The Patenting Process at Johns Hopkins Medicine

Patenting an invention out of Johns Hopkins Medicine is usually a complex process involving expertise from three disparate disciplines: (a) science, (b) law, and, because the University’s patenting efforts are undertaken to provide corporate entities with incentive to develop the technology, (c) business. These disciplines are not always natural partners: for example, science does not render law obvious, and not all patent claims are commercially relevant. Therefore, the preparation and prosecution of a strong JHU patent application requires collaboration between at least the inventors, Licensing and Technology Development (LTD) and LTD’s patent attorney. If the technology is licensed, input from the licensing company can be instrumental in securing commercially valuable rights.

The below Figure provides a schematic diagram of a typical patenting scenario.

The uppermost box of the Figure represents LTD’s filing of a Provisional Application at the United States Patent & Trademark Office (the April issue of this publication provides more information on provisional patent applications). Importantly, input from only the inventors and LTD are involved in this step of the overall process. The inventors’ Report of Invention (ROI) and any associated manuscripts provided to LTD will constitute the bulk of the provisional application. LTD may add written support for commercial aspects of the invention not covered in the ROI in either the form of a claim and/or descriptive paragraph(s).

In the event JHU decides to further pursue patent protection (usually based upon demonstrable commercial interest), a Utility Application is prepared and filed on or before the end of the provisional year. In this step, the emphasis of the collaboration with the inventors shifts to LTD’s chosen patent counsel. Usually the inventors’ manuscript is the starting point for the drafting process. Although the attorney does the actual writing and provides the utility application’s legal structure, significant technical consultation with the inventors is vital. No attorney, no matter how rigorous his or her scientific training (many of LTD’s attorneys hold PhDs), can know a particular technology to a level comparable with the JHU faculty, fellows, students or staff who invented it. If the invention is not yet licensed, LTD will communicate with the attorney and/or inventor to ensure coverage of the commercial embodiments of the invention. If the invention has been licensed, LTD’s review may focus on confirming that JHU’s interests have been adequately represented.

Once a utility application is filed at the USPTO, the timing of the next event in the patent process is out of JHU’s control. Depending upon the workload at the USPTO, the application may not undergo its first government review for months or even years.

Typically, the first review by the USPTO does not examine the merits of the application. Patent law states that each patent will be drawn to a single invention. In the biotechnology field, originally filed claims usually include what the patent office deems to be multiple inventions, e.g. nucleic acid, protein, antibody, methods of use. A Restriction Requirement from the USPTO demands that only one of these distinct inventions be elected for examination. JHU’s election is often based upon a combination of scientific (which invention is best supported by the current data?) and business (which invention is most commercially attractive?) considerations.

An Election in response to the restriction requirement sets the USPTO upon a fairly predictable clock. The USPTO’s Examiner will usually mail out a First Action on the patent application’ s merits within two-three months of his or her receipt of JHU’s election. The vast majority of applications are rejected at this point. Such “non-final” rejections (termed as such because the applicant is entitled to a rebuttal) will be based upon legal reasoning. In many cases, however, the roots of the government’s legal arguments are based in the Patent Examiner’s interpretation of the science. Therefore, a response strategy is best formulated with input from the inventors.

With few exceptions, JHU’s Response will either put the application in condition for Allowance, or the USPTO will issue a Final Rejection. Consideration of newly set forth issues is no longer an entitlement for the applicant at this stage of patent prosecution. Therefore, if finally rejected, JHU must seriously re-evaluate the application to determine whether the high expense of continued prosecution is warranted. If the application is allowed, it will issue as a patent at some reasonable future date. Upon issuance, JHU and its licensees will have the right to exclude others from practicing the invention covered by the allowed claims.

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