Mexico’s Health Ministry Publishes Medical Cannabis Rules

墨西哥卫生部公布医用大麻条例

2021-01-14 00:54:00 Business Times

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Canopy Growth Corp., one of the largest cannabis producers in the world, filed a federal lawsuit in late 2020 against GW Pharmaceuticals, the UK-based cannabis business behind the FDA-approved Epidiolex. At issue is an extraction method that Canopy asserts is newly protected by patent. Read the full complaint below. Canopy Growth alleges that GW Pharmaceuticals produces Epidiolex via the protected CO2 extraction method. Since its 2018 approval from the FDA, GW then distributes Epidiolex across the U.S. and elsewhere at $1,235 per 100mL bottle. “GW reported approximately $366 million in net product sales of Epidiolex in the United States in the first nine months of 2020,” according to the lawsuit. Although the patent protection on this extraction method is a new issue for Canopy Growth, an earlier iteration of the patent in question was published in 2000. Its contents were acquired by Canopy Growth Corp. amid an acquisition of Germany’s C3 Cannabinoid Compound Company (founded by Bionorica SE), a company with which GW allegedly considered partnering in 2016 for its cannabinoid processing work. Canopy Growth specifically points to two claims in its patent, asserting that GW Pharmaceuticals performs the described actions in its manufacture of Epidiolex. For example, in Claim 1 of the patent, Canopy Growth writes: A process for producing an extract containing Tetrahydrocannabinol (THC) and/or cannabidiol (CBD), and optionally the carboxylic acid thereof, from a cannabis plant material or a primary extract thereof, said processing comprising: (1)   Subjecting the cannabis plant material or primary extract thereof to CO2 in liquefied form under subcritical pressure and temperature conditions to extract cannabinoid components; and (2)   reducing the pressure and/or temperature to separate tetrahydrocannabinol and/or cannabidiol, and optionally the carboxylic acids thereof, from the CO2. This lawsuit is the first action Canopy has taken to argue its patent. Marijuana Moment first reported on the contents of this lawsuit in December.  The case echoes the UCANN v. Pure Hemp lawsuit that we covered in 2019. UCANN went after Pure Hemp for cannabis tincture formulation that fell under a patent for “liquid cannabinoid formulations wherein at least 95% of the total cannabinoids” is THCa THC, a combination of THCa and CBDa, and a combination of THC and CBD. In other words, the patent covered a broad swath of the cannabis concentrate market segment.  In April 2020, UCANN filed for Chapter 11 bankruptcy, and the federal lawsuit was administratively closed by the court.   Canopy Growth Corp. vs. GW Pharmaceuticals by sandydocs on Scribd  
世界上最大的大麻生产商之一Canopy Growth Corp.于2020年末向联邦政府提起诉讼,起诉总部位于英国的大麻企业GW Pharmaceuticals,该公司生产了FDA批准的Epidiolex。有争议的是一种提取方法,Canopy声称这是一种新获得专利保护的方法。 阅读下面的完整投诉。 Canopy Growth声称,GW Pharmaceuticals通过受保护的CO2提取方法生产附睾。自2018年获得FDA的批准后,GW在美国和其他地方以每100毫升1235瓶的价格销售附睾灵。根据诉讼,GW报告称,在2020年前9个月,Epidiolex在美国的净产品销售额约为3.66亿美元。 虽然这种提取方法的专利保护对树冠生长来说是一个新问题,但有关专利的早期迭代是在2000年公布的。Canopy Growth Corp.收购了德国C3大麻化合物公司(由Bionorica SE创建),据称GW在2016年考虑与该公司合作开展大麻素加工工作。 Canopy Growth公司特别提到了其专利中的两项权利要求,声称GW Pharmaceuticals公司在生产Epidiolex的过程中进行了上述操作。 例如,在该专利的权利要求1中,Canopy Growth写道: 一种从大麻植物材料或其初级提取物制备含有四氢大麻酚(THC)和/或大麻二酚(CBD)和任选其羧酸的提取物的方法,所述方法包括: (1)在亚临界压力和温度条件下将大麻植物材料或其主要提取物置于液化形式的CO2中提取大麻素成分;和 (2)降低压力和/或温度以从CO2中分离四氢大麻酚和/或大麻二酚,以及任选的其羧酸。 这起诉讼是冠盖公司为争辩其专利而采取的第一个行动。《大麻时刻》在12月首次报道了这起诉讼的内容。 这起案件与我们在2019年报道的UCANN诉纯大麻案遥相呼应。UCANN以纯大麻作为大麻酊剂制剂,该制剂属于液体大麻素制剂专利,其中至少95%的总大麻素是THCa,THC,THCa和CBDa的组合,以及THC和CBD的组合。换言之,该专利涵盖了大麻浓缩物市场的一大段。 2020年4月,UCANN申请第11章破产,联邦诉讼被法院行政结案。 Canopy Growth Corp.vs.GW Pharmaceuticals

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