Intellectual Property Protection
Emory Patent Group. As leaders in the tech transfer community, Emory is focused on cutting-edge operational initiatives. In 2009, the OTT received approval from senior leadership to implement an alternative to traditional intellectual property management by bringing a practicing patent group in-house. The office created the Emory Patent Group (EPG) in 2010 and has been exceedingly pleased with its success. In its initial incarnation, the EPG includes two patent attorneys and a senior paralegal who provide patent services on unlicensed technologies for the OTT. While bringing patent work in‐house is very uncommon for university tech transfer offices, it is possible at Emory in part because of Emory’s strong focus in biomedical research. This focus makes it practical to cover all relevant technical areas with a limited in-house team. In its first few years, the EPG has helped Emory ride the wave of the recession and reduce patent costs without sacrificing protection. Indeed, since implementation of the EPG, Emory has increased its patent filings by more than 50% while cutting its overall patent-related expenditures.
Winsome Dunn, James Mason, Randi Isaacs
- What is intellectual property?
- Intellectual property (IP) refers to creations of the mind: inventions, know-how, literary and artistic works, symbols, names, images, and designs. IP protection occurs through patents, copyrights, trademarks, or trade secrets.
- What is a patentable invention?
- A patentable invention could be a process or method, a machine, an article of manufacture, or a composition of matter. With certain limitations, almost anything that is "made by man" may be patentable.
- What is a patent?
- A patent is a publically available document issued by the government that establishes certain rights to inventions, i.e., limited rights to stop others from making, using or selling your invention. Patents are available in the U.S., through the U.S. Patent and Trademark Office (USPTO), as well as many other countries. Patent protection exists, generally, for 20 years from the date of filing of a patent application.
- What are requirements to obtain a patent?
- To be eligible for patent protection an invention must be useful, novel, and non-obvious. The patent application must also show that the inventor has enabled the invention and include a sufficient description of the invention.
- Usefulness. An invention is useful if it provides some practical benefit. It must have a credible and substantial real-world use. For example, merely identifying a composition without any known properties, solely to research future possible uses, may be insufficient.
- Novelty. An invention is considered novel when it is different from previous inventions in one or more of its parts. A novel invention may be the use of previously known features used in a new way or it may be a completely new solution to a problem.
- Nonobviousness. Obviousness may be an issue when considering combinations of what is already known. With certain exceptions, all prior public disclosures, including your own, are considered when evaluating obviousness. An invention is non-obvious if someone skilled in the particular field of invention would view it as an unexpected or surprising development. Thus, experimental evidence of unpredictability and superiority of the invention are factors that weigh heavily in favor of non-obviousness. Without such evidence, obtaining a patent can become expensive and time consuming with no clear indication of a favorable outcome.
- Enablement/Description. Patent rights provide an incentive to disclose new innovations to the public. Therefore, your patent application must fully describe and "enable" your invention, so that anyone of ordinary skill in your field could make and use your invention once your patent term expires. An aspect of enablement relates to whether the invention has been reduced to practice or constructed, e.g., the existence of prototypes, or whether the invention is in the "idea" stage. Sometimes, being able to describe an invention that is merely in the "idea" stage is sufficient, but in certain cases a patent will be very difficult to obtain without a working example.
- What is the one year grace period?
- In the U.S., an inventor's own disclosures made one year or less before filing a patent application can sometimes be avoided for purposes of novelty or obviousness. Prior to March 16, 2013, the U.S. Patent system was based on "first-to-invent" laws. Under those laws, inventors could get a U.S. patent even if they made their invention publically available for less than a year. After March 15th, 2013, the America Invents Act (AIA) modified the U.S. patent system to harmonize it with the "first-to-file" laws of other countries. An exception to a bar of patentability still exists for an inventor's own publication up to one year before his filing date however, the publications of others affect patentability differently than they have in the past. For example, others may recapitulate your published information with their own twist, thereby limiting the ability to patent your inventions. Further, very few foreign countries allow any such grace period except in extremely limited circumstances. Ultimately, it is best to file a patent application before making any public disclosures.
- What is the process to obtain a patent?
- The OTT relies on an experienced group of patent attorneys, both internal and external, to oversee this complex, lengthy, and costly process. Put simply, a patent defines the scope of the rights to inventions using sentences called "claims." To get claims issued, a patent application with proposed claims is submitted to the patent office for review of patentability in each country a patent is desired. Patent examiners will review the proposed claims in light of, literature and public disclosures, and then negotiate the exact language. A "provisional" patent application can be utilized to preserve the ability to file a future application within certain timelines since it is not reviewed for patentability.
Although there are many different ways to manage patent filings, a typical process includes:
- Filing a "provisional" patent application at the USPTO;
- Filing an international patent application under the Patent Cooperation Treaty (PCT) often referred to as a "PCT application" (an international search is performed on these applications, and these also preserve the ability to file future applications within certain timelines) – a PCT application is filed within one year after filing the provisional application;
- Filing a patent application in each country in which a patent is desired – this occurs 30 months after filing the provisional application; and
- Issuance of patents after negotiating claim language with examiners – although this timeline varies, it is typically between about 2 to 4 years.
- Why does my patent application look like my publication manuscript?
- If OTT personnel are notified of an imminent publication, there may not be enough time to evaluate patentability or have a patent professional prepare a patent application. Instead of forfeiting patent rights, OTT is often forced to file a publication manuscript at the patent office in lieu of a patent application. Because a provisional patent application is not reviewed for patentability, the patent office will accept the publication manuscript or other document for what it contains as if it was any other provisional application. This type of provisional application is sometimes referred to as a "coversheet application." Although they are effectively a band-aid type solution to an imminent publication, coversheet applications are risky since the publication manuscript may not sufficiently describe the invention.
- What is a copyright?
- Copyright protects original works of authorship including literary, dramatic, musical, and artistic either published or unpublished. It also protects various aspects of computer software. Copyright protection covers the form of expression rather than the subject matter or idea expressed. Protection exists automatically once the work is created and fixed in a tangible form. Duration of copyright protection depends on several factors but generally extends for the lifetime of the author plus 70 years.
- What is the process to obtain a copyright?
- Copyright protection is automatically granted and registration is voluntary. However registration is sometimes recommended. Registration with the U.S. Copyright Office ensures that copyright certificate is public record, and is required to support the litigation process if a future legal dispute arises. In some instances, Emory registers copyrights for commercial and legal purposes, however this is only necessary in limited instances.
- What is a trademark?
- Trademarks protect words, names, symbols, sounds, or colors that distinguish goods or services among companies. Trademarks can be owned by individuals, companies, or any legal entity. Trademarks can be licenseed out. In the U.S. trademark protection can be renewed indefinitely as long as the trademark is used in commerce.
- What is the process to obtain a trademark?
- Like copyrights, trademark registration is voluntary. However, trademark registration is not required to prevent others from infringing the trademark. Similar to copyright registration, Emory may register trademarks for commercial and legal purposes. More information on trademarks and the process can be found on USPTO website http://www.uspto.gov/trademarks/process/index.jsp The OTT will assist in registering a trademark when deemed commercially relevant.
America Invents Act (AIA)
The Leahy-Smith America Invents Act (the "AIA") provides the most comprehensive change to U.S. patent law in at least half a century. It was signed into law on September 16, 2011 and enacted under a 'rolling implementation' scheme. Final implementation occurred on March 16, 2013.
An Overview of the AIA
The AIA is the culmination of a decade long debate on how to “improve patent quality,” arising from a series of studies on the relationship of patent law to the economy. The U.S. Patent and Trademark Office (“USPTO”) has invested in an extraordinary effort to develop rules for implementing the AIA. It has reviewed hundreds of public comments and hosted multiple national roadshows to collect customer input on its proposals. The changes that are most relevant for biomedical researchers took effect on March 16, 2013: changing from a first-to-invent to a first-to-file system, and changing the standard for prior art. See below for a review of these provisions.
These changes in the AIA are particularly challenging in the “publish or perish” environment of academic research. Under the new law, researchers are no longer protected through early conception of an invention, and disclosures to third parties can impair patentability. Please begin to retain not only your laboratory notebooks and other documents related to conception, but also any communication of new ideas to anyone outside of the University. Indeed, we encourage you to contact our office early and often so we can help you ensure that disclosures are made under confidentiality or other agreements. With these added protections, we can help ensure that you retain intellectual property rights and that your technologies can be effectively commercialized.
First-to-File: Document, Document, Document
Up until March 16, 2013, the U.S. has focused on who ‘invented’ a patent, rather than who filed the patent application itself. Under the AIA, the new focus will shift to whether a “first filer” obtained, or could have obtained, the invention from a “later filer.” Most researchers are familiar with a need to document their conception dates and keep appropriately witnessed notebooks. This requirement was not eliminated in the AIA, but expanded.
Under the AIA, an inventor on a later-filed patent application can attempt to prove that an earlier-filed invention belonged to them. The second inventor must request a “Derivation Proceeding” within one year and support his allegations with “substantial evidence.” In September 2012, the USPTO issued guidance on what is considered substantial evidence. A Derivation Proceeding petitioner must show that he had an earlier conception date and that he communicated his idea with the other party. The USPTO requires that the petitioner corroborate the earlier conception date and include at least one corroborated affidavit addressing the communication of the invention to the other party.
Prior Art: Call Us Before You Publish!
The AIA substantially revised what constitutes “prior art” against an invention. Under the AIA, prior art encompasses anything that is “patented, described in a printed publication, or in public use, on sale, or otherwise available to the public” before the inventor files a patent application. There is much debate over how the courts will interpret “otherwise available to the public,” but the USPTO has suggested that this includes publications such as theses, poster displays, “information disseminated at a scientific meeting,” and non-sale commercial transactions that make the invention “sufficiently available to the public.”
On its face, the AIA retains certain protections for researchers, first and foremost a grace period for an inventor’s own disclosures. Retention of the grace period was critical in allowing the bill’s passage. Specifically, a disclosure made within one year before filing is not prior art if: it was made by the inventor or under a joint research agreement; or it was made by a third party but the inventor made an earlier public disclosure.
The USPTO issued final rules to clarify whether the grace period applies to third party disclosures that occur during the one year grace period, after the inventor’s own initial public disclosure. These are termed ‘intervening’ art. To eliminate intervening art, the subject matter must be “the same” as what the inventor previously disclosed. However, there is no requirement that either: a) the mode of presentation be the same (for example, the first can be an oral presentation and the intervening art a peer reviewed article); or b) that the language be verbatim. Further, the USPTO clarified that an intervening generic description of an invention that had been previously described as a specific embodiment would not count as prior art.
Still, there are several critical caveats. First, if an inventor initially disclosed a species of an invention (e.g., a specific chemical entity), and a third party discloses a different, but related species, then the intervening art will count as prior art that could invalidate the inventor’s broader genus claim filed at the end of the grace period. Second, if the inventor initially disclosed a genus and the intervening art describes a species within that genus, then the intervening art will count as prior art and could invalidate claims to the broad genus that the inventor originally disclosed.
One of the few changes in the AIA that could benefit biomedical researchers is a broader protection for collaborative research. Disclosures in an earlier-filed patent application are eliminated from prior art if they are co-owned. Applications are considered co-owned if the current invention was made under a joint research agreement. Prior to the AIA, the joint research agreement had to be in place before the present invention existed. However, under the AIA, a joint research agreement merely needs to be “in effect on or before the effective filing date.” In academic research, it may now be more advisable to enter into more formal research arrangements at least prior to filing of a new patent application. Please let us know if you are regularly collaborating with external groups, especially when the collaborations are informal.