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Legal & intellectual Property Glossary & Taxonomy
volving terminology for emerging technologies

Suggestions? Comments? Questions? Mary Chitty
Last revised November 18, 2013  

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anti-trust guidelines:  Pharmaceutical Industry: A Discussion of Competitive and Antitrust Issues in an Environment of Change, Federal Trade Commission,

Bayh Dole:  The transfer of new technology from university laboratories to the private sector has a long history and has taken many different forms.  The current national emphasis on this activity, however, can be dated to the 1980 enactment of P.L. 96-517, The Patent and Trademark Law Amendments Act, more commonly known as the Bayh-Dole Act, and amendments included in P.L. 98-620, enacted into law in 1984. The Bayh-Dole Act     A Guide To The Law And Implementing Regulations , University of California Technology Transfer  

Bilski vs. Kappos Wikipedia

blocking patents: Around the block, Y Philip Zhang, Nature Biotechnology 28(12) Dec 2010 1239 

Cohen- Boyer:  Stanley Cohen's and Herbert Boyer's basic science discovery of recombinant DNA technology in 1973 sparked a revolution in biology and spurred development of the biotechnology industry. The invention’s far- reaching implications for the interconnected worlds of science, commerce, and society are suggested in what follows. .. [Biotech at 25: The founders, Univ. of California - Berkeley Library, 1999-2000]  Related term: licensing

cross-licensing: A legal agreement in which two or more parties which have potentially conflicting patent claims strike a deal to share rights to the product or process in question. [PhRMA]  
Broader term: licensing  Related term: technology transfer

Diamond v. Chakrabarty, 1980: Prior to 1980, life forms were considered a part of nature and were not patentable.  Diamond v Chakrabarty changed this with the 5- 4 U.S. Supreme Court decision that genetically engineered (modified) bacteria were patentable because they did not occur naturally in nature. In this case, Chakrabarty had modified a bacteria to create an oil- dissolving bioengineered microbe. [Genetics and patenting, Oak Ridge National Lab, US, 2002]

disease gene patents: I wish to direct my comments to the emerging pattern of exclusive licensing of so-called Disease Gene Patents. These patents generally claim a gene sequence, one or more mutations in which are found to be associated with disease or risk of disease. In addition to claims covering all uses of the chemical sequences, the patents also claim all methods of diagnosis of disease by identifying in a specific patient the disclosed genetic alleles, mutations, or polymorphisms. ..Oversight Hearing on Gene Patents and Other Genomic Inventions, Jon F. Merz, Assistant Professor of Bioethics, Department of Molecular and Cellular Engineering, and Center for Bioethics, University of Pennsylvania, Subcommittee on Courts and Intellectual Property of the Committee on the Judiciary, U.S. House of Representatives, July 13, 2000  

DNA patents: Patents and applications included in the DPD [DNA Patent database]  are identified by a search algorithm that captures documents with a nucleic-acid specific term in its claims section and also with a relevant classification code. Terms specific to nucleic acids include “DNA,” “RNA,” “nucleotide,” polynucleotide,” etc. The relevant class codes are those designated by the U.S. classification system for genomic or biotechnological inventions.  DNA patent database   
DNA Patent Licensing
Broader term: gene patents  Related term: cDNA patents; Broader term: gene patents

electronic lab notebook: 

A definition was developed by the Collaborative Electronic Notebook Systems Association (CENSA)  "A system to create, store, retrieve, and share fully electronic records in ways that meet all legal, regulatory, technical and scientific requirements” 

enablement criterion: See under patents

EPO European Patent Office: An international patent- granting authority established under the European Patent Convention (EPC), which was signed in Munich on 5 October 1973 and came into force on 7 October 1977. The EPO has its headquarters in Munich, a branch in The Hague, and sub- offices in Berlin and Vienna. The EPO is not an EU institution. It is completely self- financing and has a large degree of administrative autonomy. Its operating and investment budgets are funded entirely from procedural fees and from part of the annual renewal fees levied on granted European patents. [European Patent Office website]

EST patents: The PTO ruled that ESTs -- short sequences of coding DNA derived, assembly-line style, from messenger RNA extracted from cells -- were patentable in the early '90s.  ,,No one knows how many ESTs are in line waiting for patents -- not even the PTO. "We quit tracking them," says John Doll, the PTO's director of biotechnology examination. "We had about a half a million, and that was about four years ago." [Ken Garber, Homestead 2000: The Genome, Signals Magazine, Recombinant Capital, Mar. 3, 2000]  

exclusivity and patents: 

experimental use: See under patent infringement

gene fragments:   

gene patent guidelines: See utility patent guidelines (Jan. 2001)

gene patents:  A patent on a specific isolated gene sequence discovery Wikipedia accessed Dec. 17, 2010 

The controversy over gene patents emerged when Dr. Craig Venter, CEO of Celera Genomics, sent 20,000 gene sequences to the PTO, claiming patents to the sequences and to procedures that would be used to diagnose disorders with the genes. The PTO denied these applications, suggesting that simply finding DNA sequences and claiming their use as a research reagent was not sufficient for a patent. The PTO thus indicated that it required the inventor of a gene to show a level of utility beyond the gene’s use as a research tool. ¶ 6 The standard of utility wielded by the PTO, however, has been far from clear. THE FATE OF GENE PATENTS UNDER THE  NEW UTILITY GUIDELINES, Feb.  28 , 2001, Duke Law and Technology Review, Cite as 2001 Duke L. & Tech. Rev. 0008  

Impact of Gene Patents on Patient Liberty Interest, Sapna Kumar
Beginner's guide to gene patents, Guardian, UK, 2000,2763,397385,00.html
Oversight Hearing on Gene Patents and other genomic inventions

Narrower terms: cDNA patents, disease gene patents, EST patents, gene fragments, SNP patents; Related terms: utility guidelines; Gene definitions gene 

genetic discrimination: Molecular diagnostics

genomic patents: Allen K Yu, Why it is time to eliminate genomic patents, Paper 1473, Berkeley Electronic Press, 2006  

human life, patenting:  Patenting Human Life, President's Council on Bioethics, 

Intellectual Property IP, Biotechnology Industry Organization, US
IP Mall
, Franklin Pierce Law Center, US 
Related terms: patent, patent stacking, patent system, royalty stacking, stealth patents, submarine patents

international patents: The Trilateral Offices, the European Patent Office (EPO), the Japanese Patent Office (JPO), and the U.S. Patent and Trademark Office (USPTO) have been cooperating for the administration of their patent functions in order to gain possible mutual benefits since 1983. US PTO 

JPO Japanese Patent Office: The system of industrial property rights (which is a general terms used when referring to the system for patents, new utility models, designs and trademarks) is to contribute to development of industry by securing and protecting the successful and creative development of structures for patents, etc. The system of industrial property rights is also designed to promote development of sciences and technology. As Japan is on the threshold of the twenty first century, the importance of this system has gradually grown by a considerable amount. The role of the Patent Office is to deal with the development in the entire industrial sphere through its system for industrial property rights, including examinations, trials, and designing of plans for this system. [Japanese Patent Office website]

license: A contract between the owner(s) of the subject matter of the license and one or more parties that seeks the right to make, use, sell, or import the subject mater of the license. Commonly, a license conveys rights to patented subject matter, but it may also convey rights to tangible subject matter that is not unpatented. Licenses are negotiated agreements that become binding contracts when signed by the parties. In the United States, only one owner need to sign a license if the subject matter is patented. Thus, a patented technology co-owned by three parties can be licensed by one of the parties without the other owners' knowledge or consent. This is not so in most European countries, which require that all owners join in any licenses. Although licenses generally address a standard set of legal issues, there is no standard license or license term. The terms negotiated into licenses by the parties are as varied as the circumstances driving the agreement. Appendix B Definitions related to Technology Transfer,  Report of the National Institutes of Health (NIH) Working Group on Research Tools, US June 4, 1998

licensing: Contractual agreement granting permission to use intellectual property under specific conditions. Licensing agreements, in which one company contracts to buy technology from another company, can be much faster, easier and cheaper to arrange than trying to challenge an intellectual property claim in court. More important than ever these days with R&D expenses increasing faster than the approval of new drugs. Narrower term: biopharma licensing, cross-licensing; Related terms: patent pooling, research joint venture, technology transfer

licensing practices: One of the goals of U.S. patent policy is to encourage development of useful products by inventors and those to whom inventions are licensed. However, some of the recent developments described above have created a situation in which pursuit of the protected information and materials by both the for- profit and not- for- profit sector may be restricted, rather than promoted, as intended historically. Sub-optimal use is likely to result when the patent appears to others to over-value the invention and when the terms of use - that is, the licensing policies - are unduly restrictive. For example, potential licensees are frequently confronted with so-called "reach -through" provisions that would provide royalties from any downstream commercial products to those who own property that may now be of uncertain value and vague utility. This situation does not encourage vigorous development of the protected discoveries. Likewise, an inappropriate insistence on exclusive, rather than non- exclusive, licensing of genetic sequences for diagnostic tests could slow the development of this important application of genetic tools. [Harold Varmus testimony, HEARING ON GENE PATENTS AND OTHER GENOMIC INVENTIONS HOUSE JUDICIARY SUBCOMMITTEE ON COURTS AND INTELLECTUAL PROPERTY, JULY 13, 2000

Mayo vs Prometheus: Intellectual Property Today

MTA Material Transfer Agreement: A negotiated contract between the owner of a tangible material and a party seeking the material and the right to use the material for research purposes. The material may be either patented or unpatented. Material transfer agreements tend to be shorter than license agreements, and they are generally/ considered to be more informal than licenses agreements, although both are enforceable contracts. The purpose of an MTA is to document the transfer and outline the terms of use, including identification of the research project, terms of confidentiality, publication, and liability. As with licenses, there are no standard MTAs, although the academic community and NIH developed an under used model MTA for biological materials called the Uniform Biological Material Transfer Agreement (UBMTA).  Appendix B Definitions related to Technology Transfer,  Report of the National Institutes of Health (NIH) Working Group on Research Tools, US June 4, 1998   See also: research tools, university- industry partnerships and intellectual property

Myriad gene patent legislation: Genomics Law Report

NCRA, NCRPA:  Alliances pharmaceutical

non-obvious; novelty: See under patents

PTO Patent and Trademark Office, US: The PTO promotes industrial and technological progress in the United States and strengthens the national economy by: Administering the laws relating to patents and trademarks. Advising the Secretary of Commerce, the President of the United States, and the administration on patent, trademark, and copyright protection. Advising the Secretary of Commerce, the President of the United States, and the Administration on the trade- related aspects of intellectual property.

patent:  A document issued [in the United States] by the Department of Commerce Patent and Trademark Office (PTO) under authority of the United States Constitution and other laws and implementing regulations. A patent contains a narrative description of the subject matter covered by the patent called the specification. It also contains one or more claims that describe the subject matter covered by the patent in highly technical and specific terms, much as the metes and bounds of a survey might exactly describe and identify the land conveyed by a deed. A patent represents the right to exclude others from making, using, or selling the subject matter described by the claims of the patent. Virtually every country in the world provides its government with the right to issue patents in order to allow patent owners to exclude others from using the patented subject matter within its borders. In the United States, only the person or people who invent the subject matter have the right to obtain a patent. However, it is commonplace for employers to require employee- inventors to assign to the employer the right to seek the patent, and therefore the ownership of the patent. Appendix B Definitions related to Technology Transfer,  Report of the National Institutes of Health (NIH) Working Group on Research Tools, US June 4, 1998

A patent application is judged on four criteria. The invention must be "useful" in a practical sense (the inventor must identify some useful purpose for it), "novel" (i.e., not known or used before the filing), and "nonobvious" (i.e., not an improvement easily made by someone trained in the relevant area). The invention also must be described in sufficient detail to enable one skilled in the field to use it for the stated purpose (sometimes called the "enablement" criterion).   Related terms: intellectual property; Narrower terms: EST patents, genomic patents, international patents, patent portfolio, patent system, provisional patent applications, SNP patents, stealth patents, submarine patents, utility patents

Google Patents 
Patent FAQs    
Patents full-text & patent applications, US Patent & Trademark Office, US

patent acquisition:
Securing intellectual property rights by means of patents.

patent citation: SEE under patinformatics analysis

patent cliff: A colloquialism to denote the potential sharp decline in revenues upon patent expiry of one or more leading products of a firm.

 “Investors are increasingly willing to accept that pharma companies can navigate the patent cliff through factors including growth in emerging markets, cost management, diversification and in some cases new drug launches,” said Deutsche Bank analyst Mark Clark “ Big pharma approaching bottom of patent cliff,, Nature Blog Oct 2012

patent mapping: SEE under patinformatics 

patent pooling: A patent pool is an agreement between two or more patent owners to license one or more of their patents to one another or third parties.  A patent pool allows interested parties to gather all the necessary tools to practice a certain technology in one place, e.g, "one- stop shopping," rather than obtaining licenses from each patent owner individually. US Patent and Trademark Office "USPTO issues white paper on patent pooling" Jan. 19, 2001

Patent pools: A solution to the problem of access in biotechnology patents?, Jeanne Clark et al, USPTO, 2000 
Wikipedia "patent pools"   

patent portfolio: Patents owned and applied for.  Refers to owned intellectual property, does not include licensing arrangements. 

patent stacking: Taking out many patents for different aspects of a single innovation, thus forcing several royalty applications and payments. Aaron Cosbey , Sustainable Development Effects of the WTO TRIPS Agreement: A Focus on Developing Countries, International Institute for Sustainable Development, Canada, 2000 Related term: royalty stacking 

patent system: The [patent system] has changed from focusing on conventional drugs to being a system that also encompasses patents on biological molecules containing genetic information. . Many thousands of patents with claims to human DNA sequences have been filed and granted, and few have as yet been subject to legal challenge. The many patents include claims for genomic DNA sequences, complementary DNAs, individual mutations, expressed sequence tags (ESTs) and single nucleotide polymorphisms (SNPs) Martin Bobrow, Sandy Thomas "Patents in a genetic age" Nature 409:763-764, 15 Feb. 2001  Related terms: international patents, EPO European Patent Office, JPO Japanese Patent Office, PTO Patent and Trademark Office (US) WIPO World Intellectual Property Office 

patent thicket:  An overlapping set of patent rights requiring those seeking to commercialize new technology obtain licensees from multiple patentees.  Navigating the patent thicket, Carl Shapiro, Univ. of California, Berkeley, Mar. 2001  

patent trolls: President Obama’s executive order is aimed at limiting the negative effect of Patent Assertion Entities (PAEs) also known as ‘patent trolls’ on the innovation ecosystem and on the economy at large. ,,, While the executive order itself will not change the system, it sets the direction for future.  The direction provided by the order coupled with the legislations like the SHIELD (Saving High-tech Innovators from Egregious Legal Disputes) Act will help reduce the damage caused by non-value adding and frivolous infringement suits. The amount of patent infringement suits brought about by PAEs has increased tremendously over the last few years. In the last two years, it has risen from 29 per cent to 62 per cent. Estimates suggest that PAEs may have threatened over 100,000 companies with patent infringement last year alone …  the impact could be significant on the biotech space where there is scope of functional claiming. Under most circumstances, pharma patents cover function of a drug tied to a particular composition of the drug. Therefore, the scope for the meaning of the claim to change over time is less. Biotech is a field at the cusp of many different fields and is a rapidly evolving field. There is more scope for meaning of a claim to change over a period of time, and functional claims in the field could be restricted in the way they are allowed to be written today. Nandita Vijay, Obama’s recent orders on ‘patent trolls’ could impact biotech cos more than pharma cos, PharmaBiz July 2013  

patinformatics: Describes the science of analyzing patent information to discover relationships and trends that would be difficult to see when working with patent documents on a one-on-one basis. The term encompasses all forms of analyzing patent information, including the following:  Patent intelligence — The use of patent information to identify the technical capabilities of an organization and the use of that intelligence to develop a strategy for strategic technical planning; Patent mapping — Sometimes described as white space mapping, which uses published patent data to create a graphical or physical representation of the relevant art pertaining to a particular subject area or novel invention; Patent citation analysis — the study of patent citations for potentially determining a patent's value or, perhaps more reliably, the identification of potential licensing partners or leads based on the citation of an organization's patents by another company in the same or a completely different market space  Patinformatics can also cover additional applications of patent information involving a subsequent analysis step.  Anthony Trippe,  Patinformatics: Identifying Haystacks from Space, Searcher 10(2): Oct. 2002

pre-competitive: Biopharmaceutical Research

prior art: Definition and relationship to patents, Wikipedia 

provisional patent applications:  Since June 8, 1995, the United States Patent and Trademark Office (USPTO) has offered inventors the option of filing a provisional application for patent which was designed to provide a lower- cost first patent filing in the United States and to give U.S. applicants parity with foreign applicants under the GATT Uruguay Round Agreements. US PTO, "Provisional Application for Patent, Nov. 29, 2000

A provisional application for patent is a U. S. national application for patent filed in the USPTO under 35 U.S.C. §111(b). It allows filing without a formal patent claim, oath or declaration, or any information disclosure (prior art) statement. It provides the means to establish an early effective filing date in a non- provisional patent application filed under 35 U.S.C. §111(a) and automatically becomes abandoned after one year. It also allows the term "Patent Pending" to be applied. USPTO Glossary

reach through provisions: MTAs do not usually require financial payments at the time of the transfer, but many MTAs allow the provider to either own, or license exclusively, or obtain payments upon the sale of, developments that the recipient makes with the provider's materials. These are loosely called "reach- through" provisions, and are considered by many providers to be desirable because they allow the provider to obtain rights in subject matter that the provider would not otherwise have rights to through its ownership or patent coverage of the material alone. Reach- through provisions are considered undesirable by many recipients because they burden all the developments created after the use of the material, and because they are seen as providing an unfairly high level of compensation to the provider for use of the material. Appendix B Definitions related to Technology Transfer, Report of the National Institutes of Health (NIH) Working Group on Research Tools, US June 4, 1998  
Related term: Material Transfer Agreement MTA

Patentability of reach through claims, US PTO, Jose G. Dees, Supervisory Patent Examiner Related term: Material Transfer Agreement MTA

royalty stacking: The concept of royalty stacking arises from the risk that multiple patents may affect a single product. Such a risk is said to be particularly high in the biotech field which is dominated by patent filings. …Royalty stacking arises when, in order to take a product to market, the developer of the product takes licences from all of the owners of the patents which affect the final product. When the royalty payments are added together, the licensee may find itself with a non-profitable product. Hence it has become quite usual for licensees to insist on including anti-stacking provisions in licence agreements. Vicky Clark Pitfalls in drafting royalty provisions in patent licences, Pharmalicensing, 2004  .

Results from situations such as the development of a particular drug  which could involve licensing array technology from one company,  high- throughput  screening from another, a gene product  that was discovered by virtue of a  patented SNP from a third, and a small molecule drug candidate that came from a  combinatorial target library generated in partnership with a fourth. Each could call for the technology supplier to earn royalty payments on the ultimate drug.  Related term: patent stacking  

SNP Patents: In April 1999, ten large pharmaceutical companies and the U.K. Wellcome Trust philanthropy announced the establishment of a non- profit foundation to find and map 300,000 common SNPs. Their goal is to generate a widely accepted, high- quality, extensive, publicly available map using SNPs as markers evenly distributed throughout the human genome. The consortium plans to patent all the SNPs found, but they will not enforce the patents. This will be done only as a measure to prevent others from patenting the same information.  Resources for Genetics and patents, Human Genome Project, Oak Ridge National Lab, US, 2002  

safe harbor: See under patent infringement

stealth patents: Beware of submarine- stealth genetic patents, they can be deadly for scientific research. That was the consensus of genetic patent experts Monday at CHI's Genome Tri-Conference The biggest enemy of scientific progress, the experts said, are so- called "stealth" patents -- those which are filed on genes that researchers have located, but haven't discovered their function. They sit on the patent, sometimes for long periods of time, during which no research is done. In January [2001], the U.S. Patent and Trademark Office finalized guidelines forbidding stealth patenting, but finding these patents will be a long process. Kristen Philipkowski "New Quest: Mapping Gene Patents" Wired, Mar 6, 2001,1282,42214,00.html

Patents filed on genes which have been discovered but have unknown function(s). Also known as submarine patents

submarine patents: Wikipedia 

technology transfer: There is no widely accepted definition of technology transfer, but, generally speaking, technology transfer is the sharing of knowledge and facilities among: Federal laboratories, Industry, Universities, Federal, state, and local governments , Third party intermediaries. The concept of technology transfer as a practical matter becomes clearer when one understands what technology transfer is designed to accomplish. For instance, the purpose of a federal technology transfer program is to make federally generated scientific and technological developments accessible to private industry and state and local governments. These users are then encouraged to develop the technology further into new products, processes, materials, or services that will enhance our nation's industrial competitiveness or otherwise improve our quality of life. What is Technology Transfer? National Technology Transfer Center, Wheeling College Inc. 1996

Can cover a wide spectrum of activities, from informal exchanges of ideas between visiting researchers to contractually structured research collaboration involving the joint use of facilities and equipment. Only since the late 1980s, however, has technology transfer become an important mission component of  most Federal labs. Some agencies, however, have long shared their research with the private sector (e.g., USDA’s Agricultural Research Experiment Stations and NASA’s civilian aeronautics programs), and several laws passed in the early 1980s encouraged such sharing — notably, the Stevenson- Wydler Technology Innovation Act of  1980. National Science Foundation Science and Engineering Indicators, 2000
NIH Office Of Technology Transfer 

trade secrets: A trade secret is something which confers a business advantage, is not generally known, and that the owner of the trade secret takes steps to maintain as a secret. Because of the disclosure requirements of patents and the secrecy requirements of trade secrets, these two forms of intellectual property usually cannot be maintained for any one particular technology. A choice either to patent or to maintain as a trade secret must be made. PATENT LAW YOU CAN USE™ Patents vs. Trade Secrets Howard M. Eisenberg

European Journal of Human Genetics (2013) 21, 585–588; doi:10.1038/ejhg.2012.217; published online 14 November 2012  The next controversy in genetic testing: clinical data as trade secrets?  Robert Cook-Deegan, John M Conley, James P Evans and Daniel Vorhaus

university-industry partnerships and intellectual property: The protection of intellectual property has been one of the most challenging issues in the recent proliferation of university- industry- government partnerships - largely because costs and benefits associated with protection of intellectual property are distributed unevenly among different sectors. Even though different sectors might share the general goal of providing useful innovations to society, there are vast differences in how people can contribute to this goal.  Intellectual Property Rights and Research Tools in Molecular Biology, Summary of a Workshop Held at the National Academy of Sciences, Feb. 15-16, 1996, National Academy Press, 1997

utility guidelines [Jan.2001]: The utility Guidelines are applicable to all areas of technology. However, they are particularly relevant in areas of emerging technologies, such as gene- related technologies, where uses for new materials that have not been fully characterized are not readily apparent.  Press release, USPTO PUBLISHES FINAL GUIDELINES FOR DETERMINING UTILITY OF GENE- RELATED INVENTIONS, Jan. 4, 2001
Utility Examination Guidelines
, Federal Register 66 (4): 1092- 1099, January 5, 2001 Notices  Related term: gene patents

utility patents: May be granted to anyone who invents or discovers any new, useful, and nonobvious process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof. USPTO Glossary

W3C patent policy:

WIPO World Intellectual Property Organization: One of the 16 specialized agencies of the United Nations system of organizations. It administers 21 international treaties dealing with different aspects of intellectual property protection. The Organization counts 175 nations as member states.

An intergovernmental organization of the United Nations system. WIPO is responsible for the promotion of the protection of intellectual property throughout the world and for the administration of various multilateral treaties dealing with the legal and administrative aspects of intellectual property. USPTO Glossary

white space mapping: SEE under patinformatics

American Intellectual Property Law Association, Glossary of Patent Terms 
National Academy of Sciences, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health 2006
USPTO Glossary, US Patent and Trademark Office,  200 + definitions.

There are a number of other legal dictionaries online (at least seven in Onelook

Alpha biopharmaceutical glossary index

How to look for other unfamiliar biopharmaceutical  terms

IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry.

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