Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA828508
`06/21/2017
`
`ESTTA Tracking number:
`
`Filing date:
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Petition for Cancellation
`
`Notice is hereby given that the following party has filed a petition to cancel the registration indicated below.
`
`Petitioner Information
`
`Name
`
`Entity
`
`Address
`
`Attorney informa-
`tion
`
`Sage Therapeutics, Inc.
`
`Corporation
`
`Citizenship
`
`Delaware
`
`215 First Street
`Cambridge, MA 02142
`UNITED STATES
`
`Sharona H. Sternberg
`Sunstein Kann Murphy & Timbers LLP
`125 Summer Street
`Boston, MA 02110
`UNITED STATES
`Email: ssternberg@sunsteinlaw.com, ltittemore@sunsteinlaw.com, sab-
`reu@sunsteinlaw.com
`Phone: 6174439292
`
`Registration Subject to Cancellation
`
`Registration No.
`
`1717434
`
`Registration date
`
`09/22/1992
`
`Registrant
`
`Sage Pharmaceuticals, Inc.
`5408 Interstate Drive
`Shreveport, LA 71119
`UNITED STATES
`
`Goods/Services Subject to Cancellation
`
`Class 005. First Use: 1990/07/17 First Use In Commerce: 1991/04/05
`All goods and services in the class are subject to cancellation, namely: oral analgesics and antipyret-
`ic pharmaceutical preparations
`
`Grounds for Cancellation
`
`Abandonment
`
`Trademark Act Section 14(3)
`
`Attachments
`
`Petition to Cancel SAGE PHARMACEUTICALS with Exhibits.pdf(283923 bytes )
`
`Signature
`
`/Sharona H. Sternberg/
`
`Name
`
`Date
`
`Sharona H. Sternberg
`
`06/21/2017
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`1,717,434
`SAGE PHARMACEUTICALS (plus design)
`September 22, 1992
`Sage Pharmaceuticals, Inc.
`Oral analgesics and antipyretic pharmaceutical preparations in Class 5
`
`
`In the Matter of Registration:
`
`Registration No.:
`Mark:
`
`Registration Date:
`Registrant:
`
`For:
`
`
`_________________________________
`
`
`
`
`
`
`SAGE THERAPEUTICS, INC.
`
`
`
`
`
`
`
`
`Petitioner,
`
`
`
`
`
`
`
`
`
` v.
`
`
`
`
`
`
`
`
`
`
`
`SAGE PHARMACEUTICALS, INC.
`
`
`
`
`
`
`
`Registrant.
`
`
`
`_________________________________
`
`United States Patent and Trademark Office
`Trademark Trial and Appeal Board
`P.O. Box 1451
`Alexandria, VA 22313-1451
`
`Sir or Madam:
`
`
`
`
`
`
`
`
`PETITION FOR CANCELLATION
`
`Sage Therapeutics, Inc. (“Petitioner”), a corporation organized and existing under the
`
`laws of the Delaware and having its principal place of business at 215 First Street, Cambridge,
`
`Massachusetts 02142, believes that it has been and will be damaged by Registration No.
`
`1,717,434, filed on September 22, 1992, and thus hereby petitions to cancel said registration
`
`under 15 U.S.C. §1064, as amended, on the grounds that:
`
`1.
`
`Registrant Sage Pharmaceuticals, Inc. is a corporation previously organized under
`
`the laws of Louisiana, with a business address of 1945-D East 70th Street Shreveport, LA 71105,
`
`and which has been administratively terminated in the records of the state of Louisiana.
`
`
`
`1
`
`

`

`2.
`
`Registrant is the listed owner of Registration No. 1,717,434, for the mark SAGE
`
`PHARMACEUTICALS (plus design) for “Oral analgesics and antipyretic pharmaceutical
`
`preparations” in Class 5.
`
`3.
`
`Registration No. 1,717,434 resulted from Application Serial No. 74/224,953, filed
`
`November 25, 1991, and registered on September 22, 1992.
`
`4.
`
`Petitioner Sage Therapeutics is a well-known biopharmaceutical company, and is
`
`the owner of the trademarks SAGE and other SAGE-formative trademarks in connection with
`
`pharmaceutical preparations.
`
`5.
`
`On March 10, 2017, Petitioner filed an application for the mark SAGE
`
`THERAPEUTICS (plus design) for use in connection with a “House mark for pharmaceutical
`
`preparations” in Class 5, filed on March 10, 2017, and assigned Serial No. 87/366,176.
`
`6.
`
`The USPTO Examining Attorney assigned to examine Petitioner’s application for
`
`SAGE THERAPEUTICS (plus design) has refused registration because of a likelihood of
`
`confusion with the mark in Registration No. 1,717,434.
`
`7.
`
`Because Registration No. 1,717,434 has been cited against Petitioner’s
`
`Application No. 74/224,953 as a ground for refusal, Petitioner has been harmed by Registrant’s
`
`registration and will continue to be so harmed.
`
`8.
`
`On information and belief, Registrant has abandoned use of the mark SAGE
`
`PHARMACEUTICALS (plus design) mark entirely.
`
`9.
`
`On information and belief, according to the Louisiana Secretary of State’s office,
`
`Registrant Sage Pharmaceuticals, Inc. has been inactive since September 8, 2015, and its date of
`
`Administrative Termination was October 18, 2016. A copy of the Louisiana Secretary of State’s
`
`corporate business record for Sage Pharmaceuticals, Inc. is attached as Exhibit A.
`
`
`
`2
`
`

`

`10.
`
`Petitioner’s investigation has shown that Registrant was under investigation by the
`
`United States Food and Drug Administration (FDA) subsequent to which a lawsuit was brought
`
`against it by the United States Department of Justice, the United States Attorney, and other
`
`federal agencies. See USA v. Sage Pharmaceuticals Inc. et al, 5:13cv1983 (W.D. La. 2013). A
`
`copy of the complaint is attached as Exhibit B.
`
`11. According to Court records, on March 5, 2014, the Registrant informed the
`
`Louisiana District Court that it was winding down and no longer doing business. A copy of the
`
`Court’s docket is attached as Exhibit C.
`
`12. On August 6, 2014, the Department of Justice filed a consent motion to dismiss
`
`the case stating that Registrant Sage Pharmaceuticals was undergoing dissolution proceedings
`
`and was no longer registered as a drug manufacturer with the Food and Drug Administration.
`
`The motion also stated that Dr. Chen, President of Registrant, passed away in October 2013, and
`
`his estate returned or destroyed the drugs that were the subject of this case, sold or disposed of
`
`the company’s drug manufacturing equipment, and sold the manufacturing facility. A copy of the
`
`Consent Motion to Dismiss is attached as Exhibit D.
`
`13. On information and belief, Registrant is not currently using and has no intent to
`
`resume use of the mark SAGE PHARMACEUTICALS (plus design) in connection with the
`
`goods listed in the registration.
`
`14. Based on the foregoing, Registrant has abandoned its rights in the mark SAGE
`
`PHARMACEUTICALS (plus design) in connection with the goods listed in its registration.
`
`15. Abandonment is a basis for cancellation of a U.S. trademark registration pursuant
`
`to 15 U.S.C. §1064 (3).
`
`
`
`
`
`3
`
`

`

`WHEREFORE, Petitioner prays that the present cancellation be sustained and Registration No.
`
`1,717,434 owned by Registrant be cancelled in its entirety.
`
`
`
`Dated: June 21, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`SAGE THERAPEUTICS, INC.
`
`By its attorneys,
`
`
`
`
`
`/Sharona H. Sternberg/
`Lisa M. Tittemore
`Steve A. Abreu
`Sharona H. Sternberg
`SUNSTEIN KANN MURPHY & TIMBERS LLP
`125 Summer Street
`Boston, Massachusetts 02110-1618
`(617) 443-9292
`ltittemore@sunsteinlaw.com
`ssternberg@sunsteinlaw.com
`
`4
`
`

`

`
`
`Exhibit A
`Exhibit A
`
`
`
`
`
`

`

`Tom Schedler
`
`Secretary of State
`
`State of
`Louisiana
`Secretary of
`State
`
`COMMERCIAL DIVISION
`225.925.4704
`
`Fax Numbers
`225.932.5317 (Admin. Services)
`225.932.5314 (Corporations)
`225.932.5318 (UCC)
`
`Name
`
`Type
`
`City
`
`Status
`
`SAGE PHARMACEUTICALS, INC.
`
`Business Corporation
`
`SHREVEPORT
`
`Inactive
`
`Previous Names
`
`Business:
`
`SAGE PHARMACEUTICALS, INC.
`
`Charter Number:
`
`34360085D
`
`Registration Date:
`
`7/19/1990
`
`Domicile Address
`
`1945-D EAST 70TH STREET
`
`SHREVEPORT, LA 71105
`
`Mailing Address
`
`C/O LINDA C. SELL, CPA
`
`1945-D EAST 70TH STREET
`
`SHREVEPORT, LA 71105
`
`Principal Office Address
`
`C/O LINDA C. SELL, CPA
`
`1945-D EAST 70TH STREET
`
`SHREVEPORT, LA 71105
`
`Status
`
`Status:
`
`Inactive
`
`Inactive Reason:
`
`ADMINISTRATIVE TERMINATION
`
`File Date:
`
`7/19/1990
`
`Last Report Filed:
`
`9/8/2015
`
`Type:
`
`Business Corporation
`
`Registered Agent(s)
`
`Agent:
`
`DR. J. R. CHEN
`
`Address 1:
`
`1945-D EAST 70TH STREET
`
`City, State, Zip: SHREVEPORT, LA 71105
`
`Appointment
`Date:
`
`Officer(s)
`
`7/21/1997
`
`Officer:
`
`DAVID C.T. CHEN
`
`Additional Officers: No
`
`

`

`Title:
`
`Director
`
`Address 1:
`
`1945-D EAST 70TH STREET
`
`City, State, Zip: SHREVEPORT, LA 71105
`
`Officer:
`
`Title:
`
`J. R. CHEN
`
`President
`
`Address 1:
`
`1945-D EAST 70TH STREET
`
`City, State, Zip: SHREVEPORT, LA 71105
`
`Amendments on File (2)
`
`Description
`
`Disclosure of Ownership
`
`Administrative Termination
`
`Date
`
`10/16/2000
`
`10/18/2016
`
`Print
`
`

`

`
`
`Exhibit B
`Exhibit B
`
`
`
`
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 1 of 11 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF LOUISIANA
`SHREVEPORT DIVISION
`
`
`
`Plaintiff,
`
`
`
`v.
`
`CIVIL NO. 13-cv-1983
`
`
`
`UNITED STATES OF AMERICA
`
`
`
`
`
`SAGE PHARMACEUTICALS, INC.
` a corporation, and
`JIVN REN CHEN, and
`CHARLES L. THOMAS,
` individuals
`
`
`
`
`
`
`
`
`
`Defendants.
`
`
`
`COMPLAINT FOR PERMANENT INJUNCTION
`
`Plaintiff, the United States of America, by its undersigned attorneys, respectfully
`
`represents to this Honorable Court as follows:
`
`Introduction
`
`1.
`
`This action is brought by the United States of America (hereinafter “Plaintiff”)
`
`pursuant the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 332(a), and the
`
`inherent equitable authority of this Court, to enjoin and restrain Sage Pharmaceuticals, Inc., a
`
`corporation (“Sage”), and Jivn Ren Chen and Charles L. Thomas, individuals (hereinafter,
`
`collectively, “Defendants”) from violating:
`
`a.
`
`21 U.S.C. § 331(d), by introducing or delivering, or causing to be
`
`introduced or delivered, into interstate commerce any new drug within the
`
`meaning of 21 U.S.C. § 321(p) that is neither approved under 21 U.S.C.
`
`§ 355(a), nor exempt from approval pursuant to 21 U.S.C. § 355(i);
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 2 of 11 PageID #: 2
`
`b.
`
`21 U.S.C. § 331(a), by introducing or delivering, or causing to be
`
`introduced or delivered, into interstate commerce any article of drug that is
`
`misbranded within the meaning of 21 U.S.C. § 352(f)(1); and
`
`c.
`
`21 U.S.C. § 331(k), by causing drugs that Defendants hold for sale after
`
`shipment of one or more of their components in interstate commerce to
`
`become misbranded within the meaning of 21 U.S.C. ' 352(f)(1).
`
`Jurisdiction and Venue
`
`This Court has jurisdiction pursuant to 21 U.S.C. § 332(a) and 28 U.S.C. §§ 1331
`
`Venue in this District is proper pursuant to 28 U.S.C. § 1391(b).
`
`Defendants
`
`Defendant Sage is incorporated under the laws of Louisiana, and does business at
`
`2.
`
`and 1345.
`
`3.
`
`4.
`
`5408 Interstate Drive, Shreveport, LA 71109, within the jurisdiction of this Court. Sage
`
`manufactures, processes, labels, holds, and distributes drugs.
`
`5.
`
`Defendant Jivn Ren Chen is the President of Sage. He is responsible for
`
`overseeing the overall operations of Sage, including sales, manufacturing, quality assurance, and
`
`finances. He has the duty, power, and responsibility to prevent, detect, and correct violations.
`
`6.
`
`Defendant Charles L. Thomas is the Director of Corporate Quality at Sage. He is
`
`responsible for establishing and maintaining the quality assurance system at the firm. He has
`
`been present at all FDA inspections, and a regulatory meeting where unapproved new and
`
`misbranded drugs were discussed. He also has the duty, power, and responsibility to prevent,
`
`detect, and correct violations.
`
`7.
`
`Defendants have been and are now engaged in the business of manufacturing,
`
`processing, packing, labeling, holding, and distributing in interstate commerce several products,
`
`
`
`2
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 3 of 11 PageID #: 3
`
`including pain relievers, cough and cold remedies, and topical wound cleansers that are drugs
`
`within the meaning of 21 U.S.C. § 321(g).
`
`Defendants’ Violations
`
`8.
`
`Defendants' products are drugs within the meaning of 21 U.S.C. § 321(g) because
`
`they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in
`
`man or other animals, and/or are intended to affect the structure or any function of the human
`
`body.
`
`
`
`9.
`
`Defendants regularly manufacture drugs using components they receive in
`
`interstate commerce and introduce finished drug products into interstate commerce for shipment
`
`outside the state of Louisiana.
`
`9.
`
`The United States Food and Drug Administration (“FDA”) inspected Defendants’
`
`facility most recently between February 14 - 17, 2012 (“February 2012 Inspection”).
`
`10.
`
`The February 2012 Inspection revealed that Defendants manufacture and
`
`distribute into interstate commerce the following drug products:
`
`a.
`
`b.
`
`c.
`
`Relagesic, which is a prescription pain reliever;
`
`Ru-Hist D tablets and Ru-Hist D liquid, which are over-the counter
`
`(“OTC”) cough and cold remedies; and
`
`Septicare Wound Cleanser and Deodorant (“Septicare”) and Perifoam
`
`Anti-Bacterial Cleanser (“Perifoam”), which are topical skin cleansers.
`
`11.
`
`During the February 2012 Inspection, FDA investigators also observed that Sage
`
`had manufactured Nu-COPD and Ru-Hist Plus, two OTC cough and cold remedies, but had not
`
`yet distributed these products. Defendant Thomas stated that Sage planned to distribute all
`
`inventory on site.
`
`
`
`3
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 4 of 11 PageID #: 4
`
`12.
`
`During the February 2012 Inspection, Defendants also stated that they were no
`
`longer manufacturing the pain reliever Dolorex. However, when FDA returned to collect
`
`samples in June 2012, investigators found that Sage manufactured Dolorex in March 2012.
`
`Defendants’ Products are Unapproved New Drugs
`
`13.
`
`Defendants have been and are now engaged in the manufacture, processing,
`
`packing, labeling, holding, or distributing of numerous unapproved new drugs that they
`
`introduce or cause to be introduced into interstate commerce, in violation of 21 U.S.C. § 331(d).
`
`These unapproved new drugs include, but are not limited to: Relagesic, Dolorex, Ru-Hist Plus,
`
`Ru-Hist D tablets, Ru-Hist D liquid, Nu-COPD, Septicare, and Perifoam.
`
`14.
`
`FDA has conducted a search of its records for New Drug Application (“NDA”),
`
`Abbreviated New Drug Application (“ANDA”), and Investigational New Drug Application
`
`(“IND”) submissions by Defendants. FDA has ascertained that Defendants have no approvals on
`
`file of an NDA, ANDA, or IND for any of the eight drugs listed above.
`
`15.
`
`A “new drug” is defined as any drug “the composition of which is such that the
`
`drug is not generally recognized, among experts qualified by scientific training and experience to
`
`evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions
`
`prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 321(p)(1).
`
`16.
`
`For a product to be deemed “generally recognized as safe and effective”
`
`(“GRAS/GRAE”), it must: (1) have substantial evidence of safety and effectiveness, or (2) if it
`
`is an OTC drug, comply with a monograph established pursuant to an FDA regulation.
`
`21 U.S.C. § 355(d); 21 C.F.R. § 330.1.
`
`17.
`
`Based upon searches of the publically available medical and scientific literature,
`
`FDA has determined that there are no published adequate and well-controlled investigations or
`
`
`
`4
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 5 of 11 PageID #: 5
`
`any other scientific literature demonstrating that Defendants’ drug products are GRAS/GRAE for
`
`any use. Because there are no adequate and well-controlled investigations of the intended use of
`
`these drugs, qualified experts cannot come to a consensus of opinion concerning the
`
`effectiveness of Defendants’ drugs. Therefore, these drugs are not GRAS/GRAE, and are new
`
`drugs under the Act.
`
`18.
`
`Also, a drug product may be deemed GRAS/GRAE, and thus marketed without an
`
`approved NDA, ANDA, or IND application, if the drug is manufactured and distributed in strict
`
`compliance with an OTC monograph. 21 C.F.R. § 330.1. With respect to OTC drugs, FDA has
`
`reviewed the active ingredients and the labeling for over 80 therapeutic classes of drugs. For
`
`each of these categories, FDA has published an OTC drug monograph in the Federal Register.
`
`OTC drug monographs clearly identify acceptable ingredients, doses, formulations, and labeling
`
`for specific active ingredients used in OTC drug products.
`
`19.
`
`Defendants’ two OTC topical wound cleansers, Septicare and Perifoam, do not
`
`conform to any OTC monograph set forth in 21 C.F.R. § 330.1.
`
`20.
`
`Although there are monographs for cold/cough remedies—see 21 C.F.R. Part 341,
`
`Cold, Cough, Allergy, Broncho-dialator, and Antiasthmatic Drug Products for Over-the-Counter
`
`Human Use—none of Defendants= four OTC cough and cold drug products conform to it.
`
`21.
`
`For example, Ru-Hist D tablets, Ru-Hist D liquid, and Ru-Hist Plus contain a
`
`nasal decongestant—phenylephrine hydrochloride—and an antihistamine—pyrilamine maleate.
`
`Under the applicable OTC monographs, phenylephrine hydrochloride is to be taken every 4
`
`hours, see 21 C.F.R. § 341.80(d)(1), and pyrilamine maleate is to be taken every 6-8 hours, see
`
`21 C.F.R. § 341.72(d)(11). Thus, Ru-Hist D tablets, Ru-Hist D liquid, and Ru-Hist Plus cannot
`
`meet the applicable OTC monographs because there is no way to write adequate directions for
`
`
`
`5
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 6 of 11 PageID #: 6
`
`use that would be meet the dosage interval requirements for each of the active ingredients
`
`according to their respective monographs.
`
`22.
`
`In addition, Nu-COPD does not meet the applicable monographs for its active
`
`ingredients, phenylephrine hydrochloride, see 21 C.F.R. § 341.80(d)(1), and guaifenesin, see 21
`
`C.F.R. § 341.76(d). Both ingredients’ monographs require dosing every four hours, and Nu-
`
`COPD’s label states that the product can be dosed every four to six hours.
`
`23.
`
`Accordingly, by manufacturing and distribution these unapproved new drugs,
`
`Defendants introduce unapproved new drugs, or cause them to be introduced, into interstate
`
`commerce, in violation of 21 U.S.C. ' 331(d).
`
`Defendants’ Products Are Misbranded Drugs
`
`24.
`
`A drug is misbranded within the meaning of 21 U.S.C. § 352(f)(1) if its labeling
`
`fails to bear “adequate directions for use.” Pursuant to 21 C.F.R. § 201.5, “adequate directions
`
`for use” are defined as “directions under which the layman can use a drug safely and for the
`
`purpose for which it is intended.” Adequate directions for use must be based on animal and
`
`clinical data derived from extensive, scientifically controlled testing.
`
`25.
`
`It is not possible to write such directions for Defendants’ drugs listed above,
`
`because adequate directions for drug use—including indications, contraindications, dosages,
`
`routes of administration, warnings, side effects, and necessary collateral measures—are
`
`necessarily premised on animal and clinical data derived from extensive, scientifically controlled
`
`testing.
`
`26.
`
`Defendants do not have any well-controlled clinical test data for the eight drugs
`
`listed above. Consequently, adequate directions under which a layman can safely use these
`
`drugs cannot be written. Moreover, because the products at issue are unapproved new drugs, as
`
`
`
`6
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 7 of 11 PageID #: 7
`
`described above, these drugs are not exempt from the requirement for adequate directions for
`
`use—21 C.F.R. §§ 201.100(c)(2), 201.115.
`
`27.
`
`Furthermore, Ru-Hist D tablets, Ru-Hist D liquid, Ru-Hist Plus, and Nu-COPD
`
`are misbranded because the dosage intervals provided on their labels do not strictly adhere to the
`
`dosage intervals listed in the relevant FDA OTC monographs.
`
`28.
`
`Defendants violate 21 U.S.C. § 331(a) by introducing or delivering, or causing to
`
`be introduced or delivered, into interstate commerce drugs that are misbranded within the
`
`meaning of 21 U.S.C. § 352(f)(1).
`
`29.
`
`Defendants violate 21 U.S.C. § 331(k), by causing drugs that defendants hold for
`
`sale after shipment of one or more of their components in interstate commerce to become
`
`misbranded within the meaning of 21 U.S.C. § 352(f)(1).
`
`History of Violations
`
`30.
`
`Defendants are aware that their conduct violates the law and that continued
`
`violations could lead to regulatory action.
`
`31.
`
`In 1998, the United States of America sought to enjoin Sage for violations of
`
`FDA’s current good manufacturing regulations and for distributing unapproved new drugs.
`
`32.
`
`In 2000, as a result of that injunction action, the Court issued an order, requiring
`
`Sage to cease manufacturing and distributing two specific unapproved new drugs at issue in that
`
`case—Palgic D and Palgic DS—until FDA approval of an NDA for those products.
`
`33.
`
`Since the entry of that order, Defendants have refused to cease manufacturing and
`
`distributing other unapproved new and misbranded drugs, despite various warnings from FDA.
`
`34.
`
`FDA has issued repeated warnings over the last thirteen years during in-person
`
`meetings and in written letters. Defendants have responded to the agency’s letters and meetings
`
`
`
`7
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 8 of 11 PageID #: 8
`
`with promises to stop manufacturing certain unapproved products, promises to file applications
`
`for approval for specific products; and claims that FDA is incorrect about the interpretation of its
`
`regulations.
`
`35.
`
`At a prior FDA inspection between May 2-6, 2011, FDA investigators informed
`
`Defendants that they were distributing unapproved new and misbranded drugs. Defendants did
`
`not respond orally to this information at the May 2011inspection. In their written responses to
`
`the May 2011 inspection, however, they stated that they would cease manufacturing and
`
`distributing Relagesic.
`
`36.
`
`At the February 2012 Inspection, the FDA investigator collected evidence that
`
`Defendants continued to manufacture and distribute Relagesic.
`
`37.
`
`During the February 2012 Inspection, Defendants stated that they no longer
`
`manufactured Dolorex.
`
`38. When FDA returned to collect samples in June 2012, investigators found that
`
`Sage had manufactured Dolorex in March 2012.
`
`39.
`
`FDA informed Defendants that they are manufacturing and distributing
`
`unapproved new and misbranded drugs in letters dated January 13, 2012, December 14, 2011,
`
`September 28, 2011, November 21, 2007, August 28, 2007, January 29, 2007, and June 23,
`
`1999. Several of those letters specifically state that Septicare and Relagesic are unapproved new
`
`drugs.
`
`40.
`
`Defendants also received a Warning Letter dated October 11, 2002 that warned
`
`Defendants that the extended release guaifenesin tablets they were manufacturing at the time
`
`were unapproved new drug products that could be subject to an enforcement action.
`
`
`
`8
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 9 of 11 PageID #: 9
`
`41.
`
`The agency also held meetings with Defendants on September 15, 2011, July 31,
`
`2000, and January 13, 2000 to discuss the firm’s manufacture and distribution of unapproved
`
`new and misbranded drugs, including Septicare, Relagesic, and Perifoam.
`
`42.
`
`Although Defendants stopped manufacturing particular products, such as the
`
`products that were the subject of the previous injunction and the October 11, 2002 Warning
`
`Letter, they began manufacturing different unapproved new and misbranded drugs to take the
`
`place of the discontinued products.
`
`43.
`
`As demonstrated by the results of FDA’s most recent inspection, Defendants
`
`continue to violate the Act, by inter alia continuing to manufacture Septicare, Relagesic, and
`
`Perifoam, despite numerous warnings from FDA that these products are illegal.
`
`44.
`
`Based on Defendants’ course of conduct throughout the past thirteen years and the
`
`results of FDA’s inspections, Plaintiff is informed and believes that, unless restrained by order of
`
`this Court, Defendants will continue to distribute unapproved new and misbranded drugs in
`
`violation of the Act, 21 U.S.C. § 331(a) and (d), and to cause drugs that Defendants hold for sale
`
`after shipment of one or more of their components in interstate commerce to become misbranded
`
`within the meaning of 21 U.S.C. § 331(k).
`
`WHEREFORE, Plaintiff respectfully requests that this Court:
`
`Prayer for Relief
`
`I.
`
`Permanently restrain and enjoin, pursuant to 21 U.S.C. § 332(a), Defendants, and
`
`each and all of their agents, representatives, employees, attorneys, successors, assigns, and any
`
`and all persons in active concert or participation with any of them (including individuals,
`
`directors, partnerships, corporations, subsidiaries, and affiliates) who receive notice of the
`
`Court’s order, from doing or causing to be done, any of the following acts:
`
`
`
`9
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 10 of 11 PageID #: 10
`
`A. Violating 21 U.S.C. § 331(d) by distributing unapproved new drugs in
`
`interstate commerce;
`
`B. Violating 21 U.S.C. § 331(a) by distributing misbranded drugs in
`
`interstate commerce; and
`
`C. Violating 21 U.S.C. § 331(k), by causing drugs that Defendants hold for
`
`sale after shipment of one or more of their components in interstate
`
`commerce to become misbranded within the meaning of 21 U.S.C.
`
`§ 352(f)(1).
`
`II.
`
`Order Defendants, and each and all of their agents, representatives, employees,
`
`attorneys, successors, assigns, and any and all persons in active concert or participation with any
`
`of them (including individuals, directors, partnerships, corporations, subsidiaries, and affiliates)
`
`who receive notice of the Court’s order, to cease manufacturing and distributing any drug
`
`product unless and until:
`
`A. An approved new drug application or abbreviated new drug application
`
`pursuant to 21 U.S.C. § 355(a) or (j) is in effect for the product; or
`
`B. An investigational new drug exemption filed pursuant to 21 U.S.C. §
`
`355(i) is in effect for the product; or
`
`C. The product is manufactured and distributed in strict compliance with an
`
`OTC monograph set forth in 21 C.F.R. § 330.1; and
`
`III.
`
`That Plaintiff be granted judgment for its costs herein, including costs of
`
`investigation to date, and that this Court grant such other and further relief as it deems just and
`
`proper.
`
`///
`
`
`
`10
`
`

`

`Case 5:13-cv-01983 Document 1 Filed 06/20/13 Page 11 of 11 PageID #: 11
`
`DATED this 20th day of June, 2013
`
`
`OF COUNSEL:
`
`WILLIAM B. SCHULTZ
`General Counsel
`
`ELIZABETH DICKINSON
`Associate General
`Counsel
`Food and Drug Division
`
`ANNAMARIE KEMPIC
`Deputy Chief Counsel,
`Litigation
`
`TARA BOLAND
`Associate Chief Counsel
`United States Department of
`Health and Human Services
`Office of the General Counsel
`10903 New Hampshire Ave.
`Silver Spring, MD 20993-0002
`Phone: (301) 796-8549
`
` Respectfully Submitted,
`
`STEPHANIE A. FINLEY
`United States Attorney
`
`KATHERINE W. VINCENT
`Assistant U.S. Attorney, Civil Chief
`
`RAMSAY MCCULLOUGH
`No. 802717
`Assistant U.S. Attorney
`300 Fannin St., Suite 3201
`Shreveport, LA 71101
`Phone: 318-676-3600
`
`
`STUART F. DELERY
`Acting Assistant Attorney General
`
`MAAME EWUSI-MENSAH FRIMPONG
`Deputy Assistant Attorney General
`Civil Division
`U.S. Department of Justice
`
`
`
`_________________________
`SANG H. LEE
`Trial Attorney
`Consumer Protection Branch
`U.S. Department of Justice
`Civil Division
`P.O. Box 386
`Washington, DC 20044
`Phone: (202) 514-0516
`E-mail: Sang.H.Lee@usdoj.gov
`
`
`
`
`
`
`
`11
`
`

`

`(cid:45)(cid:54) (cid:23)(cid:23) (cid:11)(cid:53)(cid:72)(cid:89) (cid:20)(cid:21)(cid:18)(cid:20)(cid:21)(cid:12)
`
`Case 5:13-cv-01983 Document 1-1 Filed 06/20/13 Page 1 of 2 PageID #: 12
` CIVIL COVER SHEET
`(cid:55)(cid:75)(cid:72) (cid:45)(cid:54) (cid:23)(cid:23) (cid:70)(cid:76)(cid:89)(cid:76)(cid:79) (cid:70)(cid:82)(cid:89)(cid:72)(cid:85) (cid:86)(cid:75)(cid:72)(cid:72)(cid:87) (cid:68)(cid:81)(cid:71) (cid:87)(cid:75)(cid:72) (cid:76)(cid:81)(cid:73)(cid:82)(cid:85)(cid:80)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81) (cid:70)(cid:82)(cid:81)(cid:87)(cid:68)(cid:76)(cid:81)(cid:72)(cid:71) (cid:75)(cid:72)(cid:85)(cid:72)(cid:76)(cid:81) (cid:81)(cid:72)(cid:76)(cid:87)(cid:75)(cid:72)(cid:85) (cid:85)(cid:72)(cid:83)(cid:79)(cid:68)(cid:70)(cid:72) (cid:81)(cid:82)(cid:85) (cid:86)(cid:88)(cid:83)(cid:83)(cid:79)(cid:72)(cid:80)(cid:72)(cid:81)(cid:87) (cid:87)(cid:75)(cid:72) (cid:73)(cid:76)(cid:79)(cid:76)(cid:81)(cid:74) (cid:68)(cid:81)(cid:71) (cid:86)(cid:72)(cid:85)(cid:89)(cid:76)(cid:70)(cid:72) (cid:82)(cid:73) (cid:83)(cid:79)(cid:72)(cid:68)(cid:71)(cid:76)(cid:81)(cid:74)(cid:86) (cid:82)(cid:85) (cid:82)(cid:87)(cid:75)(cid:72)(cid:85) (cid:83)(cid:68)(cid:83)(cid:72)(cid:85)(cid:86) (cid:68)(cid:86) (cid:85)(cid:72)(cid:84)(cid:88)(cid:76)(cid:85)(cid:72)(cid:71) (cid:69)(cid:92) (cid:79)(cid:68)(cid:90)(cid:15) (cid:72)(cid:91)(cid:70)(cid:72)(cid:83)(cid:87) (cid:68)(cid:86)
`(cid:83)(cid:85)(cid:82)(cid:89)(cid:76)(cid:71)(cid:72)(cid:71) (cid:69)(cid:92) (cid:79)(cid:82)(cid:70)(cid:68)(cid:79) (cid:85)(cid:88)(cid:79)(cid:72)(cid:86) (cid:82)(cid:73) (cid:70)(cid:82)(cid:88)(cid:85)(cid:87)(cid:17) (cid:55)(cid:75)(cid:76)(cid:86) (cid:73)(cid:82)(cid:85)(cid:80)(cid:15) (cid:68)(cid:83)(cid:83)(cid:85)(cid:82)(cid:89)(cid:72)(cid:71) (cid:69)(cid:92) (cid:87)(cid:75)(cid:72) (cid:45)(cid:88)(cid:71)(cid:76)(cid:70)(cid:76)(cid:68)(cid:79) (cid:38)(cid:82)(cid:81)(cid:73)(cid:72)(cid:85)(cid:72)(cid:81)(cid:70)(cid:72) (cid:82)(cid:73) (cid:87)(cid:75)(cid:72) (cid:56)(cid:81)(cid:76)(cid:87)(cid:72)(cid:71) (cid:54)(cid:87)(cid:68)(cid:87)(cid:72)(cid:86) (cid:76)(cid:81) (cid:54)(cid:72)(cid:83)(cid:87)(cid:72)(cid:80)(cid:69)(cid:72)(cid:85) (cid:20)(cid:28)(cid:26)(cid:23)(cid:15) (cid:76)(cid:86) (cid:85)(cid:72)(cid:84)(cid:88)(cid:76)(cid:85)(cid:72)(cid:71) (cid:73)(cid:82)(cid:85) (cid:87)(cid:75)(cid:72) (cid:88)(cid:86)(cid:72) (cid:82)(cid:73) (cid:87)(cid:75)(cid:72) (cid:38)(cid:79)(cid:72)(cid:85)(cid:78) (cid:82)(cid:73) (cid:38)(cid:82)(cid:88)(cid:85)(cid:87) (cid:73)(cid:82)(cid:85) (cid:87)(cid:75)(cid:72)
`(cid:83)(cid:88)(cid:85)(cid:83)(cid:82)(cid:86)(cid:72) (cid:82)(cid:73) (cid:76)(cid:81)(cid:76)(cid:87)(cid:76)(cid:68)(cid:87)(cid:76)(cid:81)(cid:74) (cid:87)(cid:75)(cid:72) (cid:70)(cid:76)(cid:89)(cid:76)(cid:79) (cid:71)(cid:82)(cid:70)(cid:78)(cid:72)(cid:87) (cid:86)(cid:75)(cid:72)(cid:72)(cid:87)(cid:17)
`(SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)
`
`I. (a) PLAINTIFFS
`United State of America
`
`DEFENDANTS
`Sage Pharmaceuticals, Inc.; Dr. Jivn Ren Chen; Charles L. Thomas
`
`(b) (cid:38)(cid:82)(cid:88)(cid:81)(cid:87)(cid:92) (cid:82)(cid:73) (cid:53)(cid:72)(cid:86)(cid:76)(cid:71)(cid:72)(cid:81)(cid:70)(cid:72) (cid:82)(cid:73) (cid:41)(cid:76)(cid:85)(cid:86)(cid:87) (cid:47)(cid:76)(cid:86)(cid:87)(cid:72)(cid:71) (cid:51)(cid:79)(cid:68)(cid:76)(cid:81)(cid:87)(cid:76)(cid:73)(cid:73)
`(EXCEPT IN U.S. PLAINTIFF CASES)
`
`(c) (cid:36)(cid:87)(cid:87)(cid:82)(cid:85)(cid:81)(cid:72)(cid:92)(cid:86) (Firm Name, Address, and Telephone Number)
`Sang H. Lee, United States Department of Justice
`450 5th St. NW, Suite 6400
`Washington, DC 20530
`
`II. BASIS OF JURISDICTION (Place an “X” in One Box Only)
`
`(cid:117) (cid:20) (cid:56) (cid:54) (cid:42)(cid:82)(cid:89)(cid:72)(cid:85)(cid:81)(cid:80)(cid:72)(cid:81)(cid:87)
`(cid:51)(cid:79)(cid:68)(cid:76)(cid:81)(cid:87)(cid:76)(cid:73)(cid:73)
`
`(cid:117) (cid:22) (cid:41)(cid:72)(cid:71)(cid:72)(cid:85)(cid:68)(cid:79) (cid:52)(cid:88)(cid:72)(cid:86)(cid:87)(cid:76)(cid:82)(cid:81)
`(U.S. Government Not a Party)
`
`(cid:38)(cid:82)(cid:88)(cid:81)(cid:87)(cid:92) (cid:82)(cid:73) (cid:53)(cid:72)(cid:86)(cid:76)(cid:71)(cid:72)(cid:81)(cid:70)(cid:72) (cid:82)(cid:73) (cid:41)(cid:76)(cid:85)(cid:86)(cid:87) (cid:47)(cid:76)(cid:86)(cid:87)(cid:72)(cid:71) (cid:39)(cid:72)(cid:73)(cid:72)(cid:81)(cid:71)(cid:68)(cid:81)(cid:87)
`Caddo Parish
`(IN U.S. PLAINTIFF CASES ONLY)
`(cid:44)(cid:49) (cid:47)(cid:36)(cid:49)(cid:39) (cid:38)(cid:50)(cid:49)(cid:39)(cid:40)(cid:48)(cid:49)(cid:36)(cid:55)(cid:44)(cid:50)(cid:49) (cid:38)(cid:36)(cid:54)(cid:40)(cid:54)(cid:15) (cid:56)(cid:54)(cid:40) (cid:55)(cid:43)(cid:40) (cid:47)(cid:50)(cid:38)(cid:36)(cid:55)(cid:44)(cid:50)(cid:49) (cid:50)(cid:41)
`(cid:55)(cid:43)(c