BLG News Summer 2006
News from the Baylor Licensing Group
Volume 5, No. 2 Summer 2006
This bi-annual newsletter brings you the latest on licensing and patenting of technologies developed at Baylor College of Medicine.
This issue covers recent court decisions clarifying the scope of patent claims and infringement criteria and subsequently BLG’s patenting practices. We receive many questions about what can and what cannot be patented, and why. Many past experiences with patent prosecution no longer apply. Recent court decisions have altered the way we approach patenting and essentially narrow the scope of technologies on which we will consider filing a patent application. In addition, the examiners in the Patent Office are adhering to their guidelines more firmly. This has further narrowed the scope of technologies on which we will file a patent application, taking into consideration the type and amount of data available at the time of filing.
Topics in this issue:
Patenting Targets: A Thing of the Past
Our Own Experience with Targets
Use of Patented Inventions in Studies to be Submitted to a Federal Agency
No Longer "File Patent Now, Get Data Later"
Patenting Targets: A Thing of the Past
Many target discoveries start with a knockout mouse model or a cell-based assay. In the past, patent applications filed on those discoveries would claim:
1. "A method for treating CONDITION Y in a mammal comprising administering a compound that inhibits PROTEIN X activity"
or,
2. "A method of inhibiting PROTEIN X activity in a mammal, comprising administering a compound that inhibits activity of the GENE X product to a mammal in need of such treatment."
The judgment on a recent U.S. District Court case involving a patent regarding COX-2 inhibitors (i.e. Celebrex) has changed the ability to prosecute claims such as those listed above. In this court case, claims like that in example 2 above were challenged and it was decided by the courts that these claims were not valid.
It was argued, and the court agreed, that claims such as the ones cited above are not sufficient unless there is some description of compounds that could be used in the treatment. The treatment claim depends on a compound of some sort. The patent was viewed by the court as a research plan to screen for those compounds by describing the desired function of the compound. However, without any idea of the nature of the compounds, it is considered an indefinite endeavor and does not fit into the “reasonable amount of research” allowance. As a result of this court decision, unless a target has some level of validation through activation or inhibition by some compound (either a known compound or preferably, a novel compound), it would be difficult for Baylor to justify filing patent applications on these discoveries. Read a brief excerpt from the written decision of the U.S. District Court.
Unfortunately, even if Baylor is able to get a patent due to minimal validation data, a licensee is unlikely to take a license to that patent due to other recent court case decisions (see section in this issue titled "Use of Patented Inventions in Studies to be Submitted to a Federal Agency"). To make the invention more commercially viable, a patent to a novel compound is needed. Our office has been trying to identify companies or other facilities that generate compound libraries that will help our faculty develop these targets to a point where a compound has been identified which can be patented and licensed. Several investigators at Baylor are actively screening targets identified in their laboratories and we are working with them to patent and license the compounds identified via their screening efforts. We are also working with these faculty members to identify potential collaborators who can help them develop and optimize proprietary derivatives of the compounds. If you have any questions about how this decision influences target patenting, please contact us at 713-798-6821 or blg@bcm.edu.
Our Own Experience with Targets
BLG has completed a brief survey of target disclosures we have received over the past three fiscal years to analyze our experiences with the licensing of targets. Of 31 target disclosures received, one was licensed via an exclusive option, and the licensee chose not to exercise its option and continue with a license. The licensee optioned the target with the intent of finding a company to partner with to screen the targets against compound libraries. Potential partners did not want to commit resources to this project due to the fact that the targets had not been previously screened against any potentially novel compounds. The partner would have assumed almost all of the risk.
We have also received feedback from industry regarding targets and their comments reflect the lack of interest we have experienced. Essentially, in light of the recent court cases, they are not interested in licensing targets because any company can screen against targets without a license once they know about them. Targets would be valuable to them but only if they are kept a trade secret. This would mean not patenting because patents are published 18 months after filing. This limits the scientists’ ability to publish and goes against the mission of Baylor College of Medicine as an academic institution to disseminate research findings through publication. Some companies do patent targets they discover. But they do so only when they have sufficient data showing compound modulation of that target. In effect, they are patenting the use of the compound and its action on the target. If you have any questions, contact us at 713-798-6821 or blg@bcm.edu.
Use of Patented Inventions in Studies to be Submitted to a Federal Agency
A recent Supreme Court decision effectively expanded the type of studies that are considered exempt from infringement of patent claims (“expanded use” provisions) to include not only data from clinical studies submitted to the FDA but also preclinical data that may be used directly or indirectly in an application to the FDA. The preclinical data can include studies of mechanism of action, toxicology and pharmacokinetics. In the past, BLG might have patented screens and those materials used in the screens (cell lines, clones, etc) as well as other research materials. Today, however, it is less likely that we would be able to license such patents because of the expanded use provisions. Even materials such as compounds and vectors, which we are likely to continue to patent, may not be subject to infringement under the expanded use provisions.
The reason for this is a recent court case surrounding RGD peptides that more clearly defined the context under which patented materials can be used without infringing a patent. The RGD peptides were being used in studies to find derivatives that inhibit angiogenesis. The patent owner asserted that the RGD peptides were not the subject of an FDA submission by the user and therefore, the user was infringing the RGD patents.
The United States Supreme Court supported the expanded use provision by reasoning that the FDA must review some preclinical studies in order to assess whether the proposed clinical trials pose unreasonable risk to those involved and that it was not reasonable to dictate exactly what data would be reviewed. Such decisions were at the discretion of the FDA and should be handled on a case by case basis.
Essentially, this means that it is not necessary for companies to take a license to patents on screens or other tools. Therefore, it does not make sense for us to file patents on such tools since the cost of obtaining a patent does not add commercial value to the tools. But we might still be able to license the related research materials without a patent. Companies would rather license these unpatented tools rather than go through the time and expense to make them. If you have any questions about the impact of this expanded use provision, please contact us at 713-798-6821 or blg@bcm.edu.
No Longer "File Patent Now, Get Data Later"
We often find that some of our faculty’s prior experience with patent prosecution has generated expectations about filing patents that may no longer be valid in light of the current patent prosecution climate. One frequent expectation is that one can file and prosecute a non-provisional patent application before generating data to support the concepts and ideas discussed in the text and/or claims in that patent application. This typically results in the patent application being rejected because it lacks “written description.” Written description is that information in the patent application, including data, which proves that you had the invention and can practice the invention at the time the patent application was filed. Patent examiners are taking a more literal view of written description. They are more closely scrutinizing the description and data provided in the application relative to the invention claimed. This is not to say that one cannot generate and submit supportive data after a patent application has been filed. But one cannot provide data for something discussed in the text and/or claimed that had no data at the time of filing and expect that to meet the written description requirement.
Accepted forms of supportive data are those that corroborate data already presented in the patent. For example, you have a compound that you have shown cures a particular disease by using a particular animal model. Additional supportive data could be subsequent tests of that same compound using a different animal model of the same disease or further details of mechanism of action of that compound.
On the other hand, discussing the concept of the compound curing an unrelated disease in the patent and/or including claims that cover this with no data is likely to be rejected due to lack of written description. Providing data after filing the non-provisional patent is not sufficient because the concept was not adequately described at time of the original filing. If you have any questions, please contact us at 713-798-6821 or blg@bcm.edu.
BLG Contact Information
For any questions related to inventions, patents and licenses, please contact BLG.
Baylor Licensing Group
One Baylor Plaza
BCMD-600D, MSC 210
Houston, TX 77030b
Phone: 713-798-6821
E-Mail: blg@bcm.edu
Web site: http://www.bcm.edu/blg/