As 2013 approaches, some major changes to the patent system will soon take effect. The U.S. patent system will effectively change from a “first-to-invent” system to a “first-to-file” system. This will have a significant impact on the way that patent-dependent companies, such as bioscience companies, do business. Following are six issues such companies should consider.

1. Provisional applications. A provisional patent application is a placeholder patent application that does not have to include patent claims and is not examined by the United States Patent and Trademark Office. A provisional patent application expires within one year of its filing and must be converted to a regular utility patent application. Provisional applications are quite useful for bioscience inventions, where publications or presentations can require the early filing of an application and time precludes the preparation of a regular utility application.
2. Enablement. A provisional patent application can be useful for obtaining an effective filing date for a bioscience invention. To be useful, the provisional application must sufficiently describe the invention such that that the claims that are eventually filed with the utility application are supported. Applicants must take care during preparation of provisional applications to ensure the disclosure is enabling for what ultimately will be claimed. Although claims are not necessary for provisional applications, the drafting of at least one broad claim will help to focus attention on what information and data should be included in the provisional application. Also, the provisional application should provide some attention to alternative embodiments. Applicants should avoid filing narrow provisional applications with only specific test results and describing perhaps only one embodiment.
3. The first-to-file impact of the AIA. The America Invents Act (AIA), enacted in 2011, implements the change from a first-to-invent to a first-to-file system for patent applications filed on or after March 16, 2013. The time from discovery to filing of a patent application will have serious consequences, as interference proceedings will no longer be available to award later filed patents to the first to invent. Instead, the patent will be awarded to the first to file.
4. Disclosure programs. Prompt invention disclosure will be a key to reducing the discovery-to-filing timeline. Employees must be educated as to the importance of a prompt disclosure of inventions. Companies should review disclosure forms and procedures to encourage prompt disclosure. For example, companies should ensure that disclosure forms do not require inordinate amounts of time to complete and are easy to understand and fill out. Employee incentive programs for invention disclosures can be useful.
5. Invention review procedures. Many organizations have lengthy invention disclosure procedures aimed at controlling costs by requiring approvals and sometimes multiple approvals prior to filing patent applications. A streamlined procedure that shortens the approval timeline will now be desirable.
6. Application filing programs. Companies should implement filing programs that will expedite the time from disclosure to filing. Provisional applications can be filed as a prelude to a more complete, and more time-consuming, utility applications and to provide some protection prior to more lengthy invention review procedures and assignment to outside counsel for preparation of a utility application. Companies should hold outside counsel to timelines for filing patent applications promptly, and companies should instruct employee-inventors to assist counsel in meeting these timelines.

The AIA is profoundly changing the patent system. As with most statutory changes, being prepared for the changes will help to ensure that the changes work for the company rather than against it.