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• W2079245144 abstract "Pharmaceutical Patent AnalystVol. 1, No. 5 EditorialFree AccessCommunicating the needs of businesses to patent analystsEdlyn S SimmonsEdlyn S SimmonsSimmons Patent Information Service, LLC, 5528 Brewer Road, Mason, OH 45040, USA. Search for more papers by this authorEmail the corresponding author at edlyns@earthlink.netPublished Online:23 Nov 2012https://doi.org/10.4155/ppa.12.55AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Keywords: freedom-to-practicepatent search categoriesprior-art searchreference interviewsearch reportsThe perils of the failure to communicateOne day early in my career as a pharmaceutical patent analyst, I had a telephone call from the general patent counsel. “I just met with Dr X at our European labs, and he’d like us to do a patent search on medicated dandruff shampoos,” he said.“Okay,” I said, “how do you suggest that I approach the search?”“You can start by searching for patents claiming dandruff treatments in the USA and European countries,” he responded. “Dr X gave me a patent he’s interested in, and I’ll send you a copy.”Several weeks and thousands of US dollars later, I sent Dr X a comprehensive summary of dandruff patents and he called to thank me. “But what I really wanted to know,” he said, “was whether that patent would cover a shampoo with a combination of Drug A and Drug B.”“What we have here is a failure to communicate,” I thought, to quote the movie ‘Cool Hand Luke’.The scientist asked for a ‘patent search,’ but he didn’t tell us what he really needed to know. Patents can be used to answer all kinds of questions, and each question requires a unique combination of databases, search strategies and in-depth analysis. If the person requesting a patent search does not tell the analyst what he or she needs to know and how the information will be used to meet the needs of the business, time and money can be wasted without ever finding the answer to the real question. A clear understanding of what is needed will determine the scope of the search, the tools to be used, and the depth of analysis.What are the questions a patent search and analysis can answer? Here are some examples.▪ ‘A new molecular entity, formulation, method of treatment, or process for preparing a compound or composition has been created. Is it patentable?’A classic patentability analysis [1] requires a comprehensive search of the patent and nonpatent literature. There should be no time limits, no geographical limits and no restrictions as to the types of publications to be considered. The search should look for both specific and generic disclosures; Markush structure databases should be searched when the topic involves a chemical structure and biosequence databases should be searched when the topic includes a protein or nucleic acid. The analyst should report publications disclosing products or processes that differ slightly from the topic of the search, as these could be cited during patent prosecution as relating to obviousness or inventive step. It is not necessary to consider factors other than the technical content of the publications; for example, the identity of the patentee or whether patent documents are in force. It would not be helpful to illustrate a report with charts and graphs because each cited reference will have a specific technical disclosure.▪ ‘Do we have freedom-to-operate?’In other words, ‘can we be sued for patent infringement if we make, use, sell or import this product or process?’ A freedom-to-operate search [2], also known as a freedom-to-practice or freedom-to-use search, is a true patent search. Only patents need to be considered, and only patents that may be in force at the relevant time and place will be important. The analyst can limit his or her search to particular countries and regional patent offices and need not look for patents filed so early that they will have expired. The current status of each cited patent is important – an expired patent is not an impediment to freedom-to-operate, but a pending patent application can issue in the future. The ownership of cited patents is important, because you cannot be sued for infringing your own patent. Analysis must be based on the patent claims alone, either the claims of a granted patent or claims pending in a published application.▪ ‘Is our competitor’s patent (or our own) valid & enforceable’ or ‘can we successfully oppose a patent newly granted to a competitor?’An invalidity or opposition search [3] has the same requirements as a patentability search, but it need only consider prior art published before the effective filing date of the patent you seek to invalidate. The underlying search objective is to find prior art that was missed or misunderstood by the patent examiner.▪ ‘We are thinking of acquiring another company. What patents does it have?’This is part of the due diligence process [4] and it is important to find all of the patents and applications currently belonging to the company, including those originally assigned to a different corporate entity, and to avoid counting patents that have lapsed or been transferred to someone else. The analyst who performs the search may or may not be responsible for evaluating the technology in the patents or the financial value of the patent portfolio.▪ ‘We would like to acquire a new product or technology. What patents have been filed in this area & who owns them’ or ‘who are our competitors & what have they been developing lately?’A patent map or landscape can be created by a wide variety of tools [5,6], but the most important factor is a reliable search for the technologies of interest. A more up-to-date listing of patent analysis tools can be found in the Patent Information Users Group (PIUG) wiki [101]. The results of the search can be provided as a simple listing or organized by patentee names, patent classification codes, or customized categorizations. Visual representations can be simple charts and graphs or imagined geographical landscapes. Graphical representations of sets of patent documents can be organized to reveal statistical distributions of technologies based on patent classifications or appropriate ontologies, development of particular technologies over time and the institutions that developed the technologies. Maps of distributions and trends greatly accelerates decision-making and business-development strategy, and, ideally, the graphical display will be hyperlinked to images of the patent documents so that the high-level view provided by graphs can easily be clarified by reference to individual patents.▪ ‘I know about a patent that seems to be related to a research project. Will this patent be a problem for us?’This should have been Dr X’s question – what was needed was an interpretation of claim language and not a search.Improving communicationThese are typical questions that need to be answered in order to proceed with R&D or to commit the company to a business deal, but they are not usually asked when the decision maker requests a patent study. Executives and attorneys who ask for patent information are often unaware of the different types of approach and resources that can be used in searching the patent literature and analyzing the patents the search retrieves. They may request information that is broader or narrower in scope than what is needed. Frequently, the requestor already has a great deal of information and has not considered the possibility that the analyst’s job is much easier when relevant references are already in hand. In many cases, the request does not come directly from the individual who will be using the information, and details are lost as the request is transmitted from person to person.The analyst must make every effort to engage the ultimate requestor in a discussion of the project that motivated the request. Librarians call this kind of discussion a reference interview. A detailed reference interview gives the analyst an opportunity to learn what the business need is and to find out what the client already knows. This discussion will enable the analyst to understand what kind of question needs to be answered, to decide what kind of data are needed to answer the question and to use the right tools to answer the business need rather than simply providing what was asked for.In many organizations, requests for search and analysis are submitted through a centralized reference desk or electronic request log. The requestor is asked a series of questions about the work that needs to be done, and the work assigned to the analyst only after the standard questions have been answered. These standardized request forms often ask the client to identify databases to be searched and reporting tools to be used. Asking the client to prescribe the mechanics of the search rather than the business need to be met is unrealistic at best. It overestimates the familiarity of scientific and legal specialists with search and analysis tools and undervalues the expertise of the patent analyst. Most such questionnaires could be improved greatly by reformulating the questions to focus on the needs that have driven the request rather than the tools that should be used in answering it. The proper approach to a project should never be left up to the requestor; it should be decided after the business needs have been discussed with the analyst who will be doing the work.There are many patent data-mining and mapping tools, and many patent analysts routinely use them to produce attractive graphics for their reports. Although graphs, charts and maps can simplify understanding of trends and relationships, there are many problems that do not have a graphical solution. The objective of the analysts report is to communicate information that will help to solve a business problem. The graphics are often extraneous. They add nothing to a patentability or freedom-to-practice analysis. The analyst can communicate the results of the project by omitting them when they interfere with a clear answer to the underlying question.Had graphical tools been available to me when I answered Dr X’s question about dandruff shampoos, I might have been tempted to illustrate my already voluminous report with multicolored graphs showing the various anti-dandruff agents used over the years or the companies owning the patents. Instead, it was only necessary to answer, “Yes, that combination of ingredients is claimed.”Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.References1 Simmons ES. The paradox of patentability searching. J. Chem. Inf. Comp. Sci.25(4),379–386 (1985).Crossref, CAS, Google Scholar2 Wolff TE. Freedom-to-operate patent searching: my six basic rules. Searcher – the Magazine for Database Professionals16(5),34–40 (2008).Google Scholar3 Wolff TE. What’s so special about invalidity searches? Presented at: Patent Information Users Group 2011 Annual Conference. OH, USA. 21–26 May 2011.Google Scholar4 Hantos S. Helping others acquire, license or invest in patents with confidence – a guide for patent searchers to patent due diligence. World Patent Information32(3),188–197 (2010).Crossref, Google Scholar5 Trippe AJ. Patinformatics: identifying haystacks from space. Searcher – the Magazine for Database Professionals10(9),28 (2002).Google Scholar6 Anthony J. Trippe, patinformatics: tasks to tools. World Patent Information25(3),211–221 (2003).Crossref, Google Scholar101 Patent analysis, mapping, and visualization Tools. http://wiki.piug.org/display/PIUG/Patent+Analysis%2C+Mapping%2C+and+Visualization+ToolsGoogle ScholarFiguresReferencesRelatedDetails Vol. 1, No. 5 Follow us on social media for the latest updates Metrics Downloaded 535 times History Published online 23 November 2012 Published in print November 2012 Information© Future Science LtdKeywordsfreedom-to-practicepatent search categoriesprior-art searchreference interviewsearch reportsFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download" @default.
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