Zydus Pharma USA Inc v. Novartis Pharma Corp

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Zydus Pharmaceuticals (USA) Inc. (New Jersey)
  • Defendant: Novartis Pharmaceuticals Corp. (Delaware) and Novartis AG (Switzerland)
  • Plaintiff’s Counsel: Epstein Becker & Green, P.C.
• Case Identification: 2:19-cv-21259, D.N.J., 12/10/2019
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey based on Defendant Novartis Pharmaceuticals Corp.'s principal place of business in the district, its substantial and systematic business contacts, and its history of filing patent infringement suits in the forum.
• Core Dispute: Plaintiff seeks a declaratory judgment that its generic deferasirox tablets, for which it has filed an Abbreviated New Drug Application (ANDA), do not infringe any valid claim of Defendant's U.S. Patent No. 9,283,209.
• Technical Context: The technology concerns oral pharmaceutical formulations of deferasirox, a drug used to treat chronic iron overload caused by blood transfusions.
• Key Procedural History: This case arises under the Hatch-Waxman Act. Zydus, a subsequent ANDA filer, received a Paragraph IV notice from the FDA for its 180 mg deferasirox tablets. After Zydus notified Novartis of its ANDA filing, Novartis declined to sue for infringement within the statutory 45-day period. Zydus alleges its path to market is now blocked by a "first filer's" 180-day marketing exclusivity. This declaratory judgment action seeks a judicial determination of non-infringement to trigger a forfeiture of that exclusivity and clear the way for final FDA approval of Zydus's product. The complaint notes that the patent-in-suit is the subject of other pending litigation in the same district.

Case Timeline

Date	Event
2013-03-08	'209 Patent Priority Date
2016-03-15	'209 Patent Issue Date
2016-04-21	First Filer ANDA Submission Date (180 mg)
2017-12-13	Zydus Submits its ANDA for Deferasirox Products
2018-02-14	Zydus Sends Paragraph IV Notice Letter to Novartis
2018-02-15	Novartis Receives Zydus's Notice Letter (approx.)
2018-03-26	Zydus Provides Novartis a Copy of its ANDA
2019-12-10	Complaint for Declaratory Judgment Filed

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

U.S. Patent No. 9,283,209 - Oral Formulations of Deferasirox

• Patent Identification: U.S. Patent No. 9,283,209, Oral Formulations of Deferasirox, issued March 15, 2016. (Compl. ¶33).

The Invention Explained

• Problem Addressed: The patent's background section describes challenges with the then-marketed version of deferasirox (Exjade™). These problems included the drug's poor solubility, which necessitated high doses and led to side effects like gastrointestinal (GI) irritation. (’209 Patent, col. 1:21-28, 1:46-56). The existing formulation was a "dispersible tablet" that had to be mixed into a liquid before administration and taken on an empty stomach, creating patient compliance issues. (’209 Patent, col. 1:30-41).
• The Patented Solution: The invention is a swallowable tablet formulation with a higher drug load (45-60% by weight) and specific dissolution characteristics: "reduced release under gastric conditions and fast release at near neutral pH." (’209 Patent, Abstract; col. 2:37-44). This design aims to limit the drug's direct contact with the stomach mucosa, thereby reducing GI irritation, minimizing food-related effects on absorption, and improving patient convenience compared to the prior dispersible tablets. (’209 Patent, col. 2:1-17). The formulation achieves this through a specific combination of excipients detailed in the claims. Figure 3 of the patent illustrates this intended effect, showing minimal drug release at low pH (simulating the stomach) followed by rapid release at pH 6.8 (simulating the intestine). (’209 Patent, Fig. 3).
• Technical Importance: This technology represents an effort to create a more tolerable and convenient "life-cycle improvement" for a chronic medication, aiming to enhance patient adherence by simplifying administration and reducing side effects. (’209 Patent, col. 2:1-5).

Key Claims at a Glance

• The complaint seeks a declaratory judgment of non-infringement of any valid claim of the ’209 patent. (Compl. ¶65). The patent contains three independent claims, each directed to a specific dosage strength. As the dispute centers on Zydus's 180 mg tablet, Claim 2 is the most relevant.
• Independent Claim 1: A tablet for oral administration consisting of:
  • 90 mg deferasirox
  • 53.61 mg microcrystalline cellulose
  • 3.65 mg poly vinyl pyrrolidone K-30
  • 11.34 mg crospovidone
  • 0.16 mg poloxamer
  • 0.81 mg fumed silica
  • 2.43 mg magnesium stearate; and
  • 4.86 mg seal-coat
• Independent Claim 2: A tablet for oral administration consisting of the same eight ingredients as Claim 1, but with 180 mg of deferasirox and proportionally doubled amounts of each excipient.
• Independent Claim 3: A tablet for oral administration consisting of the same eight ingredients as Claim 1, but with 360 mg of deferasirox and proportionally quadrupled amounts of each excipient.

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is "Zydus's deferasirox tablets, 180 mg, described in Zydus's Abbreviated New Drug Application ('ANDA') No. 211383." (Compl. ¶1).

Functionality and Market Context

• The complaint alleges that Zydus is a "subsequent filer" for a generic 180 mg deferasirox tablet and that its final FDA approval is blocked by the 180-day marketing exclusivity held by an unidentified "first filer." (Compl. ¶¶ 40, 48). The action is intended to obtain a court judgment that would trigger the forfeiture of this exclusivity. (Compl. ¶50). The complaint states that Zydus provided Novartis with its ANDA containing "detailed information about the composition and manufacture" of its tablets, but this detailed information is not included in the complaint itself. (Compl. ¶44). Therefore, the complaint does not provide sufficient detail for a direct comparison between the accused product's composition and the patent claims.
• No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint is an action for a declaratory judgment of non-infringement and therefore does not contain infringement allegations or a claim chart mapping product features to claim elements. It alleges, in a conclusory manner, that "No valid and enforceable claim of the '209 patent will be infringed by the manufacture, use, offer for sale, sale, and/or importation of Zydus's deferasirox tablets, 180 mg." (Compl. ¶64). The complaint notes that the "detailed factual and legal basis" for its non-infringement position was provided to Novartis in a notice letter, but these details are not recited in the pleading. (Compl. ¶43). As such, the complaint does not provide sufficient detail for a complete infringement analysis.

Identified Points of Contention

• Scope Questions: The infringement analysis will likely center on the scope of the phrase "consisting of," which prefaces all three independent claims. This term creates a very narrow claim scope, excluding any unrecited ingredients. The central factual question will be whether Zydus's 180 mg tablet is compositionally identical to the formulation recited in Claim 2. Any difference in the type of ingredients, or a material difference in their amounts, may support a finding of no literal infringement.
• Technical Questions: A key technical question will be a direct comparison of the composition of Zydus's product (as detailed in its confidential ANDA) with the specific list of eight ingredients and their precise weights recited in Claim 2 of the '209 patent. The case may also raise questions about whether Zydus's product infringes under the doctrine of equivalents, although the use of "consisting of" language significantly restricts the availability of this doctrine.

V. Key Claim Terms for Construction

The Term: "consisting of"

• Context and Importance: This transitional phrase is the most critical term in the patent for determining the scope of infringement. Unlike the more open term "comprising," "consisting of" is legally defined as a closed term, meaning the claimed invention includes only the elements that are expressly recited. Practitioners may focus on this term because if Zydus’s tablet contains any additional excipient not listed in the claims—even a coloring agent or processing aid—it would fall outside the literal scope of the claims.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party might argue that the term does not exclude impurities ordinarily associated with the recited ingredients. Case law supports that this closed language can permit the presence of such trace impurities without defeating a claim of infringement.
  • Evidence for a Narrower Interpretation: The patent claims recite a specific list of eight ingredients and, for each dosage strength, provides their exact weights. (’209 Patent, col. 18:24-51). This high degree of specificity in the claims and the corresponding examples (e.g., Example 5) strongly supports a narrow, exclusionary interpretation where the presence of any other functional or structural component would preclude a finding of literal infringement.

The Term: "seal-coat"

• Context and Importance: All three claims require a specific weight of a "seal-coat" (e.g., 9.72 mg for the 180 mg tablet in Claim 2). The composition of this "seal-coat" is not defined in the claims. Its definition could be a point of dispute if Zydus's tablet has a coating that it argues is functionally or compositionally different from what the patent contemplates as a "seal-coat."
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The term "seal-coat" is not explicitly defined in the specification, which could support an argument that it should be given its plain and ordinary meaning in the pharmaceutical arts, potentially covering a wide range of simple, non-functional film coatings.
  • Evidence for a Narrower Interpretation: The specification discloses using "Opadry coating material" for the film-coated tablets. (’209 Patent, col. 5:8-13). A party could argue that the term "seal-coat" should be limited by this disclosure to a specific type of coating, such as the "Opadry™ Blue" used in the example corresponding to the claimed embodiments. (’209 Patent, col. 9:30).

VI. Other Allegations

• Indirect Infringement: Zydus seeks a declaration that its product will not infringe "directly or indirectly" and prays for a declaration that it will not "induce or contribute to the infringement of any valid claim." (Compl. ¶65; Prayer for Relief ¶B). However, as a complaint for declaratory judgment of non-infringement, it does not plead any specific facts regarding the elements of indirect infringement.

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

This case appears to be driven more by the procedural mechanics of the Hatch-Waxman Act than by a complex technical dispute over patent scope. The key questions are:

• A primary issue will be one of compositional identity: does Zydus's 180 mg tablet formulation contain only the eight ingredients recited in Claim 2 of the '209 patent, in the exact specified amounts, or does it contain additional or different components that would place it outside the scope of the narrowly drafted "consisting of" claim?
• The case also presents a key procedural question under the Hatch-Waxman Act: given that Novartis declined its statutory opportunity to sue Zydus, will this declaratory judgment action succeed in obtaining a court ruling on non-infringement, thereby triggering the forfeiture of the first-filer's 180-day market exclusivity and clearing the path for Zydus's market entry?