Deston Therapeutics LLC v. Trigen Laboratories Inc.

723 F. Supp. 2d 665, 2010 U.S. Dist. LEXIS 70540, 2010 WL 2773317
CourtDistrict Court, D. Delaware
DecidedJuly 12, 2010
DocketCivil 09-809 (JBS/KW)
StatusPublished
Cited by14 cases

This text of 723 F. Supp. 2d 665 (Deston Therapeutics LLC v. Trigen Laboratories Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Deston Therapeutics LLC v. Trigen Laboratories Inc., 723 F. Supp. 2d 665, 2010 U.S. Dist. LEXIS 70540, 2010 WL 2773317 (D. Del. 2010).

Opinion

OPINION

SIMANDLE, District Judge: 1

This matter is before the Court on a motion to dismiss submitted by Defendants Trigen Laboratories Inc. and Irisys Inc. [Docket Item ll]. 2 Defendants ask the Court to dismiss this patent infringement action brought by Plaintiffs Deston Therapeutics LLC and Unigen Pharmaceuticals Inc., because Plaintiffs’ patent claims cannot be construed to include Defendants’ product. Plaintiffs’ remaining causes of action, Defendants argue, are insufficiently pled. As will be explained at greater length below, the Court finds that patent claim construction would be premature and that Plaintiffs have adequately alleged violations of Section 43(a) of the Lanham Act and the Delaware Deceptive Trade Practices Act, as well as common law unfair competition. The Court will consequently deny Defendants’ motion to dismiss.

1. FACTUAL ALLEGATIONS

A. Allegations in the Complaint

The present action turns on Defendants’ use (or failure to use) a chemical composition called “u-polycosanol 410” in their purportedly generic version of Plaintiffs’ ear drops. While polycosanol (also know as “policosanol”) is a general term for a type of alcohol extracted from waxes, Plaintiffs allege that u-polycosanol 410 is a unique polycosanol composition subject to two patents (United States Patent No. 7,034,060 and No. 6,683,116) owned by Plaintiff Unigen. (Compl. ¶¶ 9-13.) The “u” is a reference to Unigen and the “410” refers to the product’s molecular weight. (Id. at 4 n. 2.) The u-polycosanol patents include both “a novel policosanol composition and a method of making the composition from wax secreted by the insect Enceras pela, a soft scale insect indigenous to southern China.” (Id. ¶ 11.) Plaintiff De *668 ston markets Auralgan, a prescription ear drop solution, for which it holds an exclusive license to use Unigen’s u-polycosanol 410. (Id. ¶¶ 3,18-19.)

In July 2009, Defendants began marketing and manufacturing Treagan, an ear drop solution whose packet insert indicates that it contains “u-polycosanol 410 (synthetic).” (Id. ¶¶ 22-23.) Plaintiffs allege that Defendants list u-polycosanol 410 on Treagan’s label as a way of insuring that the product will be used by drug wholesalers, distributors, and pharmacies, as a generic equivalent of Auralgan. (Id. ¶¶ 24-29.) To be considered a generic equivalent, a drug must be both pharmaceutically equivalent (the same active ingredients, strength, and dosage form) and bio-equivalent (delivers the active ingredients to the site of action in the body at the same rate and in the same amount). (Id. ¶ 25.) Without both types of equivalence, pharmacists will not substitute a generic drug for a brand-name drug prescribed by a doctor. (Id. ¶ 26.) Drug wholesalers, distributors, pharmacies and pharmacists rely on drug information databases, including First DataBank, to determine whether a particular drug is truly a generic equivalent of a brand-name product. (Id. ¶ 27.) Defendants, by labeling Treagan to include u-polycosanol 410, have succeeded in having drug information databases, including First DataBank and MediSpan, link Treagan to Auralgan as a generic equivalent. (Id. ¶¶ 29-30.) Similar ear drops that list polycosanol as an ingredient but not u-polycosanol 410 have not been linked to Auralgan, because of the unique composition of u-polycosanol 410. (Id. ¶ 28.)

As a result of this link between Treagan and Auralgan, sales of Auralgan have eroded as many drug wholesalers, distributors, pharmacies and pharmacists across the country purchase Treagan as a substitute for Auralgan. (Id. ¶ 30.) Defendants do not have a license to manufacture or use u-polycosanol 410 under either of Uni-gen’s patents. (Id. ¶ 31.) Plaintiffs allege that if Treagan truly contains Plaintiffs’ novel chemical composition in u-polycosanol 410 then Defendants are infringing on Plaintiffs’ patents and if Treagan does not contain Plaintiffs’ u-polycosanol 410 then its advertisements and promotional claims regarding Treagan’s equivalence to Auralgan are false. (Id. ¶¶ 32, 44.) Plaintiffs’ complaint alleges that Defendants are infringing on Plaintiffs’ patents (Count One), or in the alternative that Defendants have engaged in false advertising (Count Two) and unfair competition (Count Three) in violation of Section 43(a) of the Lanham Act, that they have violated the Delaware Deceptive Trade Practices Act (Count Four) and engaged in unfair competition prohibited by common law (Count Five).

B. The Patents

Attached to Plaintiffs’ complaint are the two United States Patents Nos. 6,683,116 (“'116 Patent”) and 7,034,060 (“'060 Patent”). (Compl. Exhs. A & B.) Both patents are entitled “Polycosanols from Ericerus Pela Wax” and in both patents the specifications state, “As used herein the term ‘polycosanol’ refers to the mixture of higher primary aliphatic alcohols derived from the hydrolysis of the wax of the Ericerus pela.” (Compl. Exh. A at 8; Compl. Exh. B. at 8.) The specifications also state, “It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.” (Compl. Exh. A at 7; Compl. Exh. B. at 8.)

The '116 Patent includes forty-seven claims, including six independent claims. (Compl. Exh. A at 17-20.) The first five claims read as follows:

What is claimed is:
*669 1. A polyeosanol composition of matter comprised of 35% to 55% of long chain aliphatic alcohols, wherein said alcohols are selected from the group consisting of 1-hexacosanol (~20%-30%), 1-octacosanol (~15%-25%), 1-triacontanol ( — 2%—4%), and 1-tetraeonsanol (~1%-3%).
2. The composition of claim 1, wherein said composition is derived from the wax of the insect Ericerus pela.
3. A polyeosanol composition of matter comprised of 75%-100% of long chain aliphatic alcohols, wherein said alcohols are selected from the group consisting of 1-hexacosanol (~30%-50%), 1-octaeosanol (~25%-45%), 1-triacontanol (~4%-10%), and 1-tetraconsanol (~3%-9%).
4. The composition of claim 3, wherein said composition is derived from the wax of the insect Ericerus pela.
5. A composition of higher primary aliphatic alcohols having from 24 to 30 carbon atoms (C24-30) from the wax of the insect Ericerus pela prepared according to a method comprising the steps of ... [steps omitted].

(Id. at 17.)

The '060 Patent included five claims, with one independent claim. (Compl. Exh. B. at 19-20.) The first three claims read:

The invention claimed is:
1.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
723 F. Supp. 2d 665, 2010 U.S. Dist. LEXIS 70540, 2010 WL 2773317, Counsel Stack Legal Research, https://law.counselstack.com/opinion/deston-therapeutics-llc-v-trigen-laboratories-inc-ded-2010.