Introduction
Patent protection is a crucial aspect of the biopharmaceutical industry, as it ensures innovation and investment in new treatments. In Jordan, the patent landscape is evolving, with specific regulations and practices that affect the patentability, enforceability, and scope of claims for biopharmaceutical patents.
Patentability of Biopharmaceutical Inventions
Eligible Subject Matter
In Jordan, biopharmaceutical inventions can be patented if they meet the criteria of novelty, non-obviousness, and industrial applicability. However, certain types of claims are subject to specific rules. For instance, method of treatment or medical use claims are not allowed in the traditional sense, but first and second medical use claims can be filed using the EPC 2000 ‘compound for use’ format[4].
Natural Products and Isolated Substances
Biopharmaceutical patents often involve natural products or isolated substances. In line with international standards, Jordanian patent law would likely follow the principle that isolated and purified natural substances can be patentable if they display "markedly different characteristics" compared to their naturally occurring counterparts[3].
Antibody Claims
Antibody-based treatments are a significant area in biopharmaceuticals. In Jordan, antibody claims would need to be carefully drafted to ensure patent eligibility. Claims directed to specific methods of treatment using specific compounds at specific doses are more likely to be patent-eligible. Additionally, claims that define antibodies by functional limitations may meet the written description requirement if a diverse set of exemplary antibody species is disclosed in the specification[3].
Enforceability of Biopharmaceutical Patents
Patent Term and Exclusivity
Biopharmaceutical patents in Jordan are valid for 20 years from the date of filing the application, subject to the payment of prescribed annuity fees starting from the second year. This term ensures a period of exclusivity for the patent holder to recoup their investment in research and development[5].
Bolar Exception
The Jordanian Patent Law includes the Bolar exception, which allows firms to develop and test generic drugs during the period of market exclusivity. This provision is crucial for ensuring timely delivery of generic drugs upon patent expiry and does not hinder the enforceability of the original patent but rather ensures a smooth transition to generics[2].
Data Exclusivity
While data exclusivity is not directly related to PCT accession, it is an important aspect of pharmaceutical patent protection. However, in Jordan, data exclusivity is not a significant factor in the patentability or enforceability of biopharmaceutical patents, as it is more relevant to regulatory approvals rather than patent law[1].
Scope of Claims
Claim Drafting and Format
The Jordanian Patent Office does not check the suitability of the claims format at the time of filing. Instead, it adopts the European allowed claims without any restrictions. This means that claim drafting can follow international standards, and any claims format, including method of treatment claims, can be filed and amended during the pendency of the application[4].
Divisional Applications
Divisional applications can be filed at any time until the acceptance of the parent application. These applications must be derived from the parent application and must be compatible with the number of counterparts. This allows for a broader scope of protection by enabling the filing of multiple related inventions[4].
Double Patenting
Although there are no written restrictions for double patenting in Jordan, the Jordanian Patent Office relies on European examinations to decide whether to grant the application. This indirect implementation of European restrictions means that overlapping claim scope, especially identical claim scope, would be scrutinized to avoid double patenting[4].
Impact of PCT Accession
Streamlined Process
Jordan's potential accession to the Patent Cooperation Treaty (PCT) would streamline the patent application process, allowing for a single international application to be filed, which can then enter the national phase in multiple countries. This could increase the efficiency and reduce the complexity of obtaining patent protection for biopharmaceutical inventions[1].
Concerns from the Pharmaceutical Sector
The pharmaceutical sector in Jordan has raised concerns that PCT accession could increase patent applications, potentially harming the domestic generic drug industry. However, these concerns are mitigated by the existing Bolar exception and the overall structure of Jordan's patent law, which balances innovation and generic drug development[1].
Regulatory Environment
Amendments and Enforcement
The Jordanian Patent Law is undergoing amendments to create more visibility on the patent landscape. These amendments, along with enhanced enforcement mechanisms, are designed to attract foreign investment and ensure better protection for both innovator and generic pharmaceutical companies[2].
International Cooperation
Jordan's participation in global innovation is significant, with Jordanian nationals filing national phase applications in various PCT member states. The country's engagement with international systems, such as the UPOV Act for plant variety protection, indicates a commitment to harmonizing intellectual property practices[1].
Key Statistics and Trends
Industry Concentration
Patents granted in Jordan are mostly concentrated in the pharmaceutical industry, organic chemistry, civil engineering, chemical engineering, and biotechnology. This concentration reflects the country's strong focus on these sectors and its active role in global innovation[1].
Generic vs. Patented Drugs
In Jordan, generic drugs account for nearly 50% of total sales, while patented drugs account for about 33%. This balance is supported by a strong local pharmaceutical industry and the Bolar exception, which facilitates the development and timely delivery of generic drugs[2].
Expert Insights
Legal and Regulatory Advice
Industry experts advise that the legal environment in Jordan is maturing in the right direction, with necessary laws and amendments being drafted and enforced to drive foreign investments and enhance enforcement. This includes tailored services and advice from intellectual property firms to navigate the complex landscape of biopharmaceutical patents[2].
Key Takeaways
- Patentability: Biopharmaceutical inventions are patentable in Jordan if they meet the criteria of novelty, non-obviousness, and industrial applicability.
- Enforceability: Patents are valid for 20 years, with a Bolar exception allowing for the development of generic drugs during the period of market exclusivity.
- Scope of Claims: Claims can be drafted following international standards, with the option for divisional applications and adherence to European examination standards.
- PCT Accession: Potential accession to the PCT could streamline the patent application process but raises concerns about the impact on the domestic generic drug industry.
- Regulatory Environment: The Jordanian Patent Law is undergoing amendments to enhance visibility and enforcement, supporting both innovator and generic pharmaceutical companies.
FAQs
Q: What is the patent term for biopharmaceutical patents in Jordan?
A: The patent term is 20 years from the date of filing the application, subject to the payment of prescribed annuity fees starting from the second year[5].
Q: Can method of treatment claims be filed in Jordan?
A: No, traditional method of treatment claims are not allowed, but first and second medical use claims can be filed using the EPC 2000 ‘compound for use’ format[4].
Q: How does the Bolar exception affect biopharmaceutical patents in Jordan?
A: The Bolar exception allows firms to develop and test generic drugs during the period of market exclusivity, ensuring timely delivery of generics upon patent expiry[2].
Q: What is the impact of PCT accession on the pharmaceutical sector in Jordan?
A: PCT accession could increase patent applications, potentially harming the domestic generic drug industry, but this is mitigated by the Bolar exception and existing patent law[1].
Q: Are antibody claims patent-eligible in Jordan?
A: Antibody claims can be patent-eligible if they are directed to specific methods of treatment or define antibodies by functional limitations with sufficient disclosure in the specification[3].
Cited Sources
- Jordan Accession to the Patent Cooperation Treaty (PCT): Impact Assessment - WIPO
- MENA: Evaluating Risks and Opportunities for Pharmaceutical Patenting - Sabaip
- Antibody Claims: Patent Eligibility and Written Description Issues - LexisNexis
- Summary of Prosecution: Jordan - Abu-Ghazaleh Intellectual Property (AGIP)
- FAQ - Abu-Ghazaleh Intellectual Property (AGIP) - AGIP
