DCT
1:23-cv-00556
Mylan Pharma Inc v. Bayer IP GmbH
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Mylan Pharmaceuticals Inc. (West Virginia)
- Defendant: Bayer Intellectual Property GmbH (Germany), Bayer AG (Germany), and Janssen Pharmaceuticals, Inc. (Pennsylvania)
- Plaintiff’s Counsel: Potter Anderson & Corroon LLP; Wilson Sonsini Goodrich & Rosati P.C.
- Case Identification: 1:23-cv-00556, D. Del., 05/19/2023
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because the Defendants are foreign entities, and they have consented to jurisdiction in the district by previously filing patent infringement suits related to the same drug, Xarelto® (rivaroxaban), in this court.
- Core Dispute: Plaintiff, a generic drug manufacturer, seeks a declaratory judgment that its proposed generic rivaroxaban tablets do not infringe Defendants' patent covering a specific manufacturing process for a pharmaceutical composition of the drug.
- Technical Context: The case concerns pharmaceutical formulation technology, specifically methods for granulating a poorly water-soluble drug (rivaroxaban) to improve its bioavailability when administered orally.
- Key Procedural History: This is a Hatch-Waxman Act declaratory judgment action. Mylan filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, asserting non-infringement of the patent-in-suit. After Mylan provided statutory notice to Defendants, Defendants did not file an infringement suit within the prescribed 45-day window. Mylan initiated this action to obtain "patent certainty" for its generic product. The complaint alleges that during the patent's prosecution, the applicants distinguished the claimed process from "high shear mixing" to overcome an obviousness rejection, which may give rise to a prosecution history estoppel defense against claims of infringement under the doctrine of equivalents.
Case Timeline
| Date | Event |
|---|---|
| 2003-11-27 | ’053 Patent Priority Date |
| 2015-11-12 | USPTO issues Notice of Allowance for ’053 Patent |
| 2016-08-16 | U.S. Patent No. 9,415,053 Issues |
| 2018-12-12 | Mylan sends first Notice Letter to Defendants regarding ANDA |
| 2022-06-21 | Mylan sends second Notice Letter to Defendants regarding ANDA |
| 2022-06-27 | Mylan receives tentative FDA approval for ANDA No. 212220 |
| 2023-05-19 | Complaint for Declaratory Judgment Filed |
| 2024-11-13 | ’053 Patent Expiration Date |
| 2025-02-28 | Pediatric Exclusivity for related U.S. Patent No. 7,157,456 Expires |
| 2025-05-13 | Pediatric Exclusivity for ’053 Patent Expires |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,415,053 - "Solid, Orally Administrable Pharmaceutical Composition"
- Issued: August 16, 2016
The Invention Explained
- Problem Addressed: The patent addresses the challenge that the active compound, rivaroxaban, has a relatively poor water solubility, which can lead to difficulties with oral bioavailability and increased variability in its absorption rate (Compl. Ex. A, '053 Patent, col. 1:59-63).
- The Patented Solution: The invention is a process for preparing a solid oral pharmaceutical composition of rivaroxaban. It involves a "special treatment of the surface of the active compound" through a process of moist granulation to create a "hydrophilized form" of the drug, which the patent asserts leads to a significant increase in bioavailability (’053 Patent, col. 2:31-37). The process specifically involves preparing granules using moist granulation and then converting those granules into a final pharmaceutical composition, such as a tablet (’053 Patent, col. 2:38-47).
- Technical Importance: Developing methods to improve the bioavailability of poorly soluble drugs is a critical challenge in pharmaceutical development, as it directly impacts the drug's efficacy and the consistency of its therapeutic effect.
Key Claims at a Glance
- The complaint seeks a declaratory judgment of non-infringement for all claims of the ’053 patent, specifically citing independent claims 1 and 6 (Compl. ¶40).
- Independent Claim 1 (Process Claim):
- A process for preparing a solid, orally administrable pharmaceutical composition comprising the active compound rivaroxaban in hydrophilized form.
- The process comprises the step of "first preparing granules comprising the active compound (I) in hydrophilized form using fluidized bed granulation for moist granulation".
- And the step of "converting the granules into the pharmaceutical composition".
- Independent Claim 6 (Product-by-Process Claim):
- A solid, orally administrable pharmaceutical composition comprising the active compound rivaroxaban in hydrophilized form.
- The composition is "prepared by a process comprising" the steps of "first preparing granules...using fluidized bed granulation for moist granulation" and "converting the granules into the pharmaceutical composition".
- The complaint notes that dependent claims 2-5 and 7-24 incorporate the limitations of claims 1 or 6 (Compl. ¶43).
III. The Accused Instrumentality
Product Identification
- Mylan’s proposed generic rivaroxaban tablets, as described in ANDA No. 212220 ("Mylan's ANDA Product") (Compl. ¶1).
Functionality and Market Context
- The relevant feature of Mylan's product is the manufacturing process used to create it, not its end function as a medication (Compl. ¶46). The complaint alleges that the granulation step for Mylan's ANDA Product uses "high shear granulation" (Compl. ¶48). Specifically, the process is alleged to use a Vector GMX75 Mixer or a Gral-150 High Intensity Granulator (Compl. ¶50).
- The complaint alleges that this process is distinct from the "fluidized bed granulation" process required by the claims of the ’053 patent (Compl. ¶51). The product is intended to be a generic alternative to the brand-name drug Xarelto®, and Mylan seeks to market it upon receiving final FDA approval (Compl. ¶9).
IV. Analysis of Infringement Allegations
Mylan seeks a declaratory judgment of non-infringement. The core of its argument is that its manufacturing process does not meet a key limitation present in all claims of the ’053 patent. No probative visual evidence provided in complaint.
'053 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A process for the preparation of a solid, orally administrable pharmaceutical composition... | Mylan's ANDA Product is a solid, orally administrable pharmaceutical composition (Compl. ¶1). | ¶1 | col. 10:56-61 |
| first preparing granules comprising the active compound (I) in hydrophilized form using fluidized bed granulation for moist granulation; | Mylan's ANDA Product is allegedly "not prepared by 'first preparing granules...using fluidized bed granulation for moist granulation.'" Instead, it is prepared using "high shear granulation." | ¶¶45, 48 | col. 10:62-65 |
| and converting the granules into the pharmaceutical composition. | Mylan's manufacturing process converts granules into tablets (implied by ANDA for tablets). | ¶1 | col. 11:1-2 |
- Identified Points of Contention:
- Technical Questions: The primary technical dispute is whether the "high shear granulation" process used by Mylan is functionally and structurally different from the "fluidized bed granulation" process recited in the claims. The complaint asserts that they are different processes (Compl. ¶56).
- Scope Questions: The case raises the question of whether the applicants for the ’053 patent disclaimed claim scope covering "high shear" processes during prosecution. The complaint alleges that to overcome an obviousness rejection, the applicants argued that their fluidized bed granulation process was "surprising and unexpected" and yielded "significantly higher bioavailability" compared to processes using a "high shear mixer" (Compl. ¶59). This raises the question of whether Defendants are prevented by prosecution history estoppel from arguing that Mylan's high shear process is equivalent to the claimed process.
V. Key Claim Terms for Construction
- The Term: "using fluidized bed granulation for moist granulation"
- Context and Importance: This term is the central limitation at issue. Mylan's entire non-infringement position hinges on demonstrating that its "high shear granulation" process falls outside the scope of this term, both literally and under the doctrine of equivalents. The construction of this term will likely be dispositive of the literal infringement inquiry.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue that "fluidized bed granulation" is merely an example of a broader category of moist granulation techniques intended to be covered. However, the claim language itself is specific, which may constrain such an argument.
- Evidence for a Narrower Interpretation: The patent specification explicitly distinguishes between different types of granulation, stating that moist granulation "can be carried out in a mixer (=mixer granulation) or in a fluidized bed (=fluidized bed granulation); fluidized bed granulation is preferred" (’053 Patent, col. 2:48-50). The complaint further points to the prosecution history, where the applicant allegedly distinguished the invention from "high shear mixing" to argue for patentability, suggesting a deliberate surrender of that subject matter (Compl. ¶¶ 59, 63).
VI. Other Allegations
- Doctrine of Equivalents and Prosecution History Estoppel: Mylan's complaint preemptively argues against a finding of infringement under the doctrine of equivalents. It alleges that during prosecution, the applicants submitted arguments and an inventor declaration to the USPTO to distinguish their invention from prior art involving "high shear mixing" (Compl. ¶¶ 59-60). The complaint contends that these arguments constitute a "clear and unmistakable surrender of high shear granulation," and therefore Defendants are estopped from asserting that high shear granulation is equivalent to the claimed fluidized bed granulation (Compl. ¶¶ 62-64).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this declaratory judgment action appears to depend on two primary questions for the court:
- A central issue will be one of technical distinction: Is the "high shear granulation" process, as described in Mylan's ANDA, the same as the "fluidized bed granulation" process required by the plain language of the asserted claims? The complaint suggests they are recognized as distinct methods in the pharmaceutical arts.
- A critical legal question will be one of prosecution history estoppel: Even if the two processes are not literally identical, did the patentee, in arguments made to the USPTO to secure the patent, disclaim or surrender processes involving "high shear" methods? If so, Defendants may be barred from arguing that Mylan's process infringes under the doctrine of equivalents.