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Combination products are a key aspect of personalized medicine, offering more targeted treatment to patients
The era of personalized medicine approaches more closely with each passing day, and with it comes the growth of combination products, which blend small molecule drugs, biologics, and sometimes medical devices, and which together can improve treatment for patients.
Personalized medicine is exactly that: a way to provide patients with more specialized treatments that are more effective and safer, with fewer side effects. It presents challenges along with the opportunities. By the end of 2019, global sales of combination products are expected to reach $115 billion, and the growth is largely driven by an increase in patient populations in which chronic diseases like diabetes are more common.
Complex combination products naturally present developers with challenges when it comes to drug patents. For the promise of combination products to be fulfilled, developers must have a strong patent and regulatory strategy from the very beginning of the patent process.
The Importance of the Strategic Patent Portfolio
The combination product developer that starts out with a strong drug patent portfolio has an advantage in terms of things like securing funding from venture capitalists and being a more attractive partner for collaboration with other drug developers. The longer and more expensive the path to market will be for a combination product, the more important an initial, solid drug patent portfolio becomes. Otherwise, there will be little incentive to go to the trouble of bringing the product to market.
Combination drug innovators that are prepared to address regulations, drug patents, and reimbursement at the beginning of the drug development process are also better positioned for acquisition, should it come to that. Companies looking to acquire are ready to pay a premium for companies that are at lower risk due to being further along the path to approval.
Maximizing Protection for the Core Technology
The importance of conducting an FTO (freedom to operate) search on each component of the combination product cannot be overstated. Determining whether the company is free from third-party patents and can develop its product will save significant grief later on. An FTO search should include the following:
- Third-party patents
- Intellectual property assignments of ownership
- Legal opinions of potential invalidity
Only after these possibilities are thoroughly explored can the combination product be designed with minimum risk of infringement. Coverage of every component of the combination product should include patent claims based on compounds, manufacture, diagnostics, methods of treatment, and any other innovative aspect of the combined product. Patenting incremental improvements to the technology will provide additional protection to the core technology.
A team of patent specialists may be required when pursuing drug patents related to combination products.
Ownership Rights in Joint Ventures
If two companies work together on a combination product, with one claiming ownership of the device and the other claiming ownership of the drug, then who owns the combination product? This needs to be established at the beginning of the partnership, stating clearly the rights each party will have to the combination product and the rights each party retains once the collaboration ends. Drug patent rights may be assigned entirely to one party or split between the parties. Or, special licensing of patent rights may be used to prevent development of ownership disputes.
The Need for Specialized Patent Counsel
All these considerations point to the need for specialized drug patent counsel. Finding an experienced drug patent lawyer who knows how to handle each component of the combination product may be difficult because patent attorneys tend to specialize in medical devices, small molecule drugs, or biologics rather than all those categories. Therefore, it may be necessary to engage multiple patent attorneys to handle development of the combination product.
With combination products, the burden on the patent examiner can be great, and examiners may choose to issue restriction requirements in cases where applicants try to patent multiple combinations among small molecule drugs, devices, and biologics. In some cases, providing a prior art search to the patent examiner and requesting expedited examination from the Patent Office can relieve some of the search burden borne by patent examiners when combination products are developed. Whatever route a company or partnership takes, the necessity of experienced drug patent counsel can’t be overstated.
Much excitement surrounds the development of combination products that allow a more personalized and effective approach to medicine. However, those who develop combination products face big challenges both in terms of passing regulatory requirements and in terms of protecting intellectual property. Only when combination product developers prepare for both these big challenges from the outset can they expect the drug patent process to pan out as they want it to.