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Combination products offer companies new directions for drug patent innovation.
Medicine has become more personalized over the past generation, and this has affected the drug patent system. One major trend has been the growth of combination products. These may mix biologics, small-molecule drugs, and even medical devices in order to optimize patient treatment.
These are complex products, and patents can be accordingly complex. Ideally, developers of combination products should strive to create a legal “picket fence” around core technology. This requires patenting individual components of the combination product as well as the product as a whole.
Fixed-dose combination products were relatively rare in the 1980s, with only 12 such products being approved that decade. In the first decade of the 2000s, however, there were 59 approvals of fixed-dose combination products. In a study that covered the period from 1980 through 2012, fixed-dose combination products that were not new molecular entities entered the market at a median of 5.43 years after initial FDA approval of the individual ingredients in the combination.
Such products entered the market at a median of 2.33 years before approval of a generic for any single active ingredient. The result was the addition of a median 9.70 years to the patent exclusivity of the individual active ingredients in the combination products. Here are some recommendations concerning drug patent strategy and combination products for pharmaceutical investors.
Specialized Legal Counsel Recommendations for Combination Products
Combination products are more complex than products with single active ingredients, and therefore drug patent concerns are more complex as well. It is imperative that companies creating these products enlist the help of drug patent counsel with specific experience in combination products.
A team of drug patent attorneys may be the best strategy, as long as they work together to fully execute patents for each component of the combination product. It may not be easy to assemble a team of patent attorneys for this task but doing so is increasingly necessary in order to maximize the quality and strength of the drug patent portfolio.
Combination Products Can Strengthen Patent Portfolio
That said, drug patents for combination products can strengthen a patent portfolio, helping companies secure venture capital and making companies more appealing for inter-company collaborations. The path to market for combination products is longer, less direct, and more expensive than for single-ingredient products, and without good drug patent protection, bringing a combination product to market may ultimately be seen as not worth the investment of time and effort.
Keen understanding of drug patents for combination products is considered a strong advantage by venture capitalists.
Likewise, companies that create combination products should explore and understand regulatory pathways as early in the establishment of the company as possible. This can make the company a stronger candidate for acquisition if that is the path the company wants to pursue. Acquirers are often ready to pay a premium for a company that has minimized its risk and charted a smart path toward approval.
Patenting Individual Components as Well as Combination Products
Even before the development of combination products, companies should perform freedom-to-operate searches on each component of the product to discover any third-party patents beforehand. Companies should also explore copyrights, trademarks, and assignments of intellectual property ownership, as well as legal opinions on non-infringement.
The strongest drug combination patent requires comprehensive coverage of each component of the product, as well as the whole product. Patent claims should be directed at compounds, diagnostics, therapeutics, use, manufacture, and methods of treatment. Moreover, portfolio development should include patenting of incremental technology improvements to increase protection of the core technology.
Ownership Rights in Joint Partnerships
Collaboration can help bring combination products to market, but ownership issues may arise. If one company claims ownership of one component and a partner company claims ownership of another component, then who claims ownership of the final combination product? It is important for any companies working in partnership to establish early on what rights each party will have related to the final combination product, and what rights each party would retain should the collaboration be terminated.
Approval of fixed-dose combination products has increased over the past few decades and is expected to continue to increase. Companies that take a comprehensive view of patenting individual components of combination products, patenting components as well as the final combination products, and who are careful to establish ownership rights early in partnerships with collaborator companies stand to develop the strongest drug patent portfolios. Doing this typically requires assembling a legal team with expertise in various aspects of drug patent protection so that patents are strong enough and last long enough for development of combination products to be worthwhile.