DCT
1:15-cv-02156
Reckitt Benckiser LLC v. Perrigo Co
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Reckitt Benckiser LLC (Delaware)
- Defendant: Perrigo Company and Perrigo Research and Development Company (Michigan)
- Plaintiff’s Counsel: SAUL Ewing LLP; Fitzpatrick, Cella, Harper & Scinto
- Case Identification: 1:15-cv-02156, D.N.J., 03/26/2015
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey based on Defendants' purposeful and continuous business in the district, including the marketing and sale of generic pharmaceuticals, and because Plaintiff's commercial headquarters are located in New Jersey, where the harm from the alleged infringement is felt.
- Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market generic versions of Plaintiff's Mucinex® DM products constitutes an act of patent infringement under the Hatch-Waxman Act.
- Technical Context: The technology concerns extended-release oral pharmaceutical formulations for the expectorant guaifenesin, a widely used ingredient in over-the-counter cough and cold medications.
- Key Procedural History: The lawsuit was triggered by Defendants' submission of ANDA No. 207602 to the U.S. Food and Drug Administration (FDA). As part of the ANDA, Defendants filed a "Paragraph IV Certification," alleging that Plaintiff's patents covering Mucinex® DM are invalid, unenforceable, and/or will not be infringed by the proposed generic products. Defendants sent a notice letter regarding this certification to Plaintiff on February 10, 2015, prompting this lawsuit.
Case Timeline
| Date | Event |
|---|---|
| 2000-04-28 | Priority Date for ’252, ’821, and ’032 Patents |
| 2002-04-16 | U.S. Patent No. 6,372,252 Issues |
| 2004-04-29 | FDA Approves NDA for Mucinex® DM |
| 2005-10-18 | U.S. Patent No. 6,955,821 Issues |
| 2010-11-23 | U.S. Patent No. 7,838,032 Issues |
| 2015-02-10 | Defendants Send ANDA Notice Letter to Plaintiff |
| 2015-03-26 | Complaint for Patent Infringement Filed |
II. Technology and Patent(s)-in-Suit Analysis
No probative visual evidence provided in complaint.
U.S. Patent No. 6,372,252 - Guaifenesin Sustained Release Formulation and Tablets
- Patent Identification: U.S. Patent No. 6,372,252, titled “Guaifenesin Sustained Release Formulation and Tablets,” issued on April 16, 2002.
The Invention Explained
- Problem Addressed: The patent describes the problem that guaifenesin, an effective expectorant, has a very short plasma half-life of approximately one hour, requiring frequent dosing to maintain a therapeutic effect (Compl. ¶21; ’252 Patent, col. 3:5-10). Existing sustained-release technologies were described as often failing to provide both a rapid onset of action and a full twelve hours of efficacy (’252 Patent, col. 2:23-43).
- The Patented Solution: The invention is a modified-release tablet with two distinct portions, typically in a bi-layer format. One portion provides an immediate release of guaifenesin to quickly achieve a therapeutic concentration in the blood. The second portion provides a sustained release over at least twelve hours, using a specific matrix of a hydrophilic polymer (which gels in the stomach) and a water-insoluble polymer (which slows dissolution in the intestines) to control the drug's release rate (’252 Patent, Abstract; col. 3:51-64). Figure 3 of the patent illustrates the manufacturing process for combining these two distinct preparations into a single tablet (’252 Patent, FIG. 3).
- Technical Importance: This bi-phasic approach sought to create a single oral tablet that could be taken twice a day, improving patient compliance while providing both rapid symptom relief and long-lasting therapeutic effect for a widely used medication (’252 Patent, col. 1:31-54).
Key Claims at a Glance
The complaint alleges infringement of "one or more claims" of the ’252 patent without specifying which claims are asserted (Compl. ¶36; Prayer for Relief ¶A). Independent claims 1 and 41 appear to be representative of the core invention.
- Independent Claim 1: A modified release tablet with essential elements including:
- A first portion with guaifenesin in an immediate release form.
- A second portion with guaifenesin in a release-delaying matrix.
- The matrix comprises a hydrophilic polymer and a water-insoluble polymer in a specific weight ratio (from about 1:1 to 6.8:1).
- The tablet demonstrates a maximum serum concentration (Cmax) "equivalent to" that of a standard immediate release formulation.
- The tablet provides "therapeutically effective bioavailability for at least twelve hours."
- Independent Claim 41: A modified release product with essential elements including:
- A first portion with guaifenesin in an immediate release form.
- A second portion with guaifenesin in a sustained release form.
- A ratio of the first quantity of guaifenesin to the second quantity from about 1:1 to about 1:5.
- The product provides a Cmax "equivalent to" that of a standard immediate release formulation.
- The product provides "therapeutically effective bioavailability for at least twelve hours."
U.S. Patent No. 6,955,821 - Sustained release formulations of guaifenesin and additional drug ingredients
- Patent Identification: U.S. Patent No. 6,955,821, titled “Sustained release formulations of guaifenesin and additional drug ingredients,” issued on October 18, 2005.
The Invention Explained
- Problem Addressed: This patent, a continuation-in-part of the application leading to the ’252 Patent, addresses the challenge of combining the extended-release guaifenesin technology with other active pharmaceutical ingredients (APIs) to treat multiple symptoms, such as combining an expectorant with a cough suppressant or a decongestant, within a single tablet (’821 Patent, col. 1:15-26).
- The Patented Solution: The invention claims a modified-release product, similar to the bi-layer tablet of the parent patent, but which includes "at least one additional drug ingredient" in either the immediate-release portion, the sustained-release portion, or both (’821 Patent, Abstract; col. 4:1-12). This allows for the creation of combination therapies that retain the twice-daily dosing convenience and bi-phasic release profile for guaifenesin.
- Technical Importance: This technology enabled the development of multi-symptom, long-acting over-the-counter products (like Mucinex® DM), which are a significant segment of the cough and cold market, by providing a platform to combine guaifenesin with other APIs in a single dosage form (’821 Patent, Abstract).
Key Claims at a Glance
The complaint alleges infringement of "one or more claims" of the ’821 patent without specifying which claims are asserted (Compl. ¶41; Prayer for Relief ¶E). Independent claim 1 is representative.
- Independent Claim 1: A modified release drug product with essential elements including:
- A first quantity of guaifenesin in an immediate release formulation.
- A second quantity of guaifenesin in a release-delaying matrix.
- "at least one additional drug."
- The matrix comprises a hydrophilic and a water-insoluble polymer in a specific ratio.
- The product provides a Cmax for guaifenesin equivalent to a standard immediate release formulation and provides therapeutically effective bioavailability for at least twelve hours.
U.S. Patent No. 7,838,032 - Sustained Release of Guaifenesin
- Patent Identification: U.S. Patent No. 7,838,032, titled "Sustained Release of Guaifenesin," issued on November 23, 2010.
- Technology Synopsis: This patent is a continuation-in-part of the application for the ’821 Patent and further defines the invention by claiming specific pharmacokinetic (PK) parameters (’032 Patent, col. 1:10-17). Rather than only describing the physical composition, the claims recite specific numerical ranges for the maximum serum concentration (Cmax) and area under the curve (AUC) that the drug product must achieve in human subjects, linking the patent protection directly to the drug's measured performance in the body (’032 Patent, Abstract).
- Asserted Claims: The complaint does not specify claims, but independent claims 1 and 5 are the primary product claims.
- Accused Features: Perrigo’s proposed generic products, designed to be bioequivalent to Mucinex® DM, are alleged to exhibit the specific PK profiles claimed in the ’032 patent (Compl. ¶¶27, 46).
III. The Accused Instrumentality
Product Identification
The accused instrumentalities are "Perrigo’s ANDA Products," specifically "guaifenesin and dextromethorphan hydrobromide extended-release tablets in dosages of 1200 mg/60 mg and 600 mg/30 mg" (Compl. ¶27). The infringement action is based on Perrigo's filing of Abbreviated New Drug Application (ANDA) No. 207602 with the FDA to market these products (Compl. ¶27).
Functionality and Market Context
The products are designed as generic versions of Plaintiff's Mucinex® DM products and are intended for use as both an expectorant (from the guaifenesin) and a cough suppressant (from the dextromethorphan hydrobromide) (Compl. ¶¶19, 27, 30). The filing of the ANDA is an artificial act of infringement under 35 U.S.C. § 271(e)(2), allowing for patent disputes to be resolved before the generic product enters the market (Compl. ¶¶36, 41, 46). The complaint alleges these products are "copies" of Plaintiff's Mucinex® DM, which is protected by the patents-in-suit (Compl. ¶20).
IV. Analysis of Infringement Allegations
The complaint does not provide a claim chart or a detailed narrative infringement theory beyond the statutory allegation that filing an ANDA under 21 U.S.C. § 355(j) for a drug claimed in a patent is an act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶¶36, 41, 46). The infringement analysis in such cases focuses on whether the product specified in the ANDA, if commercially manufactured and sold, would infringe one or more claims of the patents-in-suit. The following charts summarize the likely infringement theory based on the patents and the nature of the accused generic products.
’252 Patent Infringement Allegations
| Claim Element (from Independent Claim 41) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A modified release product having two portions...a first portion comprises a first quantity of guaifenesin in an immediate release form...and a second portion comprises a second quantity of guaifenesin in a sustained release form | As a bioequivalent generic, the Perrigo ANDA product is alleged to be a bi-layer or bi-phasic tablet that provides both an immediate and a sustained release of guaifenesin. | ¶¶27, 36 | col. 23:39-47 |
| wherein the ratio of said first quantity to said second quantity is from about 1:1 to about 1:5 | The Perrigo ANDA product's formulation is alleged to contain immediate-release and sustained-release portions of guaifenesin in a ratio falling within the claimed range. | ¶¶27, 36 | col. 23:48-51 |
| said product provides a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation...is dosed | The Perrigo ANDA product is alleged to exhibit a pharmacokinetic profile that achieves a rapid peak serum concentration comparable to an immediate-release drug. | ¶¶27, 36 | col. 23:52-57 |
| said product also provides therapeutically effective bioavailability for at least twelve hours after a single dose | The Perrigo ANDA product is alleged to be formulated to maintain a therapeutic level of guaifenesin in the bloodstream for at least twelve hours, enabling twice-daily dosing. | ¶¶27, 36 | col. 23:58-61 |
’821 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A modified release drug product comprising...guaifenesin... and at least one additional drug | The Perrigo ANDA product is alleged to be a combination drug product containing both guaifenesin and a second active ingredient, dextromethorphan hydrobromide. | ¶¶27, 41 | col. 29:12-16 |
| wherein the release-delaying matrix comprises a hydrophilic polymer and a water-insoluble polymer in a weight ratio...from about 1:1 to about 9:1 | The sustained release portion of the Perrigo ANDA product is alleged to use a polymer matrix with components and ratios that fall within the scope of the claim. | ¶¶27, 41 | col. 29:17-22 |
| wherein the immediate release formulation guaifenesin has a Cmax in a human subject equivalent to the Cmax obtained when a dose of a standard immediate release formulation...is dosed | The Perrigo ANDA product's immediate release component is alleged to produce a peak guaifenesin concentration equivalent to that of an immediate release drug. | ¶¶27, 41 | col. 29:23-28 |
- Identified Points of Contention:
- Scope Questions: In Hatch-Waxman litigation, the primary dispute often centers on the defendant's assertion of invalidity or unenforceability, as Perrigo has certified (Compl. ¶33). However, non-infringement arguments may still arise. A key question of claim scope will be the proper construction of functional terms like "equivalent to" and "therapeutically effective bioavailability." Does the specific polymer blend and resulting release profile of the Perrigo product, as described in its ANDA, fall outside a proper construction of these claimed parameters?
- Technical Questions: An evidentiary question will be whether the actual pharmacokinetic data submitted in Perrigo's ANDA demonstrates performance that meets every limitation of the asserted claims. For instance, what objective data establishes that the Perrigo product's Cmax is "equivalent to" a standard immediate release formulation, and what is the scientific basis for the "therapeutically effective" level maintained for twelve hours?
V. Key Claim Terms for Construction
The Term: "a Cmax in a human subject equivalent to the Cmax obtained when...a standard immediate release formulation...is dosed" (’252 Patent, cl. 1).
Context and Importance: This limitation defines the performance of the tablet's immediate-release component by comparing its peak drug concentration (Cmax) to a benchmark. The definition of "equivalent" is central to determining infringement, as it sets the standard the accused product's pharmacokinetic profile must meet. Practitioners may focus on this term because its ambiguity could either broaden or narrow the claim's scope to cover products with slightly different peak concentration profiles.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses the bi-layer tablet demonstrating a Cmax "that are equivalent to an immediate release tablet" without imposing a strict numerical identity (’252 Patent, col. 3:65-col. 4:1). This may support an argument that "equivalent" should be understood in the context of regulatory bioequivalence standards, which typically allow for a range (e.g., 80-125%).
- Evidence for a Narrower Interpretation: The patent includes figures depicting clinical data where the modified-release product's Cmax closely mirrors that of the immediate-release control product (’252 Patent, FIG. 9, 10). A defendant could argue these figures define the term, requiring a near-identical peak rather than just statistical bioequivalence.
The Term: "therapeutically effective bioavailability for at least twelve hours" (’252 Patent, cl. 1).
Context and Importance: This limitation defines the performance of the sustained-release component, requiring both a minimum duration and a minimum level of efficacy. The infringement analysis depends on the objective standard for what blood concentration level is "therapeutically effective" for guaifenesin. A defendant may challenge this term as indefinite if the patent does not provide a clear standard for its measurement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification repeatedly describes the invention's ability to "sustain therapeutic effect for at least twelve hours" and "maintain effective blood concentration" over that period (’252 Patent, col. 1:36-44; col. 3:17-19). This suggests the term should be understood according to its ordinary meaning in pharmacology—i.e., remaining above the recognized Minimum Effective Concentration (MEC) for the drug.
- Evidence for a Narrower Interpretation: The patent does not specify a numerical value for the MEC of guaifenesin. A defendant may argue that without such a benchmark, the term is subjective and fails to inform the public of the claim's scope. Alternatively, a defendant could point to the plasma concentration curves in the patent's figures as implicitly defining the "effective" level, thereby limiting the claim to products that produce similar curves (’252 Patent, FIG. 9, 10).
VI. Other Allegations
- Indirect Infringement: The complaint states that if Defendants commercially market the ANDA products, they will "induce or contribute to" infringement (Compl. ¶¶38, 43, 48). The basis for an inducement claim would likely be the product's labeling and marketing materials, which would instruct and encourage consumers and medical professionals to use the product in a manner that infringes the patents.
- Willful Infringement: The complaint does not contain an allegation of willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
This case presents issues typical of Hatch-Waxman pharmaceutical litigation. The outcome will likely depend on the court’s resolution of two central questions:
- A core issue will be one of validity: Can Perrigo, as the ANDA filer, meet its burden to prove by clear and convincing evidence that the asserted patent claims are invalid, likely for obviousness over prior art pharmaceutical formulation techniques, as it certified to the FDA? While not detailed in the complaint, this challenge is the procedural foundation of the case.
- A key infringement question will be one of definitional scope: How will the court construe the pharmacokinetic limitations in the claims, such as Cmax "equivalent to" an immediate-release product and "therapeutically effective bioavailability" for twelve hours? Whether the specific performance data in Perrigo’s ANDA falls within the scope of these terms will be a central point of contention.