Maximize societal impact - Technology commercialization can help achieve the larger mission of improving society by providing solutions to medical, environmental, social, or technical problems. Especially for anything that requires FDA approval, it is often difficult to fund the trials without patent protection.

Grant Requirements - All Federal grants and many other granting agencies require the contractor to either attempt to patent any inventions that result from the funded research or release it back to the agency so that they can evaluate the patent opportunity. Failure to comply with those requirements can bar UTRGV from future grant funding from that source.

Exclusive rights - Patents provide exclusive rights to the owners. Owners can restrict other parties from making or selling their inventions.  

Return on Investments - A patented invention might be commercialized, providing a return on the time and resources invested in the development of useful technologies. 

Industry collaborations - Patenting and commercialization could lead to collaboration with industries that are interested in the inventions. 

Higher Impact Journal Publications - Faculties with industry relation publish in higher impact journals 

Sanberg et. al. (2014, PNAS)

There are three different types of patents in the US: 

Utility patents are issued for the invention of a new and useful process, machine, manufacture, or composition of matter, or a new and useful improvement thereof. Utility patents are the most common and last for 20 years from date of patent application filing. They are subject to the payment of maintenance fees. 

Design patents are issued for a new, original, and ornamental design embodied in or applied to an article of manufacture. It permits its owner to exclude others from making, using, or selling the design. They last for 15 years from the application filing date and are not subject to maintenance fees. 

Plant patents are issued for a new and distinct, invented or discovered asexually reproduced plant including cultivated sports, mutants, hybrids, and newly found, other than a tuber propagated plant or a found in an uncultivated state. It permits its owner to exclude others from making, using, or selling the plant. Plant patents are granted for 20 years from the date of filing and are not subjected to maintenance fees. 

The five primary requirements for patentability are:  

1. Patentable subject matter: The subject matters that can be patentable include processes, machines, manufactured articles, and compositions of matter. (To contrast, some non-patentable subject matters include data structures, nonfunctional descriptive material like books or music, electromagnetic signals, laws of nature, and other abstract ideas.)
   
2. Utility: An invention should be useful and have an intended purpose in the real world.
3. Novelty: The details of an invention should not be publicly disclosed before the date of filing. (Some countries have a grace period where patent applications are still allowed after a public disclosure.)
   
4. Non-obviousness: For an invention to be patentable, it should not be obvious to an ordinary skilled person in the subject. The invention should not be apparent by looking at the prior art in the subject. 
5. Enablement: The invention should be explained with enough detail that a person with ordinary skill in the art can implement it without any undo experimentation.

Patents are granted for new, nonobvious and useful inventions, such as a process, machine, article of manufacture or composition of matter.

It is possible for some clinical innovations such as biomarker testing and diagnostic methods to be patented, but the US does not allow for patenting of natural phenomena, so the invention must have a substantial human contribution.

Some software algorithms can be patented if the invention is specific and limited enough.

The details matter for patent eligibility, so contact OTC with any questions about your ideas.

It is best to disclose any idea/technology to OTC as soon as it is deemed an invention, even while in initial development phase. It is also required to disclose any potential inventions to OTC before disclosing them to a third party. 

An invention can be disclosed to OTC by filling out the invention disclosure form. Invention disclosure form can be found here: Invention Disclosure Forms | UTRGV 

An invention is a two-step process: 

1. Conception of the invention i.e., the idea 
2. Reduction to practice of the idea i.e., making a working example of the idea.

The inventorship of a patent is determined by the conception of the invention. The Manual of Patent Examining Procedure from USPTO states: ‘unless a person contributes to the conception of the invention, he is not an inventor’. 

Inventorship is independent of ownership and authorship (e.g., for a scientific paper), and must be determined based on the material claims of the invention without regard to social, political, business, or academic considerations. 

Inventorship may change as the invention evolves or improves. Inventors may be added or deleted from patent application as claims are revised, or as research leads to new findings and new collaborations are made. 

Reduction to practice includes activities that do not count as invention, but are still important in the development. People who only reduce an invention to practice are not considered inventors. This includes people who serve as builder, prototype maker, validator, an experimenter following the inventor’s instruction, or one who merely suggests a desired result or inspires a line of study. However, someone working to reduce to practice could  contribute another novel, non-obvious idea to further improve the invention. That would make that person a co-inventor of the improved version. 

Do not deceive the patent office by submitting extra inventors or the whole patent can be invalidated! OTC will ensure the inventors correspond to the patent claims, but inventors must document who participated at each step of the development.

As of March 16, 2013, U.S. follows a first-inventor-to-file system, meaning that the first inventor to file an application is given the rights. (Prior, the US used the first-to-invent system in which the first inventor could delay the filing process and still be awarded the patent over a later inventor who happens to file first.)

When multiple people or institutions invent something together, each party has full patent rights. They can each legally compete with the others without asking permission or reporting results. They can license their rights to other competitors without notifying the other inventors. There is no law that determines who must pay for the patent, so all parties benefit even if only one of them invested in the actual patent. It can be a mess!

Strategically, co-inventors should agree on how patent prosecution will progress, who will pay for what, how they will go to market, when and how they might license rights to other parties, how royalties will be divided, how they will handle infringers and who will initiate lawsuits, and foreign filing strategy. Universities typically use an Inter-Institutional Agreement to decide all of these issues before any patenting decisions are made. OTC handles these types of agreements based on the list of inventors in an invention disclosure.

Sponsored Research Agreements should specify in advance who will own the patent rights of any possible inventions. OTC will review such agreements in collaboration with the Office of Sponsored Programs, and negotiate those terms when the work is industry sponsored.

All of the challenges of co-inventors exist, but are further complicated by some incompatible laws around the world. The US has a requirement that inventions conceived of in the US must be first filed with the USPTO before any foreign filing. If an invention is to be filed elsewhere first, then a Foreign Filing License must be obtained (this is to ensure national security and export control issues are reviewed first). Other countries have requirements that any inventions of their citizens must be filed with their own patent office regardless of where the invention was conceived of. Thus, it is possible for the laws to directly contradict each other.

Solutions to the conflict typically involve filing a PCT application in the correct patent office, but the details matter so disclose the invention to OTC as soon as the invention is thought of.

Penalties for violating the US Foreign Filing License requirement include rejection of the patent, fines, and/or imprisonment. See:

https://www.uspto.gov/web/offices/pac/mpep/s140.html

The whole process, including foreign filings, is complicated and expensive so patent attorneys are always used. OTC has the responsibility to make patent decisions for all UTRGV inventions.

The United States Patent and Trademark Office (USPTO) offers an optional provisional patent application which is lower cost than a normal utility patent and defines the priority date. However, it is not an actual patent application. The provisional protection lasts for 12 months from the date of filing but the USPTO does not examine the provisional application at all. The applicant must file a normal, non-provisional patent within 12 months referencing the provisional in order to claim the priority date of the provisional. 

An application for utility, design, or plant patent will spend 3-5 years in the examination process called "patent prosecution". The USPTO will respond with office actions rejecting claims for various reasons, and the patent attorneys will respond to those office actions with arguments or data to try and overcome the rejections. That process is repeated until either the examiner approves the patent or the inventor abandons the application.

For other countries, a patent application must be translated and adapted to fit the respective legal rules on patent eligibility. Prosecuting a patent costs roughly $30,000 per country.

The Patent Cooperation Treaty (PCT) covers most major countries and is administered by the World Intellectual Property Organization (WIPO). When an inventor submits a patent to a patent office in a member country, the application can be designated as PCT. This makes the initial application fees greater, changes many deadlines, but makes the process of multiple foreign filings much easier and standardizes the priority dates. If an inventor knows that patent protection is needed in many countries, it is overall less expensive to start as PCT.

A patent application should be filed before disclosing any invention to anyone that is not a co-inventor. This includes scientific reviewers, investors, or even family. If disclosing the invention is unavoidable, a Non-Disclosure Agreement should be put into place. In any case, it is best to contact OTC prior to disclosing an invention to a third party.

Most countries require absolute novelty for a patent application, so any public disclosure instantly kills the patent in those countries. The US has a 12-month grace period after a public disclosure, so all is not lost in the event of an unintended public disclosure, but it does complicate the filing and lowers the value of the patent because of the reduced international patent eligibility. Other countries with grace periods have specific restrictions or different durations on their grace periods, so it is much better use of tax payer funds to file before any public disclosure instead of depending on grace periods.

Patent infringement is when someone makes, uses, sells, offers to sell, or imports someone else’s patented invention without their permission. It is easy to infringe a patent as patent information is public.  

There are three types of patent infringement:  

1. Direct Infringement: Direct infringement is when someone directly violated the patent rights by making, using, selling, offering to sell, or importing a patented invention. 
2. Contributory Infringement: Contributory infringement is when someone sells a component or product whose only purpose is to be used in an infringing product or process. For example, if someone sold a product that would be useful only if combined into a patented product. 
3. Inducement: Induced infringement occurs when someone knowingly encourages or influences someone to be a direct infringer. 

Direct infringement and Induced infringement both require a single party to practice every claim in the patent for an infringement to occur. "Divided infringement" is when different parties are practicing different parts of a patent, but no one is performing all of it, so there is no real infringement occurring.

Biomarker can be defined as a measure of some characteristic of a normal biological or pathogenic process. According to the FDA biomarkers can be molecular, histological, radiographic, or physiologic characteristic such as a small molecule, the space between a joint in a radiograph, glucose monitoring, tumor size, blood pressure, etc. Biomarker claims can include software and instrumentation used to measure markers. 

According to USPTO, inventions that are not patent eligible include natural laws such as the relationship between an analyte and a disease, natural phenomena like genes, and abstract mental steps like reaching diagnoses based on observations. 

Subject matters related to diagnostics and biomarkers that are patent eligible include methods of treatment/prevention tied to diagnostic methods, and novel ways to measure a recognized property or analyte. More examples of eligible subject matters in life sciences can be found in USPTO guidance document: Subject Matter Eligibility Examples: Life Sciences 

Guidelines for nature-based subject matter eligibility can be found in MPEP 2106.04 : 2106 Patent Subject Matter Eligibility 

Like USPTO, European Patent Office considers the discovery of a natural phenomenon to not be patent eligible. However, for EPO, a patentable invention can derive from a practical use of that discovery. So for the EPO, a claim directed to a method of diagnosing a disease involving detecting a naturally occurring biomarker may be patentable even if the naturally occurring correlation is not patentable. 

EPO rejects a claim if the method is carried out on the human or animal body and includes all the steps of collecting data, comparing the data with standard values, finding a symptom, and making a diagnosis. A method that avoids any of these requirements is not considered to be a diagnostic method and is thus patent eligible. Diagnostic methods that are carried out on in vitro samples can be patented in Europe, as can methods that do not reach a diagnostic conclusion. 

US patent eligibility requires that the invention has a specific, practical application. Machine learning patent applications must be drafted with at least one well-described practical example (e.g., faster search, better search, linguistics analysis, or better weather forecasting). Also, the patent will state that the concept can be expanded to other solutions with examples (do not have to be described in depth). 

Known ML algorithms are not patentable. After the Alice v. CLS Bank decision, an attempt to claim an already known process but merely implementing it on a computer will not be patent eligible. Novel enhancements to already known processes could be eligible. 

Novel enhancements may include: 

• Special training sets 
• Encoding/representation 
• Gathering and preparing the training data 
• Selection of the training data 
• Identifying the features used by the ML algorithm 
• Defining feature representation (e.g., vector concatenation or some other vector combination, eliminating empty vector fields) 
• Conditioning the training set (e.g., dimension reduction) to accelerate training or improve accuracy 
• Enlarging the training set over incomplete data 
• Speeding up the training process with specially configured hardware 
• Devising better-predicting models 
• Tuning hyperparameters 
• Hybrid ML models 
• Combining ML with other methods

Patent licensing is when a patent owner trades away some of the rights granted by the patent (typically the rights to make and sell the invention) to a licensor in exchange for some form of consideration (usually a royalty on sales). The licensee/owner can also profit from the invention during the license period. Licenses can be exclusive or non-exclusive 

An exclusive license trades the rights to a single licensee and restricts the owner to not license those same rights to any other third party during the license period. Often, the rights to sub-license, make improvements, or sue third parties for patent infringement are included in exclusive licenses.

A non-exclusive license trades the rights to multiple licensees and each one can produce and sell the invention. Non-exclusive licenses retain most of the rights with the owner.

The European Unitary Patent System is the latest major change to patent systems in the world, and is currently expected to begin in the spring of 2023. Currently, after a PCT patent is prosecuted, each PCT member country must issue a separate patent. Once the Unitary Patent is available, a single patent will cover 17 countries and eventually grow to 25 or possibly 39 countries as they continue to ratify the agreements. Notably, the UK is not a member of this system, so it will remain a separate country under PCT.

The Unitary Patent Court is new and untested, so it may take a few cases before the process is optimized and rules are established. Because of this uncertainly, the new Unitary system is not required yet and inventors can still choose multiple, separate PCT country filings for several more years.

One major threat is that since it is a single patent, it may be revoked in all the participating territories by a single action. An inventor unsure of the strength of the patent would be wiser to choose the separate country filings. An inventor who is confident in the patent, or merely wishes to save a lot of money, would opt for the Unitary patent.

Copyright is a limited monopoly protection granted to original works of authorship fixed in a tangible medium of expression. It allows the owner to exclude others from distributing or importing copies of the work into the US. Copyright can be granted for published or unpublished works. 

US Copyright Acts over time: 

1790: Copyright act of 1790 gave the authors copyright protection for 14 years plus a 14-year renewal if the author is still living. 

1831: Revision of the Copyright Act: protection extended to 28 years plus a renewal of 14 years. 

1909: Revision of the US Copyright Act: 28 year copyright protection period with an extension of 28 years. 

1976: Revision of the US Copyright Act: copyright protection lasts for life of author plus 50 years. Corporate copyrights last for 75 years. 

1998: Sonny Bono Copyright Term Extension Act: This act extended the copyright protection term to life of author plus 70 years and for corporate copyrights to 95 years.  

Copyrights apply to original works of authorship including literary, dramatic, musical, artistic works, software, architecture, and collections. The work must be affixed to a medium for it to be copyrightable. 

Not copyrightable subjects include facts, ideas, names (including band names), systems, methods of operation, and things that have utility like recipes, clothing designs, mathematics, titles, slogans or logos. 

Each work will have its own copyright, so a new audio recording of a public domain song will have a fresh copyright. A translation of a public domain text in one language to another will also have a new copyright. Scripts, screenplays, sheet music are original works fixed in their own medium and have their own copyright. A performance cannot be copyrighted but a recording of the performance is copyrighted by the videographer. 

Per Regents' Rule 90101, faculty own their own works such as books, curriculum, manuscripts, illustrations, and artistic works. On the other hand, software is treated like a patentable invention so that must be disclosed to OTC even if faculty intended to publish the software under an open source license. Data sets are also treated like software as they can be registered and licensed for royalties. Contact OTC with any questions.

Granting agencies may prescribe their own rules regarding copyright ownership and open access to works funded by the grant. OTC can review those terms and provide guidance.

Your work is protected automatically under copyright from the moment it is created in a tangible medium. You can register a copyright voluntarily. Registration is needed for filing a lawsuit for infringement. Registered works may be eligible for statutory damages and attorney's fees in successful litigation. Registering a copyright can cost anywhere between $45 to $250 depending on the type of work and type of registration.  Learn more about copyright registration fees here.

Fair use permits the unlicensed use of copyright protected work in certain circumstances such as criticism, commentary, news reporting, teaching, scholarship, or research. This is very important for academics.

Factors considered for determining whether the use if fair are:

1. The purpose and character of the use 
2. The nature of the copyrighted work 
3. The amount and substantiality of the portion used 
4. The effect of the use upon the potential market for or value of the copyrighted work
   

Transformative use - copies made for image thumbnails, caching, or creation of digital libraries are fair use. The copy serves a different function from the original work and doesn't create a substitution.

Parody, using a work to make fun of the work itself, is fair use.

Satire, using a work to make fun of something else, is not fair use.

In the case of Authors Guild v. Google, Google collaborated with several libraries and scanned books with optical character recognition to create searchable text copies. However, Google only displayed sections, not the entire scanned copy, and even allowed authors to opt out. Authors Guild and other individual copyright owners alleged that Google infringed by using copyrighted content without permission. The court ruled that Google’s use of copyrighted books was fair use.

Google v. Oracle, Google copied around 11500 lines of code from Java API for its new Android platform in order to allow millions of programmers familiar with Java to work with the platform. Oracle sued Google for copyright infringement. The district court found Google’s use to be fair use as Google only used the code to allow programmers to work with a new and transformative program while using their already acquired talents.

The author's rights of compensation and control over distribution are fulfilled with the first sale. After the first sale, the author gets no further compensation for the use of copy sold. This is how libraries are allowed to lend out books and media they purchase.

If a publisher sells an international version at a lower price, that version can legally be imported to the US because the first sale rights are exhausted when the international sale occurred. However, if someone unrelated is selling copies internationally, those copies cannot be legally imported to the US because the author's first sale rights are not exhausted in that case.

In work for hire, the employer/buyer/producer owns the copyrights even if an employee created the work. Work for hire is automatic for an employees within scope of employment. Otherwise, work for hire must be negotiated before work begins (it cannot be retroactive).

For an independent contractor or freelancer, all these conditions are required: 

• The work must come within one of the nine limited categories of works:
  1. a contribution to a collective work
  2. a part of a motion picture or other audiovisual work
  3. a translation
  4. a supplementary work
  5. a compilation
  6. an instructional text
  7. a test
  8. answer material for a test
  9. an atlas
• The work must be specially ordered or commissioned;  and
  
• There must be a written agreement between the parties specifying that the work is a work made for hire by use of the phrase "work for hire" or "work made for hire.”

Works created under work for hire have special protection duration of 120 years after creation or 95 years after publication, whichever comes first.

One drawback to work for hire is the case where the payment is delayed. The copyright already belongs to the buyer even before the payment, so an alternative arrangement could be a Copyright Transfer Agreement which promises copyright assignment will happen after completion and payment.

Copyright holders own exclusive right to distribute derivative works such as: translation, musical arrangement, dramatization, fictionalization, motion picture version, sound recording, art reproduction, abridgment, condensation, or any other form in which a work may be recast, transformed, or adapted. A work consisting of editorial revisions, annotations, elaborations, or other modifications which, as a whole, represent an original work of authorship, is a “derivative work”. 17 U.S.C. § 101 

No permission is needed for derivative works if the underlying work is copyrighted by you, is in the Public Domain, or if your use is fair use. The new copyright in a derivative work covers only the additions, changes, or other new material appearing for the first time in the work. It does not change the copyright life of the underlying work. Derivative work must be transformative, i.e., have significant original additions, or else it's merely a copy. 

Derivative works include: 

• Motion pictures based on a book or play 
• Translations of a novel into another language or into another medium like an audio book 
• Revisions of a previously published book 
• Sculptures based on a drawing 
• Drawings based on a photograph 
• Photographs of a sculpture 
• Lithographs based on a painting 
• Musical arrangements of a preexisting musical work, like a cover a song or contemporary work based on a folk song 
• A recording of a song remixed with an already existing song 
• Adaptations of a dramatic work 
• Fan Fiction 
• Creative work with characters from a preexisting work, like a sequel

Copyright protection does not extend to any "idea, procedure, process, system, method of operation" contained in the work. Thus, news organizations are free to report on each other's scoops. The text of a news article is copyrighted, but anyone is free to describe the information in a news article in their own words. 

“Clean room” reverse engineering is not a derivative work, but that’s harder to prove now. 

Data as a mere collection of facts is not copyrightable, but databases are copyrightable under certain conditions. Mere collection of data is not enough for it to be copyrightable, but a thoughtful selection of data could be copyrightable. A phone book containing all names and numbers in a city is not copyrightable, but a phone book of only women-owned businesses would be because it required a selection effort.

(Human subject data could fall under various regulatory controls such as HIPAA, FERPA, or contractual agreement, so contact OTC before submitting an IRB proposal that you intend to commercialize.)

All software is copyrighted. It is distributed under various types of software licenses.

In proprietary software licenses, the owner maintains control over the code, its functions, and the use of the software. Changes and derivative works can only be made by the owner. Usually these licenses cost money. Some times these licenses include the source code but no permission to make changes is granted. Usually, the code is distributed in a compiled/binary format.

Open-source software is distributed under a license that allows the user access to the source code and includes the permission to inspect, modify, and share/redistribute the code.  Users can adapt the software as they like but they are not required to make their new changes available to others. These licenses are sometimes called "permissive" and famous examples of licenses in this category include BSD, MIT, and Apache.

Free software is similar to open-source but requires that if users redistribute any modified versions of the software, the users must make available the source code to their modifications. This prevents a company from taking open-source software and packaging it to sell without giving anything back to the community. Note, the word "free" does not mean zero-cost or gratis, it means freedom or libre. These licenses do not prohibit commercial sales, merely require a "share and share-alike" approach. Many companies that depend on these licenses have other ways to generate revenue in addition to distributing the software. These licenses are sometimes called "copyleft" and famous examples include the GNU Public License (GPL) and the Mozilla Public License (MPL).

Software As A Service is any model where users do not receive a copy of the software, merely interact with it through some device, usually a server/client arrangement but it could also be a kiosk or physical terminal. The AGPL was written to ensure share-and-share-alike is honored for SAAS.

Open-source and free software licenses originally did not include any language about software patents, but some of the licenses have been revised. For example, the GPLv3 and Apache 2.0 include explicit patent license for all patents owned by the author that are required to use the software. There are subtle implications here, but these licenses remain some of the most useful licenses for academics to consider. Contact OTC for a discussion of the details regarding your software.

Courts have not ruled on the specific effects of these patent licenses. There are some analysts that argue the explicit licenses cover all patents held by the organization, even unrelated patents. Some argue that other open source licenses have inferred patent licenses by their nature even without an explicit patent license.

 Here are some of the philosophical differences between Free and Open Source licenses.

https://www.geeksforgeeks.org/difference-between-free-software-and-open-source-software/ 

Creative Commons is a group of licenses for artistic works which have similar terms to the permissive and copyleft licenses for software. All CC licenses allow redistribution. Each one allows some combination of remixing, adapting, and derivative works.

• CC BY must give attribution to original author
• CC BY-SA must license modifications under same terms
• CC BY-NC non commercial
• CC BY-NC-SA same terms, non commercial
• CC BY-ND no derivatives
• CC BY-NC-ND non commercial, no derivatives
• CC0 Public Domain (in applicable countries)

A hypothetical open-source video game would need a combination of licenses to cover the software, music, artwork, and text narration.

Free Art License is another popular license for artistic works which is compatible with "CC BY-SA 4.0".

Open data is data that can be freely used, re-used and redistributed by anyone. The Open Data Commons group has been developing legally binding tools to govern the use of data sets. They have created three standard licenses that one can use in conjunction with data projects. 

Public Domain Dedication and License (PDDL): This dedicates the database and its content to the public domain, free for everyone to use as they see fit. 

Attribution License (ODC-By): Users are free to use the database and its content in new and different ways, provided they provide attribution to the source of the data and/or the database. 

Open Database License (ODC-ODbL): ODbL stipulates that any subsequent use of the database must provide attribution, an unrestricted version of the new product must always be accessible, and any new products made using ODbL material must be distributed using the same terms. It is the most restrictive of all ODC licenses. 

Some useful articles on research data:

How to License Research Data (Ball, Alex. 2012): Written with British law in mind, but it has a good discussion of the pros and cons of the ODC licenses: 

Licensing Open Data: A Practical Guide (Korn, Naomi and Oppenheim, Charles. 2011): Another guide written with UK law in mind, but with a helpful comparison of CC and ODC licensing options 

Open Data (Wikipedia) 

Project Open Data: The US Federal Government guide to open licenses and dedications   

RDA & CODATA Legal Interoperability of Research Data: Principles and Implementation Guidelines- A set of practical guidelines for researchers dealing with legal aspects of sharing data  

Sharing Research Data and Intellectual Property Law: A Primer (Carroll, Michael W. 2015): An introduction to the various kinds of property rights that can be associated with research data  

Data Citation Developments (Kratz, John. 2013): An update on efforts to standardize data attribution requirements.  

CC0 (+BY) (Cohen, Dan. 2013): A call for using CC0 with data, tempered by an ethical obligation to attribute. 

Copyright Guide for Scientific Software (Albert, Kendra, Bouquin, Daina, Farber, Alena, & Hoover, Russell. 2019. Zenodo): A joint project of the Harvard Cyberlaw Clinic and the Center for Astrophysics, in association with the Software Preservation Network, that provides clear, easy-to-read answers to common questions about how scientific software and copyright interact.

There are many types of open licenses for different works.

Use a copyleft license if your goal is to establish a strong development community and you want to remain the primary lead in the community. This incentivizes centralized adoption subject to the owner’s desires.

Use a permissive OSS license if your goal is wide spread adoption, or to publish code and forget it. This incentivizes unrestricted adoption.

Copyrights:

Software: GPL, Apache, BSD, MIT, Mozilla 

Artistic works: Creative Commons

Data: ODC-ODbL, ODC-By, PDDL  

Fonts: SIL Open Font 

Patents: License on Transfer; Defensive Patent License; Innovator’s Patent Agreement; Fair, Reasonable, and Non-Discriminatory (FRAND); Patentleft.  

Trade Secrets & Trademarks: No viable open licenses exist. Open licenses are contradictory to the law that defines trade secrets. Will need a proprietary license negotiated.

Drug repurposing is when potential new uses are identified for already approved drugs. Repurposing drugs results in reduction in cost and less approval times. It is an effective alternative to traditional drug discovery processes, as it commonly leverages existing pre-clinical studies which have typically established the safety, efficacy, and toxicity for the drug, thus somewhat reducing further development risks. Repurposing of drug had several benefits. Simplification of the regulatory procedures for introducing a previously approved drug on the market is the primary benefit. Previously acquired data on safety and toxicity of the drug makes the initial phases of drug development faster and cheaper.

Drug Repurposing can be divided into two areas:

Drug Repositioning is the development of new therapeutic use for the same drug. For example, thalidomide, which was once used as a sedative, in now used for treating multiple myeloma. The oldest example of drug repositioning is Aspirin. Aspirin, which was developed as an antiplatelet aggregation drug, can be used to prevent the development of may cancers.

Drug Reformulating is the development of different formulations for the same pharmaceutical drug. Reformulating can provide opportunities for patent protection. Some examples of unique reformulations can be:

• New forms of administration, e.g. solid dosage forms vs liquid formulations.
• New routes of administration, e.g. intravenous vs oral administration.
• New and improved solubility and/or stability of a liquid formulation.
• New dosage strengths for new indications, e.g. high concentration formulations.
• Increased purity of the API.
• New API salt forms or polymorphs, e.g. drug forms having a desirable solubility profile, improved stability or overall improved pharmacokinetic properties.

Reformulated and repositioned drugs are patentable. Composition of matter claims for repurposed drugs are not patentable. Reformulations might have to be narrowly claimed due to existing patents or prior art. Method of use patents/repositioned drugs might be easier to protect if the indication is not already patented or in public domain. Some examples of patentable matter can be:

• Novel pharmaceutical dosage forms/formulations
• New drug combinations
• New indication for existing drug
• Drug showing unexpected results or long felt need
• Surprising and unexpected effect of drug
• New and improved method of manufacturing the drug

Approved Drug Products with Therapeutic Equivalence Evaluations, the list also called a s Orange Book, is a list of drug products approved by the FDA under the Federal Food, Drug, and Cosmetic Act. The orange book also contains therapeutic equivalence evaluations for approved multisource prescription drug products. The IP associated with a drug product can also be found in the Orange book. This information is beneficial for protection a repurposed drug. The Orange book can be found here: 

The Orange Book

Additionally, the FDA also provides the lists of licenced biological products called the Purple Book, which can be found here: 

The Purple Book

The 505(b)(2) application can be used for obtaining FDA approval for a repurposed drug, while 505(b)(1) is used for approval of a new drug.

According to FDA, “The 505(b)(2) is an New Drug Application (NDA) containing full reports of investigations of safety and effectiveness, where at least some information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use”. And “NDAs requiring full reports of investigations of safety and effectiveness that were conducted by or for the applicant, or for which the applicant has a right of reference or use, known as “stand-alone” NDAs, are submitted under section 505(b)(1) of the FD&C Act.”

The 505(j) or the Abbreviated New Drug Application (ANDA) application is used for approval of a duplicate drug. For example, generic versions of already approved drugs.