. ¶¶84, 90).
  • Asserted Claims: Claims 1-13 are asserted. (Compl. ¶¶84, 90).
  • Accused Features: The complaint alleges the injection devices for both of Mylan's ANDA Products will infringe these claims. (Compl. ¶¶84, 90).

U.S. Patent No. 9,108,002 - Automatic Injection Device with a Top Release Mechanism

  • Patent Identification: U.S. Patent No. 9,108,002, issued on August 18, 2015. (Compl. ¶16).
  • Technology Synopsis: The patent relates to an automatic injection device with a release member located at the top (proximal end), opposite the needle. This design allows for activation by a thumb or index finger pressing axially, similar to a conventional manual injection pen. (Compl. ¶96).
  • Asserted Claims: Claims 1-2 are asserted. (Compl. ¶96).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶96).

U.S. Patent No. 9,132,239 - Dial-Down Mechanism for Wind-Up Pen

  • Patent Identification: U.S. Patent No. 9,132,239, issued on September 15, 2015. (Compl. ¶17).
  • Technology Synopsis: This patent describes a "dial-down" mechanism for a spring-assisted injection pen. The mechanism allows a user who has set a dose to reduce it without expelling any medicament, which is a key usability and safety feature. (Compl. ¶102).
  • Asserted Claims: Claims 1-3 are asserted. (Compl. ¶102).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶102).

U.S. Patent No. 9,457,154 - Injection Device with an End of Dose Feedback Mechanism

  • Patent Identification: U.S. Patent No. 9,457,154, issued on October 4, 2016. (Compl. ¶18).
  • Technology Synopsis: The patent covers an injection device that provides an audible feedback signal to the user at the conclusion of an injection. This non-visual confirmation helps ensure the full set dose has been delivered. (Compl. ¶108).
  • Asserted Claims: Claims 1-17 are asserted. (Compl. ¶108).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶108).

U.S. Patent No. 9,616,180 - Automatic Injection Device with a Top Release Mechanism

  • Patent Identification: U.S. Patent No. 9,616,180, issued on April 11, 2017. (Compl. ¶19).
  • Technology Synopsis: This patent is directed to an automatic injection device featuring a push-button release member located at the proximal end, opposite the needle mount. This configuration allows for user-friendly, top-down activation to initiate the injection. (Compl. ¶114).
  • Asserted Claims: Claims 1-14 are asserted. (Compl. ¶114).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶114).

U.S. Patent No. 9,687,611 - Injection Device with Torsion Spring and Rotatable Display

  • Patent Identification: U.S. Patent No. 9,687,611, issued on June 27, 2017. (Compl. ¶20).
  • Technology Synopsis: This patent, similar to the '969 patent, describes an injection device using a torsion spring and a rotatable display member. Claim 14 is directed to a pen with a dose indicator barrel having a helical scale, enabling an expanded and high-resolution dose display. (Compl. ¶120).
  • Asserted Claims: Claims 1-15 are asserted. (Compl. ¶120).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶120).

U.S. Patent No. 9,775,953 - Dose Mechanism for an Injection Device for Limiting a Dose Setting Corresponding to the Amount of Medicament Left

  • Patent Identification: U.S. Patent No. 9,775,953, issued on October 3, 2017. (Compl. ¶21).
  • Technology Synopsis: This patent, similar to the '383 patent, covers a mechanism that prevents a user from setting a dose larger than the quantity of medicament remaining in the device's reservoir, an important safety feature to prevent under-dosing. (Compl. ¶¶126, 132).
  • Asserted Claims: Claims 1-25 are asserted. (Compl. ¶¶126, 132).
  • Accused Features: The complaint alleges the injection devices for both of Mylan's ANDA Products will infringe these claims. (Compl. ¶¶126, 132).

U.S. Patent No. 9,861,757 - Injection Device with an End of Dose Feedback Mechanism

  • Patent Identification: U.S. Patent No. 9,861,757, issued on January 9, 2018. (Compl. ¶22).
  • Technology Synopsis: This patent, similar to the '154 patent, is directed to a mechanism in an injection device that provides a tactile (as opposed to audible) feedback signal to the user upon completion of the injection, confirming that the full dose has been delivered. (Compl. ¶138).
  • Asserted Claims: Claims 1-12 are asserted. (Compl. ¶138).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶138).

U.S. Patent No. 10,220,155 - Syringe Device with a Dose Limiting Mechanism and an Additional Safety Mechanism

  • Patent Identification: U.S. Patent No. 10,220,155, issued on March 5, 2019. (Compl. ¶23).
  • Technology Synopsis: This patent describes a syringe device with both a dose limiting mechanism and a safety mechanism structure. These features work together to prevent the injection of a dose that exceeds the set dose. (Compl. ¶144).
  • Asserted Claims: Claims 1-8 are asserted. (Compl. ¶144).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶144).

U.S. Patent No. 10,335,462 - Use of Long-Acting GLP-1 Peptides

  • Patent Identification: U.S. Patent No. 10,335,462, issued on July 2, 2019. (Compl. ¶24).
  • Technology Synopsis: This patent is directed to a method of treating type 2 diabetes by administering semaglutide to a subject in need thereof. It covers the therapeutic use of the active ingredient. (Compl. ¶150).
  • Asserted Claims: Claims 1-10 are asserted. (Compl. ¶150).
  • Accused Features: The complaint alleges that Mylan's First ANDA Product, which contains semaglutide and will be indicated for treating type 2 diabetes, will infringe these method-of-use claims. (Compl. ¶150).

U.S. Patent No. 10,357,616 - Injection Device with an End of Dose Feedback Mechanism

  • Patent Identification: U.S. Patent No. 10,357,616, issued on July 23, 2019. (Compl. ¶25).
  • Technology Synopsis: This patent, related to the '154 and '757 patents, covers an injection device with a mechanism that provides an audible feedback signal to the user at the end of injection, confirming dose completion. (Compl. ¶157).
  • Asserted Claims: Claims 1-9 are asserted. (Compl. ¶157).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶157).

U.S. Patent No. 10,376,652 - Automatic Injection Device with a Top Release Mechanism

  • Patent Identification: U.S. Patent No. 10,376,652, issued on August 13, 2019. (Compl. ¶26).
  • Technology Synopsis: This patent, related to the '002 and '180 patents, claims an automatic injection device that includes both a release member opposite the needle end and a display member, combining user-friendly activation with dose visibility. (Compl. ¶163).
  • Asserted Claims: Claims 1-15 are asserted. (Compl. ¶163).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶163).

U.S. Patent No. 11,097,063 - Syringe Device with a Dose Limiting Mechanism and an Additional Safety Mechanism

  • Patent Identification: U.S. Patent No. 11,097,063, issued on August 24, 2021. (Compl. ¶27).
  • Technology Synopsis: This patent, related to the '155 patent, covers a syringe device with dose limiting and safety mechanisms to prevent injection of a dose exceeding the one set by the user. (Compl. ¶169).
  • Asserted Claims: Claims 1-7 are asserted. (Compl. ¶169).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶169).

U.S. Reissue Patent No. RE46,363 - Dial-Down Mechanism for Wind-Up Pen

  • Patent Identification: U.S. Reissue Patent No. RE46,363, issued on April 11, 2017. (Compl. ¶28).
  • Technology Synopsis: This patent, a reissue of the '239 patent, is directed to a dial-down mechanism for a spring-assisted ("wind up") injection pen, allowing a user to correct an overdose setting. It also claims a method for using such a pen. (Compl. ¶175).
  • Asserted Claims: Claims 1-11 are asserted. (Compl. ¶175).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product and its use will infringe these claims. (Compl. ¶¶175-176).

U.S. Patent No. 11,311,679 - Automatic Injection Device with a Top Release Mechanism

  • Patent Identification: U.S. Patent No. 11,311,679, issued on April 26, 2022. (Compl. ¶29).
  • Technology Synopsis: This patent, related to the family of '002, '180, and '652 patents, claims an injection device with a torsion spring operatively connected to a dose setting member and a rotatably mounted display member. (Compl. ¶182).
  • Asserted Claims: Claims 1-6 are asserted. (Compl. ¶182).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶182).

U.S. Patent No. 11,446,443 - Injection Device with Torsion Spring and Rotatable Display

  • Patent Identification: U.S. Patent No. 11,446,443, issued on September 20, 2022. (Compl. ¶30).
  • Technology Synopsis: This patent, related to the family of '969 and '611 patents, claims an injection device with a torsion spring operatively connected to a dose setting member and a rotatably mounted display member. (Compl. ¶188).
  • Asserted Claims: Claims 1-19 are asserted. (Compl. ¶188).
  • Accused Features: The complaint alleges the injection device for Mylan's Second ANDA Product will infringe these claims. (Compl. ¶188).

III. The Accused Instrumentality

Product Identification

Mylan's First ANDA Product, a proposed generic semaglutide injection at concentrations of 1.34 mg/ml, and Mylan's Second ANDA Product, a proposed generic semaglutide injection at a concentration of 2.68 mg/ml. (Compl. ¶¶34, 37).

Functionality and Market Context

The accused products are generic versions of Plaintiff's Ozempic® drug, intended for subcutaneous injection for the treatment of type 2 diabetes. (Compl. ¶¶34, 37, 150). The complaint alleges that Mylan's ANDAs rely on the safety and efficacy data from Novo Nordisk's New Drug Application for Ozempic® and contain data intended to demonstrate bioequivalence between the generic and branded products. (Compl. ¶¶35, 38). The filing of the ANDAs containing Paragraph IV certifications constitutes a technical act of infringement under the Hatch-Waxman Act, signaling Mylan's intent to market a generic version prior to the expiration of the patents-in-suit. (Compl. ¶1). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 8,114,833 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical formulation comprising a peptide and propylene glycol, Mylan's First and Second ANDA Products are alleged to be pharmaceutical formulations containing the peptide semaglutide and using propylene glycol as an excipient. ¶42 col. 1:51-54
wherein the propylene glycol is present in a concentration of 1-100 mg/ml, The complaint alleges Mylan's manufacture, use, or sale of its ANDA products would infringe, suggesting the concentration of propylene glycol in the accused formulations falls within the claimed range. ¶42 col. 1:64-65
and the pH of the formulation is from 7.0-10. The complaint's general infringement allegation implies the pH of Mylan's proposed formulations falls within the claimed range. ¶42 col. 1:66-67
  • Identified Points of Contention:
    • Scope Questions: A central question may be whether the substitution of propylene glycol for mannitol, both known pharmaceutical excipients, was obvious to a person of ordinary skill in the art at the time of the invention.
    • Technical Questions: The dispute will likely focus on evidence of non-obviousness, such as unexpected results related to the reduction of manufacturing deposits or device clogging when using propylene glycol in a semaglutide formulation, which are not detailed in the complaint.

U.S. Patent No. 8,129,343 Infringement Allegations

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
A derivative of a GLP-1 analogue... wherein the amino acid at a position corresponding to position 8 of GLP-1(7-37) is Aib; Mylan's ANDA Products contain semaglutide, which is alleged to be a GLP-1 analogue derivative with an Aib substitution at position 8. ¶54 col. 57:40-59
wherein the [second K] residue is derivatized with N-epsilon-(17-carboxyheptadecanoyl)-L-y-glutamyl. The active ingredient in Mylan's ANDA Products, semaglutide, is alleged to possess the specific chemical side chain required by the claim. ¶54 col. 57:40-59
  • Identified Points of Contention:
    • Scope Questions: Given that the accused products contain the specific molecule semaglutide, the primary point of contention will likely be the validity of the claims. Mylan's Paragraph IV certification suggests it will argue the claims are invalid. (Compl. ¶36).
    • Technical Questions: The case may turn on whether the specific combination of amino acid substitutions and acylation that defines semaglutide would have been obvious to a person of ordinary skill in the art based on prior art concerning long-acting GLP-1 analogues.

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim terms that may be in dispute. However, based on the subject matter, the following terms may become central to the case.

  • The Term: "propylene glycol" (from ’833 Patent, Claim 1)

  • Context and Importance: Practitioners may focus on this term because the infringement allegation hinges on Mylan's use of this specific excipient. While the identity of the chemical itself is clear, its role in the context of the full formulation and any asserted unexpected properties will be critical. The dispute will likely focus on the patentability of its use rather than its definition.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim recites the term without further limitation beyond concentration and pH, suggesting it should be given its plain and ordinary meaning as a known pharmaceutical excipient. (’833 Patent, col. 29:32-35).
    • Evidence for a Narrower Interpretation: The specification's focus on propylene glycol as a replacement for mannitol to solve specific problems of crystallization and clogging could be used to argue that the claim's scope should be understood in that context, potentially limiting arguments of equivalence to other non-clogging agents. (’833 Patent, col. 1:30-44).

  • The Term: "a position corresponding to" (from ’343 Patent, Claim 4)

  • Context and Importance: This term is fundamental to defining the structure of the claimed peptide analogue relative to the native GLP-1 sequence. Infringement requires a proper alignment of the semaglutide sequence to the reference GLP-1(7-37) sequence to confirm the locations of the Aib substitution and the acylated lysine.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent specification explicitly defines the sequence of GLP-1(7-37) as SEQ ID NO: 1, providing a clear and unambiguous reference point for determining corresponding positions in analogues. (’343 Patent, col. 25:20-22).
    • Evidence for a Narrower Interpretation: A defendant could argue for a narrow construction if there are ambiguities in alignment for analogues with significant insertions or deletions, though this is less likely to be a central issue for an analogue like semaglutide, whose structure is well-defined in the patent's examples. (’343 Patent, Example 4).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for the method-of-use patents. It states that Mylan's commercial marketing and sale of its ANDA products, with knowledge of the patents, would intentionally induce others (e.g., physicians and patients) to use the products in an infringing manner, as will be instructed on the product labeling. (Compl. ¶¶151, 176).
  • Willful Infringement: For each asserted patent, the complaint alleges that Mylan was aware of the patent when it submitted its ANDA. This allegation is based on Mylan's submission of Paragraph IV Notice Letters prior to the lawsuit, which serves as evidence of pre-suit knowledge. (Compl. ¶¶36, 39, 45, 51, 57, etc.). This forms the basis for the request for a finding of an exceptional case and an award of attorneys' fees.

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

  • A central issue will be one of validity over the prior art: can Mylan demonstrate by clear and convincing evidence that the claimed inventions were obvious? For the '343 patent, this involves whether the specific chemical structure of semaglutide was an obvious modification of prior GLP-1 analogues. For the '833 patent, the question is whether substituting propylene glycol for other known isotonicity agents to solve known manufacturing problems was obvious.
  • A key evidentiary question will be one of non-infringement of device claims: for the numerous mechanical patents asserted against Mylan's Second ANDA product, what are the precise mechanics of Mylan's proposed injection pen? The case will require a detailed, claim-by-claim comparison of the accused device's structure and operation against the specific limitations of the asserted device patents.
  • A third core issue will be one of claim scope: can Novo Nordisk successfully argue that the scope of its various composition, method, and device claims is broad enough to cover Mylan's proposed products and their intended use, and will those constructions survive Mylan's validity challenges?