DCT
3:16-cv-08282
Medicis Pharmaceutical Corp v. DR Reddy's Laboratories Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Medicis Pharmaceutical Corp (Delaware)
- Defendant: DR Reddy's Laboratories Ltd (India) and DR Reddy's Laboratories Ltd (New Jersey)
- Plaintiff’s Counsel: Finnegan Henderson Farabow Garrett & Dunner LLP
- Case Identification: 3:16-cv-08282, D.N.J., 11/04/2016
- Venue Allegations: Venue is based on Defendant Dr. Reddy's Laboratories, Inc.'s principal place of business in Princeton, New Jersey, and Defendant Dr. Reddy's Laboratories, Ltd.'s alleged business operations and research facilities within the district.
- Core Dispute: Plaintiff alleges that Defendants’ submission of a New Drug Application to the FDA for generic extended-release minocycline hydrochloride tablets constitutes an act of infringement of six patents related to controlled-release formulations and methods for treating acne.
- Technical Context: The technology concerns oral pharmaceutical formulations of minocycline, a tetracycline-class antibiotic, designed to treat acne vulgaris while minimizing known vestibular side effects like dizziness.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Plaintiff's receipt of a notice letter regarding Defendants' New Drug Application No. 209269, which references Plaintiff's approved drug, Solodyn®. The complaint notes that U.S. Patent No. 5,908,838 underwent an ex parte reexamination, with a certificate issued in 2010 that confirmed the patentability of its claims.
Case Timeline
| Date | Event |
|---|---|
| 1998-02-19 | '838 Patent Priority Date |
| 1999-06-01 | '838 Patent Issue Date |
| 2005-06-24 | '705, '483, '776, '804, '650 Patents Priority Date |
| 2010-06-01 | '838 Patent Reexamination Certificate Issued |
| 2010-09-07 | '705 Patent Issue Date |
| 2011-04-05 | '483 Patent Issue Date |
| 2012-08-28 | '776 Patent Issue Date |
| 2012-09-18 | '804 Patent Issue Date |
| 2014-05-13 | '650 Patent Issue Date |
| 2016-09-22 | Plaintiff Receives Defendant's Notice Letter |
| 2016-11-04 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 5,908,838 - "Method for the Treatment of Acne"
- Issued: June 1, 1999
The Invention Explained
- Problem Addressed: The patent’s background section states that oral tetracycline antibiotics, while effective for treating acne, are known to cause vestibular side effects such as vertigo and dizziness, which can be disabling for patients (’838 Patent, col. 1:16-21). At the time, the standard practice was to use formulations that achieved rapid dissolution of the drug (’838 Patent, col. 1:23-27).
- The Patented Solution: The invention is a method of treatment based on the discovery that slowing the dissolution rate of oral minocycline reduces the incidence and severity of vestibular side effects (’838 Patent, col. 1:50-55). This is accomplished by administering a "slowly dissolving dosage form" that results in a reduced peak blood stream concentration of the drug, thereby improving patient tolerability (’838 Patent, col. 1:55-58).
- Technical Importance: This approach provided a way to improve the safety and tolerability profile of a widely used acne medication, which could enhance patient compliance and allow continued treatment for those who might otherwise discontinue therapy due to side effects (’838 Patent, col. 1:50-55).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" of the '838 patent, which underwent reexamination (Compl. ¶25). New independent claim 19 is representative.
- Essential elements of independent claim 19 include:
- A method for reducing the incidence or severity of vestibular side effects resulting from the treatment of acne by the use of oral minocycline,
- comprising administering the minocycline once a day for multiple days in a dosage form that is slowly dissolving as measured under standard U.S. Pharmacopeia test conditions,
- wherein the minocycline dissolves at a rate no faster than 15 percent in 15 minutes, 35 percent in 30 minutes, 50 percent in 45 minutes and 80 percent in 60 minutes.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 7,790,705 - "Minocycline Oral Dosage Forms for the Treatment of Acne"
- Issued: September 7, 2010
The Invention Explained
- Problem Addressed: The patent background acknowledges that while slowly dissolving forms of minocycline were an advance, there remained a "long-felt need for treatments that are effective in suppressing acne but associated with fewer adverse effects" than immediate-release forms (’705 Patent, col. 1:56-62).
- The Patented Solution: The patent discloses an oral dosage form of minocycline containing a "controlled-release carrier composition" that renders the dosage form "pharmacokinetically distinct" from immediate-release formulations (’705 Patent, col. 2:1-4, 16-18). This distinction is defined by specific pharmacokinetic profiles, such as a reduced maximum plasma concentration (Cmax) or an increased time to maximum concentration (Tmax), which can be achieved through once-daily administration (’705 Patent, Embodiment 3, col. 22:45-65).
- Technical Importance: This invention provided specific, engineered controlled-release formulations with defined pharmacokinetic outcomes, moving beyond a general concept of "slow dissolution" to optimize the drug's therapeutic window for both efficacy and safety (’705 Patent, col. 2:5-11).
Key Claims at a Glance
- The complaint asserts infringement of "at least one claim" of the '705 patent (Compl. ¶35). Independent claim 1 is representative.
- Essential elements of independent claim 1 include:
- An oral dosage form, comprising: minocycline or a pharmaceutically acceptable salt thereof; and
- an amount of a controlled-release carrier composition that is effective to render said oral dosage form pharmacokinetically distinct from MINOCIN® immediate-release minocycline hydrochloride.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 7,919,483 - "Method for the Treatment of Acne"
- Issued: April 5, 2011
- Technology Synopsis: The patent addresses the need for acne treatments with fewer adverse effects than immediate-release minocycline (Compl. ¶14). It provides a method of treating acne by administering an oral, weight-based dose of minocycline (approx. 1 mg/kg) in a dosage form that is pharmacokinetically distinct from immediate-release forms, which is alleged to improve tolerability while maintaining efficacy (’483 Patent, col. 2:5-11).
- Asserted Claims: At least one claim is asserted; independent claims are 1 and 9 (Compl. ¶45).
- Accused Features: Defendants' proposed generic extended-release minocycline tablets, which are alleged to be intended for use in an infringing manner upon FDA approval (Compl. ¶¶45-47).
U.S. Patent No. 8,252,776 - "Minocycline Oral Dosage Forms for the Treatment of Acne"
- Issued: August 28, 2012
- Technology Synopsis: The patent addresses the need for more tolerable acne treatments by disclosing a method of administering a continuous slow-release oral dosage form of minocycline based on patient body weight (approx. 0.7 to 1.3 mg/kg/day) (’776 Patent, claim 1). This method, which avoids an initial loading dose, is claimed to effectively treat acne with reduced vestibular side effects compared to immediate-release formulations (Compl. ¶15).
- Asserted Claims: At least one claim is asserted; independent claim is 1 (Compl. ¶55).
- Accused Features: Defendants' proposed generic extended-release minocycline tablets, which are alleged to be intended for use in an infringing manner upon FDA approval (Compl. ¶¶55-57).
U.S. Patent No. 8,268,804 - "Minocycline Oral Dosage Forms for the Treatment of Acne"
- Issued: September 18, 2012
- Technology Synopsis: This patent addresses the need for effective and well-tolerated acne treatments by disclosing a method of distributing a minocycline oral dosage form along with information for selecting the dose based on body weight (’804 Patent, claim 1). The dosage form is described as having a specific controlled-release profile designed to be pharmacokinetically distinct from immediate-release versions to reduce side effects (Compl. ¶16).
- Asserted Claims: At least one claim is asserted; independent claim is 1 (Compl. ¶65).
- Accused Features: Defendants' proposed generic extended-release minocycline tablets, which are alleged to be intended for distribution and use in an infringing manner upon FDA approval (Compl. ¶¶65-67).
U.S. Patent No. 8,722,650 - "Extended-Release Minocycline Dosage Forms"
- Issued: May 13, 2014
- Technology Synopsis: The patent addresses the need for effective acne treatments with improved side-effect profiles by disclosing a method of treating acne by administering a specific extended-release minocycline dosage form (55, 80, or 105 mg) (’650 Patent, claim 1). The formulation uses a hydroxypropylmethylcellulose carrier with a specified degree of hydroxypropoxylation to achieve a defined dissolution profile, balancing efficacy and tolerability (Compl. ¶17).
- Asserted Claims: At least one claim is asserted; independent claims are 1 and 7 (Compl. ¶75).
- Accused Features: Defendants' proposed generic 105 mg extended-release minocycline tablets, which are alleged to be intended for use in an infringing manner upon FDA approval (Compl. ¶¶75-77).
III. The Accused Instrumentality
Product Identification
- Defendants' 135 mg and 105 mg minocycline hydrochloride extended release tablets, for which Defendants filed New Drug Application No. 209269 (Compl. ¶4).
Functionality and Market Context
- The accused products are generic versions of Plaintiff's Solodyn® extended-release tablets, intended for the treatment of acne (Compl. ¶4). The complaint alleges that Defendants' regulatory filing purports to refer to and rely on the FDA approval for Solodyn® and contains data demonstrating bioequivalence between Defendants' products and Solodyn® (Compl. ¶21).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
'838 Patent Infringement Allegations
| Claim Element (from Independent Claim 19) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method for reducing the incidence or severity of vestibular side effects resulting from the treatment of acne by the use of oral minocycline, | The accused product is an oral minocycline tablet for treating acne, and its extended-release formulation is alleged to reduce side effects as compared to immediate-release forms. | ¶¶4, 26 | col. 1:16-21, 50-55 |
| comprising administering the minocycline once a day for multiple days in a dosage form that is slowly dissolving as measured under standard U.S. Pharmacopeia test conditions, | The accused product is an "extended release" tablet, alleged to be bioequivalent to the once-daily Solodyn® product, and is therefore alleged to be a slowly dissolving dosage form intended for once-daily use. | ¶¶4, 21, 26 | col. 1:50-55 |
| wherein the minocycline dissolves at a rate no faster than 15 percent in 15 minutes, 35 percent in 30 minutes, 50 percent in 45 minutes and 80 percent in 60 minutes. | The accused "extended release" product is alleged to meet the claimed dissolution profile, which is characteristic of a slowly dissolving formulation. | ¶¶4, 21, 26 | col. 2:1-5 |
'705 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An oral dosage form, comprising: minocycline or a pharmaceutically acceptable salt thereof; | The accused product is an oral tablet containing minocycline hydrochloride. | ¶4 | col. 2:12-13 |
| and an amount of a controlled-release carrier composition that is effective to render said oral dosage form pharmacokinetically distinct from MINOCIN® immediate-release minocycline hydrochloride. | The accused product is an "extended release" tablet, which implies the presence of a controlled-release carrier, and is alleged to be bioequivalent to Solodyn®, which itself is pharmacokinetically distinct from immediate-release minocycline. | ¶¶4, 21, 36 | col. 2:1-4, 16-18 |
- Identified Points of Contention:
- Factual Question: A primary factual question for the ’838 Patent will be whether the accused products literally meet the specific dissolution rate limitations recited in claim 19. The resolution will depend on expert testimony and empirical testing of the accused products' formulation.
- Scope Question: For the ’705 Patent and its family, a central issue will be the construction of the term "pharmacokinetically distinct". The dispute may focus on whether mere statistical difference from the immediate-release product is sufficient for infringement, or if the term requires a profile that more closely matches the specific pharmacokinetic parameters and curves disclosed in the patent's specification and figures.
V. Key Claim Terms for Construction
The Term: "slowly dissolving" (’838 Patent)
Context and Importance: This term is fundamental to the inventive concept of the ’838 Patent. The scope of this term will be critical in determining whether the accused "extended release" products infringe the claimed method.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the invention as reducing peak blood stream concentration by "slowing the dissolution rates" as a general principle, which may support a broader functional definition (’838 Patent, col. 1:50-58).
- Evidence for a Narrower Interpretation: Amended claims 3 and 19 provide specific, quantitative dissolution profiles (e.g., "no faster than 15 percent in 15 minutes"). A party may argue that these explicit numerical limitations define and limit the scope of "slowly dissolving" to those specific rates. The patent’s Table 2 also provides a specific dissolution profile for a "Slow Dissolving" formulation that could be cited to narrow the term’s scope.
The Term: "pharmacokinetically distinct" (’705 Patent)
Context and Importance: This term is the core limitation of the independent claims of the ’705 patent and its asserted family members. Practitioners may focus on this term because its construction will likely determine the outcome of the infringement analysis for a large portion of the asserted patent portfolio.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests that being "pharmacokinetically distinct" can result from "one or more of a reduced maximum observed plasma minocycline concentration (Cmax), a reduced area under a blood plasma minocycline concentration versus time curve (AUC), and/or an increased time (Tmax)" compared to the immediate-release formulation (’705 Patent, col. 12:1-10). This language could support an interpretation where a statistically significant difference in any one of these parameters renders a product "distinct."
- Evidence for a Narrower Interpretation: The patent’s detailed description and figures provide specific examples of pharmacokinetic profiles that are considered distinct (e.g., ’705 Patent, Fig. 1; Embodiment 3). A party may argue that the term should be construed to cover only those formulations that exhibit a profile substantially similar to those exemplified, not merely any formulation that is different from the prior art reference product.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants will contributorily infringe and induce infringement of the asserted method claims (e.g., Compl. ¶27, ¶47). The alleged basis for these claims is that Defendants' product labeling and instructions will direct and encourage physicians and patients to administer the accused tablets in a manner that practices the patented methods of treatment.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: For the ’705 patent family, can the term "pharmacokinetically distinct," which is defined relative to an immediate-release formulation, be construed to read on a generic product that is formulated to be bioequivalent to Plaintiff's own controlled-release product, Solodyn®?
- A key evidentiary question will be one of technical proof: For the ’838 patent, does the accused product’s formulation actually exhibit the specific, multi-part dissolution rates required by the asserted claims, or is there a factual mismatch in its physical properties?
- A central strategic question will be one of infringement by equivalence: Given that this is a Hatch-Waxman action based on a generic filing, to what extent can Plaintiff rely on Defendants' assertion of bioequivalence to Solodyn® as dispositive proof of infringement, versus having to prove, element-by-element, that the specific formulation of the accused generic product meets every claim limitation?