DCT

3:17-cv-03724

Acorda Therap Inc v. Micro Labs Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:17-cv-03724, D.N.J., 05/24/2017
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Micro Labs USA, Inc. is a New Jersey corporation, and because Defendants’ submission of an Abbreviated New Drug Application (ANDA) targets the future marketing and sale of the accused generic product throughout the United States, including in New Jersey.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an ANDA seeking approval to market a generic version of Plaintiff's Ampyra® (dalfampridine) tablets constitutes an act of infringement of four U.S. patents covering sustained-release formulations and methods of use.
  • Technical Context: The technology concerns sustained-release oral formulations of 4-aminopyridine, a potassium channel blocker used to improve walking ability in patients with multiple sclerosis (MS).
  • Key Procedural History: The complaint notes that in prior litigation in the District of Delaware, certain claims of the patents-in-suit were held invalid for obviousness. Plaintiff states it has appealed that decision to the Federal Circuit and, critically, alleges that the specific claims asserted in the present case were not addressed in the Delaware court's decision.

Case Timeline

Date Event
2003-12-11 Priority Date for ’826 and ’685 Patents
2004-04-09 Priority Date for ’437 and ’703 Patents
2011-08-30 U.S. Patent No. 8,007,826 Issues
2013-01-15 U.S. Patent No. 8,354,437 Issues
2013-05-14 U.S. Patent No. 8,440,703 Issues
2014-03-04 U.S. Patent No. 8,663,685 Issues
2017-03-31 District of Delaware decision finding other claims invalid
2017-04-12 Micro Labs sends Notice Letter regarding ANDA filing to Acorda
2017-05-23 Acorda appeals Delaware decision to the Federal Circuit
2017-05-24 Complaint Filed

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

U.S. Patent No. 8,007,826 - "Sustained Release Aminopyridine Composition"

Issued August 30, 2011

The Invention Explained

  • Problem Addressed: The patent describes how neurological disorders like multiple sclerosis (MS) involve demyelination of nerve fibers, which slows or blocks nerve impulses (’826 Patent, col. 1:36-42). While the active ingredient, aminopyridine, can restore nerve conduction, immediate-release formulations cause undesirable spikes and troughs in blood plasma concentration, which can lead to adverse side effects and limit therapeutic efficacy (’826 Patent, col. 15:45-48).
  • The Patented Solution: The invention is a sustained-release oral dosage form that disperses aminopyridine in a release matrix, such as a hydrophilic polymer like hydroxypropylmethylcellulose (HPMC) (’826 Patent, col. 2:45-48). This formulation is designed to provide a therapeutically effective plasma level of the drug for at least 12 hours, allowing for a more stable concentration profile and convenient twice-daily dosing (’826 Patent, Abstract).
  • Technical Importance: This sustained-release matrix technology enables the maintenance of the drug's concentration within its therapeutic window, potentially improving patient safety and compliance compared to immediate-release versions (’826 Patent, col. 2:30-41).

Key Claims at a Glance

  • The complaint identifies Claims 31 and 36 as being at issue (Compl. ¶28). The independent claim appears to be Claim 31.
  • Claim 31 is a method claim with the following essential elements:
    • A method of increasing walking speed in a human multiple sclerosis patient in need thereof
    • comprising orally administering to said patient a sustained release composition
    • of 10 milligrams of 4-aminopyridine
    • twice daily
    • for a time period of greater than two weeks
    • wherein said 10 milligram doses are the only doses of 4-aminopyridine administered to the patient during said time period

U.S. Patent No. 8,354,437 - "Method of Using Sustained Release Aminopyridine Compositions"

Issued January 15, 2013

The Invention Explained

  • Problem Addressed: This patent addresses the same fundamental problem as the ’826 Patent: the need for a stable and effective treatment for neurological conditions like MS that avoids the pharmacokinetic volatility of immediate-release aminopyridine formulations (’437 Patent, col. 1:21-34).
  • The Patented Solution: The invention claims a specific method of use for a 10 mg sustained-release 4-aminopyridine composition. The method involves administering the composition twice daily for at least two weeks to achieve and maintain a specific pharmacokinetic profile, defined by a ratio of the maximum to minimum plasma concentration at steady state (Cmaxss:Cminss) and an average plasma concentration at steady state (Cavss) (’437 Patent, Abstract; claim 1).
  • Technical Importance: By claiming the specific pharmacokinetic outcome of a dosing regimen, the patent seeks to protect not just the formulation, but the precise therapeutic method that achieves a balance of efficacy and safety for improving walking in MS patients (’437 Patent, claim 1).

Key Claims at a Glance

  • The complaint identifies Claims 38-40 as being at issue (Compl. ¶28). The lead independent claim is Claim 1.
  • Claim 1 is a method claim with the following essential elements:
    • A method for maintaining a therapeutically effective concentration of 4-aminopyridine to improve walking in a human with MS
    • comprising orally administering a sustained release composition of 10 mg of 4-aminopyridine twice daily for a day
    • and thereafter, maintaining administration twice daily for at least two weeks
    • whereby an in vivo 4-aminopyridine Cmaxss:Cminss ratio of 1.0 to 3.5 and a Cavss of 15 ng/ml to 35 ng/ml are obtained

U.S. Patent No. 8,440,703 - "Methods of Using Sustained Release Aminopyridine Compositions"

Issued May 14, 2013

  • Patent Identification: U.S. Patent No. 8,440,703, "Methods of Using Sustained Release Aminopyridine Compositions," Issued May 14, 2013 (Compl. ¶20).
  • Technology Synopsis: Similar to the ’437 Patent, this patent claims methods of using sustained-release 4-aminopyridine compositions to treat MS. The claims are directed to specific dosing regimens (e.g., 10 mg twice daily) and the resulting clinical and pharmacokinetic outcomes for improving walking (’703 Patent, Abstract).
  • Asserted Claims: The complaint identifies Claims 28, 30, 32, 33, and 35 as being at issue (Compl. ¶28, ¶63). The lead independent claim is Claim 1.
  • Accused Features: The accused features are the proposed use of the Micro Labs Generic Tablets according to their label, which allegedly instructs a dosing regimen that meets the claim limitations (Compl. ¶63-64).

U.S. Patent No. 8,663,685 - "Sustained Release Aminopyridine Composition"

Issued March 4, 2014

  • Patent Identification: U.S. Patent No. 8,663,685, "Sustained Release Aminopyridine Composition," Issued March 4, 2014 (Compl. ¶21).
  • Technology Synopsis: This patent, like the ’826 Patent, is directed to the pharmaceutical composition itself. It claims a sustained-release oral dosage formulation comprising 4-aminopyridine in a release matrix that provides a specific pharmacokinetic profile upon administration (’685 Patent, Abstract).
  • Asserted Claims: The complaint identifies Claim 4 as being at issue (Compl. ¶28). The lead independent claim is Claim 1.
  • Accused Features: The accused instrumentality is the Micro Labs Generic Tablet formulation itself, which is alleged to be a sustained-release composition meeting the claim limitations (Compl. ¶75-76).

III. The Accused Instrumentality

Product Identification

  • The accused products are "Micro Labs Generic Tablets," described as 10 mg dalfampridine extended release tablets for which Defendants have filed ANDA No. 210158 with the FDA (Compl. ¶10, ¶29).

Functionality and Market Context

  • The complaint alleges that the Micro Labs Generic Tablets are generic copies of Acorda's Ampyra® drug product (Compl. ¶29-30). The proposed labeling for the tablets allegedly states that the product "is indicated as a treatment to improve walking in patients with multiple sclerosis (MS) [as] demonstrated by an increase in walking speed . . . ." (Compl. ¶40). The labeling allegedly recommends a maximum dose of "one 10 mg tablet twice daily" with doses taken "approximately 12 hours apart" (Compl. ¶40).
  • The basis of the infringement action is the filing of the ANDA, which seeks FDA approval to market this generic equivalent prior to the expiration of the patents-in-suit (Compl. ¶2). Pursuant to FDA regulations, the proposed labeling for the generic product must be "materially the same" as the labeling for the brand-name Ampyra® product (Compl. ¶38).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

U.S. Patent No. 8,007,826 Infringement Allegations

Claim Element (from Independent Claim 31) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of increasing walking speed in a human multiple sclerosis patient in need thereof The proposed product label allegedly states it "is indicated as a treatment to improve walking in patients with multiple sclerosis (MS) [as] demonstrated by an increase in walking speed . . . ." ¶40 col. 28:16-19
comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily The proposed label allegedly instructs a "maximum recommended dose" of "one 10 mg tablet twice daily, taken with or without food," with doses to be taken "approximately 12 hours apart." ¶40 col. 28:19-21
for a time period of greater than two weeks The proposed label allegedly will instruct physicians that the drug "has been safely administered to MS patients for at least two weeks and for at least 12 weeks." ¶40 col. 28:21-22
wherein said 10 milligram doses are the only doses of 4-aminopyridine administered... during said time period The proposed label allegedly instructs that the dose "should not be exceeded," that patients "should not take double or extra doses," and that "no additional benefit was demonstrated at doses greater than 10 mg twice daily." ¶40 col. 28:23-26

U.S. Patent No. 8,354,437 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for maintaining a therapeutically effective concentration of 4-aminopyridine in order to improve walking in a human with multiple sclerosis The proposed product label allegedly states it "is indicated as a treatment to improve walking in patients with multiple sclerosis (MS) [as] demonstrated by an increase in walking speed . . . ." ¶52 col. 27:17-21
said method comprising: orally administering... a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a day The proposed label allegedly instructs a dose of "one 10 mg tablet twice daily, taken with or without food," with doses to be taken "approximately 12 hours apart." ¶52 col. 27:21-25
and thereafter, maintaining administration... for a time period of at least two weeks The proposed label allegedly will instruct physicians that the drug "has been safely administered to MS patients for at least two weeks and for at least 12 weeks." ¶52 col. 27:25-27
whereby an in vivo 4-aminopyridine Cmaxss:Cminss ratio of 1.0 to 3.5 and a Cavss of 15 ng/ml to 35 ng/ml are obtained The complaint alleges that "in light of FDA bioequivalence and bioavailability requirements, administration of Micro Labs Generic Tablets according to Micro Labs proposed labeling will achieve pharmacokinetic parameters within the ranges claimed." ¶52 col. 27:27-34

Identified Points of Contention

  • Evidentiary Questions: A central point of contention may be whether the administration of a bioequivalent generic product necessarily results in the specific pharmacokinetic ratios recited in the method claims (e.g., in the ’437 Patent). The complaint alleges this is a consequence of FDA bioequivalence requirements (Compl. ¶52), but this is a technical assertion that will likely require expert testimony and evidentiary support beyond the pleadings.
  • Scope Questions: The dispute will likely involve the scope of the method claims. The infringement alleged is indirect, based on the actions of physicians and patients who follow the proposed product label. This raises the question of whether the label's instructions are sufficient to "encourage and instruct" (Compl. ¶41) the performance of every step of the claimed methods, thereby establishing inducement.

V. Key Claim Terms for Construction

The Term: "Cmaxss:Cminss ratio of 1.0 to 3.5"

  • Context and Importance: This pharmacokinetic ratio, recited in claims of the ’437 and ’703 Patents, defines the specific steady-state fluctuation of the drug in a patient's plasma. The infringement analysis for these patents will depend entirely on whether the accused generic product, when used as directed, produces a plasma concentration profile that falls within this claimed numerical range.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself provides the bounds of the term. The specification of the parent ’826 patent notes that the sustained-release composition is designed to avoid "peaks and troughs" in general, which may support reading the claimed range as encompassing any formulation that achieves this goal (’826 Patent, col. 2:40-41).
    • Evidence for a Narrower Interpretation: The specification includes data from clinical studies showing specific, observed pharmacokinetic values (e.g., ’826 Patent, Table 2). A party might argue that the claim term should be interpreted in light of these specific examples, potentially narrowing its scope to profiles closely matching those explicitly disclosed.

The Term: "increasing walking speed"

  • Context and Importance: This phrase, appearing in the preamble of method claims like Claim 31 of the ’826 Patent, describes the intended purpose and outcome of the method. Whether this preamble is interpreted as a binding limitation on the claim's scope could be a point of dispute. Practitioners may focus on this term because if it is deemed limiting, infringement would require not only performing the administration steps but also achieving a measurable increase in walking speed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (Non-Limiting): A party may argue that the phrase merely states the intended purpose of the method and does not impose a separate, measurable limitation on the claim. The body of the claim recites the active steps of "administering" the composition, which could be argued to be the sole requirements for infringement.
    • Evidence for a Narrower Interpretation (Limiting): The patent repeatedly frames the invention's utility in terms of improving walking, and clinical trial data is presented to demonstrate this effect (’826 Patent, FIG. 3). A party could argue this context makes "increasing walking speed" an essential and limiting element of the claimed method.

VI. Other Allegations

  • Indirect Infringement: The complaint's core theory is indirect infringement. It alleges active inducement on the basis that Defendants' proposed labeling will "encourage and instruct physicians to prescribe, and patients to administer the product in a manner that infringes" (Compl. ¶41, ¶53). It also pleads contributory infringement, alleging the generic tablets are "especially made or adapted for use in infringing the claims" and are "not suitable for any substantial non-infringing use" (Compl. ¶43, ¶55).
  • Willful Infringement: The complaint does not explicitly allege "willful infringement." However, it does allege that Defendants had knowledge of the patents-in-suit prior to filing the ANDA, citing the patents' listing in the FDA Orange Book, professed knowledge of prior litigation, and the notice letter sent to Acorda (Compl. ¶37, ¶49). In the prayer for relief, Plaintiff requests a judgment that the case is "exceptional" under 35 U.S.C. § 285, which is the statutory basis for awarding attorneys' fees, often in cases of willfulness or litigation misconduct (Compl. p. 20, ¶D).

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

  • A central issue will be one of evidentiary proof: can Plaintiff's assertion that FDA bioequivalence rules mandate an infringing outcome suffice to show that the accused generic product will meet the specific pharmacokinetic ratios required by the method claims, or will a more detailed, product-specific factual analysis be required?
  • A second key question will be one of induced infringement: does the accused product's label—which is required by law to be materially similar to the brand-name label—provide sufficiently explicit instruction and encouragement to physicians and patients to satisfy the legal standard for inducing infringement of the patented methods?
  • A significant background issue will be the impact of prior litigation: how will the Delaware court's invalidity ruling on different claims from the same patents, which is currently under appeal, influence the claim construction and validity arguments concerning the distinct set of claims asserted in this New Jersey action?