Patent Cooperation Treaty (PCT) (close)
An international treaty that provides a mechanism through which an applicant can file a single application that, when certain requirements have been fulfilled, may then be pursued as a regular national filing in any of the PCT member nations. There are currently more than 120 PCT member nations.
Trade-Related Aspects of Intellectual Property Rights (TRIPS) (close)
An international agreement that was initiated under the forerunner of the World Trade Organization (WTO), the General Agreement on Tariffs and Trade (GATT), under the Uruguay round of trade negotiations. The TRIPS Agreement is the most comprehensive multilateral agreement on Intellectual Property covering all IP instruments. It was the first IP rights accord to legitimize the patenting of living organisms. TRIPS provides the guidelines for the harmonization of IP rights laws under the WTO. All WTO member countries have substantive TRIPS obligations.
UPOV (the Convention of the International Union for the Protection of New Varieties of Plants) (close)
An international treaty that guarantees to plant breeders in member nations national treatment and a right of priority. National plant variety protection statutes of member nations are brought into harmonization with the various UPOV provisions, for example, the requirements of distinctness, uniformity, stability, and novelty for new crop varieties.
The use of biological methods (often genetic engineering and related advanced-molecular-biology applications) to produce products, processes, and related services. Generally, these are patentable under U.S. patent law.
The section of the patent that defines an invention (the technology that is the exclusive property of the patentee for the duration of the patent) and is legally enforceable; that is, the claims set the metes and bounds of the patent rights. The patent specification must conclude with a claim, particularly pointing out and distinctly claiming the subject matter that the applicant regards as the invention or discovery. The claim or claims are interpreted as set forth in the specification: the terms and phrases used in the claims must be sufficiently described in the specification, that is, patent claims must read in the light of the specification. The specification discloses and the claims define the invention.
The process of taking an invention or discovery to the marketplace. It involves working the idea into a business plan, consideration of protection options, and determining how to market and distribute the finished product.
due diligence (close)
Investigations undertaken to assess the ownership and scope of one or more IP rights that are being sold, licensed or used as collateral in a transaction. This is done in order to identify business and legal risks associated with the IP rights being analyzed.
freedom to operate (close)
The ability to undertake research and/or commercial development of a product without infringing the unlicensed intellectual or tangible property rights of others.
An invasion of an exclusive right of intellectual property. Infringement of a utility patent includes making, using, or selling a patented product or process without permission. Infringement of a design patent involves fabrication of a design that, to the ordinary observer, is substantially the same as an existing design, where the resemblance is intended to induce the observer to purchase one thing supposing it to be another. Infringement of a trademark consists of the unauthorized use or imitation of a mark that is the property of another in order to deceive, confuse, or mislead others. Infringement of a copyright involves reproducing, adapting, distributing, performing in public, or displaying in public the copyrighted work of someone else.
intellectual property (IP) (close)
Creative ideas and expressions of the human mind that have commercial value and are entitled to the legal protection of a property right. The major legal mechanisms for protecting intellectual property are copyrights, patents, and trademarks. IP rights enable owners to select who may access and use their intellectual property and to protect it from unauthorized use.
The creation of a new technical idea and of the physical embodiment of the idea or the means to accomplish it. To be patentable, an invention must be novel, must have utility, and would not have been obvious to those possessing ordinary skill in the particular art of the invention.
Information that enables a person to accomplish a particular task or to operate a particular device or process. Refer to trade secret.
A grant of permission to use an IP right within a defined time, context, market line, or territory. There are important distinctions between exclusive licenses and nonexclusive licenses. An exclusive license is “exclusive” as to a defined scope, that is, the license might not be the only license granted for a particular IP asset, as there might be many possible fields and scopes of use that can also be subject to exclusive licensing. In giving an exclusive license, the licensor promises that he or she will not grant other licenses of the same rights within the same scope or field covered by the exclusive license. The owner of IP rights may also grant any number of nonexclusive licenses covering rights within a defined scope. A patent license is a transfer of rights that does not amount to an assignment of the patent. A trademark or service mark can be validly licensed only if the licensor controls the nature and quality of the goods or services sold by the licensee under the licensed mark. Under copyright law, an exclusive licensee is the owner of a particular right of copyright, and he or she may sue for infringement of the licensed right. There is never more than a single copyright in a work regardless of the owner’s exclusive license of various rights to different persons.
material transfer agreement (MTA) (close)
patent (U.S.) (close)
A grant by the federal government to an inventor of the right to exclude others from making, using, or selling his or her invention. There are three kinds of patents in the United States: a standard utility patent on the functional aspects of products and processes; a design patent on the ornamental design of useful objects; and a plant patent on a new variety of a living plant. Patents do not protect ideas, only structures and methods that apply technological concepts. Each type of patent confers the right to exclude others from a precisely defined scope of technology, industrial design, or plant variety. In return for the right to exclude, an inventor must fully disclose the details of the invention to the public so that others can understand it and use it to further develop the technology. Once the patent expires, the public is entitled to make and use the invention and is entitled to a full and complete disclosure of how to do so.
plant patent (close)
In the United States, the Plant Patent Act of 1930 provides a grant of exclusive IP rights to applicants who have invented or discovered a new asexually propagated variety of plant. Tuberous plants are not covered by plant patents.
plant variety protection (PVP) (close)
A form of patent-like protection for sexually propagated plants, as well as hybrids, tubers, and harvested plant parts. The Plant Variety Protection Act of 1970 is administered by the U.S. Department of Agriculture and not the U.S. Patent and Trademark Office (which does issue plant patents).
prior art (close)
The existing body of technological information against which an invention is judged in order to determine whether it is novel and nonobvious and can thus be patented.
public domain (close)
The status of an invention, creative work, commercial symbol, or any other creation that is not protected by some form of IP right. Items that have been determined to be in the public domain are available for copying and use by anyone.
research tools (close)
The term research tool includes the full range of tools that scientists may use in the laboratory, including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, and laboratory equipment and machines. There is concern about the patenting of research tools, because such patents may inhibit the free undertaking of research.
trade secret (close)
Business information that is the subject of reasonable efforts to preserve confidentiality and has value because it is not generally known in the corresponding trade. Such confidential information is protected against those who gain access to it through improper methods or by a breach of confidence. Misappropriation of a trade secret is a type of unfair competition.
(1) A word, slogan, design, picture, or other symbol used to identify and distinguish goods. (2) Any identifying symbol, including a word, design, or shape of a product or container, that qualifies for legal status as a trademark, service mark, collective mark, certification mark, trade name, or trade dress. Trademarks identify one seller’s goods and distinguish them from goods sold by others. They signify that all goods bearing the mark come from, or are controlled by, a single source and are of an equal level of quality. And they advertise, promote, and generally assist in selling goods. A trademark is infringed by another if the second use causes confusion of source, affiliation, connection, or sponsorship.
The usefulness of a patented invention. To be patentable an invention must operate and be capable of use, and it must perform some “useful” function for society.
Your source for expert commentary on IP management issues.
CHAPTER NO. 14.2
Kowalski SP. 2007. Freedom to Operate: The Preparations. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.
© 2007. SP Kowalski. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
Freedom to Operate: The Preparations
Freedom to Operate (FTO) is the ability to proceed with the research, development and/or commercial production of a new product or process with a minimal risk of infringing the unlicensed intellectual property (IP) rights or tangible property (TP) rights of third parties. The procedure for assessing whether the product or process possesses FTO is called the FTO analysis, performed by meticulously dissecting the product or process into its fundamental components and then scrutinizing each for any attached IP or TP rights. The early preparations for an FTO analysis are crucial, because they will influence all that follows and hence determine the quality of the work product. Thorough preparation will lay a solid foundation, supporting a credible and reliable FTO analysis. This chapter explains these preparations through an example.
1.1 Freedom to operate defined
Access to agricultural biotechnology (agri-biotech) and pharmaceutical (pharma) products, including vaccines, and processes can help developing countries improve public health and nutrition, contributing to the well-being of those most in need. Such products and processes are categorically technically complex. A cursory glance at a “materials and methods” section of any paper published in a scientific or medical journal reveals the plethora of components and processes that are routinely employed in the research, development, and eventual commercialization of an agri-biotech or pharma product. This technical complexity mirrors the corresponding intellectual property (IP) rights and tangible property (TP) rights complexity; that is, each component, process and/or combination thereof that went into the product might have either IP rights (for example, patents) or TP rights (for example material transfer agreements [MTAs]) of other parties attached. Hence, an agri-biotech or pharma product/process might not be “clean” in a legal sense, meaning that moving ahead with research, development, and commercialization could constitute infringement of another’s IP or TP rights. However, the risk of infringement liability can be systematically managed and dramatically reduced. This is what freedom to operate (FTO) is all about.
Broadly defined, FTO means the ability to proceed with the research, development and/or commercial production, marketing or use of a new product or process with a minimal risk of infringing the unlicensed IP rights or TP rights of third parties.1 The procedure for assessing whether or not the product or process possesses FTO is called the FTO analysis. An FTO analysis is performed by meticulously dissecting the product or process into its fundamental components and then scrutinizing each for any attached IP or TP rights. It is critical to make clear, however, that an FTO analysis neither explicitly nor implicitly denotes an absolute freedom to operate, but is instead a risk management tool, the purpose of which is to assess the likelihood for infringement-litigation liability associated with the new product or process: an FTO is therefore an informed, reasoned, and calculated best estimate of infringement liability, in a given jurisdiction, at a given period of time (that is, a snapshot assessment of the contours, canyons and crevasses of the IP/TP rights landscape for the specific product or process).2
Thus, an FTO analysis will inform an institution or company that the research, development, and commercialization of the new product or process may proceed with a minimal risk of infringing the unlicensed IP rights and/or TP rights of others.3 However, as the IP/TP rights and legal landscape changes, shifts, and evolves, the dynamics and results of the FTO analysis may also change. (For example, patents may issue, expire, or be invalidated; licenses may be granted or terminated; patents may be assigned and then reassigned.) Also, patent rights are strictly territorial,4 meaning that a product/invention might possess FTO in one jurisdiction (a nation where a relevant patent has not issued) but, on the other hand, would not possess FTO in another jurisdiction (a nation where a patent has issued). Therefore, the results of an FTO analysis must be periodically reassessed and updated where and when appropriate.5
1.2 FTO analysis preparations: overview
The FTO analysis must be organized, logical, methodical, meticulous, and carefully documented. An important initial step in a thorough FTO analysis (that patent counsel may then subsequently use to draft an FTO opinion) is the completion of the following preparations:
In this chapter, each of the aforementioned preparative steps is explained within the context of preparing for and conducting a successful FTO analysis. Applicable technologies might be either agri-biotech or pharma. Although the materials, methods, and tools used may be dissimilar from agri-biotech to pharma, the fundamental FTO principles and procedures remain unwavering for each of these. Hence, by following this FTO analysis blueprint, a series of sound FTO questions can be formulated, so as to lay a solid foundation from which a reliable FTO analysis will be able to develop. Patent counsel can then draw upon this analysis to formulate either one or a series of FTO opinions.
1.3 Illustrative example
Throughout this chapter, in order to help clarify and exemplify the topics covered, an illustrative hypothetical will be employed. It is a purely fictionalized situation, presented solely for the purpose of focusing the discussion and facilitating understanding.
Recently a new viral disease has emerged in east Africa. The causative agent is a virus, simian in origin, having been asymptomatically endemic in an isolated population of pygmy desert baboons for millennia. The scourges of war, famine, and drought have impelled many people to seek sustenance from bush meat, which they eventually find by scouring the wilderness for days on end. It is believed that the pathogenic virus made the leap from baboon to human when famished refugees consumed uncooked baboon meat infected with the virus, which likely rapidly entered the bloodstream via the portals of ulcerated oral lesions caused by advanced scurvy. Upon entering the new host, the virus migrated to skeletal muscles, where, in contrast to the primary baboon host, the virus causes progressive muscular degeneration with symptoms resembling myasthenia gravis. It is colloquially referred to as the “fall-down disease” (FDD). The most serious concern with this emergent disease is that it appears to be readily transmissible from human to human via bodily secretions. Hence, it may have the capacity to spread throughout crowded refugee facilities, creating even more suffering and death.
The sudden appearance of this deadly virus has prompted a series of research and development efforts across the globe. These include developing techniques to raise the virus (it can only be cultured in monkey cells), sequencing and characterizing the viral genome, cloning the battery of genes that encode the viral proteins, and developing candidate vaccines.
An east African nation is home to the Institute of Dry Land Crop Research (IDLCR). This nation has recently acceded to the World Trade Organization (WTO) and is serious about becoming compliant with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) so that it can increase economic growth, for example by attracting greater foreign direct investment, particularly in the areas of emerging technologies, such as, biotechnology. As a result, a greater number of foreign interests are filing patent applications for their biotechnological applications and technologies in this nation, usually as part of the national-phase filing pursuant to the Patent Cooperation Treaty (PCT).
In response to the looming crisis of the emergent viral disease FDD, the IDLCR, in conjunction with this nation’s leading medical research center, has launched a program to produce a large quantity of viral antigen in recombinant grain sorghum, transformed with the most immunogenic of the viral antigens. This will then be used to produce large amounts of vaccine to immunize thousands of displaced refugees. Such a research and development program will inevitably entail numerous proprietary components and techniques, likely having the IP and TP rights of third parties attached. Therefore, FTO issues will be a very real and constant concern.
2. Assembling the FTO Team
2.1 Skilled leadership of the FTO team
From the very start of an FTO analysis, it is absolutely essential to establish credible, capable, competent leadership so that the FTO analysis is properly conceived, organized, and conducted. Because an FTO analysis is a multidisciplinary endeavor, the team leader must ensure that it remains focused, on-course, and precise. Under ideal circumstances, that is, qualified patent counsel is available and affordable, such counsel should lead the way. However, in many situations this might not be possible. Also, depending on the stage of the FTO analysis, patent counsel leadership might not be required. For example, early stages of a preliminary FTO analysis can be performed in lieu of counsel, possibly in order to assess or survey the IP rights landscape. Counsel may be sought later when and if it is warranted, possibly at later stages of the FTO analysis when questions of legal significance arise (for example, patent claims analysis). At such a stage, one possible route would be to seek pro bono counsel via services provided by public interest associations (for example, Public Interest Intellectual Property Advisors [PIIPA]).
In order to be most effective, the FTO team leader ideally should have expertise in agri-biotech and/or pharma, depending on the exact product and/or process undergoing FTO analysis. Furthermore (if patent counsel will not initially lead the FTO team) the FTO team leader must be the available professional with the greatest expertise in IP-related issues (for example, a technology-transfer professional officer, an intellectual property practitioner such as a patent agent or a scientist who has participated in various IP rights and technology-transfer courses, workshops, and/or seminars). The FTO team leader must understand the dynamics of the step-by-step process of FTO analysis, not only within the legal paradigm, but also from a sophisticated technical and scientific perspective. Because an FTO analysis is conducted at the interface of science and law, the FTO team leader must be professionally amphibious (that is, capable and comfortable in two different professional environments).6
2.2 The FTO team is multidisciplinary
The FTO team leader selects who will be part of the FTO team. FTO team members should include: scientists who had supervised the project, technology transfer personnel, and technicians/support staff. The last are absolutely essential, as they frequently know what really happened during product research, development, and commercialization. The FTO team might also include business personnel (depending on the stage of commercialization) and possibly administrative staff. The latter might have information pertaining to relevant communications, documents, and agreements. It is also very important to note that the FTO team may, or may not, be the same as the client. For example, the actual client might be a research institute, and the FTO team would be composed of employees.
2.3 Work product doctrine and patent counsel
One important reason that it is judicious to have patent counsel lead the FTO team, particularly at later steps in the analysis, pertains to maintaining the confidentiality of documentation. In the event that a claim of patent infringement arises, the FTO analyses and opinions, prepared under the guidance of patent counsel, may be protected from discovery (the compulsory disclosure of documents to an opposing party), pursuant to the attorney work-product immunity doctrine. However, it is unclear how far this immunity reaches, and so one must exercise caution. In general (in the United States), “[pursuant to the U.S. Federal Rules of Civil Procedure, Rule 26(B)(3)] written material and mental impressions prepared or formed by an attorney in the course of performing legal duties on behalf of a client are protected from discovery as the attorney’s ‘work product’ in the absence of undue prejudice or hardship to the party seeking discovery.” In spite of this, “there has been disagreement among courts construing this language as to its proper interpretation and its integration with other doctrines impacting on discovery jurisprudence … With respect to the standard of protection from discovery which an attorney’s opinion work product should be given, a few courts have held that Rule 26(b)(3) mandates absolute protection, while a growing number of the more recent decisions have held that the standard of protection is less than absolute, with the strict protection generally afforded an attorney’s opinion work product allowing for exceptions in certain circumstances.”7 Such complex issues relating to work-product immunity, and the extent to which it might reach, further illustrate the advisability of having qualified patent counsel as the FTO team leader.
After the FTO team is assembled, the leader coordinates, leads, and guides the team throughout the entire FTO analysis.
2.4 The importance of scientific understanding
In the case of FDD vaccine development, the IDLCR FTO team leader must carefully select a cadre of scientists who will, collectively, comprehend the spectrum of biological, genetic, agronomic, and biotechnological components and techniques that will go into the research, development, and commercialization of the vaccine. These individuals will form the basis of the FTO team. In addition, other professionals might be selected, such as technology transfer officers, administrators, and business managers. This team will then be poised to begin the arduous task of FTO analysis.
3. Analyzing, Understanding and Dissecting the Technology
3.1 Product deconstruction
As the initial step in the FTO analysis, the FTO team must thoroughly know the precise nature of the technology itself, whether it is a product, process, or combination thereof (referred to hereinafter as the product/invention). In order to accomplish this, the FTO team must work closely with all of the research and development staff, so as to understand the nature of the technology to such an extent that it can be “disassembled” into its fundamental components, that is, deconstructed. 8
Therefore, in the deconstruction phase of the early preparations for the FTO analysis, the FTO team and any other scientists, collaborators, or staff, work together to resolve the product/invention into the fundamental processes used to make it, the components that went into its construction, and any possible combinations of processes and/or components potentially pertinent.
3.2 Research tools
At this stage it is important to identify any research tools that were used during research and development of the product/invention.9,10,11 Research tools, integral for the efficient development of commercial applications both in agri-biotech and pharma, are defined by the National Institutes of Health (NIH) as the “full range of resources that scientists use in the laboratory including [a fragment of a gene, a gene], cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines, databases and computer software.”12,13
Identifying them is a critical step in the early FTO analysis preparations, because, although seemingly ubiquitous and readily, even “freely,” available in many laboratories, there nevertheless appears to be no research tool usage (experimental use) exemption in the United States. To assume otherwise would be to unwisely overlook and thereby disregard important steps in the product/invention undergoing FTO analysis.14
3.3 Components of the vaccine
In the case of FDD vaccine development, the production and deployment of a vaccine from transgenic sorghum would entail numerous components and technologies, including, but not limited to:
Each of the above would most likely represent a deconstructed piece of the contemplated final vaccine, and each would therefore constitute an FTO question (see section 8) that the FTO team would subject to thorough scrutiny in the FTO analysis.
4. IP and TP Rights
At this stage, it will be instructive to briefly and clearly define some of the forms of IP and TP rights that are commonly encountered in an FTO analysis.
Patents, as referred to in this paper, are utility patents: a grant by a government to an inventor, for the right to exclude others from making, using, or selling his or her invention, for a specified term of years. This is done in exchange for the inventor fully disclosing the invention in the patent document (typically the specification). Hence, a patent can be viewed as a contract between the inventor and the government, wherein the inventor provides full disclosure of the invention in exchange for absolute exclusivity to the IP rights for a specified term. Patents are applicable to both agri-biotech and pharma.15
MTAs are legal instruments that typically accompany the transfer of TP. They usually (possibly ideally) document what is transferred, who transfers to whom, as well as the provisions, uses, scope of rights, confidentiality, and term of the agreement.16 MTAs are legally defined as bailments.17 So, the question naturally arises, what is a bailment? A bailment is the delivery of an item of TP from one party to another, for a specific purpose, pursuant to the terms of a contract. However, in a bailment it is critical to remember that although there is a change in the actual physical possession of the property, there is no transfer of ownership: title remains with the owner (bailer)—even though possession has shifted to the recipient (bailee).18 In addition to being a bailment, an MTA also entails contractual obligations, and hence, as a binding contract, the terms and provisions of an MTA must be taken very seriously by both parties involved in the transfer/transaction, so as to avoid the possibility of breach of contract liability.19
The terms and provisions of MTAs can vary considerably, particularly when comparing MTAs executed by the nonprofit sector (for example, universities) with those executed by the for-profit sector (for example, corporations).20 Confidentiality, publication rights, and reach-through rights may vary significantly, and one must exercise caution so as not to agree to an MTA with potentially onerous terms.21 If the material used in the development of the product or process was obtained in violation of an MTA between two other parties, then the “obtainer” of the material may be liable for unauthorized use. For example, Andy transfers (technically speaking bails) a plasmid to Roberta (with specified contractual obligations attached), which is then “obtained” by Carl, via trick, theft, or other nefarious means, and Carl then uses it to either develop, or incorporate into, his product/invention. Carl might very likely have a liability problem—possibly misappropriation of Andy’s tangible property.22 MTAs are applicable to both agri-biotech and pharma.
Bag-tags, a type of agri-biotech TP rights protection, are enforceable contracts23 that restrict the licensee (grower) in the use and/or reuse of seed.24 The bag-tag license is analogous to shrink-wrap, box-top, and tear-me-open software license transactions, such that an implicit contract is formed when the seal is broken, which then obligates the grower to the terms of the license as articulated on said seal.25,26
4.4 Plant/germplasm protection
4.4.1 Plant IP rights statutes
Germplasm IP rights protection (agri-biotech) exists in various forms, with each form addressing different types and levels of what is protected. In the United States, the Plant Patent Act (PPA), the Plant Variety Protection Act (PVPA), and Utility Patents for Plants (UPP) are the statutory forms of germplasm IP rights available.27 The PPA provides IP rights protection for asexually (vegetative) propagated plants, (for example, plants that are propagated from cuttings or by budding or grafting); tuber-propagated plants (potato varieties) are not covered by the PPA. The PVPA provides IP rights protection for sexually propagated plant varieties, F1 hybrids, and also tuber-propagated plants (potato varieties); plant varieties must meet the new, distinct, uniform, and genetic-stability requirements. With UPP, the level of IP rights protection is much broader than that afforded by either the PPA or the PVPA. The PPA and PVPA only confer IP rights protection for certain plant varieties, but UPP can claim plants, plant varieties, plant parts, seeds, and tissue cultures.28,29
4.4.2 Plant IP rights treaties
In addition to the PPA, PVPA, and UPP, there are two treaties that address germplasm IP rights protection: the International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA)30 and the Convention of the International Union for the Protection of New Plant Varieties (UPOV).31 In PGRFA, important provisions include an agreement not to claim IP rights for any of the germplasm resources “in the form received” from the multilateral system. There is also a benefit-sharing scheme triggered by the commercialization of new plant varieties.32, 33 A treaty seeking to impart international conformity in plant variety protection, UPOV, fundamentally consistent with the PVPA, specifies that the fundamental criteria for IP rights protection are distinctiveness, uniformity and stability.34
4.5 Technology-use licenses
Technology-use licenses may need to be sought for the use of certain research tools (see section 6.2), which frequently are indispensable in order to facilitate the research and development phase of an agri-biotech or pharma product, process, or application.35 Although there is currently considerable debate as to whether the patenting and licensing of research tools should be subject to either experimental use exceptions or compulsory licensing schemes,36 the basic presumption should remain that there is no experimental use exemption for research tools, regardless of whether the work is performed in a profit or nonprofit entity.37
5. Assessing Plant Pedigrees
5.1 The complexity of plant-related IP rights
When analyzing an agri-biotech product/invention, it is necessary to determine the pedigree of the germplasm forming its very foundation. In other words, the trail of germplasm, with as much detail as possible, must be traced and documented. If detailed breeding records are available, this task will be much easier. Hence, the FTO team must ask these questions: What type of germplasm is the product/invention embedded in? Where did this germplasm come from? What is the detailed pedigree of the germplasm?
Furthermore, as already discussed herein-above, plant germplasm may be protected by various overlapping forms of IP rights:
Hence, the FTO team must remain aware of the possibility of a complex IP/TP rights situation with regard to germplasm. It must therefore pro-actively corral as much information as possible.
5.2 Germplasm issues
Concerning in planta expression of viral antigen in transformed sorghum, varieties contemplated for genetic transformation with the viral gene(s) will likely present complex germplasm considerations during the FTO analysis. For example, overlapping forms of IP and TP rights protection might apply: an ideal sorghum line could simultaneously have third-party patent and plant variety protection rights attached. Since the nation where the IDLCR is located is seeking to comply with the TRIPS Agreement, it will likely have a UPOV-harmonized PVPA enacted as statutory law, and certainly also a patent statute. Hence, germplasm issues, occasionally (and foolishly) subordinated to patents in an FTO analysis, will be of critical importance.
6. Recognizing Pharmaceutical Technical Considerations
6.1 Pharma components
As with agri-biotech, when examining a pharma product/invention the FTO team will need to consider pharma-product/process-specific components.44
The compound itself must be considered:
The types of pharmaceutical compositions must also be considered:
The methods, steps, and components involved in the product synthesis are also critical (see also section 6.2):
Methods of use, that is, downstream considerations, also are important to keep in mind:
6.2 Research tools
And finally, but no less important, research tools must be considered. Biotechnology research tools are used in the development of drug products, therapeutic devices, or diagnostic methods. These research tools are not themselves physically incorporated into the final product/device/diagnostic. Hence, they represent the full range of resources used in drug discovery and development.47 (See also section 3.2.)
In the case of vaccines, there are additional FTO analytical considerations specific for vaccine research, development, manufacture and deployment, including:
As with the pharma product/invention, the FTO team must carefully analyze each of these and, using the results of this analysis, formulate an appropriate series of FTO questions (see section 8). In the case of the FDD vaccine FTO analysis, there will be:
As already discussed, each of these will likely have third-party IP and/or TP rights appurtenant.
7. Interviewing Researchers and Looking for Records
7.1 Interviews and laboratory history
To ensure success when performing the FTO analysis, a continuing rapport between the FTO team and scientific and technical staff is essential. This will help keep everyone involved on the same track, maintain momentum, and keep the FTO analysis up and running. Such informal dialogues with research personnel can reveal critical snippets of information, such as the trail of acquisitions. (For example, who got what from whom, and was it with or without proper authorization as to embedded IP and/or TP rights?) Consider this hypothetical scenario: Andy obtains a product component from Roberta, who had previously obtained it from Carl. However, there was no proper authorization (for example, no MTA) for such a transfer in the first instance, which is definitely something that the FTO team needs to know.
Such anecdotal narratives can never be found in a paper trail; these are solely preserved in the “oral history” of the laboratory. Thus, the FTO team must, at times, function as investigative cultural anthropologists, sorting through the history, habits (possibly bad habits), and “traditions” of a laboratory and research group. Additionally, this sort of dialogue will also help researchers to recall more fully what they had done, allowing them to fill gaps in the written records. What is in the laboratory notebooks may only be part of the story.
7.2 The paper trail
Still, the FTO team must tenaciously pursue every paper trail, searching the laboratory offices, greenhouse, and even the field house, in order to track down notebooks, laboratory records, associated paperwork, computer files, MTAs, bag-tags, bags of seed, and any evidence suggesting an unknown tangible property trail, misappropriated property, or unauthorized access to a third party’s confidential information. A comprehensive review of the research and development group’s written and oral records and related information will thereby enable the FTO team to acquire a sophisticated understanding of what the product/invention is and what IP and TP rights might be involved.
After the FTO team has identified and understood each of the fundamental units of the deconstructed product and/or process, they then can use this information to frame a series of “FTO questions.”
7.3 Template for FTO questions
For the FDD vaccine, the product deconstruction table (Table 1) concisely summarizes the components and process that go into its research, development, and commercialization, as well as the potentially appurtenant third-party IP and TP rights. This is the template, the roadmap, from which the FTO questions (see section 8) can be formulated, addressed and analyzed.
TABLE 1: PRODUCT DECONSTRUCTION, FDD TRANSGENIC VACCINE
8. Formulating the FTO Questions
Following the technical deconstruction of the product/invention, a series of FTO questions are formulated.49 These questions are structured to systematically analyze the dissected processes, components, and any combinations thereof, for potentially embedded IP rights (for example, patents and trade secrets) and TP rights (for example, MTAs and bag-tags50,51). Each FTO question, therefore, asks whether a method to make, a material used to make, or any combination of methods and materials, has, or may have, third-party IP or TP rights attached. Thus, a single material or method, used in the development of either an agri-biotech or pharma product/invention, may have multiple proprietary issues, that is, both an IP right (for example, a patent right) and a TP right (for example, an MTA) of potential relevance. The gravity of formulating a correct series of FTO questions, then, underscores the necessity for caution and meticulousness at this early stage in the FTO analysis, because all the work that follows is built upon this foundation.
9. Scientific Databases
Note: scientific database searches and patent database searches are mutually reinforcing, that is, the two support, verify, guide, and inform each other throughout the process of the FTO analysis. For example, inventors might be authors; institutions might be assignees; scientific discoveries might be the actual invention (disclosed in a scientific publication).
Scientific database searching, along with patent database searching, are integral to the FTO analysis. This is where the FTO team assembles the piles of raw information and data, both written and anecdotal, that will subsequently be parsed, analyzed, and organized in order to address the FTO questions that the FTO team has formulated. Furthermore, the FTO team needs to know what types of scientific informational resources are available, both freely and also on a premium, value-added, pay-per-view basis. Furthermore, the FTO team needs to understand what constitutes the value added for the pay-per-view databases, so that they will be used according to specific needs at certain times in the FTO analyses in the most cost-effective manner.
There are many examples of scientific databases. For example, freely available ones include:
Whereas premium value-added, pay-per-view databases include:
10. Patent Databases
10.1 Free and premium databases
As with scientific databases, the FTO team needs to know what resources are available vis-à-vis patent databases, both freely available and premium value-added, pay-per-view. The FTO team should also know the type of value added for the pay-per-view databases. These databases can then be accessed according to specific needs at key stages in the FTO analyses.57
For example, freely available patent databases include:
And premium pay-per-view (with value-added features) patent databases include:
10.2 Pay-for-view, value-added features
For purposes of illustration, some of the value-added features of Delphion that distinguish it from either the PTO or esp@cenet are discussed here. While free patent research sites can provide patent records, they do not offer the analytical and productivity tools needed to make sense of the data in those records. What follows are some of the key features of Delphion that can make this fee-based service the right choice at the right time in the FTO analysis.61
Rather than presenting just a patent record, the primary display record on Delphion is an integrated view that provides a cross-collection of information without the need to perform extra queries. Included in the integrated view are:
Delphion offers pay-per-use searching of the value-added DWPI database, which covers 13 million unique inventions and has a unique hierarchical system of coding allowing extra precision and accuracy in searching. DWPI data can be used in most of the Delphion analytical and productivity tools. The Delphion Snapshot analytical tool creates quick, easy-to-read bar charts allowing summarization of key bibliographic data—and then further refinement of those summaries. Delphion Work Files allow the saving of result sets or groups of patents that are to be reviewed for future reference. One can easily share these Work Files with colleagues, thus allowing worldwide collaboration. And one can also use analytical tools, like Snapshot, to perform further analyses of these groups of hand-selected records. Delphion allows a user to save frequently used queries, thus eliminating the need to reconstruct them each time. This saves time and decreases the chance for errors to occur in queries. Saved searches can be set to run automatically, advising one of the search results. Data Extract exports more than 50 key bibliographic fields in formats designed for use in other popular applications. The Family Legal Status reports the current legal status of the family members of the invention being examined, which means that there is no need to individually search for each member of the family in order to ascertain the overall view of the protection in each jurisdiction. Delphion, as part of the Thomson Scientific family of IP solutions, offers all the advantages of working with a worldwide company, including a robust infrastructure and support network, interoperability with other Thomson Scientific solutions, and a global perspective on IP research and management.
11. Pharmaceutical Patent Information
A pharma product/invention, has, in addition to the standard patent search tools and resources listed hereinabove, its own patent resource materials. These include the Orange Book, the Merck Index, and the actual physical “shoes” at the PTO.
11.1 The Orange Book
The Orange Book, “is an FDA-published document available in paper and electronic form that lists all FDA-approved drugs with any patents pertaining thereto.”62 The Orange Book contains approved drug products with therapeutic equivalence,63, 64 as well as the expiration dates of patents on therapeutic small molecules and on approved indications and compositions.65 The Orange Book is available as a printed, bound edition, complete with an orange cover, or online.66
11.2 The Merck Index
11.3 PTO shoes
When working with a pharma product/invention, a hand search of the “shoes” in the PTO may be prudent.69 This is an actual physical paper search, within the shoes: the boxes containing patent prior art.70 This is sometimes necessary due to the differences in nomenclature used by various patent drafters, differences that might not be readily identified and sorted out in electronic searching. Hence, under certain circumstances, the physical shoe search is an added measure of due diligence.
12. PTO Information
In addition to searching scientific and patent databases, and checking the Orange Book, Merck Index, and the PTO shoes, there are several other resources of which the FTO team needs be aware. These include patent applications and the patent file wrapper.
12.1 The patent file wrapper
A very specialized informational resource is the patent file wrapper. The file wrapper is a physical folder, held by the PTO. It contains documents pursuant to the patent application and prosecution, including the original patent (or trademark) applications, as well as any amendments, affidavits, and written arguments submitted by the applicant, and the actions taken by the examiner concerning the application.71 The file wrapper becomes publicly available only after the patent issues. The file wrapper can be either physically accessed,72 or accessed via a searchable, writable, PDF format, which requires an up-to-date version of Adobe® Reader® and sufficient RAM (random-access memory) on the searcher’s computer.73
12.2 Patent counsel analyzes the patent file wrapper
Since the file wrapper is such a specialized informational resource, it will typically be accessed and analyzed during an FTO analysis specifically to address very technical issues (for example, claims interpretational queries, usually done only near the terminal phase of the FTO analysis). Furthermore, the file wrapper should be searched and analyzed only by qualified patent counsel, who ideally, at this late stage in the FTO analysis, is the leader of the FTO team. This is because counsel, by reviewing any patent claim amendments or disclaimers, will be using the contents of the file wrapper to carefully construe the precise meaning and scope of the claim language.74, 75 It is important to recall that an FTO analysis proceeds from broad and general to narrow and precise. Correspondingly, the analysis of patents proceeds from the patent itself (the abstract, claims and specification) to the claim language construction, to the file wrapper contents.76 Hence, the greater the precision and specificity of the analysis, the greater the advisability for patent counsel participation: the ability to understand the legal basis of claim meaning and scope become critical at the later stages of the FTO analysis.
12.3 Patent applications
Patent Applications are filed with the PTO, the PCT, and also in the various National Phase Applications. Although patent applications do not technically confer statutory IP protection, they nevertheless are a good indicator of what might be subject to protection pending patent issuance.
13. The “Period of Silence”
It is critical to understand that patent applications will not be available prior to publication, and so their contents remain unknown for a period of 18 months after the earliest effective filing date.77 Therefore, whereas such inventions are held in trade-secret status during this period, they nevertheless are still pending as potential future patents. However, under U.S. law, if the patent application is only to be filed in the United States, then the 18-month rule may not apply. (That is, the applicant may opt out of the 18-month requirement, and in that case the invention, as disclosed in the patent application, remains a trade secret until patent issuance.78) The 18-month period of silence, therefore, has implications in the FTO analysis, in that there may be pending IP rights, still below the surface, but nonetheless relevant to the FTO analysis. A diligent analysis of the published scientific literature, including conference papers, abstracts, and presentations, might suggest what pertinent IP rights are lurking in patent applications still hidden during the 18-month period.
14. Due Diligence
During the preparation, set-up, data accumulation, and FTO question-formulation stages of an FTO analysis, due diligence is required. Due diligence, broadly defined, is “Such a measure of prudence, activity, or assiduity, as is properly to be expected from, and ordinarily exercised by, a reasonable and prudent [person] under the particular circumstances; [Due diligence is] not measured by any absolute standard, but [depends] on the relative facts of the special case.”79 From a practical standpoint, due diligence necessitates a methodical approach, such that all forms of IP and TP rights are garnered, organized, and assembled into a coherent document, for example, a Microsoft Excel spreadsheet.80 The question often arises, as to how much diligence is enough. The answer? When one finds oneself treading the same ground, then the requirements of due diligence are satisfied.
The preparations for an FTO analysis will determine the quality of the final work product. Organization, thoroughness, meticulous documentation, and solid leadership by a capable FTO team leader will all combine to contribute to a successful outcome. A comprehensive checklist of what must be established during the early stages of the FTO analysis serves as a helpful tool.81 For example, the list should include:
And finally, it is imperative that all records are properly maintained. Consistent records of all searches and search terms must be documented and organized. This should include:
Having spent the early phases of the FTO analysis with the disciplined rigor laid out in this chapter, the later steps in the FTO analysis should proceed with a minimum of problems. Diligence will pay off in the end with a solid and reliable FTO analysis that can be routinely updated and revised and that can also provide patent counsel with the requisite information for drafting FTO opinion letters.
All referenced Web sites were last accessed between 1 and 10 October 2007.
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49 See supra note 6.
50 See supra note 19.
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61 Information graciously provided by Kathy Little (Thomson Scientific).
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© 2007. SP Kowalski. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.