An Introduction to Patents

The OTD Seminar Series on Commercializing Biomedical

Technology

September 21, 2016Frank Grassler, J.D.VP For Technology Development

Who Are We?• The Office for Technology Development

(“OTD”) promotes the research enterprise at UT Southwestern Medical Center by commercializing biomedical and clinical research results in order to bring medicine to many.

• We manage UT Southwestern’s:– Disclosed Inventions– Patents– Licenses– Startup company initiatives– Cooperative Research Agreements

Our Goals• To initiate and sustain cooperation between UT

Southwestern and the biomedical industry so as to advance new technologies and therapies for the benefit of society;

• 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, in order to support the research enterprise; and

• To facilitate the growth of the North Texas biomedical industry.

What Is Intellectual Property?

• Intellectual property (IP) is a generic 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 inventions in general, and to patentable inventions in particular.

What Is a Patent?

What Is a Patent?• It’s an agreement between the US

government and the inventor.• They agree to an exchange:

– The US gives the inventor the exclusive right to benefit from their invention for a period of years.

– In exchange, the inventor discloses to the public the knowledge of what the invention is, how to make it, and how to use it.

Patents and the Constitution• 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.

Patents-Key Characteristics• 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, and therefore has no 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.

Patents-Key Characteristics• 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.

Ownership• 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 employees have already assigned their invention ownership to the UT Board of Regents as part of their employment agreement.

Ownership-The Financial Rewards• 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 (or co-inventors)– 25% to the inventor’s lab– 25% to UT Southwestern

• The UT Southwestern revenue sharing formula is not necessarily followed at other UT System institutions.

Competing Research Programs• Frequently, institution vs institution,

corporation vs corporation, 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 Lifetime of a 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.

Application Filing and Examination• 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

Application Examination• Examination can take many years.• Examiners look for eligibility, novelty,

obviousness, sufficient description, 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.

Application Examination• 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. the “prior art”.

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.

Prior Art• 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.

The Priority Date

• 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 Description of the Invention• 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.

Patent Eligible Subject Matter• There are only four categories of patent-eligible

subject matter:– Compositions of matter– Articles of manufacture– Machines– Processes

• Our research often results in scientific discovery that falls into four categories of unpatentablesubject matter:– Laws of nature– Natural or physical phenomena– Mental processes– Abstract ideas

Sample Technology Categories• Small molecules (MW <500)• Peptides, proteins• Medical or surgical devices• DNA and RNA sequences, whether coding or non-

coding, e.g. siRNA, sgRNA• Vectors• Cell Lines• Bio-processing reactors, machinery or processes• Software• Robotics

Laws of Nature• 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.

Laws of Nature

• 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.

Laws of Nature

• 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.

Laws of Nature• Association for Molecular Pathology v.

Myriad Genetics

• Another Supreme Court case, holding that a gene, i.e. the unit of information conferring a heritable trait, is notpatentable- but note carefully that the cDNA analog to the natural DNA sequence, being a man-made composition of matter and non-naturally occurring, ispatentable.

Laws of Nature

• 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

Types of Patents in Translational Medicine• 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.

Types of Patents in Translational Medicine• Composition of matter-products of:

– Organic chemistry– Nucleic acid chemistry– Peptide chemistry– Bioengineering– Fermentation– Extraction & purification from natural sources

• Method of synthesis– Improvements over bench synthesis

• Method of Use– New medical utilities/therapy

• Article of manufacture– Diagnostic devices– Therapeutic devices– Research tools, platforms, software

Pharmaceutical Patents

• Other patent types valued by the industry:– Pharmaceutical formulations– Method of treatment – Pharmacogenomic– Mechanism of action– Improved method of synthesis– Key intermediates in such synthesis– Research tools

• Targets• Naturally occurring ligands• Screening technologies• Libraries

Reach-Through Claims and Royalties

• 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 entitle the inventor to royalties on the sale of a drug discovered using that target (but you might be able to negotiate for it).

Patent Decision-Making• 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?

First Step-DISCLOSE IT• 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/about-us/administrative-offices/technology-development/transfer/intellectual-property-policies.html .

• Or call us and schedule an appointment-our place or yours (we like to see what you’re working on).

Important Things to Remember• 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-BUT WE DON’T BLOCK PUBLICATIONS

• 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.

BIOCENTER AT SOUTHWESTERN MEDICAL DISTRICT