Galderma Labs., L.P. v. Teva Pharm. USA, Inc.
Galderma Labs., L.P. v. Teva Pharm. USA, Inc.
Opinion of the Court
Before the Court are (1) a Rule 12(b)(3) motion to dismiss for improper venue [ECF #21], filed by Defendant Teva Pharmaceuticals USA, Inc. ("Teva USA") [ECF #21]; and (2) a Rule 12(b)(6) motion to dismiss for failure to state a claim [ECF #25], filed by Defendant Teva Pharmaceutical Industries Ltd. ("Teva Israel"). For the following reasons, both Motions are GRANTED.
Background
Plaintiffs Galderma Laboratories, L.P., Galderma S.A., and Nestlé Skin Health S.A. bring this civil action under the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), asserting infringement of U.S. Patent Nos. 8,815,816 (the "'816 Patent") ; 9,089,587 (the "'587 Patent") ; 9,233,117 (the "'117 Patent") ; 9,233,118 (the "'118 Patent") ; and U.S. Patent Nos. 8,362,069 (the "'069 Patent"). The patents-in-suit relate to compositions, methods, and regimens for the treatment of rosacea, using ivermectin, an anti-parasitic medication used to treat infections caused by roundworms, threadworms, and other parasites.
The patents-in-suit are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") as covering Soolantra® (ivermectin ) Cream 1% ("Soolantra®"), a topical prescription drug that contains ivermectin for the treatment of inflammatory lesions of rosacea. Plaintiff Galderma Laboratories, L.P. is the owner and exclusive beneficial holder of the rights to market Soolantra® under the FDA approval of New Drug Application ("NDA") No. 206255, approved December 19, 2014. When a party files an NDA, the FDA requires the applicant to submit certain information regarding any patent that claims the drug, or a method of using the drug, that is the subject of the NDA. See
*604A generic drug manufacturer may obtain FDA approval of a generic drug through the Abbreviated New Drug Application ("ANDA") process, if the generic drug is a bioequivalent of a drug previously granted NDA approval. The ANDA process permits a generic drug manufacturer to bypass the costly clinical trials and lengthy delays associated with the NDA process. As part of the ANDA process, the applicant must make a patent certification with respect to each patent that claims the listed drug or a use of such drug for which the applicant is seeking approval. See
(1) the NDA holder submitted no patent to the FDA; or
(2) any patent submitted has expired; or
(3) the date the applicable patent expires; or
(4) that the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug product for which the abbreviated application is submitted.
See
Generally, patent infringement occurs when an infringer makes, uses, offers for sale, sells, or imports an invention into the United States. Under Section 271(e)(2)(A) of the Hatch-Waxman Act, however, the submission of an ANDA application with a paragraph IV certification constitutes an artificial act of infringement, which can form the basis of a claim for injunctive relief to prevent the approval, sale, or use of the generic drug until after the NDA holder's patent expires. Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S ,
In this lawsuit, Plaintiffs allege that Teva USA submitted ANDA No. 210019 to the FDA seeking, approval to engage in the commercial manufacture, use, and sale of a generic ivermectin cream 1% prior to the expiration of the patents-in-suit. Plaintiffs seek declaratory relief that Defendants have and will infringe the patents-in-suit by filing the ANDA and by making or selling their accused generic creams. Plaintiffs also seek an order that the effective date of any FDA approval of the ANDA shall not be earlier than the expiration of the patents-in-suit, and other injunctive relief. Defendants generally contend the claims of the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, offer for sale, sale, or importation of their accused generic ivermectin creams.
Teva USA has filed a motion to dismiss under Rule 12(b)(3) [ECF #21], arguing venue is not proper in this district under the patent venue statute, because Teva USA (1) is incorporated in Delaware, (2) has not committed any acts of infringement in the Northern District of Texas, *605and (3) does not maintain a regular and established place of business in this district.
With respect to Teva USA's Rule 12(b)(3) motion, the Federal Circuit issued a precedential opinion on the patent venue statute, In re Cray, Inc.,
Rule 12(b)(3) Motion to Dismiss for Improper Venue
Legal Standards
Teva USA brings its motion to dismiss for improper venue under Fed. R. Civ. P. 12(b)(3). Courts are divided on which party bears the burden of proof on a motion to dismiss for improper venue. The Fifth Circuit has not ruled on which party bears the burden on a Rule 12(b)(3) motion. However, most district courts within this circuit have imposed the burden of proving that venue is proper on the plaintiff once a defendant has objected to the plaintiff's chosen forum. See, e.g., Broadway Nat'l Bank v. Plano Encryption Techns., LLC ,
In ruling on Teva USA's Rule 12(b)(3) motion, the Court initially accepts as true all of the well-pleaded allegations in the FAC and resolves any factual conflicts in Plaintiffs' favor. Nuttall,
*606Ginter ex rel. Ballard v. Belcher, Prendergast & Laporte ,
If venue is improper, the Court has broad discretion to dismiss the case or, in the interest of justice, transfer the case to any district where venue is proper.
Analysis
Venue in a patent infringement action is governed by a special patent venue statute, which provides that a patent infringement case may be brought in the judicial district where (1) the defendant resides, or (2) where the defendant has committed acts of infringement and has a regular and established place of business.
Acts of Infringement
Teva USA contends that venue is improper in the Northern District of Texas because the alleged act of infringement-the ANDA submission-did not occur in this district. Rather, the ANDA was prepared in New Jersey at Teva USA's offices and electronically submitted in Maryland at the FDA. Def. App., Jungreis Decl. at 2, ¶ 8. Plaintiffs respond that venue is proper in this district because, under the Hatch-Waxman Act, an act of infringement also occurs wherever an ANDA filer intends to market the accused product, and in this case, Defendants allegedly intend to market the accused generic drug in the Northern District of Texas. Plaintiffs further contend that Teva USA committed an act of infringement in this district when it sent the paragraph IV certification to Plaintiffs, who are located in the district.
It is undisputed that, under the Hatch-Waxman Act, filing an ANDA containing a Paragraph IV certification, such as Teva USA did with respect to Soolantra®, constitutes an act of infringement.
an applicant's submission of an ANDA, in conjunction with other acts the ANDA applicant non-speculatively intends to take if its ANDA receives final FDA approval , plus steps already taken by the applicant indicating its intent to market the ANDA product in [a particular] District, must all be considered for venue purposes, and can be sufficient to demonstrate that the ANDA-filing Defendant "has committed" "acts of infringement" in [the particular] District.
In arriving at its decision, the Delaware court observed that the choice of verb tense in the patent venue statute-"has committed"-is problematic in the context of the Hatch-Waxman Act, where the infringement analysis is focused on whether infringement will occur in the future, and not on past or present acts.
Plaintiffs urge the Court to adopt the Delaware court's reasoning and find that an act of infringement has occurred in the Northern District of Texas because Teva USA filed an ANDA and intends to market a generic version of Soolantra® in this district. Plaintiffs' argument closely follows the framework of the Delaware court's decision, pointing out the forward-looking nature of ANDA litigation and drawing heavily from the Federal Circuit's Acorda decision on specific personal jurisdiction.
While the Delaware court's opinion is very thorough, there are several issues with the decision that counsel this Court away from adopting the holding that an act of infringement occurs in any district where the ANDA filer intends to market the ANDA product after it receives FDA approval. "First, and most prominently," as the opinion itself concedes, is that the plain language of the patent venue statute provides that venue is proper "where the defendant has committed acts of infringement." Bristol-Myers Squibb ,
Plaintiffs insist that their interpretation is not only consistent with the statute, it is required to give effect to the second part of Section 271(e)(2), which requires that the submission of an ANDA will be an act of infringement if the purpose of the submission is to obtain approval to engage in the commercial manufacture, use, or sale of a patented drug before the expiration of the patent.
The Bristol-Myers Squibb decision borrowed heavily from Acorda , but Acorda is a personal jurisdiction decision, not a venue decision. In re Cray , the most recent pronouncement from the Federal Circuit on the application of the patent venue statute, warns courts to "be careful not to conflate showings that may be sufficient for other purposes, e.g., personal jurisdiction or the general venue statute, with the necessary showing to establish proper venue in patent cases." In re Cray, Inc.,
In determining proper venue in a Hatch-Waxman Act case, it is appropriate to look to the forum where the ANDA submission itself was prepared and submitted. See, e.g., Abbott Labs. v. Roxane Labs., Inc. ,
Plaintiffs argue the Court should ignore Teva USA's ANDA preparation because Section 271(e)(1) provides that "it shall not be an act of infringement to make, use, offer to sell, or sell ... a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs."
Plaintiffs also argue that Teva USA committed an act of infringement in this District when it submitted the ANDA which included a paragraph IV challenge to Plaintiffs' patents, because Plaintiffs are residents of the Northern District. But Plaintiffs cite no authority for their assertion that the location of the patent holder is relevant to the patent venue analysis, and the patent venue statute does not provide for venue based on the plaintiff's residence.
Regular and Established Place of Business
As an additional or alternative basis for granting the motion to dismiss for improper venue, the Court considers whether Teva USA has a regular and established *610place of business in the Northern District, as required by the second prong of Section 1400(b) in order for venue to be proper in this district. As the Federal Circuit recently clarified, Section 1400(b)'s "regular and established place of business" clause imposes three requirements: "(1) there must be a physical place in the district; (2) it must be a regular and established place of business; and (3) it must be the place of the defendant." In re Cray ,
With respect to the first requirement, "[t]he statute requires a 'place,' i.e. , '[a] building or part of a building set apart for any purpose' or 'quarters of any kind' from which business is conducted."
Regarding the second requirement, regularity means that the business "operates in a 'steady[,] uniform[,] orderly[, and] methodical' manner. In other words, sporadic activity cannot create venue."
The third requirement-that "the regular and established place of business" must be "the place of the defendant"-means that it cannot be solely a place of the defendant's employee, such as an employee's home, if that employee works from home. Id. "Employees change jobs. Thus, the defendant must establish or ratify the place of business. It is not enough that the employee does so on his or her own." Id. According to the Federal Circuit,
Relevant considerations include whether the defendant owns or leases the place, or exercises other attributes of possession or control over the place ... Another consideration might be whether the defendant conditioned employment on an employee's continued residence in the district or the storing of materials at a place in the district so that they can be distributed or sold from that place.... Marketing or advertisements also may be relevant, but only to the extent they indicate that the defendant itself holds out a place for its business.
Plaintiffs contend that Teva USA has a regular and established place of business in the Northern District because it has dozens of employees who live and work in the district. Specifically, Plaintiffs point to evidence that [redacted] Plaintiffs maintain that Teva USA, which is the only entity licensed to distribute Teva-branded drugs in the state of Texas, exercises significant control over [redacted] These employees distribute the promotional materials to Teva USA customers throughout the district.
*611Plaintiffs argue that the business activities performed by the sales representatives on behalf of Teva USA closely resemble, and even exceed, the activities performed by sales representatives in In re Cordis ,
Plaintiffs' argument ignores the fact that none of the sales representatives identified in the record are Teva USA employees. Rather, the record establishes that the sales representatives are employed by a separate, but related, entity-Teva Sales & Marketing, Inc. ("TSM"). See B. Scoll Depo., Pl. Supp. App. at 301, 305. [redacted] There is no evidence in the record, nor even a contention, that TSM and Teva USA are not separate corporate entities.
A subsidiary's presence in the district cannot be imputed to the parent for venue purposes so long as the two entities maintain formal corporate separateness. Symbology Innovations v. Lego Sys., Inc.,
At the November 6 hearing, for the first time, Plaintiffs suggested the Court could impute the presence of TSM's employees to Teva USA under an alter ego theory or an agency theory. However, Plaintiffs did not plead either of these theories, and the Court declines to consider whether either type of relationship may exist in this case in the absence of any specific allegations of alter ego or agency.
[redacted] Plaintiffs argue that it is a disputed fact question as to whether Teva USA actually employs sales representatives in the United States. In support of their argument, Plaintiffs point to declarations from [redacted] and a recent job posting stating that Teva USA is recruiting sales representatives in the Northern District of Texas. Plaintiffs further contend Teva USA has judicially admitted in *612two different lawsuits filed in the Northern District of Illinois that it employs sales representatives in the United States.
The Court determines proper venue from the facts as they existed at time the Plaintiffs' Original Complaint was filed. Nutrition Physiology Corp. v. Enviros Ltd. ,
In a similar way, Teva USA's alleged judicial admissions also do not raise a fact question as to whether Teva USA employed any sales representatives in the Northern District of Texas in April 2017. In Keen v. Teva USA , 1:16-cv-09964, N.D. Ill., the plaintiff, Janice Keen, sued TSM and Teva USA for employment discrimination under the Americans with Disabilities Act and Title VII. See Ans., Pl. Supp. App. at 255-61. In the answer filed in Keen , TSM and Teva USA admitted the following allegations:
Defendant, TEVA Sales and Marketing, Inc., ... during 2015-2016 issued Plaintiff, Janice Keen, IRS W-2 forms stating her employer was Defendant, Teva Sales and Marketing, Inc.
During 2013 and 2014 , at the Illinois Department of Human Rights (IDHR), Defendant TEVA Pharmaceuticals USA, Inc., ... claimed it was Plaintiff's employer notwithstanding no W-2 confirmation.
During the entire time Plaintiff was employed by Defendant TEVA, Plaintiff worked in the Chicago Metropolitan area as a Territory Sales Specialist and later an Executive Sales Specialist.
Plaintiffs also rely on job postings from June and July 2017 that purportedly advertise for sales representative positions with Teva USA. See Pl. App. at 159-163. Although the banner at the top of the job listing includes Teva USA's logo, the postings themselves do not specify that the successful candidate would be employed by Teva USA. In fact, the first posting advertising for a respiratory sales specialist in Dallas, Texas, states that the job opportunity is with "Teva Respiratory, LLC, a member of the Teva Pharmaceuticals family." Id. at 159. The other job postings are silent as to the specific entity that is recruiting candidates. The Court concludes that this evidence does not raise a fact issue as to whether Teva USA employs *613sales representatives anywhere in the United States, let alone the Northern District of Texas.
Having reviewed all the evidence, the Court finds that only two of the employees identified by Defendants as living and working in the district actually work for Teva USA: [redacted] There is no evidence that either of these two employees keep any inventory at their homes or distribute Teva-branded drugs directly to Defendants' customers. There is also no evidence that Teva USA conditioned [redacted] employment on their continued residence in the district. To the contrary, [redacted]. Nothing in the record indicates that Teva USA owned, leased, or rented any portion of [redacted] homes; nor is there any evidence that Teva USA played a part in these employees' selection of their homes in the Northern District of Texas. Teva USA did not hold out these employees' homes as the company's places of business, and no home addresses or personal phone numbers of the employees were listed in any directory or listing for Teva USA. The Court thus determines that neither [redacted] presence in the district warrants a finding that Teva USA has a regular and established place of business in this district. See Regents of the University of Minnesota v. Gilead Sciences, Inc. ,
Plaintiff also argue the facts that Teva USA has a network of authorized distributors throughout the district and derives economic benefit from sales efforts in the district on its behalf weigh in favor of finding that Teva USA has a regular and established place of business here. However, the fact that Teva USA may derive revenue from sales activities in the district does not establish a physical place in the district, as required by the patent venue statute. See Symbology ,
The Court determines that Plaintiffs have failed to carry their burden to show Teva USA has a regular and established place of business in the Northern District. Accordingly, for this additional reason, the Court GRANTS Teva USA's Rule 12(b)(3) motion to dismiss.
*614Transfer
Having found that venue is not proper in this district, Plaintiffs request that the Court transfer rather than dismiss the claims against Teva USA. It is well-established that when a court finds venue improper, it may, in the interest of justice, transfer the case to any district or division in which the case could have been brought.
Plaintiffs argue that the interests of justice weigh in favor of transfer over dismissal in this case because dismissal could result in lifting the thirty-month stay and the approval of the ANDA. Teva USA opposes transfer and prefers dismissal. Teva USA further objects to the Court severing the claims against it and transferring only those claims while retaining the claims against Teva Israel. The Court is inclined to transfer the claims against Teva USA, in the interest of justice to avoid interfering with the statutorily-mandated thirty-month stay. To avoid duplicative litigation, the Court could transfer the remaining claims under
Rule 12(b)(6) Motion to Dismiss for Failure to State a Claim
Teva Israel has filed a separate motion to dismiss under Rule 12(b)(6) [ECF #25] on the ground that the FAC admits it was Teva USA that submitted the ANDA, and the facts pled are not sufficient to state a plausible case that Teva Israel is responsible for that act.
Legal Standards
Fed. R. Civ. P. 8(a)(2) requires a pleading to contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a). The purpose of this requirement is to give the defendant fair notice of what the claim is and the grounds upon which it rests. Bell Atl. Corp. v. Twombly ,
Analysis
Teva Israel argues that Plaintiffs fail to state a claim against it because Teva Israel was not the entity that submitted the ANDA application. As discussed, the Hatch-Waxman Act makes it "an act of infringement to submit" an ANDA on a drug covered by valid and infringed patents found in the Orange Book listing for a drug.
Plaintiffs allege in the FAC [ECF #15]:
Teva USA filed ANDA No. 210019 on December 30, 2016. ¶ 50 (emphasis added).
On or about March 10, 2017, Teva USA sent the Paragraph IV Certification to GLP in Fort Worth, Texas and to GSA. Through the Paragraph IV Certification, Teva USA first notified Plaintiffs that Teva USA had filed the ANDA with the FDA relating to the Accused Product, and that the ANDA includes a certification under21 U.S.C. § 355 (j)(2)(A)(vii)(IV) that, in Teva USA's opinion, the claims of the '816 Patent, '587 Patent, '117 Patent, and '118 Patent are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, offer for sale, sale, or importation of the Accused Product. ¶ 51 (emphasis added).
The FAC contains no other allegations pertaining to the submission of the ANDA. Thus, all of Plaintiffs' allegations state that Teva USA was the entity that committed that act of infringement.
However, the FAC also contains the following allegations pertinent to Teva Israel's involvement in the alleged infringement:
Teva USA is a wholly-owned subsidiary of Teva Israel, and acts at the direction of, under the control of, and for the benefit of Teva Israel. ¶ 7.
Teva Israel [and] Teva USA ... collectively file ANDAs, including the ANDA at issue here, for the purpose of collectively manufacturing, importing, offering for sale, selling, and distributing generic pharmaceutical products throughout the United States, including this district; maintain a broad distribution network within this district; and enjoy substantial income from sales of generic pharmaceutical products in this district. ¶ 10 (emphasis added).
Teva USA conducts business in the United States as a representative of Teva's global brand and an agent of Teva Israel. According to Teva Israel's website, 1 out of every 6 generic prescriptions in the United States is filled with a Teva-branded product. Teva Israel maintains that it has over 7,500 employees at more than 30 locations in the United States, its territories, and Canada. ¶ 18.
*616Teva Israel [and] Teva USA ... work in active concert with respect to the development, manufacturing, regulatory approval, importation, marketing, sale, and distribution of generic pharmaceutical products, including the generic pharmaceutical product described in ANDA No. 210019, throughout the United States, including this district. Teva Israel works in active concert with its subsidiaries, including Teva USA and Actavis, in the submission of ANDAs for approval of its generic pharmaceutical products in the United States. ¶ 45 (emphasis added).
Teva Israel files a single annual report-Form 20-F-to the United States Securities and Exchange Commission for itself and its subsidiaries, including Teva USA and Actavis. ¶ 46.
Defendants share common directors, officers, and facilities, and operate as agents of each other. In prior litigation, Teva USA has stipulated that all documents, witnesses, and information held by Teva Israel are within the custody and control of Teva USA, and that Teva USA would accept service of case documents on behalf of Teva Israel.... ¶ 47.
Teva Israel [and] Teva USA ... were involved in the submission of the ANDA seeking FDA approval to engage in the commercial manufacture, use, and sale of a generic version of Accused Product prior to the expiration of the Asserted Patents. ¶ 48 (emphasis added).
Teva Israel [and] Teva USA ... intend to continue collectively seeking approval of the ANDA from the FDA and engage in the commercial manufacture, marketing, and sale of the Accused Product (including commercial marketing and sale of the Accused Product in the State of Texas and this district), in the event that the FDA approves the ANDA. ¶ 55 (emphasis added).
The key inquiry for the Court is whether the FAC sufficiently alleges that Teva Israel was "actively involved" in preparing the ANDA, as "[p]arties 'actively involved' in preparing the ANDA are deemed to have 'submit[ted]' the ANDA." Cephalon ,
In Cephalon, Inc. v. Watson Pharmaceuticals, Inc. , a district court in Delaware denied a Rule 12(b)(6) motion finding that the plaintiff's allegations were sufficient to raise related corporate entities' active involvement in the preparation of an ANDA above the speculative level. However, the allegations deemed sufficient in Cephalon were more specific than Plaintiffs' allegations in this case. For example, the Cephalon complaint alleged that the related entities each took part in Generic Division operations and further alleged that each related entity contributed employees to the various teams responsible for preparing the ANDA, and employees of each related entity prepared and executed ANDA-related documents. There are no similar allegations in the FAC as to Teva Israel's involvement in preparing the ANDA. To the contrary, the FAC specifically alleges that Teva USA filed ANDA No. 210019, and Teva USA sent the Paragraph IV Certification. First Am. Compl. at ¶¶ 50, 51.
The plaintiff in Cephalon further alleged that each related entity will be involved in the marketing and distribution of the accused generic drug if the ANDA is approved. Plaintiffs here make a similar allegation, but the allegation is a collective allegation against all the defendants.
*617There are no specific facts alleged that Teva Israel will be involved in marketing the Accused Product. The Cephalon complaint survived dismissal because it contained more than the bare-bones assertions made in the FAC that Teva Israel, together with Teva USA, was involved in the submission of the ANDA. Id. at ¶ 48. Additionally, the court in Cephalon found that all the allegations together were sufficient to withstand dismissal. The case does not stand for the proposition that an allegation that a parent company will be involved in post-approval marketing and distribution, with no other facts, is sufficient to plausibly state that the parent company was actively involved in the submission of an ANDA by a subsidiary of the parent company.
Two decisions from the Eastern District of Texas denied Rule 12(b)(6) motions on thinner allegations. First, in Warner Chilcott Company, LLC v. Mylan Pharmaceuticals, Inc. ,
[T]he Mylan entities "prepared ANDA No. 207826," that Mylan, Inc., Mylan Pharmaceuticals, and Mylan Laboratories are "agents of each other" or "work in active concert either directly or through one or more of their wholly owned subsidiaries" to develop, manufacture, and sell generic drug products through the United States, and that Mylan Laboratories "manufactured the Generic Product relied upon in ANDA No. 207826...."
Warner Chilcott ,
The other Eastern District of Texas case Plaintiffs point to is Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. ,
[Subsidiary] and [parent] are agents of each other and/or work in active concert with respect to the development, regulatory approval, marketing, sale and distribution of pharmaceutical products, including the drug at issue in this case ... [and parent] markets and sells the drugs manufactured by [subsidiary]. [I]f the ANDA is approved [parent] will become the generic product's marketer, seller, and distributor in the United States, and that [parent] would benefit from the ANDA's approval.... [Parent] has worked in concert with [subsidiary] with respect to the regulatory approval of the drugs at issue in this case.
Id. at *5. The Eastern District court found the allegations sufficient to state a claim.
Despite the holdings of the two Eastern District of Texas decisions that generic, factually unsubstantiated allegations are sufficient to state a claim, the Court comes to a different conclusion here. Plaintiffs' allegations do not distinguish Teva Israel's conduct from Teva USA's conduct; nor are the allegations supported by any specific factual assertions that make the allegation more than a bare-bones conclusion. Additionally, it appears that Plaintiffs may simply have copied what they perceive to be "magic words" regarding active involvement from other decisions without demonstrating how those allegations can support a claim against Teva Israel in this case.
*618Plaintiffs also assert that their allegations are sufficient to state a claim for inducement against Teva Israel because Plaintiffs have alleged that the Defendants, collectively, will be engaged in post-approval marketing and distribution of a generic version of Soolantra®. Regardless of the particular theory asserted, Plaintiffs' allegations against Teva Israel fail because they are not specific to Teva Israel. Rather, the FAC lumps together all of the Defendants. To survive dismissal, Plaintiffs must specifically allege facts that would support an inference that Teva Israel will be engaged in post-approval marketing and distribution of a generic version of Soolantra®. Plaintiffs indicate that they could allege additional facts about Teva Israel's ownership of the ANDAs and the revenues generated by those ANDAs, which may support the necessary inference.
Plaintiffs request leave to file an amended complaint setting forth more specific allegations, if the Court grants the Rule 12(b)(6) motion. This is a reasonable request, and the Court thus exercises its discretion to give Plaintiffs one last opportunity to cure the deficiencies identified herein. If all the parties do not consent to transfer this case to Delaware, Plaintiffs may file an amended complaint against Teva Israel only on or before December 15, 2017 .
Motion for Leave to File Supplemental Complaint
Also pending before the Court is Plaintiffs' opposed motion [ECF #47] for leave to file a First Supplemental Complaint and serve Supplemental Infringement Contentions, which seeks to add a related patent,
Conclusion
The Court determines that venue is not proper in this district as to Teva Pharmaceuticals USA, Inc. under
The Court further determines that the allegations in Plaintiffs' First Amended Complaint are not sufficient to state a claim that Teva Pharmaceutical Industries Ltd. was actively involved in Teva USA's submission of the ANDA at issue. Therefore, the Court also GRANTS Defendant Teva Pharmaceutical Industries Ltd.'s Motion to Dismiss for failure to state a claim [ECF #25]. Plaintiffs' claims against Teva Pharmaceutical Industries Ltd. are DISMISSED without prejudice. If all the parties do not consent to transfer this case to *619Delaware, Plaintiffs may file an amended complaint against Teva Israel only on or before December 15, 2017 .
Finally, the Court GRANTS in part Plaintiffs' Motion for Leave to File a First Supplemental Complaint and to serve Supplemental Infringement Contentions [ECF #47]. If all the parties do not consent to transfer this case to Delaware, Plaintiffs may include allegations against Teva Israel pertaining to the '425 Patent in their amended complaint to be filed on or before December 15, 2017.
SO ORDERED.
Originally, the Rule 12(b)(3) motion to dismiss was a joint motion by Teva USA and Actavis Laboratories UT, Inc. ("Actavis"). Plaintiffs dismissed their claims against Actavis on November 2, 2017. See Notice of Dismissal [ECF #52]. Accordingly, the Court considers the motion with respect to Teva USA only.
Reference
- Full Case Name
- GALDERMA LABORATORIES, L.P., Galderma S.A., and Nestlé Skin Health S.A. v. TEVA PHARMACEUTICALS USA, INC. and Teva Pharmaceuticals Industries Ltd.
- Cited By
- 27 cases
- Status
- Published