A Cost-Effective Approach to Protecting Innovation in Healthcare

healthcare-innovation

With healthcare costs expected to soon exceed twenty percent of the United States economy, the healthcare industry represents fertile ground for innovation. From medical devices and pharmaceuticals to methods for managing patient data, new technologies continue to improve patient care and outcomes. Such innovation is vital for ensuring that the healthcare industry continues to meet the demands of aging populations in the 21st century.

Patent protection is a vital component for ensuring the progress of such innovation in healthcare. Patents provide a limited monopoly to make, use, and sell an invention for a definite time period. In exchange for the grant of this monopoly, and only after filing a patent application, inventors are required to share their invention with the public. This mandatory disclosure fosters further innovation by freely disseminating new discoveries and information. At the same time, patent protection encourages investment in research by providing rights holder’s assurances that their efforts will be rewarded.
In this regard, the decision of whether to file a patent application must be made at very early stages of product development. Indeed, to ensure that rights are adequately protected abroad, a patent must be filed before any public disclosure or offer for sale of an invention. Thus, the decision to file a patent application is typically made before a product and its market have been fully validated.

Fortunately, a sound patent filing strategy can greatly reduce the costs and risks associated with protecting an invention. One often under-utilized patent protection tool is the provisional patent application. If used properly, the unique characteristics of this type of patent application can offer significant benefits in a cost-effective package.

So what is a provisional patent application?

Unlike non-provisional patent applications, provisional patent applications are never examined by the Patent Office. A provisional patent application merely serves, therefore, as an inventor’s “stake in the ground.” While a provisional application will confer priority rights to any invention disclosed in the application, unless additional action is taken, the mere filing of a provisional patent application will never result in a granted patent. In order to benefit from the priority rights obtained by filing a provisional patent application, one or more non-provisional patent applications that claim priority to the provisional patent application must be filed within 12 months of filing a provisional patent application. If a non-provisional application claiming priority to the provisional patent application is not filed within this 12-month window, the provisional patent application and the priority rights associated with it will lapse, and the provisional application’s disclosure will remain confidential.

Provisional patent applications can offer several strategic benefits. For example, an invention disclosed in a provisional patent application can be marked as “Patent Pending” once a provisional patent application is filed. Marking an invention “Patent Pending” can provide a competitive edge when marketing and also act to deter market entry by a potential or known competitor. Furthermore, because provisional patent applications can serve as the basis for both domestic and foreign patent applications, decisions about international patent strategies may be postponed until a product and market have been more fully validated. Notably, the 12-month placeholder provided by filing a provisional patent application does not count against the term of a subsequently filed non-provisional patent application.

Provisional patent applications can also limit costs in a number of ways. First, provisional patent applications allow one to delay filing non-provisional patent applications, thereby postponing the expenditures associated with such filings. And, if the invention disclosed in a provisional application proves to be unprofitable before the deadline for filing a non-provisional application, those expenditures can be entirely avoided. Second, provisional patent applications do not need to comply with many of the formalities associated with non-provisional patent applications, thereby lowering costs. For instance, provisional patent applications can be filed with informal illustrations or photographs rather than formal patent drawings. Third, because provisional patent applications are not reviewed by the Patent Office, the governmental filing fee for filing a provisional patent application is only about one-fourth of the fee for filing a non-provisional patent application.

While provisional patent applications have relatively fewer requirements, care must be exercised to ensure that they adequately protect an invention. The timing, terminology, and subject matter of a provisional patent application can significantly influence its scope and impact.