{"id":241,"date":"2020-07-31T13:42:18","date_gmt":"2020-07-31T17:42:18","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=241"},"modified":"2020-08-03T09:01:44","modified_gmt":"2020-08-03T13:01:44","slug":"juxtaposing-helsinn-with-pharmaceutical-trademarks","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2020\/07\/31\/juxtaposing-helsinn-with-pharmaceutical-trademarks\/","title":{"rendered":"Juxtaposing Helsinn with Pharmaceutical Trademarks"},"content":{"rendered":"

Ryan Smith<\/a>, Karen Kline<\/a><\/p>\n

Duane Morris LLP<\/p>\n

Pharmaceutical branded drug developers interested in obtaining trademark protection should take note of the Supreme Court holding in Helsinn v. Teva<\/em> that patent eligibility can be defeated by a private sale of a pharmaceutical drug from a manufacturer to a drug distributor (Helsinn Healthcare S.A., v. Teva Pharmaceuticals USA, INC.<\/em> (139 S.Ct. 628 (2019)).\u00a0Trademark protection via registration is often sought for branded pharmaceutical drugs when seeking to establish a market for new pharmaceutical therapies.<\/p>\n

Trademarks for pharmaceutical drugs\u00a0are subject to the requirements of two entities \u2013 the U.S. Patent and Trademark Office (\u201cUSPTO\u201d) trademark requirements when seeking trademark registration and those of the Office of Postmarketing Drug Risk Assessment (“OPDRA”). The OPDRA, a sub-group of the Center for Drug Evaluation Research (“CDER”) of the U.S. Federal Drug Administration reviews and either approves or rejects new drug trademarks (also known as proprietary names) before they can be marketed.\u00a0 The OPDRA\u2019s requirements for a pharmaceutical trademark are separate and distinct from those of the USPTO, and are not so impacted by the Helsinn<\/em> decision as are those of the USPTO.<\/p>\n

One of the USPTO requirements for issuance of a trademark registration is the use in commerce of the mark.\u00a0 An applicant must, at time of applying for registration or within a certain time thereafter, prove that the mark is used in commerce.\u00a0 A trademark registration for a pharmaceutical drug will therefore require use in commerce of the pharmaceutical drug, but oftentimes an application for trademark registration will be submitted well in advance of a market launch.\u00a0 Such a requirement can be met by certain pre-market activities, such as, inter alia<\/em>, by use of the drug in clinical studies, in distribution to clinical sites in preparation for a clinical trial, or even pre-approval sales to a distributor.\u00a0 Distribution or sales, unfortunately, may present a risk to the patentability of the pharmaceutical compound or uses thereof discovered after the date of the transaction.<\/p>\n

Enter Helsinn v. Teva<\/em><\/u><\/p>\n

Over 18 months ago, the Supreme Court held that \u201can inventor’s sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art under \u00a7 102(a).\u201d\u00a0 The subject sale consisted of two agreements: a license agreement and a supply and purchase agreement.\u00a0 Such commercial transactions could pose a bar to patent applications filed more than a year after the date of the agreements (e.g<\/em>., for claims directed to effects observed in clinical trials, to dosages, or to combination therapies). \u00a0For additional details on Helsinn<\/em>, see\u00a0<\/em>our earlier blog on this topic \u00a0here<\/a>.<\/p>\n

The Helsinn<\/em> ruling that a secret sale can qualify as a prior sale for purposes of patent law is in tension with the USPTO’s acceptance of trademark specimens from pre-clinical or clinical trials to satisfy the \u201cuse in commerce\u201d requirement for trademark protection.\u00a0 A pharmaceutical trademark applicant may face the challenge of avoiding Helsinn<\/em> while also trying to rely on specimens used in commerce to obtain trademark registration.\u00a0 Should the deciding court find that the trademark standard for \u201cuse in commerce\u201d equates to a patent \u201csale\u201d or \u201cpublic use\u201d, said use in commerce could potentially defeat patentability.\u00a0 Pharmaceutical companies would face the dilemma: patent or trademark?<\/p>\n

However, there may be another method of satisfying the trademark requirements while avoiding patentability-defeating sales or disclosures.\u00a0 The term \u201cuse in commerce\u201d for trademark requirements, includes use in connection with \u201cgoods [which] are sold OR TRANSPORTED<\/strong> in commerce\u201d (emphasis added).<\/a>[1]<\/a>\u00a0 Activities classified from the trademark perspective as \u201ctransported in commerce” which do not qualify as an “on-sale” patent bar might therefore be an elegant solution to the dilemma.\u00a0 Of course, facts matter\u2026<\/p>\n

It is instructive to pharmaceutical drug manufacturers seeking patent and trademark protection to be aware of the relative timing for applying for pharmaceutical drug trademarks, distributing samples for, and conducting clinical trials, and applying for patents directed to claims identified during the clinical trials.\u00a0 As a takeaway, a trademark applicant may want to (1) evidence the transport of a sample containing packaging bearing the mark across state lines to satisfy the trademark use in commerce requirements, and (2) file a U.S. patent application before commercial activity begins for satisfying trademark registration requirements.<\/p>\n

 <\/p>\n

<\/a>[1]<\/a> Section 45 of the Trademark Act, 15 U.S.C. \u00a71127, defines “commerce” as “all commerce which may lawfully be regulated by Congress.”\u00a0 Section 45 defines “use in commerce” as follows:<\/p>\n

The term “use in commerce” means the bona fide use of a mark in the ordinary course of trade, and not made merely to reserve a right in a mark.\u00a0 For purposes of this Act, a mark shall be deemed to be in use in commerce–<\/p>\n

(1) on goods when\u2014<\/p>\n

(A) it is placed in any manner on the goods or their containers or the displays associated therewith or on the tags or labels affixed thereto, or if the nature of the goods makes such placement impracticable, then on documents associated with the goods or their sale, and<\/p>\n

(B) the goods are sold or transported in commerce, and\u2026<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Ryan Smith, Karen Kline Duane Morris LLP Pharmaceutical branded drug developers interested in obtaining trademark protection should take note of the Supreme Court holding in Helsinn v. Teva that patent eligibility can be defeated by a private sale of a pharmaceutical drug from a manufacturer to a drug distributor (Helsinn Healthcare S.A., v. Teva Pharmaceuticals … <\/p>\n

Continue reading “Juxtaposing Helsinn with Pharmaceutical Trademarks”<\/span><\/a><\/p>\n","protected":false},"author":233,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[490,489,12,274,77,322,224,488,468],"ppma_author":[522],"class_list":["post-241","post","type-post","status-publish","format-standard","hentry","category-general","tag-drugs","tag-karen-kline","tag-patent","tag-patents","tag-pharmaceutical","tag-pharmaceuticals","tag-ryan-smith","tag-trademark","tag-u-s-food-drug-administration"],"authors":[{"term_id":522,"user_id":233,"is_guest":0,"slug":"rcsmith","display_name":"Ryan Smith, Ph.D.","avatar_url":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-content\/uploads\/sites\/15\/2015\/04\/smithryan-125x150.jpg","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/241","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/233"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=241"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/241\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=241"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=241"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=241"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=241"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}