Intellectual Property Protection Useful Guides
To provide a manner in helping researchers become familiar with Intellectual Property Rights Protection, the following guides are given for consideration when undertaking a potential project with an outcome of being a highly patentable form of invention. Further questions can be sent to this email.
- Importance of Maintaining Records in Laboratory Notebooks.
- Laboratory Notebook Material Requirements.
- Laboratory Notebook Written Entry Records.
- Laboratory Notebook Storage and Safeguarding.
Patents and Public Disclosure
- Public Disclosure.
Importance of Maintaining Records in Laboratory Notebooks
It is essential to keep thorough records of experimental work in a laboratory notebook from the beginning and throughout the entire research process. It may prove highly important when filing patent applications in particular territories and for securing ownership of an invention.
In the case of the United States, when multiple patent applications for the same invention are submitted, two dates are determined following the first-to-invent system. Firstly, the date when the invention was conceived and secondly, the date when the invention was actually reduced to practice, i.e. when it was shown to work. The patent right, in this instance, is given to the inventor who was the first to reduce the invention to practice; or if it can be shown that the inventor has diligently pursued the project from the date of conception, this earlier date will be considered the date when it was all reduced to practice.
Laboratory Notebooks thereby help establish an exclusive permanent record for a given project undertaking/invention. It can be used as evidence or proof of inventorship when filing patent applications. Written entries in a laboratory notebook determine the date of conception of the invention and its reduction to practice.
Laboratory Notebook Material Requirements
Laboratory Notebooks will contain research invention records that are permanent, complete and continuous. Material requirements for laboratory notebooks are hence strictly followed.
- Use hardbound notebooks with numbered pages. Loose-leaf pages, ring-bound notebooks and folders are not acceptable to use because pages cannot be torn out or skipped through in the process. No page can be added or deleted.
- When making notes, always use permanent, waterproof ink.
Laboratory Notebook Written Entry Records.
Written entry records in the notebook are sufficiently detailed and clear to allow "someone skilled in the art" to recreate the work and to conduct additional work without the direct assistance of the original researcher.
These entries should be made on the same day as the event. If this is not possible, the information is recorded to indicate when the actual work was done.
All entries are signed and dated by the researcher with the complete date (to include year) specified.
It is particularly important to maintain a neat and organized laboratory notebook. The following are keypoints to bear in mind:
- Legibly record the date and complete details of a project. Planned experiments are described in detail or by reference to an approved protocol, standard operating procedure or method. Factual experimental results and analytical interpretations are included. Cross-referencing data to previous pages as appropriately needed is allowed.
- Data from recording instruments, drawings, photographs, autoradiographs, charts, computer-generated printouts should be permanently attached to a notebook page. Other larger file data such as DNA sequences files may be securely kept elsewhere but should be included in the notebook.
- All entries should be made consecutively. Do not skip any pages or leave large empty areas, when necessary, cross out and mark unused page sections to prevent entry recording at later dates.
- Do not erase and or use correction fluids/whiteouts to blot out data entries. If errors need to be corrected, strike one line through the incorrect data and state the correct data in the next following space provided. All crossed out items should be signed with initials and dated.
Laboratory Notebook Storage and Safeguarding.
When not in use, laboratory notebooks are stored in a secure location. In the likelihood of an unfortunate event (ex. fire, flood), it is recommended for researchers to prepare back-up copies of the laboratory notebook through secure photocopying or digital/electronic transfers then store at a separate location. Confidentiality measures should be preserved at all times to prevent unnecessary disclosure. There is prime importance in safeguarding the valuable research entries and documentation indicated in the laboratory notebook.
Patents and Public Disclosure
A patent is an exclusive right granted for an invention, which is a product or a process that provides a new way of doing something (inventive step), or offers a new technical solution to a problem in any field of human activity. The patent is a title of ownership and patent protection is granted for a limited period, usually 20 years. Once a patent expires, the protection ends, and the invention becomes part of the public domain, the owner no longer holds exclusive rights and it becomes available for commercial exploitation, free of charge, by others. For patent purposes, inventions are made in two stages:
- "Conception," which is the intellectual act of creating a complete inventive concept, including ideas for making the invention and methods of using it.
- "Reduction to practice" of the inventive concept. This is defined either as "constructive" reduction to practice (patent application), even though physical embodiment of the invention may not have been realized, or "actual" reduction to practice which involves making a physical embodiment of an invention (for example, a prototype), and using it successfully for its intended purpose.
Inventions that are eligible to hold patent rights and protection exemplify the following three characteristics:
- New or Novel: The invention must be demonstrably different from publicly available ideas, inventions, or products (so-called "prior art"). To establish novelty, a prior art search is done to determine whether there are issued patents, published articles or other published information capturing major features of the invention in question.
- Useful: The invention must have an application, benefit, utility or be an improvement over existing products and/or techniques.
- Non-Obvious: The invention cannot be obvious to a person skilled in the art; non-obviousness usually is demonstrated by showing that practicing the invention yields surprising, unexpected results.
The legal guidelines for patent protection currently differ between countries especially the United States. Patents applications and grants are distinct to each country, many countries operate under a "first to file" system, wherein the inventor who was the first to submit a patent application to the patent office will be the one entitled to obtain the patent grant. The United States, however, follows the "first to invent" system, where the patent grant is given to the true inventor of the invention and not necessarily the first to file an application for a patent.
No patent can be granted to an invention unless a formal application is submitted and accepted by the Patent Office. A patent application contains an abstract of the invention as well as sufficiently clear and complete description details of the substantial claims with necessary drawings/material to support and be carried out by a person skilled in the art.
The use of invention by a government agency or person authorized by the government shall assume effect in circumstances where public interest is concerned as shall be determined by the appropriate agency. (Technology Transfer Act).
Public disclosure is any transfer of information about an invention, written or oral, into the public domain or to any party not obligated to keep the information confidential. If it is “enabling,” a public disclosure immediately bars one from obtaining foreign patent protection. An “enabling” disclosure is where a person having ordinary skill in the art can perform the invention given sufficient information about it. In the case of U.S. patent applications, inventors are given one-year grace period from the date of the public disclosure, this is also known as the bar date.
Appropriate steps are therefore necessary to maintain valuable patent rights of an invention. Public disclosure of an invention significantly interferes with obtaining patent rights. Once publicly disclosed, an inventor immediately loses patent rights in countries operating under the "first to file" system.
The best way to protect patents prior to public disclosure is to contact the Technology Transfer Office (TTO). This is where they can be advised on suitable procedures to be undertaken. It is important to discuss what details can be publicly disclosed without interfering and hindering academic progress. It is highly recommended for all inventors to obtain a Non-Disclosure Agreement (NDA) as well as complete an invention disclosure form at the earliest time prior to outside negotiations.
One way of protecting patent ownership from enabling public disclosure is the Non-Disclosure Agreement (NDA). The NDA, also known as the Confidentiality agreement, aims to safeguard significant findings related to an invention that are made and shared with a company, an institution or varied individuals in the field. Confidentiality of invention is accredited by signing into legal terms and conditions agreed by upon by each party.
Apart from legally binding agreements, inventors are advised to prepare and completely submit invention disclosure forms for patentable invention candidates. Herein, the complete form includes identifying and informing pending scheduled disclosures (including a publication submission, a presentation of a poster, paper or abstract at a meeting, or meeting with a company). More importantly, specific invention details are fully stated and attached with the form to support pertinent claims in a patent application. All particular details shall be discussed and negotiated with the Technology Transfer Office (TTO).
Every person with access to information is bound to confidentiality under the terms and conditions set by involved parties and will apply for the identified inventions until advised otherwise. Once a patent application has been filed, inventors can more freely share and disclose information. However, in the earnest implementation of the Technology Transfer Act, freedom to do so can only be done once approved and ascertained by the appropriate authority and until the patent for entitled claims is granted.
The following public disclosures may limit patent guarantee rights:
- Written public disclosure includes published materials such as journal articles, abstracts, posters, manuscripts, book chapters and proceedings. It can also include demonstrations, exhibits, slides, other projected material, information which is distributed or discussed at non-confidential meetings, conferences, seminars or forums, private correspondence and catalogued graduate theses. Electronic transmission of grant proposals, abstracts, articles or research reports is also a form of publication or public disclosure. Descriptions of research projects on departmental or faculty websites may also constitute public disclosure.
- Oral public disclosure can include formal talks, meeting presentations, thesis defense, departmental seminars open to the public, broadcasts and press releases. Basically, oral public disclosures encompass any discussions where another party could take detailed notes that describe an invention.
Once patent right has been granted, public disclosure can reign for the benefit of the innovative invention to the society.
To summarize, the following steps are advised for each researcher planning to patent his invention:
- Contact the official Technology Transfer Office as early as possible to assist and guide you through the process of securing patent rights to an innovative invention. The future invention considered at hand shall be discussed and crucially determined as to the relatively likelihood and successful chance of entitlement and patent ownership.
- Once given designation and directives, the Inventor(s) shall complete and submit invention disclosure forms with supporting documentation to the TTO. This step is important as it establishes “inventorship” and the date of invention.
- The TTO review the invention disclosure form to note any deadlines and/or public disclosures that may impact the invention's patentability. In addition, related grant requirements, material transfer agreements, rights of private research sponsors and other ownership issues are also given due attention.
- After critical review, Invention Disclosures are sent for evaluation to a patent attorney. Any imminent and set public disclosure dates (conference presentations, imminent publications, etc.) must be provided.
- The invention is carefully evaluated by the patent attorney for patentability according to the Country’s Patent Law. The likelihood an invention can be a patent candidate shall be determined in terms of its novelty, non-obviousness and usefulness. Once formally decided, a patent application shall be prepared and must enable the practice of the invention with sufficient written description.
The following are important considerations for an invention’s patent application:
- The written description requirements to be stated in the patent application, generally relate to how well the specifications describe the invention. Application details are provided in a manner and process that making and using the invention shall be understood in terms that enable any person skilled in the art to make and use the innovative invention.
- Thorough patent application data analysis will help to determine future aspects of the invention such as how desirable and feasible private companies can obtain a license and engage activities that are promising to a possible patent.
- To avoid potential problems associated with incomplete or inconclusive research data, the timing of filing will be considered. Premature filing not only starts a patent life clock running (20 years from the filing date), but it also might create prior art against the new findings.
- Once the Patent Application evaluation is returned to TTO, results will be shared with the inventor and, if necessary, further discussions between the inventor and the patent attorney will be arranged in order to cover all aspects that encompass the projected innovative invention. All necessary formal terms and conditions shall be legally set to protect eligibility for patent ownership of the inventor/s.
- Prudently evaluated and approved complete patent applications for the innovative invention shall be formally filed to the Patent Authority. Informed release of patent will automatically commence the exclusive ownership to invention claims.