Introduction
Biopharmaceutical patents are a critical component of the pharmaceutical industry, providing protection for innovative drugs and therapies. In Australia, the patent system offers specific provisions and challenges for biopharmaceutical patents. Here, we delve into the key insights for patentability, enforceability, and the scope of claims for these patents.
Patentability of Biopharmaceuticals
Eligibility for Patent Term Extensions (PTEs)
Under Australian patent law, biopharmaceutical patents can be eligible for a Patent Term Extension (PTE) of up to five years. This extension is granted to compensate for the lengthy regulatory approval process involved in bringing new pharmaceutical substances to market. To qualify, the patent must claim a pharmaceutical substance per se or a substance produced by recombinant DNA technology, and the goods containing this substance must be included in the Australian Register of Therapeutic Goods (ARTG) at least five years after the effective date of the patent[1][4].
Novelty and Inventive Step
For a biopharmaceutical patent to be granted, the invention must meet the standard criteria of novelty and inventive step. This means the substance or process must be new and not obvious to a person skilled in the art. The 'Raising the Bar' Act of 2012 aligned Australian patentability requirements with European standards, emphasizing support and enablement in the patent specification[3].
Enforceability of Biopharmaceutical Patents
Challenges to PTEs
Challenging the validity of PTEs has become a common tactic for generic pharmaceutical companies to avoid infringement liability. Recent Federal Court decisions, such as those involving Novartis, Biogen, and Merck Sharp & Dohme, highlight the complexities and vulnerabilities of PTEs. These decisions underscore the importance of carefully aligning the 'pharmaceutical substance per se' claimed in the patent with the product listed in the ARTG[2].
Regulatory Approval and ARTG Listing
The goods on which the PTE is based must contain or consist of the 'pharmaceutical substance per se' claimed and disclosed in the patent specification. The application for a PTE must be made within six months of the earliest inclusion in the ARTG or the grant of the patent, whichever is later. This strict timeline and the necessity for regulatory approval add layers of complexity to the enforcement of these patents[1][4].
Scope of Claims for Biopharmaceutical Patents
Pharmaceutical Substances Per Se
Claims for pharmaceutical substances must be unqualified by process, temporal, or environmental components to be eligible for a PTE. This means that product-by-process claims, unless involving recombinant DNA technology, are generally not eligible. However, in some cases, a substance can be defined by reference to a process if its chemical structure or composition is undetermined[1].
Pharmaceutical Compositions
Pharmaceutical compositions, such as formulations comprising a specified amount of an active ingredient and other components, can also be eligible for PTEs if they provide a physico-chemical interaction within the human body. Recent court decisions have clarified that the earliest Australian regulatory approval date of any pharmaceutical substance disclosed and claimed in the patent is crucial, regardless of whether the substance was developed by the patentee or a competitor[1].
Antibody Patents
For biopharmaceutical companies, claiming antibodies can be challenging. Claims can be broad if they reference previously unknown targets (antigen or epitope). For example, 'An antibody that specifically binds epitope A' can be allowed if the specification discloses the epitope and shows that antibodies can be raised against it. This approach is considered fully enabled if the specification provides sufficient detail to perform the invention without undue burden[3].
Practical Implications
Patent Strategy and Product Listing
Innovators must carefully consider their patent strategy to ensure alignment between the 'pharmaceutical substance per se' disclosed and claimed in the patent and the product on which the PTE is based. Discrepancies can lead to challenges and potential invalidation of the PTE[2].
International Differences
Australia's PTE provisions have unique nuances compared to other jurisdictions. Patentees should be aware of these differences to navigate the global patent landscape effectively[2].
Recent Court Decisions and Their Impact
Ono Pharmaceutical Co. Ltd and Merck Sharp & Dohme Corp.
The Full Federal Court decisions in Ono Pharmaceutical Co. Ltd and Merck Sharp & Dohme Corp. have clarified that the first regulatory approval date of any pharmaceutical substance disclosed and claimed in the patent is determinative for PTEs. This means that patentees cannot distinguish between their own goods and those developed by third parties when considering the basis for a PTE[1].
Novartis and Biogen Cases
The Novartis and Biogen cases illustrate the trend of generic pharmaceutical companies challenging PTEs to avoid infringement liability. These challenges highlight the need for robust patent strategies and meticulous compliance with regulatory requirements[2].
Key Takeaways
- Eligibility for PTEs: Biopharmaceutical patents can be extended by up to five years if they claim a pharmaceutical substance per se or a substance produced by recombinant DNA technology, and meet specific regulatory approval criteria.
- Challenges to PTEs: Generic companies often challenge PTEs, emphasizing the need for careful patent strategy and alignment with ARTG listings.
- Scope of Claims: Claims must be unqualified and based on the 'pharmaceutical substance per se' or specific formulations providing physico-chemical interactions.
- Antibody Patents: Broad claims for antibodies are possible if they reference previously unknown targets and meet enablement requirements.
- International Considerations: Australia’s PTE provisions differ from other jurisdictions, requiring tailored patent strategies.
FAQs
What is the maximum duration of a Patent Term Extension (PTE) for biopharmaceutical patents in Australia?
The maximum duration of a PTE for biopharmaceutical patents in Australia is up to five years, extending the total patent term to up to 25 years[1][4].
What are the key requirements for a biopharmaceutical patent to be eligible for a PTE?
To be eligible for a PTE, the patent must claim a pharmaceutical substance per se or a substance produced by recombinant DNA technology, and the goods containing this substance must be included in the ARTG at least five years after the effective date of the patent[1][4].
Can product-by-process claims be eligible for a PTE?
Generally, no. Product-by-process claims are not eligible unless they involve recombinant DNA technology. Claims must be to the pharmaceutical substance per se[1].
How do recent court decisions impact the enforceability of PTEs?
Recent court decisions, such as those involving Ono and Merck Sharp & Dohme, have clarified that the first regulatory approval date of any pharmaceutical substance disclosed and claimed in the patent is determinative for PTEs. This has made PTEs more vulnerable to challenges by generic companies[1][2].
What is the significance of the Australian Register of Therapeutic Goods (ARTG) in PTE applications?
The ARTG listing is crucial as the goods on which the PTE is based must contain or consist of the 'pharmaceutical substance per se' claimed and disclosed in the patent specification. The application for a PTE must be made within six months of the earliest inclusion in the ARTG or the grant of the patent, whichever is later[1][4].
Sources
- Spruson & Ferguson, Pharmaceutical patent term extension in Australia, 2023.
- Allens, Patent term extensions under siege: a new era of challenges for pharmaceutical patentees, 2024.
- Allens, Antibody patent protection in Australia, 2022.
- IP Australia, Pharmaceutical Patents Review, 2012.
