February 4, 2015 Frank Grassler, J.D. VP for Technology Development The Office for Technology Development (“OTD”) promotes the research enterprise at UT Southwestern Medical Center by commercializing research results in order to bring medicine to many. We manage UT Southwestern’s ◦ ◦ ◦ ◦ ◦ Inventions Patents Licenses Startup company initiatives BioCenter, UTSW’s commercial biomedical center For the benefit of society, to initiate and sustain cooperation between UT Southwestern and the biomedical industry so as to advance new technologies and therapies; To provide our faculty with strategic & legal guidance to effectively manage intellectual property developed on campus; To generate revenue for UT Southwestern and our inventors, to support the research enterprise; and To facilitate the growth of the North Texas biomedical industry. Intellectual property (“IP”) is a general term for intangible property rights that are the result of intellectual effort. Patents, copyrights, trademarks and trade secrets are the main categories of IP rights. At UT Southwestern, IP most frequently refers to patentable inventions. Underlying a patent is an agreed exchange between the US government and the inventor(s). ◦ The US gives the inventor the exclusive right to benefit from their invention for a period of years. ◦ The inventor discloses to the public the knowledge of what the invention is, how to make it, and how to use it. The US Constitution empowers Congress to secure exclusionary rights to inventors for their inventions for a limited period of time. Although the inventor receives an exclusionary right, they don’t automatically have the right to commercialize their own invention because someone else may already have an earlier, broader exclusionary right. Limited Territory-A US patent has no power outside of the US. Likewise, no foreign nation’s patent has any power outside of that nation, nor any power in the US. Property Rights-A patent can be bought, sold, assigned, given as a gift, willed to heirs, and used as collateral for a loan. Licenses-A patent owner can negotiate with others to permit them to commercialize the patent, in effect allowing them to trespass onto the property. Enforceability-A US court can grant monetary damages for infringement or a permanent injunction against further infringement. Since it’s property, a patent is always owned by someone. Under the Constitution, the first owner is always the inventor. Typically, inventors are subject to employment agreements, where they automatically assign their ownership to an institution/corporation. In our own case, all UT Southwestern faculty have already assigned their invention ownership to the UT Board of Regents as part of their employment agreement. Although the patent property is owned by the UT Board of Regents, any royalty revenue generated by the patent is shared: ◦ 50% to the inventor ◦ 25% to the inventor’s lab ◦ 25% to UT Southwestern The UT Southwestern revenue sharing policy is not necessarily followed at other UT System institutions. Frequently, corporation vs corporation, institution vs institution, or institution vs corporation races are underway to discover or invent something first. The old rule in the US was that the first party to invent, if proven by sufficient evidence, was awarded the patent. The rule in the rest of the world, and now in the US as well, is that the first to file a patent application will be awarded the patent. The old rule in the US was that the patent had a term of 17 years from the date the application issued as a patent. The current rule in the US is that the patent’s term is 20 years from the day the application is filed. Term is important because legal action to enforce a patent can’t commence until the application issues as a patent, nor can a patent be enforced after it expires. A patent application describes how to make and use the invention and sets forth precisely what the inventor regards, or claims as being, the invention. A patent application frequently ends up being the first in a series of related applications e.g. ◦ ◦ ◦ ◦ ◦ Provisional application Non-provisional application Continuation application Continuation in part application Divisional application Examination can take many years. Examiners look for eligibility, novelty, obviousness, sufficient description and enablement, specificity of the claim language and patentable utility of the claimed invention. Novelty ◦ Novelty in the legal sense means that the claimed invention was not identically described in a publication released to the public before the date the application was filed. Obviousness ◦ Obviousness in the legal sense means that the claimed invention was not obvious, to a person of ordinary skill in the invention’s field, if that person were to have read all of the relevant publications released to the public prior to the date of filing the application. ◦ Obviousness therefore CANNOT be determined by looking solely at the invention; obviousness can only be determined by looking at the claimed invention at the same time as looking at all of the relevant prior publications-i.e. “prior art”. Prior art is any relevant publication, in any form, or any demonstrative act, that was available to the public before the application filing date, i.e. the Priority Date. No publication or public demonstration can be considered that occurred after the Priority Date. The inventor’s own publication or demonstration can be used against them if it took place before the Priority Date. Therefore, we always advise filing before publishing. If your publication or poster completely describes the invention, you have lost novelty. If your publication or poster only describes part of the invention, it can be used against you as part of an obviousness rejection. There is a grace period in the US of one year to file a US patent application from the date of publication, but there is no grace period outside the US and foreign patent rights will be completely lost. This is the date that the first application is filed with a patent office. Here, this is typically a Provisional application filed in the US Patent Office. Subsequent patent applications in a chain of applications can claim the benefit of the priority date of the first provisional application. The invention must be described fully in the application ◦ The description has to enable someone of ordinary skill in the field i.e. “the art” to make and use the invention without undue experimentation. ◦ The scope of the claim has to be supported by the scope of the description. A claim to a series of tetracyclic compounds and anthracene compounds is not supported by description of one category but not the other. A claim to a pharmacogenetic association between a genotype and multiple clinical characteristics is not supported by a description of only a single clinical characteristic. There are only four categories of patent-eligible subject matter: ◦ ◦ ◦ ◦ Compositions of matter Articles of manufacture Machines Processes ◦ ◦ ◦ ◦ Laws of nature Natural or physical phenomena Mental processes Abstract ideas Our research often results in scientific discovery that falls into four categories of unpatentable subject matter: Small molecules (MW <500) Peptides Proteins DNA and RNA sequences, whether coding or non-coding, e.g. siRNA Vectors Cell Lines Bio-processing reactors, machinery or processes Software Robotics One cannot patent a natural law or correlation, fundamental truth, abstract idea or disembodied concept without applying it, using applied science or engineering that goes significantly beyond an instruction on how to make use of that law or concept. In Mayo v. Prometheus, the inventor discovered that administration of azathioprine for immune-mediated GI disorder resulted in 6-thioguanine metabolite levels that correlated with myelosuppression. The correlation led to the conclusion that levels of 6-thioguanine should stay in a range of 230 to 400 pmol per 8 x 108 RBC’s to be efficacious yet avoid myelosuppression. The claimed invention was a method of optimizing therapy by administering drug, determining levels of metabolite and adjusting subsequent dosing as needed. The Supreme Court found that this amounted to an attempt to monopolize a basic natural biological relationship. It is not enough to inform a relevant audience (doctors) about certain laws of nature (observed levels of a metobolite result in toxicity) and telling them to adjust dosing accordingly. Today, this might be a patentable invention if coupled with specific novel kit, apparatus or software that requires complex programming for a specific application to a narrow field or resolves a data field. Association for Molecular Pathology v. Myriad Genetics Another recent Supreme Court case, holding that a gene, i.e. the unit of information conferring a heritable trait, is not patentablebut note carefully that the cDNA analog to the natural DNA sequence, being a man-made composition of matter and non-naturally occurring, is patentable. Questions left unanswered by the Myriad case ◦ Claims to methods of using a gene sequence ◦ Claims to mutations of naturally-occurring sequences ◦ Claims to useful compounds extracted from natural sources Composition of Matter Target Natural ligand Synthetic ligand Analogs, homologs and congeners Enantiomers, salts, esters, prodrugs, hydrates, solvates, ultrapurified concentrations ◦ Alternative crystalline forms ◦ Fixed dose combinations ◦ Pharmaceutical formulations ◦ ◦ ◦ ◦ ◦ Improvements in timing of release, GIT crossing, BBB crossing, location in depots. Composition of matter-products of: Method of synthesis Method of Use Article of manufacture ◦ ◦ ◦ ◦ ◦ ◦ Organic chemistry Nucleic acid chemistry Peptide chemistry Bioengineering Fermentation Extraction & purification from natural sources ◦ Improvements over bench synthesis ◦ New medical utilities/therapy ◦ Diagnostic devices ◦ Therapeutic devices ◦ Research tools, platforms, software In the pharmaceutical industry, by far the most important patents are those that cover the chemical formula of the therapeutic product itself, i.e. new chemical entity (NCE) patents NCE patents frequently cover small changes to a molecule’s structure that confer some therapeutic difference. Such a small difference may leave the new drug within the coverage of an older patent, thus necessitating a license, or a cross-license. Other patent types valued by the industry: ◦ ◦ ◦ ◦ ◦ ◦ ◦ Pharmaceutical formulations Method of treatment Pharmacogenomic Mechanism of action Improved method of synthesis Key intermediates in the synthesis Research tools Targets Naturally occurring ligands Screening technologies Libraries Reach-through claims ◦ A patent on a target or a pathway does not cover all ligands of the target or molecules that target a part of the pathway. Reach-through royalties ◦ A patent on a target or a mechanism of action does not generally entitle the inventor to royalties on the sale of a drug discovered using that target. OTD receives many disclosures describing early stage inventions. In Translational Medicine, the inventions are not so much research as development. What is the product and can we protect it? Would the availability of patent rights positively impact the attractiveness of the invention? Even if available, does it make financial sense to pursue patent rights? What other third party rights may be required to practice the invention? Are they available? At what cost? An inventor recognizes that a unique observation or development has taken place that may be valued by the marketplace. The invention is disclosed to the OTD by filing an Intellectual Property Questionnaire (“IPQ”) online or by filling out the form provided for. See http://www.utsouthwestern.edu/aboutus/administrative-offices/technologydevelopment/transfer/intellectual-propertypolicies.html . Or call us and schedule an appointment-our place or yours (we like to see what you’re working on). It is important to file any IPQ as far in advance as possible before any intended public disclosure to enable a thorough evaluation of the invention and to permit adequate time to file a patent application. The information submitted in the IPQ should be as accurate as possible. Any helpful information should be attached to the IPQ. The filing of an IPQ is NOT the same as filing a patent application. Frank Grassler, J.D. Ray Wheatley, MS, CLP® Kathy Schutt, CLP® Vice President for Technology Development 214-648-1902 Frank.Grassler@utsouthwestern.edu Director for Technology Commercialization 214-648-1888 Ray.Wheatley@utsouthwestern.edu Director for Cooperative and Sponsored Research 214-648-1881 Kathy.Schutt@utsouthwestern.edu