Who shall it profit…

日期:2017-12-26 06:53:06 作者:言沔蔡 阅读:

By Ian Anderson in Melbourne and Andy Coghlan THE marketing of drugs in Australia has been thrown into confusion by a legal ruling which says new ways of using established drugs to treat patients cannot be patented. If the decision stands, companies may be reluctant to do business in Australia because they will no longer have a monopoly over a drug’s application. It could also mean that Australia will align its policy with Europe, where methods of treatment cannot be patented. Patents covering existing treatment methods could also be challenged in Australian courts, says Jacqui Rigby-King of Cullens Intellectual Property Lawyers in Brisbane. She says this could include new treatments using morphine and aspirin. “Pharmaceuticals companies could suffer severe losses,” she says. “Ultimately, the public at large will suffer.” Two heavyweight drugs companies—Bristol-Myers Squibb and F. H. Faulding—are at the centre of the dispute, which surrounds the cancer drug Taxol. Taxol is a naturally occurring compound extracted from the bark of the western or Pacific yew tree. In the 1980s its use was limited because of severe side effects, including damage to the nervous system. In the early 1990s, Bristol-Myers teamed up with the National Cancer Institute of Canada to test Taxol as a treatment for ovarian cancer. Trials showed it could be used effectively with fewer side effects if the dose size and duration were shorter than in earlier trials. Bristol-Myers took out two patents in Australia, covering the safer doses and length of treatment. Faulding began proceedings in late 1994 to have the patents revoked. In early 1995, Bristol-Myers counter-sued, saying Faulding had infringed the patents with a product called Anzatax. But late last month, the Australian Federal Court in Melbourne ruled that the two patents held by Bristol-Myers Squibb in Australia over the use of Taxol were invalid. Patenting methods of treatment has “harmful effects”, the judge said. Doctors would face great uncertainty knowing if and when they infringed patents, and there was a danger of inhibiting the sharing of knowledge by doctors and scientists. Bristol-Myers Squibb now says it will appeal against the decision. “There are numerous patents coming through the patents office for a method of medical treatment,” says the company’s lawyer, Ian Pascarl, of law firm Minter Ellison. “If this decision is allowed to stand, they will all be unpatentable. Major pharmaceuticals companies will be less inclined to ply a lot of their trade in Australia.” Applications for patents on methods of treatment are not generally accepted in Europe, although they are in the US. Dave Schmickel of the US Biotechnology Industry Organization believes the Australian verdict is a step backwards: “I think it’s a bad development. When you are trying to encourage innovation, old drugs are an important reservoir of new medications.” He adds that Viagra might have “fallen foul” of the Australian ruling,