On November 5 2015 the Canadian government released the official consolidated text of the Trans-Pacific Partnership (TPP). This follows the technical summary of negotiated outcomes posted on the Department of Foreign Affairs and Development Canada’s website following conclusion of the agreement.
The Canadian government has not released any additional information as to how it will apply the TPP in Canada. However, based on a review of the TPP, patent holders can look forward to some additional patent rights, notably patent term extensions in certain situations. No changes are expected regarding patentable subject matter.
Moreover, the TPP includes specific provisions for the pharmaceutical industry, including explicit data protection for a broad range of pharmaceuticals, including new chemical entity-based pharmaceuticals, clinical data for previously approved products and biologics. The TPP also includes provisions on patent linkage and early working exceptions for regulatory approval for pharmaceuticals.
The Canadian government has stated that Canada complies with many of the TPP provisions, but has not yet commented on all provisions. Thus, questions remain regarding the scope of patent term extension that Canada will provide and how the data protection provisions will be implemented.
This article examines the TPP provisions related to patents and pharmaceuticals and how they compare to the existing regime in Canada.
The agreement has not yet been ratified and the new Canadian government has stated that it will engage Parliament in a consultation on the TPP. Thus, the issues raised for pharmaceutical stakeholders are also addressed.
TPP provisions for patents
Patent term extension
The most apparent change for patents under the TPP is the introduction of two categories of patent term extension:
- patent term extension owing to delays in processing patent applications at the patent office; and
- specifically for pharmaceutical patents, extension owing to delays in obtaining marketing or regulatory approval.
Patent Office delays
For patent office delays, the TPP requires that patent terms be extended where “unreasonable delays” occur in application processing, meaning more than five years from the filing date or more than three years after a request for examination of an application.
As yet there is no indication of how long the patent term will be extended over such delays. The Canadian government has not commented on these provisions, and the TPP itself is silent as to the length of additional patent protection to be granted.
Regulatory or marketing approval delays for pharmaceutical patents
The TPP also grants patent term extensions to pharmaceutical patents affected by “unreasonable curtailment” or delay in obtaining regulatory or marketing approval.
At this time there is no indication of how long the delay in obtaining approval must be before a patent is entitled to a term extension. The TPP provides no definition of 'unreasonable curtailment', nor does it give any indication as to how long the delay must be to merit an extension. The Canadian government has also not commented on what it would consider to be an “unreasonable curtailment” that would qualify for a patent term extension.
Where there is an unreasonable curtailment, the TPP provides that sui generis patent extension is to be granted. Canada has stated that the sui generis patent term restoration granted under the TPP is in line with extensions that it negotiated for such delays under the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union, meaning a two-year cap on additional protection and flexibility to maintain its export exception.
Patentable subject matter
Under the TPP, patents must be granted for inventions that are new, involve an inventive step (meaning not obvious) and are capable of industrial application (meaning useful). Eligible exclusions for patentable subject matter are:
- diagnostic, therapeutic or surgical methods of treatment in humans or animals;
- animals and plants, other than microorganisms; and
- biological processes for the production of plants or animals.
The Canadian government has stated the patentable subject matter provisions in the TPP, including criteria for patentability exclusion, comply with Canada’s existing laws and regimes.
TPP provisions for pharmaceuticals
For pharmaceutical products the TPP also includes provisions for the protection of undisclosed safety and efficacy test data submitted by the manufacturer of an innovative pharmaceutical product as required to obtain regulatory or marketing approval. Distinct from patent protection, data protection prevents manufacturers of the same or similar products from referencing an innovator’s data submitted for marketing approval for specified periods of time.
The TPP provides for three main categories of data protection:
- new chemical entity based pharmaceutical products;
- clinical data; and
- biologics, for previously approved pharmaceutical products.
However, the Canadian government has provided limited information regarding how the data protection provisions will be implemented.
New pharmaceutical products – chemical entity based
Under the TPP manufacturers seeking approval to market a “same or similar” product to a “new” pharmaceutical product cannot reference the undisclosed safety and efficacy test data of the new pharmaceutical product for at least five years from the date marketing approval was first granted.
Canada has not commented on how it will apply this provision. However, Canada’s existing regime of extending data protection to eligible “innovative drugs” appears to surpass the minimum outcomes agreed to under the TPP. Under the Food and Drug Regulations a drug is eligible for up to eight years of data protection if it contains a medicinal ingredient not previously approved and is not a variation of a previously approved medicinal ingredient. Since the TPP defines a 'new pharmaceutical product' as one that does not contain a previously approved chemical entity, these products appear to fall within the definition of 'innovative drug' in Canada.
Clinical data for previously approved pharmaceutical products
Under the TPP new clinical information submitted for a new formulation, indication or form of previously approved pharmaceutical products can benefit from up to three years of data protection.
If implemented, this provision would allow for a new category of data that could benefit from data protection in Canada. At present, such clinical data are not within Canada’s existing data protection regime, which excludes data protection to previously approved pharmaceutical products or variations thereof.
However, it is uncertain whether Canada will adopt this provision. Under the TPP it appears to be an optional provision, while Canada has stated its existing laws and regimes for protection of clinical data are compliant.
For protection of undisclosed data for biologics, countries signing on to the TPP have a choice regarding the data protection that they provide to manufacturers of innovative biologics. Under the TPP “effective market protection” must be granted to undisclosed data for either five years or eight years following the first market approval for new pharmaceutical products that are or contain a “biologic”.
While Canada has not commented on which TPP option it will choose for biologics, both options appear to satisfy Canada’s existing regime of extending data protection to eligible “innovative drugs” under the Food and Drug Regulations. The TPP defines a 'biologic' as a product that is or contains a protein produced using biotechnological processes for use in humans for prevention, treatment or cure of a disease. As such, they appear to fall within the definition of an innovative drug under the Food and Drug Regulations, and thus are eligible for up to eight years of data protection.
Patent linkage and early working exception
The TPP also includes provisions analogous to Canada’s early working exception and regulatory regime for challenging pharmaceutical patents under the Patented Medicines (Notice of Compliance) Regulations.
However, no major changes to the regulations are expected as a result of the TPP. Canada has stated the TPP provisions for patent linkage and regulatory review exceptions reflect existing laws and regimes.
Issues for pharmaceutical stakeholders related to TPP application in Canada
Until ratification occurs, how Canada proceeds in implementing the TPP remains uncertain. The new minister of international trade has stated that the government is committed to holding a full and open public debate in Parliament and to ensure Canadians are consulted on the TPP.
Yet questions remain regarding the impact that the TPP will have on pharmaceuticals in Canada. For example, will the TPP apply to issued patents or will it apply only to patents issued after ratification? How will any enforcement provisions apply or change the law in Canada for pharmaceuticals, if at all? These questions cannot be answered without further clarification from the Canadian government.
John Norman, Kelly A McClellan, Justin Smith
This article first appeared in IAM. For further information please visit www.iam-media.com.