DCT
1:17-cv-01481
Forest Laboratories LLC v. Teva Pharma USA Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Forest Laboratories, LLC (Delaware); Forest Laboratories Holdings, Ltd. (Ireland); Allergan USA, Inc. (Delaware); and Ironwood Pharmaceuticals, Inc. (Delaware)
- Defendant: Teva Pharmaceuticals USA, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:17-cv-01481, D. Del., 10/20/2017
- Venue Allegations: Venue is asserted as proper in the District of Delaware on the basis that Defendant is a Delaware corporation.
- Core Dispute: Plaintiffs allege that Defendant’s filing of an Abbreviated New Drug Application (ANDA) for generic versions of the drug Linzess® constitutes an act of infringement of a patent covering a specific peptide derivative of linaclotide.
- Technical Context: The technology is in the field of pharmaceutical compositions for treating gastrointestinal disorders, specifically irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
- Key Procedural History: This action arises under the Hatch-Waxman Act. Defendant previously filed an ANDA seeking approval for generic linaclotide, which prompted an earlier lawsuit by Plaintiffs on other patents. The current complaint was triggered by Defendant’s subsequent amendment of its ANDA to include a Paragraph IV certification asserting that the patent-in-suit is invalid, unenforceable, or will not be infringed by the proposed generic product.
Case Timeline
| Date | Event |
|---|---|
| 2011-08-17 | Priority Date for U.S. Patent No. 9,708,371 |
| 2016-10-21 | Teva submits ANDA No. 209568 for generic Linzess® |
| 2016-11-30 | Plaintiffs file prior lawsuit against Teva on other patents |
| 2017-07-18 | U.S. Patent No. 9708371 Issues |
| 2017-09-11 | Plaintiffs receive notification of Teva's ANDA amendment |
| 2017-10-20 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,708,371 - "Treatments for Gastrointestinal Disorders" (Issued Jul. 18, 2017)
The Invention Explained
- Problem Addressed: The patent background describes the significant medical need for new treatments for gastrointestinal (GI) disorders like Irritable Bowel Syndrome (IBS) and Chronic Constipation (CC), noting that many patients are not satisfied with currently available options (’971 Patent, col. 2:6-10).
- The Patented Solution: The invention relates to specific peptide derivatives of linaclotide, a known agonist of the guanylate cyclase C (GC-C) receptor used to treat GI disorders. The patent describes a modification where the first amino acid of linaclotide, a cysteine (Cys¹), is deaminated to form a "Cys¹-a-ketone peptide" (’971 Patent, col. 4:22-35). This modified peptide is also capable of activating the GC-C receptor, which initiates a cascade of events leading to increased intestinal fluid secretion and accelerated transit, thereby alleviating constipation symptoms (’971 Patent, col. 4:1-9).
- Technical Importance: The invention describes and claims a specific, modified form of a known therapeutic peptide, which may arise as a related substance or degradant in a pharmaceutical product. By characterizing and claiming such derivatives, the patent seeks to cover compositions containing these specific molecular structures.
Key Claims at a Glance
- The complaint asserts infringement of claims 1-28 (Compl. ¶18). Independent claim 1 is central to the dispute.
- Independent Claim 1:
- A peptide or a pharmaceutically acceptable salt thereof,
- wherein the peptide comprises the amino acid structure of the "Cys¹-a-ketone" derivative of linaclotide (SEQ ID NO: 2), and
- the peptide activates the guanylate cyclase C receptor.
- The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶18).
III. The Accused Instrumentality
Product Identification
Teva’s proposed generic linaclotide capsules in 145 µg and 290 µg dosages, as described in ANDA No. 209568 ("the Teva Generic Products") (Compl. ¶6, ¶14).
Functionality and Market Context
The Teva Generic Products are intended as generic equivalents to Plaintiffs' branded drug, Linzess®, for the treatment of IBS-C and CIC (Compl. ¶12). The act of infringement alleged is the filing of the ANDA itself, which seeks FDA approval to market these generic products before the expiration of the ’971 Patent (Compl. ¶17). The core technical theory of infringement is that the Teva Generic Products, which have linaclotide as their active pharmaceutical ingredient, will also contain the specific Cys¹-a-ketone peptide recited in the patent claims (Compl. ¶18).
Visual Evidence
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
’971 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A peptide or a pharmaceutically acceptable salt thereof, wherein the peptide comprises the amino acid structure of: [the Cys¹-a-ketone peptide, SEQ ID NO: 2] | The complaint alleges that the Teva Generic Products will contain the claimed Cys¹-a-ketone peptide, a deaminated derivative of linaclotide. | ¶18 | col. 4:46-52 |
| and the peptide activates the guanylate cyclase C receptor. | The complaint alleges that the claimed peptide, when present in the Teva Generic Products, will have the function of activating the GC-C receptor. | ¶18 | col. 3:5-10 |
Identified Points of Contention
- Technical Question: The primary factual dispute will be whether Teva’s proposed generic product actually contains the specific Cys¹-a-ketone peptide recited in Claim 1. This will likely require significant discovery into Teva's manufacturing process, formulation, and stability data to determine the presence and quantity of this alleged impurity or degradant.
- Scope Questions: If the Cys¹-a-ketone peptide is found only in trace amounts, a key legal question will be whether the term "comprises" is met. The court may need to decide if the presence of a minute impurity in a bulk drug product satisfies the claim limitation, or if the patent's specification implies that a more substantial amount is required for infringement.
V. Key Claim Terms for Construction
- The Term: "comprises" (as in, "the peptide comprises the amino acid structure of...")
- Context and Importance: This term is fundamental to the infringement analysis. The case may turn on whether the presence of the claimed Cys¹-a-ketone peptide as a potential low-level impurity in a product primarily consisting of linaclotide satisfies this limitation. Practitioners may focus on this term because the outcome could determine whether patents claiming specific impurities can be used to block generic products where those impurities are present in only trace, and potentially clinically irrelevant, amounts.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "comprises" is a standard term of art in patent law that is interpreted to be open-ended, meaning "including but not limited to." A plaintiff could argue that this broad, established meaning covers any composition that includes the claimed peptide, regardless of its quantity relative to other components.
- Evidence for a Narrower Interpretation: A defendant may point to the specification, which describes pharmaceutical compositions containing the Cys¹-a-ketone peptide in specific, non-trivial amounts (e.g., "from about 0.5% to about 2% by weight of the composition") (’971 Patent, col. 13:41-43). This could support an argument that the claims, when read in light of the specification, should be construed to require a quantitatively significant amount of the claimed peptide, not just a fleeting or trace presence.
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Teva will induce infringement by others, such as doctors and patients (Compl. ¶19, ¶21). This allegation is based on the assertion that Teva's proposed product label will instruct users to use the generic product in a way that infringes the ’371 Patent (Compl. ¶21).
- Willful Infringement: Willfulness is alleged based on Teva’s pre-suit knowledge of the ’371 Patent. The complaint cites Teva's amendment of its ANDA to include a Paragraph IV certification against the patent as evidence of this knowledge (Compl. ¶21). The complaint also asserts this is an exceptional case warranting attorneys' fees (Compl. ¶22).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of evidentiary proof: Can Plaintiffs demonstrate through chemical analysis that Teva's proposed generic product, as manufactured and stored, will in fact contain the specific Cys¹-a-ketone peptide recited in Claim 1 of the ’971 patent?
- The case will also likely involve a key question of quantitative scope: If the claimed peptide is present, does the term "comprises" in Claim 1 require a certain minimum quantity for infringement, or is the presence of any detectable trace amount sufficient? The court’s answer to this question will be critical in a dispute centered on a pharmaceutical impurity.