Pamlab, LLC v. Macoven Pharmaceuticals, LLC

881 F. Supp. 2d 470, 2012 WL 2540234
CourtDistrict Court, S.D. New York
DecidedJune 29, 2012
DocketNo. 11 Civ. 9022 TPG JCF
StatusPublished
Cited by9 cases

This text of 881 F. Supp. 2d 470 (Pamlab, LLC v. Macoven Pharmaceuticals, LLC) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Pamlab, LLC v. Macoven Pharmaceuticals, LLC, 881 F. Supp. 2d 470, 2012 WL 2540234 (S.D.N.Y. 2012).

Opinion

MEMORANDUM AND ORDER

JAMES C. FRANCIS IV, United States Magistrate Judge.

This is a patent infringement and false advertising case. Pamlab, L.L.C. (“Pam-lab”) developed a pharmaceutical product, which it markets as Foltx, using patented technology that it licensed from Metabolite Laboratories, Inc. (“Metabolite”). Foltx contains 2.5 mg of Folic Acid, 2 mg of Vitamin B12, and 25 mg of Vitamin B6, and was designed to treat elevated levels of homosysteine. Pamlab, in turn, has authorized Breckenridge Pharmaceuticals, Inc. (“Breckenridge”) to market a generic version of the same product, which is sold as Folbic. Both Foltx and Folbic are labeled as “medical foods.”

Macoven Pharmaceuticals, L.L.C. (“Ma-coven”) has begun marketing a Folic Acid product labeled as “Folic Acid 2.5 mg Tablets — Prescription Dietary Supplement.” According to the label, Macoven’s product contains the same active ingredients in the same amounts as Foltx and Folbic. Based on these representations, Macoven’s product has been designated as equivalent to Foltx — and as a substitute for Folbic — in the databases utilized by pharmacy chains to identify products that are alternatives for one another. The label of Macoven’s product also includes an expiration date two years after the date of manufacture.

Pamlab and Breckenridge contend that, in several respects, the labeling of Macoven’s product constitutes false advertizing in violation of Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a). First, the plaintiffs argue that Macoven’s identification of its product’s active ingredients is misleading because it did not test its product prior to release to confirm the contents. Similarly, they maintain that the expiration date is false because it is not supported by adequate stability testing. Finally, the plaintiffs contend that the term “prescrip[473]*473tion dietary supplement” is meaningless and therefore deceptive.

Pamlab and Breckenridge have moved pursuant to Rule 65 of the Federal Rules of Civil Procedure for a preliminary injunction (1) enjoining Macoven from labeling its product in a way that suggests that it is the equivalent of Foltx or Folbic; (2) enjoining Macoven from marketing its product with statements that represent that it contains the specified amounts of active ingredients, has the specified expiration date, or is a “prescription dietary supplement”; (3) requiring Macoven to take action to have its product listed as obsolete or inactive on the industry databases; and (4) requiring Macoven to retract all pending offers to sell its product. The parties consented to referral of this motion to me for determination pursuant to 28 U.S.C. § 636(c). A hearing was held on May 30 and 31, 2012; and the parties subsequently made post-hearing submissions. This opinion constitutes my findings of fact and conclusions of law as required by Rules 52 and 65.

Background

Macoven’s Folic Acid product was manufactured by Viva Pharmaceutical Inc. (“Viva”), a company based in British Columbia. (Tr. at 294; Declaration of Sherry Xie dated Feb. 29, 2012 (“Xie Deck”), ¶¶4, 7).1 Ultimately, the product was marketed with a label that claims active ingredients consisting of 2.5 mg of Folic Acid, 2.0 mg of B12, and 25.0 mg of B6. (Exh. 5).2 The label also shows an expiration date of September 2013. (Exh. 5). Viva formulated a pre-manufacture batch of the product in June 2011 and subjected it to preliminary testing, (Xie Deck, ¶ 7). On June 14, 2011, test results showed that representative tablets contained 3.23 mg of Folic Acid. (Pl. Exh. 6, Appendix A to Plaintiffs Sur-Sur-Reply Memorandum in Support of Their Motion for a Preliminary Injunction Based on Defendant’s Violation of the Lanham Act, at 1). Similarly, on June 22, 2011, tests showed that the tablets in the pre-manufacture batch contained 2.75 mg of Vitamin B12 and 27.63 mg of Vitamin B6. (Exh. 6 at 1). Viva also subjected samples of the pre-manufacture batch to accelerated stability testing. “This involves placing the samples” in a chamber with conditions of high temperature and relative humidity (40° Celcius ± 2°C and 75% Relative Humidity ± 5% RH) to cause accelerated degradation of the active ingredients. (Declaration of William Ment dated April 3, 2012 (“Ment 4/3/12 Deck”), ¶ 9). Results of the accelerated stability testing on this batch were recorded at two different times. On October 19-20, 2011, Folic Acid was measured at 3.29 mg, while on February 17, 2012, after the batch had been removed from the chamber and stored at room temperature for four months, B12 tested at 2.06 mg and B6 at 29.39 mg. (Exh. 6 at 1; Xie Decl., ¶ 17).

On September 2, 2011, Viva proposed to produce 750,000 tablets of the product for Macoven and submitted a production formula. (Xie Deck, ¶¶ 8, 9). That formula provided for overages for each of the active ingredients, that is, amounts by which these ingredients would exceed the label claims. (Xie Deck, ¶ 9 & Exh. G). According to that formula, the product would be manufactured with 3.0 mg of Folic Acid, 2.4 mg of B12, and 33.4347 mg of B6. (Xie Decl., 1 ¶ & Exh. G). Macoven accepted the proposal, and Viva manufactured the commercial batch of tablets, identified as Lot 41110122, on October 4, 2011, with 3.0 [474]*474mg of Folic Acid, 3.0 mg of B12, and 33.0 mg of B6. (Exh. 5 eft 2; Xie Decl., ¶ 13).

Like the pre-manufacture batch, the production batch was subjected to testing. Viva issued a certificate of analysis on October 4, 2011, representing that the tablets in this batch contained 3.0 mg of Folic Acid and had an expiration date of September 2013, two years later. (Xie Decl., Exh. I). However, the certificate did not reflect results of any testing of the quantities of B12 or B6. (Xie Decl., Exh. I).

Viva did not subject the commercial batch to accelerated stability testing until February 2012. At the initiation of that test on February 13 and 14, the tablets were found to contain 2.99 mg of Folic Acid, 2.50 mg of B12, and 29.01 mg of B6. (Exh. 6 at 2). Thereafter, a sample was removed from the chamber and tested once a month for three months. After one month, testing showed 2.93 mg of Folic Acid, 2.25 mg of B12, and 26.78 mg of B6; after two months, 2.62 mg of Folic Acid, 2.22 mg of Bj2, and 27.66 mg of B6; and after three months, 2.575 mg of Folic Acid, 2.17 mg of B12, and 27.04 mg of B6.3 (Exh. 6 at 2). The significance of the testing will be addressed below.

Once Macoven’s product was on the market, it was listed on industry databases such as First DataBank and Medi-Span as an equivalent for Foltx and Folbic. (Tr. at 28, 73-74; Exhs. 3, 4). Such databases list as pharmaceutical equivalents those products that have the same active ingredients in the same concentrations and in the same dosage form (e.g., capsule or tablet). (Tr. at 71). A representative of a pharmacy making a purchasing decision is likely to consult one or more of the databases to determine what alternative products might fill the pharmacy’s needs. (Tr. at 86). A major chain or a wholesaler that in turn sells to independent stores then generally negotiates price and other terms and selects a product. (Tr. at 87-88).

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Cite This Page — Counsel Stack

Bluebook (online)
881 F. Supp. 2d 470, 2012 WL 2540234, Counsel Stack Legal Research, https://law.counselstack.com/opinion/pamlab-llc-v-macoven-pharmaceuticals-llc-nysd-2012.