Evergreening is any of various legal, business, and technological strategies by which producers (often pharmaceutical companies) extend the lifetime of their patents that are about to expire in order to retain revenues from them.
Often the practice includes taking out new patents (for example over associated delivery systems or new pharmaceutical mixtures), or by buying out or frustrating competitors, for longer periods of time than would normally be permissible under the law.
[3] Robin Feldman has documented several types of patent tactics commonly used in the U.S. by pharmaceutical companies, including evergreening,[2] pay-for-delay,[4] gaming the citizen petition process,[5] and the misuse of trade secrets,[6] among others.
[9] Product hops are distinguished from genuine improvements, such as a new version of a drug with an easier route of administration that leads to meaningful benefits for patients.
[9] In one case, product hopping of the multiple sclerosis drug glatiramer acetate (Copaxone) led to a cost to consumers of $4.3 to 6.5 billion dollars over two and a half years, before the new patent was invalidated by the courts.
[12] The impact of product hops can be less visible to the public than the cost of new drugs, because of a lack of awareness that the prices would have decreased due to generic competition.
Linkage evergreening is the process whereby pharmaceutical safety, quality and efficacy regulators are required to 'link' their normal evaluation with an assessment of whether an impending generic product may infringe an existing patent.
They are a strong statement of Australia's legitimate expectations of benefit (that is of freedom from pharmaceutical price rises due to evergreening) in this area.
[26] Issues which prevent generics from reaching the market include:[27] The main arguments in favor of governments regulating against evergreening are that rapid entry of multiple generic competitors after patent expiry is likely to lower prices and facilitate competition, and that eventual loss of monopoly was part of the trade-off for the initial award of patent (or intellectual monopoly privilege) protection in the first place.
Yet, it appears that article 18.9.4 of the Republic of Korea-United States Free Trade Agreement (KORUSFTA) has been specifically drafted to permit the establishment of such a pharmaceutical patent "anti-evergreening" oversight agency.
Moreover, the new regulations made it clear that patents covering areas without direct therapeutic application, such as processes or intermediates, could not be used to delay generic approval.
[35] In Australia, anti-evergreening amendments to the Therapeutic Goods Act 1983 (Cth)were part of the package of legislation required to be passed by the Australian Government as a precondition to entry into force of the Australia-United States Free Trade Agreement (AUSFTA).
If the certificate is found to be false or misleading, fines of up to $10 million apply and the Cth Attorney General is permitted to join the action to recoup losses to the PBS.
Section 26D provides that a patent holder who seeks an interlocutory injunction to prevent the marketing of the generic pharmaceutical must obtain leave from the government to do so.
On the other hand, international trade law recognises that where a unique problem arises specifically referable only to a particular field of technology, a solution applying sui generis only to that field of technology cannot be said to be discriminatory according to the ordinary meaning and purpose of the TRIPS agreement or the AUSFTA as required by article AUSFTA 21.9.2 (incorporating articles 31 and 32 of the Vienna Convention on the Law of Treaties (VCLT).