Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA868150
`12/29/2017
`
`ESTTA Tracking number:
`
`Filing date:
`
`Proceeding
`
`Party
`
`Correspondence
`Address
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`91226322
`
`Plaintiff
`Lupin Pharmaceuticals, Inc.
`
`Diane B. Melnick
`Powley & Gibson P.C.
`304 HUDSON ST. SUITE 202
`NEW YORK, NY 10075
`UNITED STATES
`Email: thcurtin@powleygibson.com
`
`Submission
`
`Motion for Summary Judgment
`
`Yes, the Filer previously made its initial disclosures pursuant to Trademark Rule
`2.120(a); OR the motion for summary judgment is based on claim or issue pre-
`clusion, or lack of jurisdiction.
`
`The deadline for pretrial disclosures for the first testimony period as originally set
`or reset: 01/01/2018
`Suzanna M. M. Morales
`
`smmorales@powleygibson.com, thcurtin@powleygibson.com
`
`/suzanna m m morales/
`
`12/29/2017
`
`for public filing - binder_Part1.pdf(5569156 bytes )
`for public filing - binder_Part2.pdf(5725718 bytes )
`for public filing - binder_Part3.pdf(5530390 bytes )
`for public filing - binder_Part4.pdf(2855426 bytes )
`
`Filer's Name
`
`Filer's email
`
`Signature
`
`Date
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`Attachments
`
`

`

`IN THE U.S. PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
`-----------------------------------------------------x
`LUPIN PHARMACEUTICALS, INC.,
`
`
` Opposer,
`v.
`
`Opposition No. 91226322
`
`
`
`
`
`
`
`
`
`
`
`
`AMPEL, LLC,
`
`
`
`
`
`Applicant.
`------------------------------------------------------x
`
`
`
`
`MOTION FOR SUMMARY JUDGMENT BY OPPOSER
`LUPIN PHARMACEUTICALS, INC.
`
`I.
`
`PRELIMINARY STATEMENT
`
`
`
`
`
`The undisputed facts demonstrate that the educational and support group services covered by
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`Applicant’s application to register the mark LuPPiN are offered to the same or similar consumer groups,
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`in overlapping channels of trade, as Opposer’s full line of pharmaceutical products sold under Opposer’s
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`federally registered mark LUPIN. Taking the facts in the light most favorable to Applicant Ampel, LLC
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`(“Ampel” or “Applicant”), there is no genuine issue of material fact that a likelihood of confusion will
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`arise from the registration of Applicant’s LuPPiN mark. Accordingly, Opposer Lupin Pharmaceuticals,
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`Inc. (“Lupin” or “Opposer”) is entitled to summary judgment pursuant to Fed. R. Civ. P. 56 refusing
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`registration of Application Serial No. 86/509,184 under Section 2(d) of the Lanham Act.
`
`II.
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`STATEMENT OF FACTS
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`Opposer’s Well-Known LUPIN Brand
`
`1.
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`Origins of Opposer’s LUPIN Mark and Entry into the U.S. Market
`
`A.
`
`
`
`
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`In 1968, long prior to the actions of the Applicant set forth herein, the predecessor-in-interest of
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`Opposer’s ultimate parent company, Lupin Limited, began doing business in India under the name and
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`mark LUPIN. See the Affidavit of Dave Berthold (“Berthold Aff.”) at ¶ 3. The mark LUPIN finds its
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`origin from the lupin flower. Id. at ¶ 4. A true and correct copy of a dictionary definition of “lupin” is
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`
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`1
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`

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`attached as Exhibit A to the Declaration of Thomas H. Curtin (“Curtin Decl.”). Opposer’s mark is
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`pronounced “LOO-pin.” Id.; Berthold Aff. at ¶ 3.
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`In the 1980s and 1990s, the predecessors-in-interest of Lupin Limited received approval from the
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`United States Food and Drug Administration (“FDA”) to allow various manufacturing facilities located
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`in India to manufacture pharmaceutical products intended for distribution and sale to U.S. consumers.
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`Berthold Aff. at ¶ 5. In the early 2000s, Lupin Limited filed its first of many Abbreviated New Drug
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`Applications (“ANDA”) with the FDA. Id. at ¶ 6.1
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`On March 28, 2002, Lupin Limited filed an ANDA for the drug ceftriaxone for injection, which
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`was approved by the FDA on September 30, 2003. Id. at ¶ 7. In 2003, Lupin Pharmaceuticals, Inc. was
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`incorporated in the U.S. and began doing business at its headquarters in Baltimore. Id. at ¶ 11.
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`Ceftriaxone for injection eventually became the first drug marketed under the LUPIN trademark in the
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`United States, beginning in July 2005. Id. at ¶ 7-9. Since 2005, Lupin’s pharmaceutical products bearing
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`the LUPIN mark have been distributed, offered for sale, and sold continuously throughout the United
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`States. Id. at ¶ 10.
`
`2.
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`Opposer’s Valid Federal Registrations for the Mark LUPIN
`
`
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`Opposer is the owner of the following United States Trademark Registrations on the Principal
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`Register of the USPTO:
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`Reg. No. 4,024,405 for the mark LUPIN, filed on June 24, 2009 and issued on September 13,
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`2011 covering a “house mark for full line of pharmaceuticals for medical purposes, but excluding dietary
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`supplements and edible flour” in Class 5, claiming a date of first use in United States commerce of July
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`1, 2005.
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`Reg. No. 4,874,579 for
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`, filed on June 24, 2009 and issued on December 22, 2015
`
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`1 ANDAs are applications for approval by the FDA of a generic version of an existing, FDA-approved drug. Id.
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`
`
`2
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`

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`covering:
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`Pharmaceutical preparations for the treatment of infectious and parasitic diseases;
`antibiotics; pharmaceutical preparations for the treatment of diseases and disorders of
`the endocrine and metabolic systems; pharmaceutical preparations for the treatment
`of mental and behavioral conditions and disorders; antidepressants; pharmaceutical
`preparations for the treatment of diseases and disorders of the nervous system;
`pharmaceutical preparations for the treatment of diseases and disorders of the eye and
`adnexa; pharmaceutical preparations for the treatment of diseases and disorders of the
`ear and mastoid process; pharmaceutical preparations for the treatment of diseases
`and disorders of
`the circulatory system; antihypertensives; pharmaceutical
`preparations for the treatment of diseases and disorders of the respiratory system;
`pharmaceutical preparations for the treatment of diseases and disorders of the
`digestive system; pharmaceutical preparations for the treatment of diseases and
`disorders of the skin and subcutaneous tissue; pharmaceutical preparations for the
`treatment of diseases and disorders of the musculoskeletal system and connective
`tissue; pharmaceutical preparations for the treatment of diseases and conditions of the
`genitourinary system; and pharmaceutical preparations for the treatment of diseases
`and disorders associated with pregnancy, childbirth and the peurperium, namely,
`contraceptives; oral contraceptives; oral hormonal contraceptives; contraceptive
`preparations and substances; hormone replacement therapies; hormonal agents for
`treating disorders and conditions related to women’s health, namely, symptoms and
`conditions associated with menopause, pre-menstruation syndrome and other
`symptoms and conditions associated with menstruation
`
`
`in Class 5, claiming a date of first use in United States commerce in 2005.
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`Opposer’s registered trademarks are referred to herein collectively as “the LUPIN Mark.” Both
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`of the foregoing registrations are valid and subsisting and are in full force and effect, and have been
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`pleaded in this matter. Reg. No. 4,024,405 has become incontestable by operation of law. 15 U.S.C. §
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`1065. True and correct copies of the foregoing certificates of registration and corresponding TSDR
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`current status printouts are attached as Exhibits B and C, respectively, to the Curtin Decl.
`
`3.
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`Opposer’s Sale of a Wide Variety of Pharmaceutical Products
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`
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`Today, Opposer manufactures, offers for sale, and sells more than 150 types of pharmaceutical
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`products for a wide range of indications including, for the treatment of fever; headache; fatigue;
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`confusion; chest pain; stiffness; shortness of breath; joint or muscle pain; anemia; swelling in the legs,
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`ankles, and feet; joint swelling; and rash, among others. Berthold Aff. at ¶¶ 12, 16. Lupin’s products
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`include both branded and generic pharmaceuticals. Id. at ¶ 13. Opposer conducts clinical trials in
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`
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`3
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`

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`conjunction with the development of its drug products. Id. at ¶ 17. Opposer is continually expanding its
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`pharmaceutical product offerings into new therapeutic areas, such as cardiology, diabetes, women’s
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`health, and gastroenterology, among others. Id. at ¶ 18; see also Curtin Decl., Ex. Q at LUP-002911.
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`Both Opposer’s branded and generic products are sold in packaging bearing the LUPIN mark.
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`Berthold Aff. at ¶ 14. Some of Opposer’s products also bear the LUPIN mark imprinted directly on the
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`drug capsule. Id. at ¶ 15. Among the primary consumers of Opposer’s products are women of
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`childbearing age. Id. at ¶ 19.
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`Opposer sells its products through wholesalers including AmeriSource Bergen, Cardinal, and
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`McKesson, which are the three largest pharmaceutical wholesalers in the United States. Id. at ¶ 20. These
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`wholesalers, in turn, distribute Opposer’s LUPIN products to independent pharmacies and pharmacy
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`chains, which distribute the products to the end consumer through an extensive network of retail
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`outlets. Id. Examples of retail outlets where Opposer’s LUPIN products are available to consumers are
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`major retail chains such as CVS, Walgreens, and WalMart, as well as grocery store chains such as Giant,
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`Harris Teeter, Publix, and Kroger. Id. at ¶ 21. Opposer’s pharmaceuticals are also widely prescribed at
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`hospitals throughout the United States. Id. at ¶ 22. In addition, Lupin’s pharmaceutical products are
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`offered and sold to various federal government agencies and programs including, without limitation, the
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`Department of Veterans Affairs (particularly VA Hospitals), federal prisons, and through the Medicare
`
`and Medicaid programs. Id. at ¶ 23.
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`Lupin also has thousands of agreements,
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` with pharmaceutical and biopharmaceutical companies
`
`
`
`
`
` Id. at ¶ 29.
`
`4.
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`Opposer’s Extensive Promotion and Advertising of the LUPIN Mark
`
`Since entering the United States market, Opposer has engaged in extensive and widespread
`
`4
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`
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`
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`

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`marketing, promotional, and advertising efforts featuring the LUPIN Mark. Opposer has spent more than
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` on those promotional efforts in the past ten years alone. See the Affidavit of Jay Liska
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`(“Liska Aff.”) at ¶¶ 3-4.
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`Opposer advertises its products under the LUPIN Mark through various media including:
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`Opposer’s website at lupinpharmaceuticals.com; internet banner ads; internet pop-up ads; infomercials
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`on television networks including Lifetime and Oxygen; and advertisements in medical journals and
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`pharmaceutical trade journals, pharmaceutical bulletins, and specialty consumer medical publications. Id.
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`at ¶ 5. Examples of the wide range of publications in which Opposer advertises its LUPIN products
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`include Infectious Disease in Children; Clinical Psychiatry Today; Pharmacy Times; Chain Drug
`
`Review; Contemporary OB/GYN; American Academy of Pediatrics Newsletter; ADDitude Magazine;
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`Asthma & Allergy Today; Ready Set Grow; and Drug Topics, as well as the online outlets of certain of
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`these publications and other online sources. Id. at ¶ 6 and Ex. A. Some of these publications are available
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`to consumers in doctors’ offices as well as directly to subscribers. Id. To the extent it is able to do so
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`under the laws and codes of conduct governing the marketing activities of pharmaceutical
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`companies, Lupin distributes a variety of collateral merchandise that features and promotes the
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`LUPIN Mark, including such goods as mugs, reusable grocery bags, car air fresheners, memo pads,
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`and pens. Id. at ¶ 9 and Ex. B.
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`Opposer underwrites and sponsors pharmaceutical and medical seminars, such as regional and
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`national meetings of the Society of Maternal Fetal Medicine; American College of Obstetrics &
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`Gynecology; Association of Women’s Health, Obstetric and Neonatal Nurses; Society of Obstetrics
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`& Gynecological Hospitalists; Maryland Society of Health System Pharmacists; and New Jersey
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`Obstetrical & Gynecological Society. Id. at ¶ 7. Lupin also provides financial support to educational
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`initiatives,
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`
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`
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`5
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`

`

`
`
`
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` Id. at ¶ 8.
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`Opposer has engaged several advertising agencies and hundreds of vendors in conjunction with the
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`promotion, advertising, and marketing of Opposer’s pharmaceutical products under the LUPIN Mark. Id.
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`at ¶ 10.
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`
`
`5.
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`The Resulting Success of the LUPIN Brand
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`Opposer’s efforts to promote and grow the LUPIN Mark have been extraordinarily successful.
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`Since its introduction into the U.S. market, Opposer’s business has grown tremendously in both the
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`branded and generic segments. In fiscal year 2017, with a 5.3% market share by prescriptions, Opposer
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`was the fourth largest generic company in the United States. Berthold Aff. at ¶ 27; see also Curtin Decl.,
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`Ex. Q at LUP-002933, LUP-002935 and LUP-002941. In fiscal year 2012, the year before Applicant was
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`founded, Opposer recorded U.S. revenues in excess of $500 million. Id. at ¶ 28. By fiscal year 2017,
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`Opposer’s revenues had nearly doubled, surpassing the $1 billion mark in the United States. Id. As a
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`result of its remarkable growth, Opposer have often been the subject of favorable press. Curtin Decl., Ex.
`
`Q.
`
`
`
`B.
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`Applicant’s Claimed Mark LuPPiN
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`On January 21, 2015, Ampel filed an application to register the mark LuPPiN on the Principal
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`Register under Section 1(a) of the Trademark Act, 15 U.S.C. § 1051(a). The application claims that the
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`mark is in special form, and the description of the mark states, inter alia, that “[t]he word ‘LuPPiN’ has
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`capitalized letters ‘L’, ‘P’, ‘P’, and ‘N’.”
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`On June 29, 2015, in response to an Office action issued by the assigned Examining Attorney,
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`Applicant amended the application’s recitation of services to the following:
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`Organizing and conducting support groups for Lupus patients who are undergoing
`treatment and clinical trials, and for the caregivers of Lupus patients who are
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`
`
`6
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`

`

`undergoing treatment and clinical trials, in Class 45, and
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`Education services, namely, providing seminars and one-on-one mentoring in the
`fields of Lupus, Lupus treatment options and the importance of clinical trials; training
`Lupus patients to teach other Lupus patients about the nature of Lupus, available
`treatments and the importance of clinical trials, in Class 41.
`
`Applicant also submitted the following Miscellaneous Statement:
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`LUPPIN has no meaning or significance in the industry in which the services are
`provided and is not a “term of art” within applicant’s industry. Further, LUPPIN is
`not the surname of any person known to the applicant and, to applicant’s knowledge,
`has no meaning in any foreign language.
`
`
`
`
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`Applicant claimed a date of first use anywhere and in the United States of at least as early as
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`November 17, 2014. Applicant has not asserted any counterclaim for cancellation of Opposer’s pleaded
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`registrations, nor has Applicant brought a concurrent use proceeding. Applicant has conceded that
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`Opposer used its LUPIN Mark prior to Applicant’s adoption and use of the mark LuPPiN. See Response
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`No. 1 of Ampel LLC’s Responses to Opposer’s First Requests for Admission attached as Ex. D to the
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`Curtin Decl. Applicant also has admitted that it has no basis to challenge Opposer’s claimed first use
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`date. Id. at Nos. 3, 4.
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`C.
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`Applicant’s Claimed “Use” of Its Mark
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`1.
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`Formation of Applicant Ampel, LLC
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`Applicant’s co-founders Dr. Amrie Grammer and Dr. Peter Lipsky formed the Applicant entity in
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`2013. See Deposition of Amrie Grammer (“Grammer Depo.”) at 35:3-6, attached as Ex. E to Curtin
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`Decl. Applicant’s business model consists of obtaining contracts with pharmaceutical companies, as well
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`as obtaining monetary support from voluntary organizations. See Fed. R. Civ. P. 30(b)(6) Deposition of
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`Ampel, by its designee, Peter Lipsky, M.D. (“30(b)(6) Depo.”) at 68:12-15, attached as Ex. F to Curtin
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`Decl. Approximately
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` of Applicant’s funding comes from pharmaceutical companies. Id. at 94:19-
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`95:7. Dr. Lipsky admitted that “[e]verything in our business is eventually supported by the
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`pharmaceutical industry.” See Individual Deposition of Peter Lipsky (“Lipsky Depo.”) at 75:16-22,
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`7
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`attached as Ex. G to Curtin Decl.
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`2.
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`“Patient Partner” Programs
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`While Dr. Lipsky was on the faculty of the University of Texas Southwestern Medical Center
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`about thirty years ago, Dr. Lipsky and a rheumatoid arthritis patient began a “patient partner” program.
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`Lipsky Depo. at 47:7-23, 68:16-23. According to Dr. Lipsky, the patient partner program paired
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`rheumatoid arthritis patients receiving treatment with fellow patients who had been screened and trained,
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`called “patient partners” or “patient educators.” Id. The patient partners would communicate with the
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`other patients about subjects related to the disease, including the value of clinical trials. Id.
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`Eventually, Lipsky partnered with Searle, a pharmaceutical company, which supported training
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`for patient partner programs elsewhere in the United States and around the world. Lipsky Depo. at 69:23-
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`70:4.
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`3.
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`Inception of the LuPPiN Program and Adoption of the Mark
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`One of Ampel’s chief goals is to offer and provide clinical trial services to pharmaceutical
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`companies and others. 30(b)(6) Depo. at 6:7-25. To that end, Applicant hopes to replicate the prior
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`success of Dr. Lipsky’s “patient partner” program in the field of rheumatoid arthritis by establishing a
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`similar network of and for Lupus patients. 30(b)(6) Depo. at 81:20-82:5. One of the services Applicant
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`intends to offer its clients is to train Lupus patients to teach other Lupus patients about clinical trials, and
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`allay some fears and misconceptions that may prevent patients from participating in clinical trials. Lipsky
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`Depo. at 47:24-48:17. Applicant’s services to be offered under its claimed LuPPiN mark are to be a
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`“critical aspect” of patient recruitment as part of Applicant’s services of planning and providing clinical
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`trials to its pharmaceutical company clients. Lipsky Depo. at 142:4-16; 38:18-39:12. Dr. Lipsky testified
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`“[w]hat we’re trying to do is convince the pharma sponsors that by engaging . . . the LuPPiN network it
`
`will facilitate enrollment in the [clinical] trial. That’s really the strategy.” 30(b)(6) Depo. at 87:7-14.
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`
`
`8
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`

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`In 2014, Applicant sought to develop a name for its planned patient educator program. Applicant
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`adopted LuPPiN, a coined acronym meaning Lupus Patient Partner Integrator Network. 30(b)(6) Depo.
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`at 13:17-14:2. Dr. Lipsky testified that the word, not the claimed stylization, “was the important
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`aspect.” Id. at 52:21-53:13. In any event, Applicant has not made extensive use of its claimed mark.
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`What limited use Applicant has made has been inconsistent. For example, Applicant used the mark with
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`the “I” capitalized in one presentation on November 17, 2014. See, e.g., id. at 35:24-36:7; Curtin Decl.,
`
`Ex. H2 In another presentation made on December 9, 2014, the two “P”s are in italics and the “I” is still
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`capitalized. See Curtin Decl., Ex. I.
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`Applicant’s LuPPiN mark is pronounced LOO-pin. 30(b)(6) Depo. at 97:24-98:6; Curtin Decl.,
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`Ex. D at No. 36. Applicant’s LuPPiN mark is identical to Opposer’s LUPIN Mark when spoken or
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`heard. Id. at No. 38; Lipsky Depo. at 163:19-25. Aside from the capitalization, the only difference
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`between the parties’ respective marks LUPIN and LuPPiN is the additional “p” in Applicant’s mark.
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`30(b)(6) Depo. at 98:7-12. That additional “p” is not pronounced, but is silent. Curtin Decl., Ex. D at No.
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`34, 35. Further, the capitalization does not affect the pronunciation of Applicant’s mark. Lipsky Depo. at
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`62:1-5.
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`4.
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`Claimed “First Use” of the LuPPiN Mark
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`On November 17, 2014, Dr. Lipsky conducted a presentation during the annual meeting of the
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`American College of Rheumatologists (“ACR”), discussing certain efforts Ampel was undertaking to
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`develop new treatments for Lupus. 30(b)(6) Depo. at 36:11-37:4; 41:13-15; Lipsky Depo. at 140:16-21;
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`Curtin Decl., Ex. H. Lipsky’s presentation, held at 6:30 in the morning, was attended by approximately
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`80 to 120 individuals, mostly rheumatologists as well as trainees and nurses. 30(b)(6) Depo. at 37:17-
`
`
`2 Applicant has admitted that all of the documents Bates labeled with the indication “APB” discussed herein are
`authentic and created and maintained by Applicant in the ordinary course of Applicant’s business. Curtin Decl., Ex.
`D at Nos. 72, 73.
`
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`9
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`

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`38:10, 66:10-17; Lipsky Depo. at 141:8-12. This presentation also marked the launch of Applicant’s
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`Lupus Clinical Investigators Network, or LuCIN, a network of approximately 59 clinical investigators at
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`academic medical centers in the United States and Canada. 30(b)(6) Depo. at 15:5-20. This network was
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`organized to conduct clinical trials for Lupus. Id. Applicant intends to establish its patient partner
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`network at these same facilities to aid in recruitment of Lupus patients for clinical trials. Id.
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`This presentation, on Applicant’s claimed first use date, was the first time Applicant displayed
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`the claimed LuPPiN mark, in any form, to the public. 30(b)(6) Depo. at 39:6-10. As noted earlier, rather
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`than the presentation of LuPPiN as covered by the application, the mark was displayed as LuPPIN, with
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`the “i” capitalized in the one and only PowerPoint slide that contained Applicant’s Mark. Curtin Decl.,
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`Ex. H.
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`Because the November 17, 2014 presentation was in the “early days” of Applicant’s programs,
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`the presentation contained “a lot of aspirational things.” 30(b)(6) Depo. at 39:6-21. No actual educational
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`services or support group services for Lupus patients were provided under Applicant’s Mark at the time
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`of the November 17, 2014 presentation, nor was Applicant prepared to provide such services at that
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`time. Id. at 40:7-41:1; 54:9-21; Curtin Decl., Ex. D at Nos. 7-13, 27-28. Applicant was not aware of any
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`Lupus patients in attendance. 30(b)(6) Depo. at 66:18-20.
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`Over four months later, on March 31, 2015, Applicant provided a presentation during a meeting
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`of the Maryland Biotech Forum. The Maryland Biotech Forum was hosted by the pharmaceutical
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`companies MedImmune and AstraZeneca and was sponsored by those and other companies and
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`organizations that are part of the biotech sector in Maryland, Virginia, and the Washington, D.C. area, in
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`the “so-called 270 corridor.” Lipsky Depo. at 18:8-22, 148:12-149:25. There were approximately 100 to
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`200 attendees in the biotech field, mostly scientists or individuals in administrative roles, as well as
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`attendees from pharmaceutical companies. 30(b)(6) Depo. at 67:13-18; Lipsky Depo. at 150:14-19.
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`
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`10
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`LuPPiN was referenced in a single slide of Dr. Lipsky’s PowerPoint presentation during this
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`March 2015 meeting. Lipsky Depo. at 150:25-151:6; Curtin Decl., Ex. J. No one began participating in
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`the LuPPiN program as a result of this presentation. Lipsky Depo. at 153:20-24.
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`Indeed, Applicant admits that it has never provided services under the LuPPiN mark, but merely
`
`has developed a draft training manual, which does not even feature the claimed LuPPiN mark. 30(b)(6)
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`Depo. at 59:14-60:10; 58:23-59:2, Depo. Ex. 10, attached as Ex. K to the Curtin Decl. Applicant admits
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`that it has not provided educational seminars, mentoring, training, or support groups under the LuPPiN
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`mark. 30(b)(6) Depo. at 95:11-24. In short, aside from Dr. Lipsky’s three PowerPoint slides at
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`professional or fundraising meetings, there has been no use or traditional advertising of the LuPPiN
`
`mark.
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`Since around the time the Notice of Opposition was filed in this matter, Applicant has largely
`
`stopped referring to its patient partner program by the mark LuPPiN. Dr. Lipsky testified that, if this
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`matter is resolved in Applicant’s favor, “[w]e would aggressively market the whole program under the
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`LuPPiN name. We would identify patients and then we would start to train them. And we would start to
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`provide that service to support clinical trials,” including clinical trials funded by pharmaceutical
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`companies. Id. at 79:17-80:3.
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`5.
`
`The Market for Applicant’s Services
`
`Certain services identified in the application relate specifically to Lupus patients and Lupus
`
`caregivers. For example, the application recites “organizing and conducting support groups for Lupus
`
`patients who are undergoing treatment and clinical trials.” Other services, such as “education services,
`
`namely, providing seminars and one-on-one mentoring in the fields of Lupus, Lupus treatment options
`
`and the importance of clinical trials,” do not specify a particular consumer group. Indeed, even where the
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`services are intended for Lupus patients, the ultimate beneficiaries of these services are the
`
`
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`11
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`pharmaceutical companies to whom Applicant offers its network of patients as participants in clinical
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`trials for the pharmaceutical companies’ drugs. 30(b)(6) Depo. at 87:7-14.
`
`
`
`
`
` Id. at 83:2-6.
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`
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`
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`Applicant’s active advertising and marketing efforts consist of its website; presentations to
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`rheumatology or biotech professionals; consultations with pharmaceutical companies; and networking
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`using Dr. Lipsky’s personal contacts in the pharmaceutical industry. 30(b)(6) Depo. at 61:9-14; 67:24-
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`68:11; Lipsky Depo. at 40:8-25, 154:1-11. However, as noted above, Applicant voluntarily ceased use of
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`the LuPPiN mark around February, 2015 and will not be using the mark until this opposition is resolved.
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`D.
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`Symptoms and Treatment of Lupus
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`1.
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`Common Signs and Symptoms of Lupus
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`Lupus is a chronic autoimmune disease. 30(b)(6) Depo. at 23:24-24:1; Curtin Decl., Ex. D at No.
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`49. Lupus affects different patients in different ways, and the symptoms can vary among patients and
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`even in the same patient over time. Curtin Decl., Ex. K at APB-00429. Symptoms of Lupus may include
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`extreme fatigue; headache; painful or swollen joints; fever; anemia; pleuritis (inflammation of the
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`membrane surrounding the lungs); rash on the face and other skin rashes; photosensitivity; hair loss;
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`abnormal blood clotting; Raynaud’s Phenomenon (constriction of the blood vessels that may cause
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`blanching in the fingers); arthritis; mouth and nose ulcers; kidney involvement; and central and
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`peripheral nervous system involvement such as confusion, stroke, seizures, psychosis, decreased
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`cognitive function, and peripheral neuropathy (inflammation of the nerves causing loss of motor
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`function, loss of sensation, or extreme painful sensation). 30(b)(6) Depo. at 72:3-75:4; Lipsky Depo. at
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`107:15-108:6; Curtin Decl., Ex L (Respondent’s Answers to Opposer’s Second Set of Interrogatories),
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`No. 1. Lupus can affect the musculoskeletal system, including through joint or muscle pain and arthritis.
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`30(b)(6) Depo. at 74:25-75:4; Curtin Decl., Ex. K at APB-00436; Curtin Decl., Ex. D, Nos. 64-66. It can
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`affect the cardiovascular system, the pulmonary system, and the nervous system, as well as skin and
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`eyes. Curtin Decl., Ex. K at APB-00429 and APB-00437 – APB-00445.
`
`2.
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`Demographics of Lupus Patients
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`The majority of Lupus patients are women between the ages of 15 and 45. Curtin Decl., Ex. D,
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`No. 48.
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`3.
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`Current Treatment Options
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`There is no known cure for Lupus. 30(b)(6) Depo. at 24:5-7. Only one drug has been approved
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`by the FDA specifically for the treatment of Lupus in the past fifty years, and, according to Dr. Lipsky,
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`that has had limited efficacy. Id. at 109:2-5; Curtin Decl., Ex. M at APB-00446 – APB-00448.
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`Today, Lupus is commonly treated with a combination of drugs. 30(b)(6) Depo. at 26:17-27:5.
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`Most of these drugs are immunosuppressants that have been approved for treatment of other diseases, but
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`not for Lupus. Lipsky Depo. at 37:8-38:1. Because of the variety of manifestations of the disease and the
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`limited options for treatment, the treatment commonly involves taking various drugs to control
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`symptoms and/or prevent or slow the damage to organs. Curtin Decl., Ex. K; 30(b)(6) Depo. at 108:6-12.
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`Drugs that may be used in the treatment of Lupus include non-steroidal anti-inflammatory drugs
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`(“NSAIDs”), acetaminophen (such as Tylenol), corticosteroids, anti-malarial drugs,
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`immunosuppressives, intravenous immunoglobulin, monoclonal antibodies, ACE (Angiotensin-
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`converting enzyme) inhibitors, statins, and anticoagulants. Curtin Decl., Ex. K at APB-00446 – APB-
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`00448; Curtin Decl., Ex. D, Nos. 42-47. For example, celecoxib is a type of NSAID that may be used to
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`treat Lupus, although there are negative side effects. Id., No. 44.
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`Opposer offers and sells NSAIDs including celecoxib, corticosteroids, anti-malarials, ACE
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`inhibitors, and other drugs intended for the treatment of arthritis, among numerous types of drugs.
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`Berthold Aff. at ¶ 25.
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`4.
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`Drug Repurposing
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`Much of Applicant’s work has focused upon the repurposing of existing, FDA-approved drugs
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`for the treatment of Lupus. Repurposing – also called repositioning – is the practice of taking a drug that
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`has been approved by the FDA for treatment of one disease, and using it for the treatment of another,
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`different disease. Lipsky Depo. at 38:18-39:12; 30(b)(6) Depo. at 23:20-23, 27:6-19. Repurposing can be
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`more economical than developing a new drug because the preliminary safety testing has already been
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`conducted. Lipsky Depo. 29:7-30:19. If a drug is identified that already has been approved for another
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`disease, with a known side effect profile, that decreases the potential cost and risk to a pharmaceutical
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`company in bringing a drug to market for Lupus. Id. at 33:20-34:6.
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`In this case, one goal of repurposing in the field of Lupus is to reposition existing
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`pharmaceuticals to alleviate the symptoms of the disease. Applicant’s ultimate goal, however, is to find
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`and repurpose an existing, FDA-approved drug that would lead to remission of the disease. 30(b)(6)
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`Depo. at 24:8-19.
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`In 2016, Drs. Grammer and Lipsky, along with several other researchers from Ampel and two
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`other researchers, published a paper discussing the results of their research on repurposing drugs for
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`treatment of Lupus. The paper highlighted the process Applicant had used to prepare a list of potential
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`drugs as candidates for repurposing. This included a review of approximately 1,100 currently available
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`FDA-approved drugs as well as other possible treatments such as food supplements. Lipsky Depo. at
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`97:4-99:1; Curtin Decl., Ex. M. From hundreds of initial candidates, the list was narrowed to 157
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`potential treatments. 30(b)(6) Depo. at 29:1-3; Lipsky Depo. at 98:9-11.
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`The narrowed list was then scored by a system Applicant devised. This system provided higher
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`scores based upon benefits to patients and other positive factors and lower scores based upon adverse
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`side effects, whether the drug induced Lupus, and other negative factors. Curtin Decl., Ex. M at APB-
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`00402 – APB-00403. The objective was to find drugs that scored higher than the current standard of care
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`drugs for Lupus. Lipsky Depo. at 104:6-23. Drugs that already were commonly used to treat Lupus were
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`not scored. Lipsky Depo. 100:12-101:8.
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`The list of 157 included the drugs abacavir, lamivudine, statins, and zidovudine, each of which
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`are manufactured, either alone or in combination with other pharmaceutical preparations, by Opposer.
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`Berthold Aff. at ¶ 26; Curtin Decl., Ex. M at APB-00403, Table 1. Of the drugs that Lupin has provided,
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`lamivudine and statins received positive scores, though not as high as the current standard of care.
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`There were approximately 20 to 25 treatments of the 157 that Applicant found to be most
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`promising, and Applicant approached the pharmaceutical companies that held the patents for those drugs
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`about the possibility of conducting clinical trials for repurposing the drugs for treatment of Lupus.
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`30(b)(6) Depo. at 29:1-9, 10-12, 30:5-14.
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`Applicant has approached more than
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`
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` pharmaceutical companies for this purpose,
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`including
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`: “everyone you can think of, we have
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`approached.” Id. at 27:20-28:8.3
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`In addition to Applicant’s outreach to pharmaceutical companies as potential customers for
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`Applicant’s clinical trial services, pharmaceutical companies also have approached Applicant and shared
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`their drug data with Applicant to determine whether that company’s data could reveal a drug that may be
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`useful for treating Lupus. Id. at 27:6-19; Lipsky Depo. at 133:7-22.
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`The article a