Assessment, Analysis and Patents

Researcher working in Purdue Drug Discovery lab.

The OTC IP managers assess all disclosures for feasibility of intellectual property protection and commercialization as described below.

Technology Assessment Process

The assessment process is depicted in the flow diagram on page 6. Success of any technology evaluation hinges on strong communication and full transparency in a disclosure between inventors and project managers, who help define an invention. The description of the invention is needed for the marketability and patentability analyses carried out by OTC and enable a preliminary determination of commercial viability of the technology. This process occurs within a six-month period, which starts when the Technology Disclosure Form submission is fully completed and signed by the inventor(s) and verified by OTC. If OTC and the Purdue inventor(s) arrive at a consensus to proceed with investment of additional resources, then the appropriate steps are taken for intellectual property protection, which for patentable inventions involves the preparation of the patent application(s).

Market Analysis

A variety of resources are employed to assess and project market size of the product or service derived from an invention. Industry representatives are consulted to assess the target industry’s interest and usefulness and feasibility of that market space. Other factors, e.g., regulatory hurdles, development investment levels and investment trends in a target industry(ies), are also considered.

Patent Analysis

While each technology is assessed for patentability, patent protection is not required for commercial viability in every industry. Confidential patentability opinions, territories to seek protection and portfolio analysis are considered in deciding if and where to seek patent protection.

Patent Process

After a decision to pursue patent protection is made, a patent attorney or agent is identified to prepare and file the patent application(s). Often a provisional application is filed to obtain a priority date describing the invention. The provisional application is not examined, it is a confidential document, and expires 12 months from the date of filing. As of March 2013, the U.S. patent law awards patents to the first inventor(s) to file, making early disclosure of inventions particularly important. Therefore, if time is short before an upcoming public disclosure, or when an innovation is to be made public, OTC can file a “stop-gap” provisional patent application before the full technology assessment is complete to help protect the invention and enable licensing managers to effectively market the technology. It should be noted that a “stop-gap” provisional patent application should be filed only as a last resort.

OTC uses a provisional patent application’s 12-month term to work with Purdue innovators to develop a marketing and licensing strategy. If the commercial potential of the technology appears to be strong, prior to expiration of the 12-month provisional term, OTC files either a U.S. non-provisional patent application and/or an international patent application under the Patent Cooperation Treaty (often referred to as a ‘PCT application’). In the case of an international application, 30 months after the initial filing (31 months in certain jurisdictions), additional "national stage" applications are filed in select countries and regions at additional expense.

Some time after the filing of a non-provisional patent application, examination of the filed patent application begins at the respective patent office, which can take one or more years. If the examination of the patent application is favorable, then the allowed claimed invention (referred to as ‘claims’) issues into a Letters patent. Each country requires an independent examination of a patent application in accordance with its own national patent laws. An invention described in a pending patent application is referred to as ‘patent pending,’ and an invention described in an issued Letters patent is referred to as ‘patented.’ The term of a U.S. Letters patent is 20 years from the filing date of the earliest non-provisional application. A U.S. Letters patent requires payment of maintenance fees at 3 ½, 7 ½, and 11 ½ years post-issuance to maintain enforceability of the patent rights. Non-U.S. countries require payment of annual fees (called ‘annuities’) to maintain pendency of pending patent applications and enforceability of issued Letters patents.

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