There is a time and place for expansive thinking. And then there’s a time and place where getting down to brass tacks and concentrating on one or just a few things pays off.
IP is no exception. It can be tempting to file patent applications on every new idea. But this broad approach can siphon off a great deal of resources and result in a platform that might be described as “a mile wide and an inch deep.”
Cost At the stage of filing provisional patents, this might not seem so bad. But what happens down the road? Converting a provisional application to a non-provisional for worldwide filings can run from the tens of thousands to more than a hundred thousand dollars in filing costs, apart from the attorney fees. Then there’s prosecution fees and costs for each of the countries down the road as well.
Support More practically, there’s the question of whether the multiple filings will get you where you want to be. To support a reasonable breadth of claims, say for example, to a family of therapeutic compounds, you will want working examples for the synthesis of representative structures and activity testing. After filing the provisional application, you will have 12 months to round it out with additional data before the PCT filing. If you have multiple applications going in multiple areas, will you have the resources to provide research support and experimental data for each application? Or near the 12-month mark, will you find yourself with many half-finished projects?
Landscape As the patent filings progress, you will want to shape your claims to cover your products, fend off competition and avoid prior art traps. For each of the projects you undertake, what is the IP landscape? What else is out there that will shape your ability to get patent protection in each area? Will you have freedom-top-operate or will a design-around or a licenses be necessary? Each of these investigations amounts to a substantial resource investment.
As ideas evolve from initial research to commercial products, consider a phased approach to focusing your IP protection.
- Type of protection Claims to a new drug product, a new method of treatment with a known drug or perhaps a platform technology that can be applied to may potential targets.
- IP landscape Who is your competition? What approaches are already covered by 3rd party IP and where is there “white space” for patent coverage?
- Resources Do you have sufficient research staff and budget allocated to perform the initial research and gather data that will support a patent filing? There may be materials or technical capabilities that will need to be acquired from 3rd parties to make headway.
- Timelines How long will the experiments take? Realistically map out what progress is feasible before the 12 month “clock” expires.
Later stage focus
As ideas progress pass the research stage and into more commercially-focused, development, a different twist on focus may be appropriate. Within the project at hand, how best to protect the asset with multiple layers of IP and when to lay down this protection to assure maximum strength and longevity?
For example, in development of a therapeutic, consider formulations, combinations with other active ingredients, combinations with diagnostics (for applicable patient populations and/or as a monitor for efficacy and safety) and treatment regimens (dosage, timing).
For a platform technology, the considerations may differ. For example, it may be important at the outset to establish the applicability of the platform to multiple targets. Once broad IP coverage is in place, focus may evolve to concentrate developing a subset of specific targets in-house while developing an out-license or partnership strategy for others.
Various trigger events may drive a focus on the what and when for patent filings.
- When will product be “fixed” as to components and materials? For instance, for a medical device, the final decisions on materials and design may trigger more focused filings.
- What is the timing of disclosures? Do you have a university collaborator who wants to publish or present the data at an upcoming conference? When will your innovation be visible to 3rd parties such as contract manufacturers or clinical sites?
- Where is the competition? Is a competitor’s activities or announcements a push towards an earlier filing date?
- When is your next funding cycle and do you want to have certain filings in place to show progress?
Applying focus can help prudently use resources to ensure sufficient IP protection for the innovations you choose to advance.