4 world events involving pharmaceutical intellectual property rights in 2007

PharmaceuticalS.com
2007 Pharmaceutical Hot Spot Review - Drug Regulatory Boom
Pharmaceutical Networkfinishingin the pharmaceutical industry, patents are the lifeblood, the patent industry anddrug-related issuesThe lifeline means important, and the problems are more complexFor the survival and development of pharmaceutical enterprises, both important and complexdrugpatent issues, need enterprise decision makers to pay attention to, and then pay attention to!Not long ago, the European Monetary Association Investor Company listed 26 world intellectual property events in 2007 on the Intellectual Property Management Network, four of which involveddrugsThree directly or indirectly involved in patent infringement litigation, one of which is a patent reviewThe following is the author's brief assessment of these four events: , Novartis heavy bomb anti-cancer drug Greve patent case Greve's compulsory patent licensing has been at the centre of controversy in India and Thailand The Indian Patent Office has rejected a patent application, and next year the Indian Appeals Board will rule on its patentability Greve is mainly used for the treatment of chronic leukemia, side effects are few, oral convenience Previously, Thailand has been fighting AIDS Weilun, Lopinavir and treatment of heart disease of clopidogrel patent compulsory licensing, may be in the future for anti-cancer drugs patents issued compulsory licensing Greve is one of four cancer drugs the Thai government wants to issue compulsory licenses The introduction of compulsory patent licensing will make drugs cheaper and more affordable Second, Pfizer regains the patent rights of Viagra's inventions in China In September 2007, the Beijing High Court issued a final judgment in the Viagra patent case, upholding the original judgment of the first instance, overturning the invalidity of the patent office's review committee's patent patent court's patent patent, No 94192386.x, for the use of pyrethroid and ketones for impotence The active ingredient of the drug Viagra is sildenaw, which is sildenaw Pfizer's 94192386.x patent is a new-use patent for a group of compounds, including sildenafiate In principle, in the case of a known compound, i.e the compound has no patent protection, and the preparation of the compound avoids a method patent, and the only patent for the use of the compound is now, the enterprise is free to manufacture, use, sell, promise to sell and import the compound However, new indications for patent protection for this use cannot be noted on drug labels or instructions For example, aspirin is an old medicine that was first used to anti-inflammatory analgesics and later in small doses to prevent cardiovascular disease Suppose existing people find that aspirin can fight cancer and obtain a patent for the new use of "the application of aspirin in the preparation of anti-cancer drugs" Then, after that, others can still produce aspirin, can write in the drug labels and instructions that the indications are anti-inflammatory analgesia or prevent cardiovascular disease, but other than the patentee or the patentee authorized person, no one else can indicate in the drug label and instructionmanual indication that indication is the treatment of cancer, nor can they advertise their own aspirin can treat cancer For doctors or patients, it is legal and not patent infringement to treat cancer with aspirin that indicates that indications are anti-inflammatory analgesicor or cardiovascular disease prevention, because China's patent law does not protect treatment Third, the United States Supreme Court ruled that the patent licensee may challenge the validity of the patent The U.S Court of Appeals for the Federal Circuit has held that once a patent license agreement is signed between the patentee and the licensee, it means that the licensee (the person who purchased the right to use the patented technology) recognizes the validity of the patent, and the licensee cannot question or challenge the validity of the patent in the patent license agreement However, in Medimmune v Genetech, the U.S Supreme Court rejected the decision of the Federal Circuit Court of Appeals, which held that the licensee could not be barred from making an invalid claim for the validity of the patent in the agreement because the two parties had entered into a patent license agreement This puts the licensee in a position of superiority Patents as an intangible property, to judge its novelty, creativity, whether full disclosure, often appear fuzzy zone, so that "public sense, mother-in-law reason." So there will be a first-instance loss, second trial win, retrial and lose the helpless situation, the risk is very big The U.S Supreme Court's decision leaves the licensee in a safe position Lost, I have signed a license agreement, paid the license fee, there is no suspicion of infringement, not to mention intentional infringement Win, better, license fees can never be paid Fourth, the European Commission in EPC2000 clearly: patent second-use claims can be written as "A drug in the preparation of drugs for the treatment of B disease application." Prior to this, European countries on the so-called "Swiss form" claims of the form of dispute, there has been no uniform provisions In New Zealand, a court decision in January 2007 established the patentability of such claims and upheld Genetech's claim EPC200 (European Patent Convention 2000) codified the practice of The EPO (European Patent Office) EPC200 is the most comprehensive revision of the European Patent Treaty in 30 years The EPC member States agreed in 2000 and implemented on 13 December 2007 in the existing 32 Member States The last member State to ratify the revised version was Italy (approved on 29 November 2007) Norway and Croatia, the new member states that will join the EU on 1 January 2008, have also accepted the EPC 2000 Although, the world's 360 lines, pharmaceutical suppendle spent only one line Intellectual property rights include designs, trademarks, trade secrets, copyrights and so on However, in 2007, about one-half of the 26 intellectual property events were patented This at least shows that patents are the lifeblood of the pharmaceutical industry, and there are many drug-related problems in the patent community The lifeline means important, and the problems are more complex Therefore, for the survival and development of pharmaceutical enterprises, both important and complex drug patent issues, need enterprise decision-makers to pay attention to, and then pay attention to! (The author is the Deputy Director of the Intellectual Property Office of The Chinese Pharmaceutical University, this article is part of the Soft Project Project of the State Intellectual Property Office)