Patents provide a means for protecting an invention. The government grants a period of exclusivity for the use of the technology in exchange for a thorough description of the invention which others may use at the end of the period of exclusivity. Through this exchange, technologies are advanced by two means. First by encouraging further investment and development of the invention during the period of exclusivity and second through the dissemination of information to all interested parties. After the period of exclusivity has expired, these other interested parties can utilize the technology without a license. The patentee’s period of exclusivity is enforced through patent infringement litigation.
UNeMed seeks patent protection on behalf of UNMC for technologies which it determines have a high probability of being licensed and patented. The resulting patents and patent applications are owned by the Board of Regents of the University of Nebraska as per Regents Policy 4.4.2. To document this ownership, University of Nebraska inventors are required to sign Assignments.
Inventorship of a patent is determined by the claims and may change as the claims are altered during patent prosecution. Due to differences between the claims, the inventorship of subsequent patent applications may vary greatly from the inventorship of the earlier patent(s). Inventorship is taken very seriously by UNeMed and UNMC’s outside patent attorneys because errors in inventorship can invalidate an issued patent.
Inventorship is a matter of law and involves conception as well as certain aspects of reduction to practice. Conception can occur at a variety of levels – from the broad conception of an idea to the more specific conceptions which occur during reduction to practice. For legal purposes, it doesn’t matter at what level conception occurred – all are treated equally in terms of qualifying an individual as an inventor.
Likewise, it doesn’t matter how many claims in a patent an individual is associated with as an inventor. If there are thirty claims and an individual is only an inventor of one of those claims while another is an inventor of all thirty claims, under U.S. patent law both are treated as equal inventors.
Lastly, unlike publications, the order in which inventors are listed in a patent application does not convey any meaning. Some organizations always list inventors in alphabetical order while others choose to list inventors in order of seniority. UNeMed tends to have inventors listed in the same order in which their names were listed in the New Invention Notification (NIN).
To be patented, an invention must: 1) be novel, 2) have utility, and 3) be non-obvious. To be novel, the invention must be new. This means that the invention must be different in some way from all other ideas that have already been disclosed to the public in any form (publications, presentations, posters, dissertations, etc.). To have utility, the invention must perform some useful function and benefit society in some manner. Lastly, the invention must not be obvious to anyone knowledgeable in the in the area of science. For biotech and biomedical patents it is also necessary to have in vitro data supporting your invention. More and more the United States Patent and Trademark Office (USPTO) is also expecting in vivo data to be included within the patent application.
The novelty and non-obviousness factors of patentability can be greatly impacted by the earlier publications of others. It may not be possible to patent an invention if many different publications mentioned each of the separate elements of the invention. A publication is relevant to the USPTO even if it was not widely disseminated to the public or if the current invention is only mentioned briefly and/or obliquely in the publication.
Earlier public disclosures of the invention by the inventors can also prohibit patenting. U.S. patent law allows for the patenting of an invention up to one year after it has been publicly disclosed. (This one year date after publication is commonly referred to as a bar date.) However, the patent laws of nearly all foreign countries prohibit patenting once a public disclosure has occurred. This immediate prohibition of patenting after a public disclosure includes International (PCT) patent applications.
UNeMed researches the patentability and marketability of UNMC inventions thoroughly before making a decision regarding whether to seek patent protection for an invention. U.S. biotech and biomedical patents typically cost between $12,000 and $22,000 apiece. UNeMed is responsible for paying these legal expenses and strives to ensure it is investing its resources in the most promising inventions.
It is important to note that patentability is only an assessment of whether protection can be procured for an invention; it is not a proper assessment of the scientific value of an invention. An invention may be a great contribution to the body of science, but not be patentable.
Anatomy of Patent Application
The United States Patent and Trademark Office’s (USPTO) regulations dictate the formatting of utility patent applications. There are four major sections of a patent application which serve different purposes and have unique formatting requirements. These sections are listed below in order of their occurrence within a utility patent application.
The specification often encompasses the bulk of a patent application and includes the following subsections (listed in order of appearance): Field of the Invention, Background of the Invention, Summary of the Invention, Brief Description of the Drawings, and Detailed Description of the Invention. The specification determines how words used within the entire patent application will be defined. If the specification doesn’t fully enable/support the contents of the claims, the patent probably will not be allowed to issue or withstand litigation. This is the area of the patent application where the invention must be described in enough detail to enable one skilled in the art to reproduce the patented technology. Generally, applicants cast as wide a net as possible around the technology within the specification – sometimes including speculations and predictions regarding future developments of the technology.
This is the most “legal” portion of the patent application. There are many federal laws, USPTO regulations, and much case law which specifies how claims can be written and even what some specific words mean when used within claims. The claims can only cover material which is thoroughly described within the specification. Claims can be altered/amended by either the applicant’s patent attorney or the Examiner during patent prosecution. When a patent issues, the actual patent protection obtained is limited to what is covered in the final format of the claims. For the most part, claims can only be independent (stand alone) or dependant (citing back to a previous claim). Dependant claims contain all the limitations set forth in the cited claim.
The abstract is fairly self explanatory. It will appear on the front of the issued patent. There is a limit on how long it can be and Examiners can force applicants to alter an abstract if they believe it isn’t descriptive enough.
The United States Patent and Trademark Office (USPTO) has strict guidelines for the formatting of drawings and these pages are traditionally prepared by professional drafters who specialize in preparing drawings for filing with the USPTO. In biotech patent applications the drawings most often include figures (charts, graphs, etc.). Once an application is filed, drawings cannot be altered in any substantive manner.
Types of Patent Applications
Categories of U.S. Patents
U.S. patent law includes three distinct categories of patent applications: plant, design and utility. Plant patent applications can be sought for new asexual varieties of plants. Design patents provide protection for the appearance of an article of manufacture. Utility applications are granted for new and useful processes, machines, articles of manufacture, or compositions of matter. UNeMed primarily uses utility patents to protect UNMC’s intellectual property.
Types of U.S. Utility Applications
U.S. patent law allows utility patent applications to claim priority to other patent applications. As a result, utility patent applications are divided into several different subcategories based on their immediate claim to priority. Below is a table outlining these subcategories.
|Regular||Describes a patent application which either doesn’t claim priority back to another application or claims immediate priority to a U.S. provisional application.|
|Divisional||Applications filed after an Examiner has issued a Restriction Requirement (divides claims into separate inventions) in the immediate prior application (parent) and the applicant desires to seek patent protection for one of the groups of claims dropped from the parent application.|
|Continuation||A subsequent application which contains no new subject matter.|
|Continuation-In-Part or CIP||A subsequent application which contains some combination of older subject matter from the parent application and new information.|
|Nationalized||Describes a patent application which claims immediate priority to an International (PCT) application.|
Provisionals are a procedural type of patent application which cost less than other types of patent applications to file, but are never prosecuted and never issue as patents. Provisionals have a one year life span during which a second, nonprovisional patent application must be filed to protect the technology described in the provisional patent application. There is much more flexibility in the formatting of provisional applications than with other types of patent applications and, as a result, provisionals sometimes don’t resemble other types of applications. Care must be taken with the content of provisional applications because subsequent nonprovisional applications can only claim priority back to the subject matter disclosed within the provisional.
U.S. Provisional Applications
Like the U.S., most countries have established their own patent offices and patent laws. There are two major differences between U.S. patent law and the patent laws of most other countries. First, the U.S. operates under a system where patents are granted to the earliest inventor of a technology who diligently developed and sought protection for the technology (i.e. “first to invent”). Most other countries operate under a “first to file” system where patents are granted to the first to seek patent protection. Second, the U.S. provides a one year grace period to seek patent protection after the public disclosure of an invention while the majority of other countries consider all rights to seek patent protection lost immediately after a public disclosure has occurred. This immediate prohibition of patenting after a public disclosure includes International (PCT) patent applications.
Foreign patent prosecution can be costly and difficult due to the subtle differences between each country’s patent laws and the need to locate an experienced foreign associate to oversee patent prosecution with each individual patent office. Rather than immediately filing patent applications in each individual country where patent protection is desired, most organizations take advantage of International (PCT) applications.
Most countries have agreed to participate in the World Intellectual Property Organization (WIPO) and its corresponding International (aka PCT – Patent Cooperation Treaty) patent application. This system allows applicants to file an International (PCT) application with a designated receiving office (the USPTO is one of these entities) and receive some feedback regarding the invention’s patentability from that office before committing financially to filing patent applications in numerous individual countries. PCT applications never issue as patents, but do receive some prosecution. PCT applications are expensive and most entities (including UNeMed) file them judiciously.
The Life of a U.S. Patent
Inventor participation in the patenting process results in better patents. Overall, University inventors are encouraged to participate in the patenting process to the extent they are able. However, inventor participation is needed at some points of the process including:
- 1. Reviewing a draft of the patent application (Step 1)
- 2. Reviewing a draft list of references for inclusion in the Information Disclosure Statement (IDS) (Step 3)
- 3. Signing Declarations (Step 3)
- 4. Signing Declarations (Step 3)
- 5. Sometimes during the prosecution process when an Examiner request additional data, clarification, etc. (Step 4)
UNeMed regularly keeps inventors informed as patent applications progress through each state of patenting process. Inventors should always feel free to contact UNeMed if they have any questions regarding one of their patent applications or the patenting process in general.
The process of obtaining a U.S. patent for a biomedical or biotech invention currently lasts approximately 3-7 years. After the patent application has been filed there will be a 2-4 year delay before an Examiner at the United States Patent and Trademark Office (USPTO) reviews the application followed by another 1-3 years of patent prosecution. Once issued, a U.S. utility patent expires 20 years after its earliest, nonprovisional priority date. The USPTO does grant patent extensions based on USPTO delays in prosecution. Below is a more detailed outline of the patenting process.
Step 1 – Drafting (estimated timeframe 2-6 weeks)
UNeMed engages a wide variety of outside patent counsel to write and prosecute patent applications on behalf of UNMC. All of these patent attorneys are experienced in patent prosecution and are experts in a specific area of science. The majority of these individuals earned doctorate degrees and conducted industrial and/or academic research in an area of science pertinent to UNMC’s current research before attending law school. The expertise and experience of these professionals is necessary to ensure UNeMed obtains the best patent protection possible for UNMC’s technologies. UNeMed closely monitors and coordinates the efforts of these patent attorneys throughout the patenting process.
Step 2 – Filing
Once a final draft is approved, the external patent attorney will file the application either immediately or within one or two days. UNeMed provides outside counsel with the final approval of the draft. Before providing this final approval, UNeMed ensures that all of the inventors’ questions regarding the draft have been addressed and that all inventors have been given ample opportunity to review a draft.
Step 3 – Waiting for a first Office Action (estimated timeframe 1-4 years)
Once a patent application is filed, there will be at least a 12 month delay before the first communication is received from an Examiner at the USPTO. Several administrative activities are attended to during this time period. Some of these activities require inventor participation such as: submitting Declarations and Assignments to the USPTO (inventors sign these documents and return them to UNeMed) and filing Information Disclosure Statements (IDSs) (inventors review a draft list of references for inclusion in the IDS). UNeMed strives to make each inventor’s participation in these activities as easy as possible.
Step 4 – Prosecution (estimated timeframe 1-3 years)
Patent prosecution is essentially a negotiation between the applicant’s patent attorney and the USPTO’s Examiner regarding what is patentable. The process is initiated by an Examiner issuing an official written communication. The first of these written communications is usually either a Restriction Requirement or an Office Action. Generally, Examiner’s include a multitude of reasons for rejecting the claims in the first Office Action. Usually, it is not until the second Office Action that we obtain a true sense of how patentable the Examiner finds the current claims.
Later communications from Examiners include additional Office Actions, Final Office Actions, Advisory Actions and Examiner Amendments.
Applicants are given a set period of time to file responses to the Examiner’s communications. In these responses, applicants’ patent attorneys argue that the Examiner’s rejections are not appropriate. In making these arguments, patent attorneys will sometimes include amendments to the claims or clarify the scientific nature of the invention for the Examiner
Step 5 – Post Prosecution Activities (estimated timeframe 1-6 months)
Once prosecution has ended, the Examiner will issue a Notice of Allowance and UNMC’s patent attorney will pay the USPTO’s issue fee. UNeMed sends inventors notice that the patent will issue. It’s at this stage that UNeMed determines whether any additional patent applications (divisional, continuation, continuation-in-part) are warranted.
Step 6 – Patent Issues (estimated timeframe 1-4 months after fee paid)
UNeMed sends inventors a copy of the issued patent. The original Letters Patent are stored by UNeMed on behalf of the Board of Regents of the University of Nebraska.
Step 7 – Pre Patent Expiration Activities
After a patent issues and before it expires, patent holders must pay maintenance fees to the USPTO. These maintenance fees are due 3.5, 7.5 and 11.5 years after the patent issues. If one of these fees are not paid, the USPTO classifies the patent as abandoned.
Step 8 – Patent Expiration
U.S. patents expire 20 years from the earliest nonprovisional priority filing date. The USPTO grants patent term adjustments to compensate applicants for USPTO caused delays in the patenting process. Additionally, patent term extensions can be granted due to delays in the FDA approval process. Once a patent expires, the applicant’s period of exclusivity is over and anyone can utilize the claimed invention.