10月10日，美国联邦巡回上诉法庭在HZNP Medicines v. Actavis Labs的上诉案中对地区法院的涉及12个专利的侵权和无效的裁决维持原判。判决意见书比较长，涉及的问题比较多，这里先介绍其中关于一个使用方法的不侵权问题的部分。(见文后链接判决意见书34-41页。)
 
该案涉及原告的用于治疗膝盖疼痛的PENNSAID? (diclofenac sodium topicalsolution 2%) 产品。其中原告的‘450专利包括使用方法的claim 10，该使用方法要求三个步骤1）涂药；2）等待涂药部位变干；3）然后再涂上防晒霜或驱虫剂:
 
10. A methodfor applying topical agents to a knee of a patient with pain, said methodcomprising: 
 applying afirst medication consisting of a topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient,wherein the topical diclofenac preparation comprises a therapeutically effective amount of a diclofenac salt and 40–50% w/w dimethyl sulfoxide; 
 waiting for the treated area to dry;
 subsequently applying a sunscreen, or an insect repellant to said treated area after said treated area is dry,
 wherein saidstep of applying a first medication does not enhance the systemic absorption of the subsequently applied sunscreen, or insect repellant; 
 and wherein said subsequent application occurs during a course of treatment of said patient with said topical diclofenac preparation。
 
对于药品使用专利的诱导侵权问题，法庭分析了被告的产品说明书，说明书包括以下说明：
The recommended dose is 2 pump actuations on each painful knee, 2 times a day.(2) 
? Apply diclofenac sodium topical solution, to clean, dry skin. (2.1) 
? Dispense 40 mg (2 pump actuations) directly onto the knee or first into the hand and then onto the knee. Spread evenly around front, back and sides of the knee.(2.1)  . . . . 
? Wait untilarea is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances. (2.2) . . . .
? Avoidwearing clothing over the diclofenac sodium topical solution-treated knee(s) until the treated knee is dry. 
? Protect the treated knee(s) from natural and artificial sunlight. 
? Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution. 
? Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s). 
 
法庭指出，说明书允许用衣物覆盖或使用防晒霜或驱虫剂以外的涂布，并没有要求一定使用防晒霜或驱虫剂，而只是提醒患者，如果要用防晒霜或驱虫剂，应该等涂药部位变干以后再用。所以，产品说明书没有鼓励，推荐或提倡（“encourage, recommend or promote infringement”）使用专利的方法，因此没有诱导侵权。由于关于产品说明书没有事实上的争议（“material issues of fact”）, 法庭给出了不侵权的summary judgment, 上诉法庭维持原判。
这个专利的方法看起来没有太多的技术含量，被轻易规避侵权也就不奇怪了。
作者简介：王华律师(Howard Wang)具有十几年的美国律师执业经验，目前在美国Windels Marx律所执业，主要提供美国专利法尤其在制药，Hatch-Waxman，化学，医疗器械等领域的专利诉讼和咨询服务。王律师毕业于美国Illinois大学(UIUC)法学院，获法学博士学位，之前在中国科大，美国匹兹堡大学和耶鲁大学学习获得化学学士，硕士学位，并曾在美国施贵宝公司从事药物化学工艺开发研究。有关于美国专利法的问题请随时联系王律师（微信号hhowardwang）咨询讨论。
 
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