exam-ple, Schering-Plough was marketing Clarinex as the only drug approved against indoors allergies.
609This should not be taken to mean that other allergy drugs – including Schering’s own Claritin
610– are not effective indoors … they are. The difference is that Schering-Plough designed its clinical trial so the results would support this specific in-dication and corresponding marketing claim.
Most countries limit drug advertising to therapeutic indications that have been ap-proved by the drug agency.
611Such a rule is relatively easy to apply to straightforward advertisement campaigns. However, companies are not entirely banned from disclos-ing the results of their clinical trials, includdisclos-ing early phase studies. Companies routinely
605 Since 1997, the United States has relaxed this rule. See O’Reilly & Dalal, supra note 429, at 295 (explaining how § 401 of the 1997 Food and Drug Administration Modernization Act (“FDAMA”) (Pub. L. 105– 115) loosened the 1962 requirement that pharmaceutical manufacturers prove efficacy before marketing their products).
606 In the United States, only the label intended for physicians is mandatory. Patients’ notice of use are not always compulsory, except for contraceptives or particularly dangerous drugs. See, e.g., OIG (FDA Review), supra note 20, at 46. The United States plans on soon aligning its practice on that of other developed coun-tries and make patients’ notice of use mandatory too.
607 The label includes among others the approved therapeutic indications, the recommended dosages, the precautions of use, the identified contraindications and safety warnings.
608 See OIG (FDA Review), supra note 20, at 17-18. See also with respect to labels for pediatric patients, GENERALACCOUNTING OFFICE(“GAO”), PEDIATRIC DRUGRESEARCH, SUBSTANTIAL INCREASE IN STUDIES OF DRUGS FORCHILDREN, BUT SOMECHALLENGES REMAIN, at 9 (GAO-01-705T) (May 8, 2001), (“In some cases, FDA offi-cials said they have had substantial difficulty in getting drug manufacturers to incorporate unfavorable pedi-atric research results into drug labels.”) at http://www.gao.gov/new.items/d01705t.pdf [hereinafter GAO (Pediatric)].
609 See Press Release, Schering-Plough, Schering Laboratories Begins Clarinex DTC Education Program, (Mar. 4, 2002), at http://www.schering-plough.com/schering_plough/news/release.jsp?releaseID=264909.
610 Claritin was Schering’s former blockbuster until it lost its Rx-only status and its patent protection. Many have argued that Claritin and Clarinex are in fact almost identical compounds. See Rita Rubin, Claritin to go OTC next spring, Clarinex to replace it, USA TODAY, (Apr. 4, 2002), at
http://www.usatoday.com/news/health/drugs/2002-04-23-claritin.htm.
611 According to Article 5.1. OPMéd, advertisement to health care practitioners must be limited to therapeutic uses recognized by Swissmedic.
present such results. Publicly-traded companies may even be obliged to do so in accor-dance with securities laws, given that clinical trial results heavily affect stock prices.
These opportunities to present clinical trial results influence the sales of the not-yet approved drug/therapeutic indication. On the basis of this information, physicians often start to prescribe the drugs “off-label.”
612Hence, clinical trials help companies cash in on a new treatment before it has been approved.
Sometimes, the clinical trial is not even intended to support a new therapeutic use, but is only meant to bolster the sales of the existing drug use. Sham trials, often organ-ized as phase IV trials, have come under heavy criticisms
(see subsection 6.1.4.2. below).
6134.1.4.2. After marketing approval
If the sponsor makes use of clinical data in its advertisement, it must do so fairly. In particular, if the advertisement refers to a published clinical study, the reference should be clear so as to enable readers to find the publication.
614Under Swiss law, advertising must refer only to studies that were conducted according to Good Clinical Practices (GCP).
615In addition, the studies must be either already or soon to be published. Lastly, the studies must be available to interested parties.
6164.1.5. Minimizing liability
The agency’s grant of a marketing authorization does not protect pharmaceutical manu-facturers against product liability actions.
617When a drug found safe and effective by the drug agency nonetheless causes injury to a patient, its manufacturer faces liability
612 This requires, of course, that the drug be already legally sold on the market for some other therapeutic indication. See, e.g., William F. Clark et al., Effect of Awareness of a Randomized Controlled Trial on Use of Experimental Therapy, 290 JAMA 1351-1355 (Sept. 10, 2003), at
http://jama.ama-assn.org/cgi/reprint/290/10/1351.pdf.
613 See, e.g., Frank Davidoff et al., supra note 603, at 825.
614 See generally decision of the Swiss federal appeal commission for therapeutic products, JAAC 66.102, at point 4.b. (Apr. 17, 2002), at http://www.vpb.admin.ch/franz/doc/66/66.102.html; International Federation of Pharmaceutical Manufacturers Associations (“IFPMA”), Code of Pharmaceutical Marketing Practices (last revised Jan. 2000), at
http://www.afpmbg.org/info/IFPMA%20Code%20of%20Pharmaceutical%20Marketing%20Practices.doc.
615 Article 5.5 of the Federal Council’s Ordinance on publicity for pharmaceuticals of October 17, 2001; in French: “Ordonnance sur la publicité pour les médicaments”; abbreviated (from the French): OPMéd; RS 812.215.5; text in French at http://www.admin.ch/ch/f/rs/8/812.212.5.fr.pdf. See also Valerie Junod, La pu-blicité pour les médicaments, Difficultés et faiblesses de la réglementation actuelle, RSDA 5/2005, at 235-43.
616 Id. The 2004 revision of the OPMéd reinforces this requirement, by specifying that health care professionals are entitled to ask for the full report of the clinical trial referred to in the advertising.
617 According to sixth Circuit, “FDA approval [does not preempt] state product liability claims based on design defect. … The jury may weigh FDA approval as it sees fit ….” Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, at 537 and at 538 (6th Cir. 1993) (a case where the plaintiff successfully argued, despite FDA approval, that the manufacturer should not have launched its product on the market given its lack of effec-tiveness and its serious side effects).
suits. In the United States, liability claims are very common and the amounts awarded can be incredibly high.
618To fend off liability suits, the manufacturer must prove that it took all possible pre-cautions before deciding to place its product on the market. This creates a separate obli-gation to test drugs. Only if the manufacturer can show that it thoroughly tested its product can it escape liability in case of patients’ injury.
4.1.6. Intellectual property (“IP”)
4.1.6.1. Getting IP rights (“IPR”)
Clinical trial results may also be used to support a patent application. A patent will, for example, cover a new drug use discovered in the course of a clinical trial (e.g., Viagra was originally designed as a drug against angina, not impotence
619). However, under most jurisdictions, patent applicants can obtain a patent even if their supporting evi-dence is far less exacting than that required by drug agencies.
620Preclinical evidence of utility usually suffices.
621Hence, clinical trials are not an absolute necessity for a patent to be granted.
In fact, by the time a compound enters clinical trials, it has already received sub-stantial patent protection. Sponsors do not incur the risk of using unpatented com-pounds in clinical trials, since trade secret protection (the alternative to patent protec-tion) is insufficient: Too many people involved in the trial are to receive access to the compound for secrecy to be maintained. Moreover, publication of clinical trial results would destroy the novelty of any invention disclosed therein.
622Widespread use of a compound in clinical trials may also invalidate the (yet) un-patented invention under the public use bar.
623Under U.S. law, use by the inventor (or under his control) which is strictly limited to testing the viability, functionality, or qual-ity of an invention does not, however, fall under the public use bar. These tests fall un-der the experimental use exception, an exception to unpatentability or invalidity.
624In the case of clinical trials, it is unlikely that the sponsor can invoke the experimental use exception.
625First, for most inventions, the sponsor should already have applied for a
618 Pharmaceutical companies regularly argue that high jury awards in product liability lawsuits have the effect of raising drug prices for all patients.
619 See Jim Kling, From Hypertension to Angina to Viagra, 1(2) Modern Drug Discovery, 33-34, (Nov.-Dec.
1998), at http://pubs.acs.org/hotartcl/mdd/98/novdec/viagra.html.
620 See In re Wesley Gale Irons, 340 F.2d 974 (C.C.P.A. 1965).
621 See, e.g., In re Georges Jolles, 628 F.2d 1322 (C.C.P.A. 1980).
622 In other words, if the publication or any other release of information to unauthorized third party reveals an invention for which a patent has not yet been requested, the invention will no longer be patentable, because one of the conditions of patent protection is complete novelty. Novelty requirements in Europe are even stricter than those in the United States. In the United States, see 35 U.S.C. § 102(a).
623 In the United States, 35 U.S.C. § 102(b). See Shashank Upadhye, To Use or Not to Use: Reforming Patent Infringement, the Public Use Bar, and the Experimental Use Doctrine as Applied to Clinical Testing of Phar-maceutical and Medical Device Inventions, 4 MINN. INTELL. PROP. REV. 1, at 3 (2002).
624 See Upadhye, supra note 623, at 10-13.
625 See id. at 14-15.