Protection

Your guide to navigating the complex roadmap of protecting your intellectual property

In the U.S., a patent gives the holder the right to exclude others from making, using, selling, offering to sell, and importing the patented invention. A patent does not necessarily provide the holder any affirmative right to practice a technology since it may fall under a broader patent owned by others. Instead, it provides the right to exclude others from practicing the invention.  Patent claims are the legal definition of an inventor’s protectable invention.

Under U.S. law, an inventor is a person who takes part in the conception of at least one idea in at least one claim of a patent application. Thus, inventorship of a patent application may change as the patent claims are changed during prosecution of the application. An employer or person who only furnishes money to build or practice an invention is not an inventor. Inventorship is a legal issue and may require an intricate legal determination by the patent attorney prosecuting the application.

Patents and Patentability

Patent applications are generally drafted by a patent attorney or a patent agent (a non-attorney with a science education licensed to practice by the PTO). The patent attorney generally will interview you about the invention before drafting the application.  During this interview the attorney will ask several questions, such as how the invention was made, different ways of making and using the invention, etc.  After the application is drafted, the attorney will provide you with an opportunity to review the application and provide comments before it is filed.  The attorney will  also ask you questions about inventorship of the application claims. At the time an application is filed, the patent attorney will ask the inventor(s) to sign an Inventor’s Declaration and an Assignment.  The Declaration is required by the USPTO and provides evidence that you are indeed an inventor of the submitted application.  The Assignment document assigns ownership of the invention to Duke and places you under Duke’s patent policy.

Generally, in about 1-3 years (time depends on the technology and/or if the application was filed as a PCT application), the patent attorney will receive written notice from the PTO Examiner as to whether the application and its claims have been accepted in the form as filed. More often than not, the PTO Examiner rejects the application because either certain formalities need to be cleared up, or the claims are not patentable over the “prior art” (anything relating to the novelty or obviousness of the invention that is available in the public domain before the priority date of the patent application). The letter sent by the PTO Examiner is referred to as an Office Action or Official Action.

Patentable subject matter includes processes, machines, compositions of matter, articles of manufacture, and methods (including methods of making and/or using a composition or article of manufacture).  If in the Office Action the application is rejected, the patent attorney must file a written response, usually within three to six months. Generally the attorney may amend the claims and/or point out why the PTO Examiner’s position is incorrect. This procedure is referred to as patent prosecution. Often it will take two or more PTO Official Actions and responses by the patent attorney before the application is resolved. If the PTO Examiner agrees with the arguments and/or amendments to the claims made by the attorney, the Examiner will issue a Notice of Allowance; in other words, the PTO Examiner agrees to issue a patent. Importantly, the PTO Examiner may allow all, some or none of the claims.  During the patent prosecution process, input from the inventor(s) is often needed.  Such input may include confirming the patent attorney’s understanding of the technical aspects of the invention and/or the prior art cited against the application and/or providing scientific input in the form of a declaration to be submitted to the PTO Examiner and/or supporting experimental results. The PTO holds patent applications confidential until published by the PTO, 18 months after initial filing.

Types of patents

In many circumstances, U.S. provisional patent applications provides a tool for preserving patent rights while temporarily reducing costs. The provisional patent is valid for 12 months and is not examined or published during that period.  As a result, the provisional patent application does not adhere to the same requirements as a formal utility patent application, such as requiring claims, formal drawings, etc.  A regular utility U.S. application and related foreign applications must be filed within one year of the provisional application in order to receive its early filing date. However, an applicant only receives the benefit of the earlier filing date for material that is adequately described and enabled in the provisional application. As a result, the patent attorney may need your assistance when an application is filed as a provisional.

Foreign patent protection is subject to the laws of each individual country, although in a general sense the process works much the same as it does in the United States. In foreign countries, however, an inventor will lose any patent rights if he or she publicly discloses the invention prior to filing the patent application. In contrast, the United States has a one-year grace period.  It should be noted that under the America Invents Act that took effect in March 2013, the U.S. is now a first-inventor-to-file system.  While the grace period still exists (i.e., your own disclosure will not be considered prior art for 1 year after the disclosure), a third-party can independently file during the grace period and create a patent bar for your invention.

Although an international patent does not exist, an international agreement known as the Patent Cooperation Treaty (PCT) provides a streamlined filing procedure for most industrialized nations. For U.S. applicants, a PCT application is generally filed one year after the corresponding U.S. application (either provisional or regular) has been submitted. The PCT application must later be filed in the national patent office of any country in which the applicant wishes to seek patent protection, generally within 30 months of the earliest claimed filing date.

The PCT provides two advantages:

  1. First, it preserves foreign rights while delaying the need to pay costly foreign application fees at the time of filing. This offers an applicant the opportunity to further develop, evaluate and/or market the invention for licensing.
  2. Second, the international preliminary examination often allows an applicant a glimpse to what the prior art landscape looks like and the types of arguments that might be made during the prosecution stage.

An important international treaty called the Paris Convention permits a patent application filed in a second country (or a PCT application) to claim the benefit of the filing date of an application filed in a first country. However, pursuant to this treaty, these so-called “convention applications” must be filed in foreign countries (or as a PCT) within one year of the first filing date of the U.S. application.

Public Disclosures

Public Disclosures

A public disclosure happens if the claimed invention is patented, described in a printed publication, or in public use, on sale, or otherwise available to the public (e.g., posted online, placed in a library, etc.) before the effective filing date of the claimed invention. As a result, your public disclosure may lead to prior-art for your own invention.

  • In all countries other than the United States, once something is publicly disclosed, it cannot be patented – absolute novelty is required.
  • As described earlier, in the United States, there is a one year “grace period” after public disclosure for a patent application to be filed

How can the need to publish be balanced with protecting patent rights?

  • Contact OLV early and often!
  • Protect “patentable” information under confidentiality agreements.
  • Manage the timing of patenting vs. publishing/disclosing

Providing OLV with too much information early is better than too little, too late!

Patenting Costs and Timeline

Patent Expenses:

The cost of a patent application can vary depending on a number of factors such as complexity of the invention, length of the application, requirement for translations etc. Generally, filing a regular U.S. patent application may cost between $10,000 and $20,000. To obtain an issued patent may require an additional $10,000 to $15,000 for patent prosecution. Filing and obtaining issued patents in other countries may cost $25,000 or more per country. Also, once a patent is issued in the U.S or in foreign countries, certain maintenance fees are required to keep the patent alive.  In the U.S., maintenance fees are due 3.5, 7.5 and 11.5 years after the issue date.  In foreign countries, fees are due every year (annuity fees).  In both cases, the fees increase each year after filing.

Timeline:

Currently, the average U.S. utility patent application is pending for about two-three years, though inventors in the biotech and computer fields should plan on a longer waiting period. Once a patent is issued, it is enforceable for 20 years from the initial filing of the utility application that resulted in the patent.  The patent term may be extended in certain cases, such as USPTO delays during patent prosecution and delays by the FDA during the regulatory process. For foreign patents, the patent is enforceable 20 years from the filing date of the PCT application. U.S. patents that derived from a PCT application also are enforceable for 20 years from the filing date of the PCT application.  Enforceability in any of the above cases is dependent on all patent office-mandated fees being timely paid and no adverse legal decisions from a competent Court.

Patent protection is often a requirement of a potential commercialization partner (licensee) because it can protect the commercial partner’s often sizable investment required to bring the technology to market. Due to their expense and the length of time required to obtain a patent, patent applications are not possible for all University intellectual property. We carefully review the commercial potential for an invention before investing in the patent process. However, because the need for commencing a patent filing usually precedes finding a licensee, we look for creative and cost-effective ways to seek early protections for as many promising inventions as possible.