Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`
`ESTTA Tracking number:
`
`ESTTA1019531
`
`Filing date:
`
`12/02/2019
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Proceeding
`
`91251839
`
`Party
`
`Correspondence
`Address
`
`Defendant
`Minnesota Resuscitation Solutions LLC
`
`BRIAN P. O'DONNELL
`KILPATRICK TOWNSEND & STOCKTON LLP
`1400 WEWATTA STREET, SUITE 600
`DENVER, CO 80202
`denverteas@kilpatricktownsend.com, bodonnell@kilpatricktownsend.com, tmad-
`min@kilpatricktownsend.com
`no phone number provided
`
`Submission
`
`Filer's Name
`
`Filer's email
`
`Signature
`
`Date
`
`Attachments
`
`Answer and Counterclaim
`
`Brian P. O'Donnell
`
`denverteas@kilpatricktownsend.com, tmadmin@kilpatricktownsend.com,
`bodonnell@kilpatricktownsend.com
`
`/Brian P. O'Donnell/
`
`12/02/2019
`
`Answer to Notice of Opposition and Counterclaim.pdf(531822 bytes )
`Exhibit 1.pdf(636382 bytes )
`Exhibit 2.pdf(73787 bytes )
`Exhibit 3.pdf(18628 bytes )
`Exhibit 4.pdf(40475 bytes )
`Exhibit 5.pdf(3961100 bytes )
`
`Registration Subject to the filing
`
`Registration No.
`
`2645629
`
`Registration date
`
`11/05/2002
`
`International Re-
`gistration No.
`
`Registrant
`
`NONE
`
`International Re-
`gistration Date
`
`NONE
`
`TOLMAR THERAPEUTICS, INC.
`701 CENTRE AVENUE
`FORT COLLINS, CO 80526
`UNITED STATES
`
`Goods/Services Subject to the filing
`
`Class 005. First Use: 0 First Use In Commerce: 0
`All goods and services in the class are requested, namely: pharmaceutical preparations for the treat-
`ment of cancer [ ; drug delivery systems for the treatment of cancer comprisedof chemicals to facilit-
`ate the internaldelivery of pharmaceuticals in the body]
`
`Grounds for Cancellation
`
`Fraud on the USPTO
`
`Trademark Act Section 14(3); In re Bose Corp.,
`580 F.3d 1240, 91 USPQ2d 1938 (Fed. Cir.
`2009)
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
`TOLMAR THERAPEUTICS, INC.,
`
`
`
`v.
`
`MINNESOTA RESUSCITATION
`SOLUTIONS LLC,
`
`
`
`Opposer,
`
`Applicant.
`
`
`
`
`
`Opposition No. 91251839
`
`Serial No. 88/048,084
`
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`
`
`ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
`
`COMES NOW Applicant Minnesota Resuscitation Solutions LLC (“Applicant”) and for
`
`its Answer, Affirmative Defenses and Counterclaims to the Notice of Opposition filed by Tolmar
`
`Therapeutics, Inc. (“Opposer”) states as follows.
`
`In response to the first un-numbered paragraph of the Notice of Opposition (the
`
`“Notice”), Applicant admits that Tolmar Therapeutics, Inc. is a corporation organized under the
`
`laws of the state of Delaware with its principal place of business at 701 Centre Avenue, Fort
`
`Collins, CO 80526. Applicant admits Application Serial No. 88/048,084 is for the mark
`
`ELEGARD in International Class 10 (“Applicant’s Mark”), and further admits that it is the
`
`owner of the Application. Applicant denies all remaining allegations contained in the first un-
`
`numbered paragraph.
`
`In response to the numbered allegations of the Notice, Applicant states as follows.
`
`1.
`
`Applicant admits Applicant’s U.S. Trademark Application Serial No. 88/048,084
`
`published for opposition on July 2, 2019. Applicant further admits Opposer filed a 90 Day
`
`Request for extension of Time to Oppose on that same day and the Extension of Time to Oppose
`
`1
`
`

`

`was granted until October 30, 2019. The remaining allegations of paragraph 1 call for a legal
`
`conclusion to which no response is required. To the extent a response is required, Applicant
`
`admits the remaining allegations of paragraph 1.
`
`2.
`
`Applicant admits that Opposer is identified by the U.S. Patent & Trademark
`
`Office TESS database as the current owner of U.S. Reg. No. 2,645,629 for the mark ELIGARD
`
`(“Opposer’s Mark”) filed on October 30, 2001 and registered on November 5, 2002 covering the
`
`goods in International Class 5 “pharmaceutical preparations for the treatment of cancer.”
`
`Applicant states that the documents in Exhibit 1 speak for themselves, but to the extent a
`
`response is required, Applicant admits those documents purport to be the registration certificate
`
`and TSDR status printout for U.S. Reg. No. 2,645,629. Applicant denies the remaining
`
`allegations contained in this paragraph 2.
`
`3.
`
`4.
`
`5.
`
`Applicant denies the allegations of paragraph 3.
`
`Applicant denies the allegations of paragraph 4.
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`Applicant is without information or knowledge sufficient to form a belief as to the
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`truth or falsity of the averments of paragraph 5, and therefore denies such allegations.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`11.
`
`12.
`
`Applicant admits the allegations of paragraph 6.
`
`Applicant denies the allegations of paragraph 7.
`
`Applicant denies the allegations of paragraph 8.
`
`Applicant denies the allegations of paragraph 9.
`
`Applicant denies the allegations of paragraph 10
`
`Applicant denies the allegations of paragraph 11.
`
`Applicant denies the allegations of paragraph 12.
`
`2
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`

`

`13.
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`Applicant admits Applicant’s use of ELEGARD in connection with Applicant’s
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`Goods is without Opposer’s consent or authorization but denies any consent or authorization
`
`from Opposer is necessary or required.
`
`FURTHER ANSWER AND AFFIRMATIVE DEFENSES
`
`By way of further Answer and as affirmative defenses, Applicant denies that Opposer is
`
`entitled to the relief requested. Applicant further denies each and every allegation set forth in
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`Opposer’s Notice that is not expressly admitted. Applicant undertakes the burden of proof only
`
`as to those defenses deemed affirmative defenses by law, regardless of how such defenses are
`
`denominated below, and states as follows:
`
`FIRST AFFIRMATIVE DEFENSE
`
`The Notice of Opposition fails to state a claim upon which relief can be granted.
`
`SECOND AFFIRMATIVE DEFENSE
`
`Opposer’s U.S. Reg. No. 2,645,629 is void and unlawful for fraud on the U.S. Patent &
`
`Trademark Office because there was no lawful use in commerce of the ELIGARD mark due to
`
`Opposer’s violation of the Patent Act (35 U.S.C. § 271) as determined by the U.S. District Court
`
`for the Northern District of Illinois (Civil Action No. 1:03-cv-07822), a court of competent
`
`jurisdiction (the “Court”), which held from the first sale of ELIGARD products in the United
`
`States in 2002 that those “products were all made in violation of the law, which prohibits making
`
`an infringing product” (emphasis added). Opposer’s violation of the Patent Act resulted in a
`
`permanent injunction ordering the recall of all ELIGARD products, enjoining the marketing,
`
`advertising and sale of ELIGARD products and a settlement payment by Opposer’s predecessor
`
`in interest of tens of millions of dollars. Thus, there is a nexus between the use of the ELIGARD
`
`mark and Opposer’s violation of the Act and Opposer’s non-compliance with the patent laws of
`
`3
`
`

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`the United States was material and of such gravity and significance to the use of the ELIGARD
`
`mark that it could neither create nor maintain valid trademark rights. Upon information and
`
`belief, the Section 8& 15 Declaration by Opposer declaring that the ELIGARD mark “has been
`
`in continuous use in commerce for five consecutive years after the date of registration” was
`
`material, knowingly and intentionally false and was submitted with intent to deceive the U.S.
`
`Patent & Trademark Office because shortly before the submission of the Declaration the Court
`
`found that all ELIGARD products were made and sold in violation of the patent laws of the
`
`United States and, thus, in failing to disclose the fact that Opposer’s “continuous use in
`
`commerce for five years after the date of registration” was not continuous lawful use sufficient to
`
`support the Section 8 & 15 Declaration, the USPTO was, in fact, deceived into maintaining a
`
`registration to which Opposer was not entitled.
`
`THIRD AFFIRMATIVE DEFENSE
`
`Opposer’s application and resulting U.S. Reg. No. 2,645,629 are void and unlawful for
`
`Opposer’s fraudulent declaration of a bona fide intention to use the ELIGARD mark in
`
`connection with “drug delivery systems for the treatment of cancer comprised of chemicals to
`
`facilitate the internal delivery of pharmaceuticals in the body.” Opposer’s ELIGARD product is
`
`leuprolide acetate for injectable suspension. Section 44(e) of the Trademark Act requires all
`
`applicants to submit a declaration affirming a bona fide intent to use the mark in the U.S.
`
`Opposer is the owner of the ARTIGEL drug delivery system that was first used in the United
`
`States by Opposer’s predecessor in interest in March 1992. Upon information and belief,
`
`including an online investigation into Opposer’s past use and advertisement of the ELIGARD
`
`product, Opposer and Opposer’s predecessors in interest have only ever marketed and used in the
`
`United States the ARTIGEL delivery system to ensure the controlled release of ELIGARD
`
`4
`
`

`

`product in the body over time and did not ever market and use ELIGARD as a trademark for a
`
`drug delivery system to ensure the controlled release of ELIGARD leuprolide acetate for
`
`injectable suspension or any other drug. Accordingly, upon information and belief, Opposer’s
`
`declaration of bona fide intent to use the ELIGARD mark in connection with “drug delivery
`
`systems for the treatment of cancer comprised of chemicals to facilitate the internal delivery of
`
`pharmaceuticals in the body” was material, knowingly and intentionally false and was submitted
`
`with intent to deceive the U.S. Patent & Trademark Office and, in fact, did deceive the USPTO
`
`into granting a registration to which Opposer was not entitled.
`
`FOURTH AFFIRMATIVE DEFENSE
`
`There is no likelihood of confusion, mistake or deception between Opposer’s Mark and
`
`Applicant’s Mark.
`
`FIFTH AFFIRMATIVE DEFENSE
`
`Opposer is barred from the relief sought under the equitable doctrine of unclean hands,
`
`including unclean hands in the form of the above-plead unlawful use in commerce.
`
`SIXTH AFFIRMATIVE DEFENSE
`
`Applicant’s actions at all times were reasonable, justified, and undertaken in good faith,
`
`and Applicant did not directly or indirectly undertake or fail to undertake any action in violation
`
`of law.
`
`ADDITIONAL DEFENSES
`
`Applicant reserves the right to rely on any statutory defenses of the Lanham Act to the
`
`extent such defenses are supported by information developed through discovery or by evidence
`
`at a hearing before the Trademark Trial and Appeal Board. Applicant also gives notice that it
`
`5
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`

`

`intends to assert additional defenses based on information learned or obtained during discovery
`
`in this action and reserves the right to amend its Answer to assert any such defenses.
`
`
`
`WHEREFORE, Applicant Minnesota Resuscitation Solutions LLC prays that the Notice
`
`be dismissed, that Opposer Tolmar Therapeutics, Inc. take nothing for this action, that
`
`Applicant’s Application mature to registration, and for such other and further relief as may be
`
`just and proper.
`
`COUNTERCLAIMS
`
`Applicant-Counterclaimant Minnesota Resuscitation Solutions LLC (“Applicant”), a
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`Minnesota limited liability company with a principal place of business at 5201 Eden Avenue,
`
`Suite 300, Edina, Minnesota 55436, believes it will be damaged by the continued registration for
`
`the trademark ELIGARD in U.S. Reg. No. 2,645,629 registered on November 5, 2002 and thus
`
`for its counterclaims against Opposer-Counterclaim Defendant Tolmar Therapeutics, Inc.
`
`petitions to cancel same. As grounds for its counterclaims, Applicant alleges as follows:
`
`COUNT I
`Cancellation Based on Fraud/Unlawful Use in Commerce – Violation of Patent Act
`
`Opposer-Counterclaim Defendant Tolmar Therapeutics Inc.’s predecessor-in-
`
`1.
`
`interest, Sanofi-Synthelabo, commenced use of the ELIGARD mark in the United States in 2002
`
`and the mark was registered on November 5, 2002 (Tolmar Therapeutics, Inc. and its
`
`predecessors-in-interest are collectively referred to in this Count I as “Opposer”).
`
`2.
`
`Opposer’s ELIGARD product is a gonadotropin releasing hormone (GnRH)
`
`agonist indicated for the palliative treatment of advanced prostate cancer.
`
`3.
`
`4.
`
`Opposer’s ELIGARD product is leuprolide acetate for injectable suspension.
`
`The only product Opposer has ever sold in the United States being leuprolide
`
`acetate for injectable suspension is the ELIGARD-branded product.
`
`6
`
`

`

`5.
`
`In order to establish trademark rights in the ELIGARD mark sufficient to obtain
`
`U.S. Reg. No. 2,645,629, Opposer’s use of the mark must be lawful use in commerce. See 15
`
`U.S.C. § 1051(a)(3)(C); 37 C.F.R. § 2.69; T.M.E.P § 907 (“Use of a mark in commerce must be
`
`lawful use to be the basis for federal registration of the mark.”).
`
`6.
`
`The patent laws of the United States provide, among other things, that “whoever
`
`without authority makes, uses, offers to sell, or sells any patented invention, within the United
`
`States or imports into the United States any patented invention during the term of the patent
`
`therefor, infringes the patent.” See Exhibit 1, 35 U.S.C. § 271(a).
`
`7.
`
`Arising out of a patent infringement complaint filed on November 3, 2003 by a
`
`third-party competitor against Opposer’s ELIGARD products, the United States District Court
`
`for the Northern District of Illinois, a court of competent jurisdiction under the Patent Act (the
`
`“Court”), made a final determination that Opposer “conceded infringement,” that all sales of
`
`Opposer’s ELIGARD products infringed the valid patent rights of the third-party competitor and,
`
`thus, all such sales of the product from its first sale in 2002 were unlawful (the “Case”). See
`
`Exhibit 2, and at p. 5 (“[Eligard] products were all made in violation of the law, which prohibits
`
`making an infringing product”) (emphasis added).
`
`8.
`
`Facing permanent injunction, Opposer was part of a motion to the Court seeking
`
`to ensure continued patient access to the Eligard Prostate Cancer Treatments, which motion was
`
`denied. See Exhibits 2-3.
`
`9.
`
`Instead, on February 27, 2006, the Court issued an injunction in the Case
`
`permanently enjoining Opposer from, among other things (i) “[a]ny further manufacture, use,
`
`sale, or offer for sale of defendants’ Eligard products”; and (ii) “[a]ny further promotion of
`
`defendant’s Eligard products, by any means, including without limitation through defendant’s
`
`7
`
`

`

`websites, through continuing medical education, through defendants’ sales force, through
`
`advertising, or through sales literature.” See Exhibit 4 at p. 2.
`
`10.
`
`The permanent injunction also required Opposer to (i) “recall any Eligard product
`
`that they still own, whether or not these products are still in defendants’ possession;” and (ii)
`
`“provide a voluntary recall program from physicians, wholesalers, and distributors who may
`
`wish to return their Eligard products for a full refund.” Id.
`
`11.
`
`Subsequent to the issuance of the permanent injunction by the Court, Opposer
`
`was part of a settlement that paid the plaintiffs an aggregate $157.5 million to resolve the Case.
`
`See Exhibit 5 at p. 35.
`
`12.
`
`Accordingly, Opposer’s violation of the Patent Act was material and significant
`
`and there is a nexus between the use of the ELIGARD mark, the only leuprolide acetate for
`
`injectable suspension product Opposer has sold in the United States, and Opposer’s violation of
`
`the Patent Act. Therefore, Opposer’s non-compliance with the patent laws of the United States
`
`was of such gravity and significance to the use of the ELIGARD mark that it could create no
`
`valid trademark rights.
`
`13.
`
`The unlawful use of the ELIGARD mark included at least the period 2002 to
`
`2006.
`
`14.
`
`Nevertheless, on August 8, 2008, Opposer submitted a Section 8 & 15
`
`Declaration declaring that the ELIGARD mark “has been in continuous use in commerce for five
`
`consecutive years after the date of registration.”
`
`15.
`
`Upon information and belief, the declaration by Opposer that the ELIGARD mark
`
`“has been in continuous use in commerce for five consecutive years after the date of registration”
`
`was material, knowingly and intentionally false and was submitted with intent to deceive the
`
`8
`
`

`

`U.S. Patent & Trademark Office because shortly before the submission of the Section 8 & 15
`
`Declaration the Court found that all ELIGARD products were made and sold in violation of the
`
`patent laws of the United States and, thus, in failing to disclose the fact that Opposer’s
`
`“continuous use in commerce for five years after the date of registration” was not continuous
`
`lawful use sufficient to support the Section 8 & 15 Declaration, the USPTO was, in fact,
`
`deceived into maintaining a registration to which Opposer was not entitled.
`
`COUNT II
`Cancellation Based on Fraud/Lack of Bona Fide Intent to Use
`
`Opposer’s U.S. Reg. No. 2,645,629 for ELIGARD was registered in the name of
`
`16.
`
`Tolmar Therapeutics Inc.’s predecessor-in-interest, Sanofi-Synthelabo, pursuant to Section 44(e)
`
`of the Trademark Act (15 U.S.C. § 1126(e)) for use in connection with, among other things,
`
`“drug delivery systems for the treatment of cancer comprised of chemicals to facilitate the
`
`internal delivery of pharmaceuticals in the body” in International Class 5. (Tolmar Therapeutics,
`
`Inc. and its predecessors-in-interest are collectively referred to in this Count IV as “Opposer”).
`
`17.
`
`18.
`
`Opposer’s ELIGARD product is leuprolide acetate for injectable suspension.
`
`Section 44(e) of the Trademark Act requires all applicants to submit a declaration
`
`affirming a bona fide intent to use the mark in the United States for the goods and/or services
`
`listed in the application. See 15 U.S.C. § 1126(e) (“The application must state the applicant’s
`
`bona fide intention to use the mark in commerce, but use in commerce shall not be required prior
`
`to registration.”).
`
`19.
`
`Opposer submitted the required declaration of a bona fide intent to use together
`
`with its application filed on October 30, 2001.
`
`20.
`
`Opposer is the owner of the ARTIGEL drug delivery system that was first used in
`
`the United States in March 1992.
`
`9
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`

`

`21.
`
`Opposer registered the ARTIGEL mark in the United States on August 15, 1995
`
`(U.S. Reg. No. 1912166).
`
`22.
`
`The ARTIGEL drug delivery system is used in conjunction with the ELIGARD
`
`product to ensure the controlled release of the ELIGARD product in the body over time.
`
`23.
`
`Upon information and belief, including an online investigation of Opposer’s past
`
`use and advertising of the ELIGARD product, Opposer has only ever marketed and used in the
`
`United States the ARTIGEL delivery system to ensure the controlled release of the ELIGARD
`
`product in the body over time and did not ever market and use ELIGARD as a trademark for a
`
`drug delivery system to ensure the controlled release of ELIGARD leuprolide acetate for
`
`injectable suspension or any other drug.
`
`24.
`
`Upon information and belief, Opposer never marketed and used in the United
`
`States the ELIGARD mark in connection with “drug delivery systems for the treatment of cancer
`
`comprised of chemicals to facilitate the internal delivery of pharmaceuticals in the body.”
`
`25.
`
`Upon information and belief, Opposer never had a bona fide intent to use in the
`
`United States the ELIGARD mark in connection with “drug delivery systems for the treatment of
`
`cancer comprised of chemicals to facilitate the internal delivery of pharmaceuticals in the body.”
`
`26.
`
`Upon information and belief, Opposer’s declaration of bona fide intent to use the
`
`ELIGARD mark in connection with “drug delivery systems for the treatment of cancer
`
`comprised of chemicals to facilitate the internal delivery of pharmaceuticals in the body” was
`
`material, knowingly and intentionally false and was submitted with intent to deceive the U.S.
`
`Patent & Trademark Office into obtaining a registration to which it was not entitled.
`
`
`
`
`
`10
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`

`

`COUNT III
`Partial Cancellation – Restriction of Opposer’s Asserted Registration
`(Plead in the Alternative)
`
`Applicant is the owner of U.S. Application Serial No. 88/048,084 for the mark
`
`27.
`
`ELEGARD for use in connection with a “medical device, namely, a patient placement system
`
`comprising a base with circumferential handles, lower back and thoracic plates, adjustable head
`
`and neck support, control panel, back plate holder, back plate release knob, battery and carrying
`
`case, for administering cardiopulmonary resuscitation” in International Class 10 (“Applicant’s
`
`Mark”).
`
`28.
`
`Opposer is the owner of U.S. Reg. No. 2,645,629 for the mark ELIGARD for
`
`“pharmaceutical preparations for the treatment of cancer” in International Class 5 (“Opposer’s
`
`Mark”).
`
`29.
`
`Opposer uses, and has used, the ELIGARD mark only in connection with a
`
`gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of
`
`advanced prostate cancer.
`
`30.
`
`31.
`
`32.
`
`Opposer’s ELIGARD product is used in the field of urology.
`
`Opposer’s ELIGARD product is available only by prescription.
`
`There are four (4) dosing options for the ELIGARD product: 1-Month (12
`
`injections per year); 3-month (4 injections per year); 4-month (3 injections per year); and 6-
`
`month (2 injections per year).
`
`33.
`
`34.
`
`Opposer’s EIGARD product must be refrigerated.
`
`Opposer’s ELIGARD product uses a special delivery system Opposer calls the
`
`ATRIGEL delivery system to ensure the controlled release of the ELIGARD product in the body
`
`over time.
`
`11
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`

`

`35.
`
`Opposer’s ELIGARD product must be brought to room temperature and then
`
`mixed with the ATRIGEL delivery system by trained medical professionals prior to
`
`administration to a patient within thirty (30) minutes of mixing.
`
`36.
`
`Opposer’s ELIGARD product is administered through subcutaneous injection
`
`(shot) by trained medical professionals.
`
`37.
`
`Opposer does not use the ELIGARD mark or any formative thereof for use in
`
`connection with any goods other than a gonadotropin releasing hormone (GnRH) agonist
`
`indicated for the palliative treatment of advanced prostate cancer.
`
`38.
`
`Opposer does not currently and has never used the mark ELIGARD in connection
`
`with a “medical device, namely, a patient placement system comprising a base with
`
`circumferential handles, lower back and thoracic plates, adjustable head and neck support,
`
`control panel, back plate holder, back plate release knob, battery and carrying case, for
`
`administering cardiopulmonary resuscitation.”
`
`39.
`
`Opposer does not currently and has never used the mark ELIGARD in connection
`
`with medical devices of any kind.
`
`40.
`
`Opposer has asserted U.S. Reg. No. 2,645,629 in support of its claim of likelihood
`
`of confusion with respect to Applicant’s pending Application Serial No. 88/048,084.
`
`41.
`
`Applicant contends there is no likelihood of confusion between Applicant’s Mark
`
`and Opposer’s Mark as described in Opposer asserted U.S. Reg. No. 2,645,629.
`
`42.
`
`The Trademark Trial and Appeal Board has the authority to cancel registrations in
`
`whole or in part, to restrict the goods or services identified in an application or registration, or to
`
`otherwise restrict or rectify the registration of a registered mark. See 15 U.S.C. § 1068.
`
`12
`
`

`

`43.
`
`In the alternative, however, should it be determined that Opposer’s asserted U.S.
`
`Reg. No. 2,645,629 should not be cancelled in its entirety, and should it be determined that there
`
`is a likelihood of confusion based on Opposer’s ELIGARD registration for “pharmaceutical
`
`preparations for the treatment of cancer,” such likelihood of confusion will be avoided by a
`
`restriction of the goods claimed in U.S. Reg. No. 2,645,629 to conform to Opposer’s actual use
`
`in commerce: “pharmaceutical preparations for the treatment of cancer, namely, refrigerated
`
`prescription hormone therapy for the palliative treatment of advanced prostate cancer
`
`administered through multiple subcutaneous injections over the course of one year by trained
`
`medical professionals in the field of urology.”
`
`WHEREFORE, Applicant-Counterclaimant Minnesota Resuscitation Solutions LLC
`
`prays that Opposer-Counterclaim Defendant Tolmar Therapeutics, Inc.’s U.S. Reg. No.
`
`2,645,629 be cancelled in its entirety or, in the alternative, in part so as to correctly reflect
`
`Opposer’s use, together with such other and further relief as the Board may find appropriate and
`
`just.
`
`Please charge the fee for these Counterclaims in the amount of $400, and any other
`
`appropriate fee, to Deposit Account No. 20-1430, and direct correspondence to the undersigned.
`
`Dated: December 2, 2019.
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`Respectfully submitted,
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`/s/ Brian P. O’Donnell
`Brian P. O’Donnell
`KILPATRICK STOCKTON LLP
`1400 Wewatta Street, Suite 600
`Denver, Colorado 80202
`(303) 571-4000
`bodonnell@kilpatricktownsend.com
`DenverTEAS@kilpatricktownsend.com
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`Attorneys for Applicant-Counterclaimant
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`CERTIFICATE OF SERVICE
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`I hereby certify that I have caused a true and correct copy of the foregoing ANSWER,
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`AFFIRMATIVE DEFENSES AND COUNTERCLAIMS to be served, via first class mail,
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`postage prepaid, and electronic mail on this 2nd day of December 2019, to Opposer as follows:
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`Tolmar Therapeutics, Inc.
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`701 Centre Avenue
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`Fort Collins, CO 80526
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` Miriam D. Trudell
`Sheridan Ross P.C.
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`1560 Broadway, Suite 1200
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`Denver, CO 80202
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`mtrudell@sheridanross.com
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`s/Brian P. O’Donnell__________________
`Brian P. O’Donnell
`Kilpatrick Townsend & Stockton LLP
`1400 Wewatta Street, Suite 600
`Denver, CO 80202
`bodonnell@kilpatricktownsend.com
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`12/1/2019
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`[USCOZ] 35 USC 271: Infringement of patent
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`II Result 122 of 198
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`II Current
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`V
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`II
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`<< Previous TITLE 35 / PART III / CHAPTER 28 / § 271 Next >>
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`[lint] [W]
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`“Viewing keyword hit 0 of 7 u
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`[C'LS‘B] MR
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`— : Infringement of patent
`Text contains those laws in effect on November 30, 2019
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`From Title l-PATENTS
`PART Ill-PATENTS AND PROTECTION OF PATENT RIGHTS
`CHAPTER 28-INFRINGEMENT OF PATENTS
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`Jump To:
`Source Credit
`References In Text
`Amendments
`Effective Date
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`§-. Infringement of patent
`(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells
`any patented invention, within the United States or imports into the United States any patented invention
`during the term of the patent therefor, infringes the patent.
`(b) Whoever actively induces infringement of a patent shall be liable as an infringer.
`(c) Whoever offers to sell or sells within the United States or imports into the United States a component of
`a patented machine, manufacture, combination or composition, or a material or apparatus for use in
`practicing a patented process, constituting a material part of the invention, knowing the same to be especially
`made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of
`commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.
`(d) No patent owner othenNise entitled to relief for infringement or contributory infringement of a patent shall
`be denied relief or deemed guilty of misuse or illegal extension of the patent right by reason of his having
`done one or more of the following: (1) derived revenue from acts which if performed by another without his
`consent would constitute contributory infringement of the patent; (2) licensed or authorized another to perform
`acts which if performed without his consent would constitute contributory infringement of the patent; (3)
`sought to enforce his patent rights against infringement or contributory infringement; (4) refused to license or
`use any rights to the patent; or (5) conditioned the license of any rights to the patent or the sale of the
`patented product on the acquisition of a license to rights in another patent or purchase of a separate product,
`unless, in view of the circumstances, the patent owner has market power in the relevant market for the patent
`or patented product on which the license or sale is conditioned.
`(e)(1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or
`import into the United States a patented invention (other than a new animal drug or veterinary biological
`product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913)
`which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other
`processes involving site specific genetic manipulation techniques) 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 or veterinary biological products.
`(2) It shall be an act of infringement to submit-
`(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in
`section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent,
`(B) an application under section 512 of such Act or under the Act of March 4, 1913 (21 U.S.C. 151—158)
`for a drug or veterinary biological product which is not primarily manufactured using recombinant DNA,
`recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation
`techniques and which is claimed in a patent or the use of which is claimed in a patent, or
`(C)(i) with respect to a patent that is identified in the list of patents described in section 351 (l)(3) of the
`Public Health Service Act (including as provided under section 351(l)(7) of such Act), an application
`seeking approval of a biological product, or
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`https://uscode.house.gov/view.xhtml?req=35+usc+271&f=treesort&fq=true&num=121&hl=true&edition=prelim&granuleld=USC-prelim-title35—section271
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`1/1
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`Case: 1:03-cv-07822 Document #: 353 Filed: 02/27/06 Page 1 of 6 PageID #:4414
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF ILLINOIS
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`EASTERN DIVISION
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`TAP PHARMACEUTICAL PRODUCTS,
`INC., TAKEDA CHEMICAL
`INDUSTRIES, LTD. and WAKO PURE
`CHEMICAL INDUSTRIES, LTD.,
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`Plaintiffs,
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`v.
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`ATRIX LABORATORIES, INC. and
`SANOFI-SYNTHELABO, INC.,
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`Defendants.
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`No. 03 C 7822
`Judge James B. Zagel
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`MEMORANDUM OPINION AND ORDER
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`Most of this patent battle is over. After patent construction, Defendants conceded
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`infringement. The issue of whether the claims were invalid as obvious or anticipated was tried to
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`a jury and lost. The dispute over whether the patent applicants had perpetrated inequitable
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`conduct in the prosecution of the patent was tried before me and lost. What remains to be
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`decided is the issue of damages (an issue bifurcated for later trial) and injunctive relief. It is this
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`last matter I decide now.
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`This patent is aged, expiring on May 1 of this year. Plaintiffs want the injunction because
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`they want to stop Defendants’ marketing of Eligard, a drug delivery device that competes with
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`Lupron Depot, Plaintiffs’ product. Both products offer sustained release of the same drug –
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`leuprolide acetate, an LHRH agonist – used in the treatment of advanced prostate cancer. There
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`is little to show here that either product is clinically superior to the other in ordinary usage. The
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`dispute centers over whether Eligard ought to be left on the market for the benefits it offers a
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`1
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`Case: 1:03-cv-07822 Document #: 353 Filed: 02/27/06 Page 2 of 6 PageID #:4414
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`certain group of patients.
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` The patent holder is entitled, absent exceptional circumstances, to keep others from
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`practicing its invention. Richardson v. Suzuki Motor Co., 868 F.2d 1226 (Fed. Cir. 1989);
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`MercExchange, LLC v. eBay, Inc., 401 F.3d 1323 (Fed. Cir. 2005), cert. granted, 126 S.Ct. 733
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`(2005). Plaintiffs’ rationale for pursuing the injunction is that Defendants have been marketing
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`an infringing product for more than three years, appropriating someone else’s property and
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`benefitting from the delay in litigation during re-examination. Plaintiffs argue this ought to stop
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`now, even if only for a few weeks. The rationale is legally unnecessary: the patent holder has a
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`right to stop others from making and selling the invention for a good reason or for no reason.
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`Defendants do not dispute this principle. Rather, they argue that the Eligard product is better
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`than Lupron Depot in some ways and, to benefit those patients for whom it is better