Introduction to Patent Filing in Chile
When considering the protection of biopharmaceutical patents in Chile, it is crucial to understand the specific requirements and regulations governing patent filing, enforceability, and the scope of claims. Here are the key insights to guide you through the process.
Patent Filing Requirements
Documents Needed for Filing
To file a patent application in Chile, particularly under the PCT national phase, several documents are mandatory:
- Applicant and Inventor Details: Full particulars of the applicant and inventor, including name and address. If these details differ from those in the PCT publication, form PCT/IB/306 must be submitted[1].
- Title and Description: A Spanish description of the invention, including claims and drawings.
- Abstract: An abstract of the invention.
- Biological Material and Sequence Listing: Details of the deposit of biological material and sequence listing, if applicable[1].
Power of Attorney
While not mandatory, submitting a Power of Attorney is highly recommended to avoid formal office actions[1].
Patent Term and Maintenance
Duration of Protection
In Chile, patents are protected for a term of 20 years from the date of application. This applies to both product and process patents. For designs and utility models, the protection period is five years (quinquennium) and ten years (decennium) respectively[1].
Maintenance Fees
To maintain the patent, annual maintenance fees must be paid. Failure to pay these fees results in the abandonment of the application. Upon payment of the final registration fees within a 60-working-day period after the application is accepted, INAPI (the local patent office) issues the Official Certificate of Registration[1].
Patentability Requirements
Legal Framework
Pharmaceutical patents became patentable in Chile in 1991 through Law 19.039. This law provided patent protection for both products and processes, initially with a statutory patent life of 15 years from the date the patent was granted. However, this was later amended to 20 years from the application date to align with TRIPS and other international agreements[3].
Primary and Secondary Patents
Foreign pharmaceutical companies often employ a strategy of filing both primary and secondary patents. Primary patents cover the active ingredient, while secondary patents cover modified compounds, formulations, dosages, and specific medical uses. In Chile, there is a significant ratio of primary to secondary patents, with secondary patents dominating older therapeutic classes like anti-ulcer and anti-depressants[2][4].
Enforceability of Patents
Regulatory Exemptions
Chile recognizes the Bolar exemption, which allows for the preparation of generic pharmaceuticals before the expiration of a previous patent, provided it is for the purpose of submitting testing data to a regulatory agency. The new IP Law extends this exemption to include acts performed in a private manner without commercial reasons and purely experimental acts[5].
Patent Information and Regulatory Approval
Unlike in some other countries, patent information is not requested or verified when marketing approval is granted by the health authorities in Chile. This means that the regulatory approval process does not depend on the patent status of the drug[3].
Scope of Claims
Claim Construction
The scope of claims in a biopharmaceutical patent is crucial for determining the extent of protection. Claims must be clear, concise, and supported by the description. In Chile, the claims must be translated into Spanish and must align with the international standards for patent claim construction[1].
Data Exclusivity
Apart from patent protection, Chile offers data exclusivity for new chemical entities. This provides a five-year exclusivity period for the data related to the safety and efficacy of new drugs, preventing generics companies from using this data during this period. This helps avoid the duplication of expensive and time-consuming clinical trials[3].
Challenges and Strategies
Secondary Patents and Patent Term Extensions
Secondary patents are often used to extend the patent protection period. In Chile, these patents are filed over several years following the original primary patent, after the protected active ingredient has obtained market approval. This strategy is effective in extending the patent term and maintaining market exclusivity[2].
Matching Patents with Products
The Chilean Intellectual Property Office (INAPI) and the National Public Health Institute (ISP) maintain databases that link registered drugs to their corresponding patents and trademarks. This helps in identifying the IP protection associated with each product, with a significant proportion of products and active ingredients being associated with some form of IP protection[4].
Expert Insights and Statistics
Industry Practices
Industry experts note that the use of primary and secondary patents is a common strategy among multinational pharmaceutical companies in Chile. This is reflected in the data showing that 78% of the matched patents are secondary patents, indicating a significant reliance on these to extend patent protection[4].
Statistical Overview
Of the 2,630 distinct active ingredients registered in Chile, 322 match to at least one Chilean patent, with 113 identified as primary patents and the remaining 78% as secondary patents. This highlights the prevalence of secondary patents in the pharmaceutical sector[4].
Key Takeaways
- Patent Filing: Ensure all necessary documents, including Spanish translations, are submitted.
- Patent Term: Patents are protected for 20 years from the application date.
- Maintenance Fees: Regular fees must be paid to maintain the patent.
- Primary and Secondary Patents: Secondary patents are widely used to extend protection.
- Regulatory Exemptions: Bolar exemption allows for generic preparation before patent expiration.
- Data Exclusivity: Five-year exclusivity for new chemical entities to prevent data duplication.
FAQs
What documents are required for patent filing in Chile?
For patent filing in Chile, you need to submit the applicant’s and inventor’s full particulars, the title of the invention, a Spanish description with claims and drawings, an abstract, and details of biological material or sequence listing if applicable[1].
How long is the patent term in Chile?
The patent term in Chile is 20 years from the date of application[1].
What is the Bolar exemption in Chile?
The Bolar exemption in Chile allows for the preparation of generic pharmaceuticals before the expiration of a previous patent, provided it is for the purpose of submitting testing data to a regulatory agency[5].
How does data exclusivity work in Chile?
Data exclusivity in Chile provides a five-year period during which generics companies cannot use the safety and efficacy data submitted for the approval of new chemical entities[3].
What is the significance of primary and secondary patents in Chile?
Primary patents cover the active ingredient, while secondary patents cover modified compounds, formulations, dosages, and specific medical uses. Secondary patents are used to extend the patent protection period and dominate older therapeutic classes[2][4].
Sources
- PatHUBlatam - Patent filing in Chile: All you need to know
- NBER - An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile
- WIPO - Committee on Development and Intellectual Property (CDIP)
- WIPO - Committee on Development and Intellectual Property (CDIP) - Introduction
- European Union Intellectual Property Helpdesk - New IP law in Chile (I): main changes in the patent system
