Evergreening - Wikipedia
Using the URL or DOI link below will ensure access to this page indefinitely Hemphill, C. Scott and Sampat, Bhaven N., Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals (May 3, ). Journal of Health . ' Linkage' Pharmaceutical Evergreening in Canada and Australia SSRN Quick Links. which was sure to take place asap as the key patent expired as generic drug manufacturers .. () discusses evergreening in the context of the Australia- United States Free Trade. Agreement countries covering Canada, Australia, India, Philippines, and Thailand. "'Linkage' pharmaceutical evergreening in Canada. In , under the North American Free Trade Agreement (NAFTA)-induced Canadian Notice Of Compliance (NOC) 'linkage' regulations, drug.
The majority, comprising of Gleeson CJ, Gaudron, Gummow and Hayne JJ in a joint judgment and Callinan J in a separate judgmentfound that the combination of elements used in the new tablet formulation and their interaction was inventive, even if some integers were previously known while others were new. Here, the High Court is seen to condone evergreening practices provided follow-on inventions satisfy the patentability requirements. In contrast to Aktiebolaget and Lundbeck, the follow-on patent in Merck attempted to claim a dosing regime that was not essential to the commercial exploitation of the pharmaceutical, involved no scientific ingenuity and was contemplated early in research and development.
Conversely, the follow-on patent in Aktiebolaget was fundamental to the administration of omeprazole in treatment and involved an inventive combination of integers to achieve this purpose. Similarly, the escitalopram patent in Lundbeck involved inventiveness in its identification and isolation and had not been previously disclosed to the public.
First, it has been argued that evergreening practices undermine patent policy, and second, that they reduce competition and consequently limit affordable access to the pharmaceuticals on which the health of modern society relies.
However, as will be discussed in Part 4these concerns ignore many of the practical realities surrounding evergreening, suggesting that these criticisms are often not warranted in an Australian context. Hence, if the requirements specified in the Patents Act are applied correctly, the grant of follow-on patents should not undermine patent policy nor bypass patent laws. A patentee must disclose an actual invention meeting the patentability requirements to be granted an additional patent and, hence, be required to release further innovative information in exchange for the grant of the follow-on patent.
As such, the Pharmaceutical Patents Review, together with other commentators,  have correctly identified the patentability requirements, and not originator pharmaceutical companies, as the gatekeepers of acceptable patenting behaviour in Australia. The PBS is designed to provide equal access to affordable pharmaceuticals for all Australians through the provision of government subsidies on most pharmaceuticals.
These factors mitigating the negativity surrounding evergreening in Australia will be discussed in this Part. This suggested that the general presumption that evergreening is undertaken by originator companies is not the reality. Similarly, Parker and Mooney note that evergreening practices are open to competitors, and that the phenomenon is not only limited to original companies claiming follow-on inventions.
Additionally, IP Australia has found that later patent filings for pharmaceuticals are dominated by third parties with earlier patents mostly owned by originators. All types of pharmaceutical companies utilise the patent system for business objectives in pursuit of the profits associated with a patent monopoly.
'Linkage' pharmaceutical evergreening in Canada and Australia
Even where follow-on patents are sought by originator pharmaceutical companies, this is often a legitimate and predictable commercial strategy. Additionally, pharmaceutical innovation is often incremental and cumulative. For example, the improved lamotrigine tablet formulation that was the subject matter of the follow-on patent discussed in Part 1 offered significant practical benefits including enhanced patient compliance and the encouragement of further innovation by competitors.
It is consistent with patent policy to reward cumulative inventiveness and legitimate follow-on research and development with patent protection. This is demonstrated in the grant of follow-on patents for venlafaxine related medicines. Evergreening through the grant of follow-on patents is permissible under Australian patent law provided patent requirements are satisfied.
- Journal of Law, Information and Science
Accordingly, evergreening is appropriately regulated by the patentability requirements, which distinguish legitimate inventions from frivolous attempts to undermine the system.
To expect pharmaceutical companies to do more than the law requires by the adoption of patenting practices that promote the public interest while sacrificing their commercial interests is unrealistic.
'Linkage' pharmaceutical evergreening in Canada and Australia
The author would like to thank Dr Catherine Bond for her helpful comments on drafts of this article. The Report was provided to the Government in May The patent holder then has 45 days in which to initiate an application in the Federal Court of Canadaseeking an order to prohibit the relevant Minister from issuing a Notice of Compliance to the generic manufacturer for a period of 24 months, or upon resolution of the court application, whichever is sooner.
The amendments inserted a new section 26B which required applicants for marketing approval to certify their product would not infringe a valid patent claim, or that the patent holder had been notified of the application. In response, the Australian government passed anti-evergreening amendments in Sections 26C and 26D of the Therapeutic Goods Act Cth designed to prevent patent holders from manipulating the court system to lengthen the term of the patent and delay the entry of generic pharmaceuticals into the market.
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.
We will be monitoring the matter closely, and reserve all rights and remedies as discussed below. We also remain concerned about recent amendments to sections 26B 1 a26C and 26D of the Therapeutic Goods Act of Under these amendments, pharmaceutical patents owners risk incurring significant penalties when they seek to enforce their patent rights.
These provisions impose a potentially significant, unjustifiable, and discriminatory burden on the enjoyment of patent rights, specifically on owners of pharmaceutical patents. I urge the Australian Government to review this matter, particularly in light of Australia's international legal obligations.
The United States reserves its rights to challenge the consistency of these amendments with such obligations. Korea[ edit ] The US has achieved a similar provision to article The key basis for the rejection was the part of Indian patent law that was created by amendment indescribing the patentability of new uses for known drugs and modifications of known drugs.
That section, Paragraph 3d, specified that such inventions are patentable only if "they differ significantly in properties with regard to efficacy. No attempt has been made to create a similar multidisciplinary regulatory agency in Australia.
Yet, it appears that article The Minister responsible for Health Canada may refuse to add, or may delete, information from this Patent Register. Each patent list is audited for example as to whether potential inclusions are mere 'evergreening' attempts by the Office of Patented Medicines and Liaison.
Reports produced by that body outline statistics relating to the maintenance of the Patent Register, including the number of patents filed, the number of patents accepted and rejected, and litigation resulting from the acceptance or rejection of patents for listing on the Patent Register.