ORDER ADOPTING REPORT AND RECOMMENDATION
On this date came to be considered the - Report and Recommendation (docket no. 99) of United States Magistrate Judge Pamela Mathy, in which she recommends the Court DENY Defendant’s Motion for
Defendant filed objections thereto (docket no. 101). When a party objects to a Magistrate Judge’s Report and Recommendation, the Court must make a de novo determination of those portions of the report or proposed findings or recommendations to which objection is made. Kreim-erman v. Casa Veerkamp, S.A. de C.V.,
Therefore, having considered all of the papers filed in this case, the Magistrate Judge’s Report and Recommendation, and the Parties’ objections to the report, it is ORDERED the United States Magistrate Judge’s Report and Recommendation is ACCEPTED pursuant to 28 U.S.C. § 636(b)(1). Therefore, it is ORDERED that Defendant’s Motion for Partial Summary Judgment on Plaintiffs False Advertising and Unfair Competition Claims (docket no. 79) is DENIED.
It is so ORDERED.
REPORT AND RECOMMENDATION OF THE UNITED STATES MAGISTRATE JUDGE
PAMELA A. MATHY, United States Magistrate Judge.
Pursuant to the order of referral in the above-styled and numbered cause of action to the undersigned United States Magistrate Judge
I.Jurisdiction
II.Summary of Procedural History and Claims
III. Issue
IV. Standards
A. Summary Judgment
B. False Advertising and Unfair Competition under the Lanham Act and Common Law Unfair Competition
V.Factual Background
VI.Summary of Arguments
A. Virtus’ Motion
B. Mission’s Response
C. Virtus’ Reply
VII.Discussion
VIII.Recommendation
IX.Instructions for Service and Notice of Right to Object/Appeal
I. JURISDICTION
Plaintiff asserts claims for patent infringement under the laws of the United States, false advertising and unfair competition under the Lanham Act, and common law unfair competition, invoking jurisdiction under 15 U.S.C. §§ 1116 and 1121, and 28 U.S.C. §§ 1331, 1338 and 1367.
II. SUMMARY OF PROCEDURAL HISTORY and CLAIMS
Plaintiff Mission Pharmacal Company (“Mission”) initiated this suit on March 7, 2013, when it filed its four-page original complaint asserting a single claim of patent infringement under the laws of the United States against defendant Virtus Pharmaceuticals, LLC (“Virtus”).
claims, among other things, a nutritional supplement containing both a slowly dissolving and a rapidly dissolving iron compound, a method of alleviating iron deficiency with the dual iron nutritional supplement, and a method of making the dual iron nutritional supplement.5
Mission alleged that it sells CitraNatal® prescription prenatal supplements covered by the '247 patent and it understands Vir-tus manufactures, imports, sells, offers to sell, and induces others to sell, offer to sell, and use certain prenatal supplements including Natalvirt CA and Natalvirt 90 DHA whose formulation, use, and method of making are covered by claims of the '247 patent.
On March 27, 2013, Virtus filed its answer to the original complaint that included affirmative defenses and a counterclaim seeking a declaratory judgment of nonin-fringement.
On May 14, 2013, the parties submitted a “Discovery Plan with Proposed Scheduling Order.”
On July 1, 2013, Virtus filed an opposed motion to amend the scheduling order to provide, in sum, for certain “patent-specific deadlines” and a Markman hearing.
Also on July 29, 2013, Mission filed its first amended complaint, asserting four claims in four separate counts: patent infringement, false advertising in violation of the Lanham Act, unfair competition in violation of the Lanham Act, and common law unfair competition.
Further, Mission alleges Virtus has “falsely told national pharmaceutical databases that” the Virtus Products “use the ingredient ferrous gluconate and are therefore pharmaceutically equivalent.”
As relief, Mission seeks, in sum, preliminary and permanent injunctive relief to prevent the manufacture, distribution, use, sale or advertising of the Virtus Products or representing the Virtus Products are pharmaceutically equivalent to the Mission Products or can be freely interchanged with or substituted for the Mission Products.
a notice in location • and typeface as prominent as the comparison itself, that ‘[the Virtus Product] is not equivalent to [the Mission Pharmacal product]. Therefore, the substitution of this product for [the Mission Pharmacal product] may violate state law,
and (c) take further “corrective action to correct any erroneous impression persons may have derived concerning the nature, characteristics or qualities” of the Virtus products, “including without limitation the placement of corrective advertising to prevent the inducement of others from substituting ... [the Virtus Products] ... for prescriptions of ... [the Mission Products] ....”
On August 14, 2013, Virtus filed its answer to the first amended complaint.
On September 25, 2013, the parties filed a joint motion to stay the case and amend the scheduling order, in which the parties informed the Court they
conducted in-person mediation with Eric Galton on September 23, 2013, and need additional time to conduct settlement negotiations resulting from the mediation. The parties respectfully request that the Court stay this case for thirty (30) days and extend certain deadlines so that the parties may focus their efforts on settlement and avoid unnecessary expense.39
On September 27, 2013, the Court granted the motion and extended the discovery deadline to December 16, 2013, and the dispositive motions deadline to January 17, 2014.
On December 20, 2013, Virtus filed its motion for partial summary judgment of noninfringement of the '247 patent, supported by an appendix of documents and evidence.
On February 7, 2014, Virtus filed a motion for partial summary judgment as to plaintiffs false, advertising and unfair competition claims, supported by an appendix of documents and evidence.
III. ISSUE
Whether Virtus’ motion for partial summary judgment on Mission’s claims of false advertising under the Lanham Act, unfair competition under the Lanham Act, and common law unfair competition should be granted or denied.
IV. STANDARDS
A. Summary Judgment
The standard to be applied in deciding a motion for summary judgment is set forth in Rule 56 of the Federal Rules of Civil Procedure, which provides in pertinent part as follows:
The court shall grant summary judgment if the movant shows that there is ■ no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law. 62
Mere allegations of a factual dispute between the parties will not defeat an otherwise proper motion for summary judgment. Rule 56 requires that there be no genuine issue of material fact.
The movant on a summary judgment motion bears the initial burden of providing the court with a legal basis for its motion and identifying those portions of the record which it alleges demonstrate the absence of a genuine issue of material fact.
If “the burden of proof at trial lies with the nonmoving party, the movant may satisfy its initial burden by showing — that is, pointing out to the district court — that there is an absence of evidence to support the nonmoving party’s case.”
If the nonmovant cannot adequately defend against a motion for summary judgment, the remedy is a motion for relief under Rule 56(d), which provides:
(d) When Facts Are Unavailable to the Nonmovant. If a nonmovant shows by affidavit or declaration that, for specified reasons, it cannot present facts essential to justify its opposition, the court may:
(1) defer considering the motion or deny it;
(2) allow time to obtain affidavits or declarations or to take discovery; or
(3) issue any other appropriate order.78
Discovery motions under Rule 56(d) are “broadly favored and should be liberally granted because the rule is designed to safeguard non-moving parties from summary judgment motions that they cannot adequately oppose.”
B. False Advertising and Unfair Competition under the Lanham Act and Common Law Unfair Competition
Section 43(a) of the Lanham Act provides in part:
Any person who, on or in connection with any goods or services, or any container for goods, uses in commerce any word, term, name, symbol, or device, or any combination thereof, or any false designation of origin, false or misleading description of fact, or false or misleading representation of fact, which—
(A) is likely to cause confusion, or to cause mistake, or to deceive as to the affiliation, connection, or association of such person with another person, or as to the origin, sponsorship, or approval of his or her goods, services, or commercial activities by another person, or
(B) in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services, or commercial activities, shall be liable in a civil action by any person who believes that he or she is likely to be damaged by such an act.81
To prove a claim of false advertising under the Lanham Act, a plaintiff must establish the following elements:
(1) a false or misleading statement of fact about a product;
(2) a statement which actually deceived or had the capacity to deceive a substantial segment of potential consumers;
(3) a material deception in that it was likely to influence a consumer’s purchasing decision;
(4) the product was in interstate commerce; and
(5) plaintiff had been or was likely to have been injured as a result of the statement in issue.82
Failure to establish any element is fatal to a plaintiffs claim.
Unfair competition claims under the Lanham Act are governed by the same standard as those for trademark infringement, e.g., the likelihood of confusion.
Unfair competition claims under Texas law are analyzed under the same standard as unfair competition claims under the Lanham Act.
Y. FACTUAL BACKGROUND
Except as may be noted, the parties do not appear to contest the following facts, which are set forth to provide a background for the discussion of the motion addressed in this report:
Mission now owns the '247 patent which covers a nutritional supplement comprising an “iron compound selected to be slowly dissolving” and an “iron compound selected to be rapidly dissolving.” Mission sells prescription prenatal dietary supplements marked by the '247 patent under the brand names CitraNatal Assure and Citra-
The '247 patent was filed on March 31, 2000, and issued on February 18, 2003. Mission is the assignee of the '247 patent. During prosecution of the '247 patent, the applicant amended various claims, including claim 1, at least twice. After the patent issued, it was reexamined and an ex parte reexamination certificate issued on July 12, 2011, which further amended the claims, including claims 1 and 17. As reexamined, independent claim 1 of the '247 patent requires the combination of (a) folic acid, (b) an iron compound selected to be slowly dissolving in the form of carbonyl iron,
Virtus developed “design-around” versions of the Mission Products
Both Mission and Virtus agree that the Mission Products and the Virtus Products are regulated under the Food and Drug and Cosmetic Act (“FDCA”).
VI. SUMMARY OF ARGUMENTS A. Virtus’ Motion
Virtus seeks partial summary judgment on three causes of action alleged in Mission’s first amended complaint, that is, Mission’s claim of false advertising in violation of the Lanham Act (count two), unfair competition under the Lanham Act (count three), and common law unfair competition (count four).
In support, Virtus presents five main arguments. First, Virtus argues the labels on the Virtus Products are not “literally false,” because the labels “accurately list the ingredients and their respective amounts.”
Virtus’s labels truthfully comply with DSHEA and provide 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.116
Virtus asserts there is no regulatory requirement for labeling the ferrous gluco-nate in the Virtus Products as sustained release, therefore “the failure to make the affirmative statement does not constitute a false statement.”
Second, Virtus argues Mission’s contention that the “fast dissolution of ferrous gluconate in the body” provides a “pharmaceutical benefit” is unsubstantiated.
Fourth, Virtus argues its products’ labels are not implicitly false, because, in sum, Mission has presented no proof of actual deception.
Fifth, Virtus argues “it is impossible for Mission to recover damages for these claims” because “there is no evidence that Virtus’s labels caused any consumer to be confused or deceived.”
B. Mission’s Response
In response, at the threshold, Mission contends, contrary to Virtus’ contention that the Virtus Products are dietary supplements subject to the DSHEA amendments to the FDCA, that even though prescription prenatal vitamins, such as the Mission Products and the Virtus Products, are exempt from the FDA’s pre-market approval requirements that apply to “new drugs” or “approved drugs,” they are subject to FDA regulations as drugs.
Second, Mission argues that, applying the FDA’s definition of “generic,” the Vir-tus Products are not the generic equivalents of the Mission Products because the products are not pharmaceutically equivalent nor bioequivalent.
Virtus freely admits that “Virtus intentionally uses a ferrous gluconate formulated for a delayed release,” “Virtus denies the patient of a fast dissolving gluconate in the body,” and “[t]he Accused Products are unlike Mission Products, which contain a fast dissolving ferrous gluconate.” See Virtus’s Motion for Partial Summary Judgment, Dkt. 70, 3-4 (Statement of Undisputed Facts). Given that Virtus acknowledges that its products provide a significant difference in the rate of release of the active ingredient iron Virtus essentially concedes that its products are not “generics” of Mission’s products.139
Third, Mission emphasizes that “Mission does not contest (and has never argued) that there is anything false about Virtus’s labels;” rather, “Mission’s false advertising claims are premised on the fact that Virtus markets and promotes its products as generics of Mission’s, which is itself a literally false statement.”
Fourth, Mission argues “[b]eeause Vir-tus’s statements that its products are generics of Mission’s products are literally false, Mission need not introduce evidence that the statements actually misled consumers.”
C. Virtus’ Reply
Virtus’ reply presents further arguments in support of its position that the Mission Products and Virtus Products at issue are each “dietary supplements, that Virtus complied with all regulations concerning dietary supplement labeling, and that none of its advertising is literally false.”
First, Virtus argues “the words ‘generic’ and ‘brand’ have different meanings depending on the context (commercial v. regulatory)” as do the terms “drug” and “generic” which “are used loosely and do not mean the same thing in one context as another context.”
Second, Virtus argues the Mission Products and Virtus Products “are clearly defined as dietary supplements and not drugs under Title 21 [,] Food and Drugs Chapter 9, Federal Food, Drug, and Cosmetic Act,” referencing the definition of “dietary supplement” in the FDCA.
Third, Virtus asserts the Mission and Virtus Products “lack required drug claims,” and “are simply indicated as dietary supplements for ‘improving the nu
Fourth, Virtus argues “a product that requires a prescription does not make it a drug.”
Fifth, Virtus argues “Mission tests its products as dietary supplements.”
Sixth, Virtus argues “Mission’s labels do not comply with labeling rules for approved drugs,” “lack the required ‘side effects statement,’” and “[a]pproved drug labeling is HIGHLY regulated.”
Seventh, Virtus argues “a product with a ... [NDC] ... is not necessarily a drug,” noting that “[t]he FDA allows Unapproved Products to receive NDCs.”
Eighth, Virtus argues “bioavailability equivalence is only required for ANDAs” and NDAs, but the Mission and Virtus Products are neither.
Since Mission cannot demonstrate that Virtus’s advertising is literally false, it must prove implicit ] falsity under some industry, market standard of bioequiva-lence (not the FDA’s standard for Orange Book drugs). However, implicitly false advertising requires evidence of actual confusion' — and evidence of a different industry/market standard of bioequivalence.
In conclusion, Virtus argues “Mission cannot support a claim for literal falsity, and cannot meet the requirements of implicit falsity.”
VII. DISCUSSION
Virtus moves for partial summary judgment on Mission’s Lanham Act false advertising and unfair competition claims and common law unfair competition claim.
Prior to addressing Virtus’ central arguments in support of its request for partial summary judgment, as a threshold matter, the Court notes Virtus has not cited, expressly applied, or distinguished this Court’s prior rulings addressing false advertising claims regarding unapproved drugs. In Healthpoint v. Stratus Pharmaceuticals, the Court addressed claims based on false representations defendant’s products were “generic” to plaintiffs and could be substituted for prescriptions written for plaintiffs products.
The primary jurisdiction of the FDA would not appear to bar a court from deciding Healthpoint’s false advertising claim that Stratus has made false claims of “generic equivalence” or “bioequiva-lence” and has allegedly falsely represented that Kovia and Ziox have the “same ingredients” or the “same active ingredients.” There is a distinction, on the one hand, between respecting the FDA’s primary jurisdiction to determine in the first instance whether a drug is lawfully marketed, “generic,” “bioequi-valent,” “therapeutically equivalent,” “pharmaceutically equivalent” and, on the other hand, a Lanham Act claim that a false statement has been made about a product. Even though the FDA has not required Stratus to demonstrate the equivalence of Kovia to Accuzyme or the equivalence of Ziox to Panafil White, Stratus is not free to make false or misleading statements about its product. To hold to the contrary would mean that an administrative scheme could eviscerate a Lanham Act or related common law claim over which the agency has no jurisdiction. For example, if Stratus represents that its two ointments are “bioequivalent,” “generically equivalent,” “equivalent” or have “the same active ingredients” or “the same ingredients” or “the same active ingredients in the same amounts,” consumers and competitors have a right to expect that suchrepresentations have factual support and the Lanham Act provides a vehicle to enforce that expectation. 180
The Court stressed that Healthpoint was not alleging that Stratus had falsely implied FDA approval, but instead the claims were “of false or misleading comparisons between two specific products in the context of comparative advertising and promotion relating to whether one drug can be substituted for another under state law.”
In Healthpoint, Ltd. v. Ethex Corporation, the Court addressed whether Ethex had falsely advertised its product as an alternative to plaintiffs product, that is, had made false and misleading statements that its ointment was “a generic form of, the same as, a substitute for, an alternative to, a therapeutic equivalent to or substitute for” plaintiffs ointment.
Virtus argues the Yirtus and Mission Products are “clearly defined as dietary supplements and not drugs under the” FDCA,
Next, Virtus argues the meaning of “generic,” when used to compare an equivalent to a drug, does not apply to the Virtus Products, as they are dietary supplements, not drugs or approved drugs. But, Virtus does not provide argument or authority to support any other definition of the term “generic” when it is applied to prescription prenatal vitamins and the products at issue.
Further, Virtus contends marketing the Virtus Products as equivalent to the Mission Products “would not be a false representation because [the Virtus Products] do have the same active ingredients in the same amounts.”
Mission has presented competent summary judgment evidence to show Virtus has made allegedly false or misleading statements about the equivalency of the Virtus Products and the Mission Products. Mission has submitted the testimony of Virtus employee, Louis Saenz, who explains Virtus’ use of HDMA forms, which are “standard form[s] that tell[] you our product name, case size, case dimensions, item size.”
Virtus argues that HDMA forms that identify the Virtus Products as “generic name for brand” and link its products with the Mission Products identified as “brand name” products, “does not mean the product has an NDA and the ‘Generic Name For Brand’ has an ANDA,” and further contends “the FDA’s regulatory framework does not become operative depending on how products are listed on this
In sum, Virtus has not demonstrated there are no genuine issues of material fact that preclude entry of judgment as a matter of law on Mission’s claims of false advertising under the Lanham Act, unfair competition under the Lanham Act, and common law unfair competition. Because Virtus does not provide specific argument, evidence and authority to require an analysis of Mission’s Lanham Act and common law unfair competition claims that is distinct from the analysis of Mission’s Lan-ham Act false advertising claim, for the same reasons Mission has raised a genuine issue of material fact to preclude summary judgment on its false advertising claim, there is a genuine issue of material fact to preclude entry of judgment as a matter of law on Mission’s two unfair competition claims.
VIII. RECOMMENDATION
Based on the foregoing discussion, it is RECOMMENDED that Virtus’ motion for
IX. INSTRUCTIONS FOR SERVICE AND NOTICE OF RIGHT TO OBJECT/APPEAL
The United States District Clerk shall serve a copy of this Report and Recommendation on all parties by either: (1) electronic transmittal to all parties represented by an attorney registered as a Filing User with the Clerk of Court pursuant to the Court’s Procedural Rules for Electronic Filing in Civil and Criminal Cases; or (2) by certified mail, return receipt requested, to any party not represented by an attorney registered as a Filing User.
As provided in 28 U.S.C. § 636(b)(1) and Fed. R. Crv. P. 72(b), any party who desires to object to this Report must file with the District Clerk and serve on all parties and the Magistrate Judge written Objections to the Report and Recommendation within 14 days after being served with a copy, unless this time period is modified by the District Court. A party filing Objections must specifically identify those findings, conclusions or recommendations to which objections are being made and the basis for such objections; the District Court need not consider frivolous, conclusive or general objections.
A party’s failure to file timely written objections to the proposed findings, conclusions and recommendations contained in this Report will bar the party from receiving a de novo determination by the District Court.
SIGNED and ENTERED this 10th day of April, 2014.
Notes
.This report deals with a number of submissions by the parties, including exhibits that both sides asked to be sealed. See docket no. 80, exhibits 10, 11; text-only order dated Feb. 10, 2014; docket no. 82, exhibits D, E, G-J; docket no. 83; docket no. 87, exhibit D; docket no. 88. In preparing this report, the Court has attempted to avoid or minimize references to protected material. In an abundance of caution, the report is provisionally sealed to afford the parties the opportunity to suggest redactions to the report before it is placed in the public record. To that end, any party wishing to recommend redactions to the report must confer with the opposing party and, within 10 calendar days of the date on which the District Clerk files this report, file an advisory containing a brief explanation of the' suggested redactions and attach to that advisory, as a sealed document, a proposed redacted copy of this report. After their conference, if possible, the parties are asked to file a joint advisory and single proposed redacted report. But, if the parties are not able to agree on the nature and scope of any redactions, then the parties may submit separate advisories to briefly explain the suggested redactions, with particular emphasis on proposed redactions on which the parties do not agree, and separate sealed proposed redacted reports for the Court's further review. If no party files such an advisory and proposed redacted report within the time provided, then the District Clerk will file an unsealed version of this report in the public record without further order from the Court.
. Docket no. 73 (Jan. 6, 2014).
. Docket no. 79.
. Docket no. 1.
. Id. at 2, ¶ 7.
.Id. at 2, ¶¶ 9-11.
. Id. at 3-4.
. Id. at 4.
. Docket no. 11.
. Docket no. 17.
. Docket no. 24.
. Docket no. 32.
. Id. at 1-2.
. Docket no. 35.
. Docket no. 33 at 4.
. Docket no. 37.
. Text-only order dated Sept. 4, 2013.
. Docket no. 47.
. Id. at 2-4.
. Docket no. 48 at 8-13.
. Id. at 2.
. Id. at 3-4.
. Id. at 4.
. Id.
. Id. at 5.
. Id.
. Id. at 6-8.
. Id. at 9.
. Id.
. Id. at 10-12.
. Id. at 7.
. Id. at 13.
. Id. at 14. Mission also seeks “such other relief as the Court may deem appropriate to prevent the trade and public from deriving
. Id.
. Docket no. 50.
. Id. at 5-6.
. Id. at 6-8.
. Docket no. 51.
. Docket no. 57 at 1.
. Docket no. 58.
. Docket no. 60. See docket no. 59.
. Docket no. 62. Prior to the parties’ joint request for a stay, on September 20, 2013, Virtus filed an Opposed Motion for Leave to Serve Additional Interrogatories and to Extend Discovery Period. Docket no. 53. The December 2 motion denied this motion and, as noted, lifted the stay. Docket no. 62.
. Docket no. 70, and exhibits A-K. This report cites to the pages of the document assigned by the CM/ECF system at the time the document was electronically filed and served, not the internal pagination of the document.
. Docket no. 72, and exhibits 1-12.
. Docket no. 71.
. Docket no. 73.
. Docket nos. 74-78.
. Docket nos. 84, 85.
. Docket no. 96. See also docket nos. 89, 90, 94, 95.
. Docket no. 79, exhibits 1-9.
. Docket no. 80.
. Text-only order dated Feb. 10, 2014.
. Docket no. 80, exhibits 10-11.
. Docket no.’ 81. The response is supported by eleven exhibits. Id., exhibits A-K.
. Docket no. 82.
. Docket no. 83.
. Docket no. 81, exhibits D-K.
. Docket no. 86. The reply is supported by seven exhibits. Id., exhibits A-G.
. Docket no. 87.
. Docket no. 88.
. Docket no. 86, exhibit D. On March 12, 2014, Virtus filed a motion for a hearing on its motion for partial summary judgment as to plaintiff's claims of false advertising and unfair competition. Docket no. 91. The Court addresses Virtus’ motion for a hearing in a separate order, issued along with this report.
. Fed. R. Civ. P. 56(a). See Celotex Corp. v. Catrett,
. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247,
. Id. at 248,
. Anderson,
. Anderson, 477 U.S. at 249,
. Rule 56(c)(1) provides:
Supporting Factual Positions. A party asserting that a fact cannot be or is genuinely disputed must support the assertion by:
(A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials; or
(B) showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact.
Fed. R. Civ P. 56(c)(1). See also Celotex, 477 U.S. at 323,
. Anderson, 477 U.S. at 257,
. Scott v. Harris,
At the summary judgment stage, facts must be viewed in the light most favorable to the nonmoving party only if there is a 'genuine' dispute as to [the] facts. As we have emphasized, "[w]hen the moving party has carried its burden under Rule 56(c), its opponent must do more than simply show that there is some metaphysical doubt as to the material facts.... Where the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no 'genuine issue for trial.’ ” "The mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact.” "When opposing parties tell two different stories, one of which is blatantly contradicted by the record, so that no reasonable jury could believe it, a court should not adopt that version of the facts for purposes of ruling on a motion for summary judgment.”
. Fed. R. Civ. P. 56(c)(3).
. See Fields v. City of South Houston, 922 F.2d 1183, 1187 (5th Cir.1991).
. Fed. R. Civ. P. 56(c)(2).
. Duffie v. United States,
. Id. at 371; Boudreaux v. Swift Transp. Co.,
. Quorum Health Res., L.L.C. v. Maverick Cnty. Hosp. Dist.,
. Fed. R. Civ. P. 56(e); Stahl v. Novartis Pharm. Corp.,
. Fed. R. Civ P. 56(g).
. See Fed. R. Civ. P. 56(d).
. Raby v. Livingston,
. See Raby,
. 15U.S.C. § 1125(a)(1)(B).
. Healthpoint, Ltd. v. Ethex Corp., No. SA-01-CA-646,
. Pizza Hut,
. Id. at 497 (“With respect to materiality, when the statements of fact at issue are shown to be literally false, the plaintiff need not introduce evidence on the issue of the impact the statements had on consumers. In such a circumstance, the court will assume the statements actually misled consumers.”).
. Id.
. Id.
. Id.
. Id.
. Westchester Media v. PRL USA Holdings, Inc.,
. Matrix Essentials, Inc. v. Emporium Drug Mart,
. Scott Fetzer Co. v. House of Vacuums Inc.,
. Scott Fetzer Co.,
. Healthpoint, Ltd. v. Allen Pharm., LLC, No. SA-07-CA-526-XR,
. Taylor Publishing Co. v. Jostens, Inch
.Id.
. Docket no. 48 at 2; docket no. 79 at 2-3; docket no. 81 at 3.
. Docket no. 79 at 4.
. As discussed in the February 26 report, the patent provides two specific examples of slowly dissolving iron compounds: "Examples of slowing dissolving iron compounds include ferric pyrophosphate and carbonyl iron.” See docket no. 85 at 18, n. 100. See also docket no. 79, exhibit 4, expert report of Dr. Stephen Byrn, exhibit C (the '247 patent) at 59, col. 12, Ins. 66-67. But, as further discussed in the February 26 report, and as contended by both Virtus and Mission, the 2011 reexamination requires that the "iron compound selected to be slowly dissolving” must be carbonyl iron. See docket no. 85 at 18, n. 100, docket no. 70 at 7; docket no. 72 at 6. See also docket no. 79, exhibit 4, expert report of Dr. Stephen Byrn, exhibit C ("reexamination certificate”) at 72, col. 1, Ins. 27-32.
. Reexamination certificate at col. 1, Ins. 40-61 ("The nutritional supplement of claim 1, the rapidly dissolving iron compound is 'selected from the group consisting of ferrous fumarate, ferrous sulfate, ferrous gluconate, ferric ammonium citrate, and iron protein succinylate.”).
. Docket no. 79 at 2 ("Mission found out that Virtus had designed around the '247 patent .... ”); docket no. 81 at 3 ("Virtus manufactures and sells what it promotes as generic versions of certain Mission products”).
. Id. at 1-4; docket no. 81 at 3.
. Id. at 1, 4; docket no. 81 at 3.
. Id. at 5; docket no. 81 at 6. See reexamination certificate at col. 1, Ins. 40-61 ("The nutritional supplement of claim 1, the rapidly dissolving iron compound is selected from the group consisting of ferrous fumarate, ferrous sulfate, ferrous gluconate, ferric ammonium citrate, and iron protein succinylate.”).
. Docket no. 79 at 4 (citing Mission’s first amended complaint, docket no. 48, at ¶¶ 18, 19, 21, 29); docket no. 81 at 4, 6.
. Docket no. 79 at 4-5; docket no. 81 at 4.
. 21 U.S.C. §§ 301-399Í. Docket no. 79 at 3; docket no. 81 at 2. Mission and Virtus disagree as to the nature of the regulation. Movant Virtus argues "[both the Virtus Products and Mission's Products are prescription dietary supplements ... regulated under the ... FDCA .... ” Docket no. 79 at 3 (emphasis added) ]. But, Mission argues “all prescription prenatal vitamins, including both Mission’s and Virtus’s products are drugs, not dietary supplements. As such they are subject to the FDA’s regulations pertaining to drugs." Docket no. 81 at 2-3 (emphasis added). In 1994, Congress enacted the Dietary ■Supplement Health and Education Act of 1994 ("DSHEA”) as an amendment to the FDCA "to establish standards with respect to dietary supplements.” See Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. §§ 301 — 399f).
. Docket no. 79 at 3-4; docket no. 81 at 1-2.
. Docket no. 81 at 11. See generally docket nos. 79, 86 (Virtus does not address this element of the claim of false advertising under the Lanham Act).
. Docket no. 81 at 2-3.
. Docket no. 79 at 3. Virtus also argues, "Mission ... attempts to conflate regulations applicable to prescription drug products with regulations related to food products (e.g., nutritional supplements) in order to create a false construct in a desperate, but ultimately doomed attempt, to save the false advertisement claims.'” Id. at 4.
. Id. at caption and at 1. Virtus' motion states that it collectively refers to each of Mission’s three causes of action at issue in its motion as “false advertisement claims.” Id. at 2. To be clear, unless referring to a party’s argument, references to Mission's false advertising claim in this report is a reference to Mission’s Lanham Act violation asserted in
. Id. at 3, 6.
. Id.
. Id., attached appendix, exhibits 1-11. The exhibits are: exhibit 1 — excerpts from Rhett S. Daniels Depo.; exhibit 2 — excerpts of Dr. Stephen Byrn Depo.; exhibit 3 — plaintiff’s amended complaint; exhibit 4 — Dr. Stephen Byrn’s expert report; exhibit 5 — excerpts from Nancy Price Depo.; exhibit 6 — excerpts from Douglas Leonard Depo.; exhibit 7— product packaging labels for Natalvirt CA and Natalvirt 90 DHA; exhibit 8 — Dr. Boyd Beck's expert report; exhibit 9 — excerpts of Louis Sanchez Depo.; exhibit 10 — Mark Gallagher's expert report; and exhibit 11— Carmen R. Eggleston's expert report.
. Id. at 8.
. Id. at 9.
. Id.
. Id. at 10.
. Id. at 10-11.
. Id. at 11.
. Id. at 11-12.
. Id. at 12.
. Id. at 13.
. Id. at 14.
. Id.
. Id. (citing exhibit 11, Expert Report of Ms. Eggleston, at ¶ 153).
. Docket no. 81 at 1-4.
. Id. at 2-3.
. Id. at 12.
. Id., exhibits A-C, F; docket no. 82, exhibits D, E, G-J. The exhibits are: exhibit A— Feb. 11, 2013 letter from FDA to Edward John Allera denying Mr. Allera's Dec. 8, 2009 “citizen petition” which had asked FDA to issue order confirming “that certain prescription prenatal vitamins that are indicated for use in reducing the risk of neural tube defects and that contain 1 milligram (mg) to 4 mg folic acid, either alone or in combination with other vitamins and minerals, are generally
. As in Virtus' motion, Mission's response focuses on its "false advertising claims.” See id. at 12 ("Virtus is not entitled to judgment as a matter of law on Mission's false advertising claims and this Court should deny Virtus’s Motion”). As noted, Virtus' motion expressly states it refers to all three claims at once as "false advertising claims.” See docket no. 79 at 2. Mission’s response contains no similar statement. See generally docket no. 81.
. Id. at 4-5.
. Id.
. Id. at 5 (emphasis in original).
. Id. at 5-6.
. Id.
. Id. (citing Healthpoint, Ltd. v. Stratus Pharm., Inc.,
. Id. at 4.
. . Id. at 6.,
. Id. at 7.
. Id.
. Id. at 8.
. Id.
. Id. at 8-9.
. Id. at 9-10.
. Id. at 9 (citing Healthpoint, Ltd. v. Ethex Corp., No. SA-01-CA-646-OG,
. Id. at 10-11.
. Id. at 11.
. Id. at 12.
. Docket no. 86 at 1.
. Id. at 1-2.
. Id. at 2.
. Id.
. Id. at 2-3.
. Id. Relatedly, Virtus states the "marketing/labels” for the products at issue "reflects that the industry considers these products 'Prenatal Vitamins' rather than ‘Prenatal Drugs.' " Id. at 3.
. Id.
.Id. at 1.
. Id. at 5.
. Id. at 4.
. Id. at 5.
. Id. at 5-6.
. Id. at 6.
. Id.
. Id.
. Id. at 7.
. Id.
. Id.
. Id. at 7-8.
. Id. at 8.
. Id. at 9 & n. 15 (citing Axcan Scandipharm, Inc. v. Ethex Corp.,
. Id. at 10.
. Id.
. Id.
. Id., exhibits A-C, E-G; docket no. 87, exhibit D. The exhibits are: exhibit A — packaging labels for CitraNatal Assure, CitraNatal 90 DHA, Ferralet 90, Natalvirt FLT, Natalvirt 90 DHA, and Natalvirt CA; exhibit B — an informational packet on the Uniform System of Classification (“USC”), a chart of the First Data Bank and Medi-Span USC Codes, and product information for CitraNatal 90 DHA and CitraNatal Assure; exhibit C — Feb. 11, 2013 letter from FDA to Edward John Allera denying Mr. Allera's Dec. 8, 2009 “citizen petition;” exhibit D — Nov. 10, 2010 certificate of analysis of CitraNatal 90 (Dual Fe) and book excerpts on USP Procedures including “(61) Microbial Enumeration Tests,” "(62) Tests for Specified Microorganisms,” "(2021) Microbial Enumeration Tests — Nutritional and Dietary Supplements,” "(2022) Microbiological Procedures for Absence of Specified Microorganisms — Nutritional and Dietary Supplements,” and "(2040) Disintegration and Dissolution of Dietary Supplements;” exhibit E — Power Point presentation titled "An Introduction to the Improved FDA Prescription Drug Labeling;” exhibit F — Feb. 8, 3013 letter from FDA to Dr. S. Albert Edwards denying Dr. Edwards' Nov. 21, 2011 "citizen petition” which had asked FDA to “stop issuing NDCs for 'unapproved' drugs, that the Agency enforce this change of law and policy gradually over the next three years, and that any establishments who protest this change suffer 'immediate sanctions, including market withdrawal of their violative products;' ” and exhibit G — March 2003 FDA publication titled "Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations.”
. The parties do not explicitly assert which state's law applies to Mission's common law unfair competition claim. In the first amended complaint, Mission does not identify the source of any applicable state law. See docket no. 48 at 11-13. In its partial motion for summary judgment, Virtus cites a Texas appellate court opinion without contest from Mission. See docket no. 79 at 8; docket no. 81. The parties appear to agree that Texas law applies to Mission's common law unfair competition claim, thus, to the extent necessary, for purposes of this report, the Court will apply the elements of common law unfair competition under Texas law.
. Docket no. 48 at 8-12.
.Virtus’ motion does not set out the elements of a Lanham Act unfair competition claim, a common law unfair competition claim, or expressly state (with citations to authority) that each of the three causes of action to which its motion is directed share elements). See generally docket no. 79. Vir-tus’ motion collectively references all three claims as “false advertising claims” and only provides argument directed to "claims” of “false advertising.” Virtus’ reply does address each cause of action separately, docket no. 86 at 10, but primarily in criticism of Mission’s response. Id. Virtus has not ar- ■ gued, or disavowed, in its motion or reply, that its arguments regarding the truth and accuracy of its advertising statements should not equally be considered with respect to each of the three causes of action on which it seeks summary judgment.
.
. Id. (citation omitted).
. Id. at 792-93 (footnotes omitted).
. Id. at 793.
. Healthpoint, Ltd. v. Stratus Pharm., Inc.,
.
. Id. at 841-42.
. Id. at 843.
. Id. The Court further stated:
Although Lanham Act or related common law claims that concern whether Ethezyme is "the same as” Accuzyme — to the extent that determination requires a simple comparison of ingredients and does not entail a decision on whether sodium metabisulfite sjiould be listed as an active ingredient— appear to be properly before the District Court, a determination of whether Ethez-yme is "equivalent” to Accuzyme appears to be inextricably linked to the determination of whether Ethezyme is being marketed lawfully, a matter within the exclusive enforcement domain and "particular expertise” of the FDA. Similarly, the "task of identifying in the first instance whether one drug is the generic equivalent of another” belongs to the FDA ... The term "alternative” is less problematic ... [it] does not imply identity or equivalence.
Id. at 843-44.
.Id. at 866 (citations omitted).
. Id. at 866.
. Id. at 867. See also Healthpoint, Ltd. v. Ethex Corp., No. SA-01-CA-646-OG,
. Docket no. 86 at 3.
. Mission includes a letter dated February 11, 2013 from FDA to Edward John Allera, which states "when dietary ingredients are combined into a single dosage form with an ingredient intended for use as a drug [such as folic acid], the combination becomes a 'drug' under section 201(g) of the [FDCA].” See docket no. 81, exhibit A at 4-5 n. 17. Further, "as a statement of FDA policy, [the February 11 letter] is entitled to ... consideration.” Healthpoint, Ltd. v. Ethex Corp.,
. See docket no. 86 at 3 (quoting 21 U.S.C. § 321 (ff) ("Except for purposes of sections 201(g) and 417, a dietary supplement shall be deemed a food within the meaning of this Act.”)).
. Docket no. 86 at 3. The Court notes that the FDCA defines the term "drug” to include:
(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this subsection.
21 U.S.C. § 321(g)(1). Neither party presents argument or authority to show its products meet any part of this definition. Further, although Virtus cites the definition of a "dietary supplement,” set out in FDCA, Virtus does not distinguish the exception included within that definition. See docket no. 86 at 3 (quoting 21 U.S.C. § 321 (ff) ("Except for purposes of sections 201(g) and 417, a dietary supplement shall be deemed a food within the meaning of this Act.”)).
. Mission argues that under the FDA's definitions, a generic equivalent must be "therapeutically equivalent” to the originator drug, which means it must be pharmaceutically equivalent and bioequivalent. Docket no. 81 at 6 (citing 21 U.S.C. § 355(j)(2)(A)(i)-(viii); 21 C.F.R. § 320.1(c), (e); Axcan Scandipharm.,
. See Healthpoint, Ltd. v. Allen Pharm., LLC, No. SA-07-CA-526-XR,
. See docket no. 81 at 5-6 (citing Healthpoint, Ltd. v. Stratus Pharm., Inc.,
. Docket no. 50 at 4, ¶ 29. Again, purported, expected differences in the dissolution rate of the ferrous gluconate (or other identified iron compound "selected to be rapidly dissolving”) contained in the Virtus Products (because it is contained in a slow-dissolving matrix) as opposed to the Mission Products, is one of Virtus' key arguments in defending against infringement of the '247 patent.
. Docket no. 50 at 3, ¶ 17; docket no. 79 at 11-12. Virtus does not explain the inconsistent position Virtus took in its motion for partial summary judgment on Mission’s patent infringement claim. See docket no. 70. There Virtus contended that it does not in
. Docket no. 79 at 13.
. Id. at 11.
. See docket no. 81, exhibit D, deposition of Louis Horatio Saenz (“Saenz deposition”). Thus, Mission has produced some evidence raising a fact issue as to whether the retail pharmacist, filling a prescription for a Mission Product, the "brand name product,” might dispense instead the corresponding Vir-tus Product, the “brand name equivalent,” under the mistaken assumption the two have been determined to be “generic equivalents” or that otherwise there is factual support for the claim of equivalency.
. Saenz deposition at 45-47.
. Id. at 74-76. Further, Mission provided an email dated April 23, 2013, purportedly from Danielle Reyes, an employee with Vir-tus, to David Becher from Cardinal Health, the wholesaler for Walgreens, in which it appears Ms. Reyes responds to Mr. Becher's request for information prior to listing the Virtus Products in the Cardinal Health database for a Walgreens contract by including, among other documents, the HDMA forms for Natalvirt FLT, Natalvirt 90 DHA, and Natal-virt CA. See id., exhibit E, Reyes email communication dated April 23, 2013.
. Docket no. 86 at 2.
. Id.
. Id.
. See Laughlin Prod., Inc. v. ETS, Inc.,
. The Court has noted that certain of the arguments and exhibits submitted by both parties refer to products other than the six products included in the collective designations “Mission Products” (CitraNatal Assure, CitraNatal 90 DHA, and Ferralet 90) and "Virtus Products” (Natalvirt CE, Natalvirt FLT, and Natalvirt DHA). For example, in its response, Mission refers to Natalvirt CA Combo, Natalvirt 90 DHA Combo, and Ferralet 90 NF. Docket no. 81 at 8. See also id., exhibit E (referencing Natalvirt CA, Natalvirt 90 DHA, and Natalvirt FLT); exhibit G (referencing Natalvirt CA and Natalvirt 90 DHA); exhibit I (referencing Natalvirt CA, Natalvirt 90 DHA, and other products). In its reply, Virtus submits an exhibit referring to CitraNatal 90 (Dual Fe). Docket no. 86, exhibit D. The parties do not explain the discrepancies, or object to their party opponent's naming other products.
. Docket no. 79.
. See Thomas v. Arn,
.Acuna v. Brown & Root Inc.,