Pharmaceutical companies have an inevitable need for regular if not permanent analysis of literature published on their products. They are not only legally obligated with regards to pharmacovigilance (e.g. processing of any undesirable drug effect reported somewhere) and medical information (e.g. answering product inquires by practitioners and pharmacists). Beyond that, product reports within the scientific literature are a full treasure of real-world product behavior findings which support marketing, competitor intelligence, product innovation, and more. But we are talking about giant pool of millions of publications within thousands of scientific journals which is growing every single day. Ad-hoc searching and analyzing costs reasonable amounts of money: The solution So-called “product literature databases” (PLDs) or “corporate literature databases” deliver the knowledge about what has been published about your own products … much more efficient than highly redundant and multiplied individual ad-hoc literature searches. PLDs are sort of subsets of the worldwide literature, including only publications which mention at least one product of the company. Typically, they are filled by automatic search agents (search profiles) or by feeds delivered by database providers. Well-designed PLDs also provide mechanisms for rating publications, annotating information and signaling predefined events. External PLD providers UK-based Pi2 solutions Ltd. is an established vendor for customized pharma and biotech PLD solutions and was acquired by ProQuest Dialog this summer. Pi2 traditionally supports Pfizer, and since 2009/2010 also Wyeth (who had worked with OvidSP® for ad-hoc literature research before). A 2013 poster presented at the 9th Annual Meeting of the International Society for Medical Publication Professionals might give some information on general approaches. Beyond that are no public information available regarding Pi2’s market success or market share, and I am quite curious about impact of the new collaboration with ProQuest. Other potential providers of PLD solutions are major B2B specialist information database and service providers, like Reed Elsevier, Thomson Reuters and Wolters Kluwer, who are factually dominating the mass market for literature raw data. Particularly Elsevier has already shown strong interest in providing more customized and mature services to industry clients. They quite recently build a kind of customized product literature service for Sanofi’s pharmacovigilance by combining their database content with the QUOSA literature management software. In-house PLDs The Novartis pharma group had their own internal PLD since the late 60’s, called “eNova”. This solution has been the most mature and significant PLD I have ever seen. Novartis not only collected literature on their products, they also applied a kind of in-depth ‘digestion’ of reported product findings and clinical data. As a result, the PLD was able to very precisely answer questions on any aspect of real-world drug behavior at the push of a button. “eNova” was finally discontinued and shut-off by Novartis end of 2013, despite the fact that internal analysis had shown substantial positive impact on productivity and individual time savings for product related literature research & analysis of 93% and more. Roche once also had an internal PLD similar to “eNova”, which was shut-down a couple of years ago already. As a “side effect” corresponding product literature research & analysis activities and workload were distributed across the organisation. For example, each national affiliate had to substitute the service by an own solution to continue mandatory MedInfo deliveries and to comply with regulatory expectations. It goes without saying that this split-up of different solutions and approaches did not really result in an overall productivity increase nor in overall cost savings. A little later, after negative effects became more and more evident and clear, Roche tried to reactivate their in-house PLD. But unfortunately the reintroduction failed as 2-digit million CHF investments were needed but not provided. By the way, much more money than continuing the Roche in-house PLD would have costed. Why do PLDs have such a poor standing? Watching the developments at Novartis and Roche, one automatically ends up with the question for what reason their PLDs were shut-off … despite obvious downsides for the enterprises? Actually, there are some dependencies and basic conditions for the reasonable operation of an in-house PLD. And those dependencies and basic conditions are sometimes contrary to currently practiced management paradigms. Summary An in-house PLD – cleverly designed and implemented – is able to reliably cover the need to know that has been published about a company’s own products. It also prevents troubles with regulatory expectations and authorities, and increases productivity at once. But “cleverly designed and implemented” also includes a long-term strategic integration within the enterprise as well as a reasonable degree of independence from short-term decisions and tactical changes. Any short-term shut-down of an established in-house PLD bears the risk to create hidden but substantial costs. And in all known cases it had been an irreversible back to zero. Currently, one of the biggest challenges of PLDs is, to give medics and other non information professionals efficient access to product answers, especially by more productive and intuitive user interfaces. Success will be result of votes by the feet … resp. by the…

Information research on freedom-to-operate is daily business patent research. But it should never be undervalued. Every single project somehow is a class of its own. And missing the tiniest piece of “public” information can have major impact on the success of your IP strategy. So, standard guides and how-to’s do not really serve the need for distinct research strategy and brain power. But 10 basic rules might help to be more effective and successful … As a it could be of special interest, I added some tips to reduce your costs with FTO research at the end of this post. Step 1 – Asking questions will be crucial for success FTO research should not be like tapping around in the dark. With the words of a good friend of mine, FTO research should be defining the borders and specs of the football field (“playground”). So, start your mission with asking questions. A lot of questions. From different angles and viewpoints. As a patent attorney or research manager, feel mandated to give your information searcher as much background information and direction as possible. And allow him or her to bother and challenge you. Jointly develop authoritative search keyword synonym groups as well as a sound search strategy, which is a proper balance between quality and quantity. Last not least do some early preview searches in database indexes while developing the strategy, which will give you an impression if your strategy works as well as on volumes. Step 2 – Include non-patent literature Sometimes it is helpful to think through the backdoor. Non-patent scientific literature can increase the certainty of your FTO. Is there any publication (scientific literature, common press) that might prevent a 2nd party application? But consider the following peculiarities of scientific literature databases, please: Step 3 – Choose the right information sources There are public sources, e.g. for patent literature, like esp@cenet, USPTO, DEPATISnet, and with other national patent authorities. Pro’s free of chargequickly accessible via the internetCon’s limited search opportunitieslimited service only You get what you pay. Specialist information databases on the other hand provide “pre-digested” high quality information. Established vendors are STN, Delphion, Proquest Dialog, and FIZ Technik (in Germany). Pro’s editorial post-processingadded value (indexing, reviewing)extensive and effective search functionscrosslinks between different databasesoption of multi-file searchessubstantial service and support(e.g. helpdesk, trainings, documentation)Con’s considerable costs (royalties)professional search tools needtraining & experience So, you pay what you get. Step 4 – Dare to get external support External information specialists (agencies and freelancers) provide you a sound information research & analysis competence, a considerable level of flexibility, and – last not least – an independent viewpoint. But there are a few things you might want to consider and check before working together … Step 5 – Know peculiarities of sources No, I don’t want to give a lecture on professional information research. But again, there are some peculiarities of source databases, you should take into account when interpreting results. Taking all together, most information professionals prefer to use multi-files searches (database clusters) instead of single file searches. But a proper level of experience is needed to not just get more, but to ensure that nothing relevant is lost. Step 6 – Know peculiarities of content Be critical regarding accuracy, completeness and timeliness of any search database content. All databases are full of errors, some created with introduction of the data, some originate from the original document already. Spelling mistakes … by patent applicant, by OCR reading, by misinterpretation of special characters with some languages, by data errors during processing. As a result, your keywords do not match. Solution:truncate your search keywordsuse character maskinge.g. “er!thropo!tin*” matches “erythropoetin”, “erythropoétine”, “erithropoetines”, … Applications not using right terminology … by patent applicant, perhaps intentionally. So, again your – right – keywords do not match. Solution:think beyond the typical terminology to find additional unusual synonyms for your search keywordstruncate your search keywords Not helpful keywords … that have multiple meanings or occur regularly but unspecific within the literature. E.g. “protein”, “cell”, “screen”, “agent”, some substance names, acronyms, etc. Those keywords can give you non-relevant hits and bothersome background noise. Solution:do not use these keywords with your search increase stringency by delimitation or combination limit search to single database fields (title, claims, e.g.)use acronyms in combination with other keywords only Filing dates Several circumstances create problems with time period limitations used by your search. E.g. by the period of application, by the time gap between filing and database entry as well as by different characteristics of static and dynamic literature databases. As a result, you don’t get some publications you should. Solution:include “preview” databases with your search repeat search after 18 months to completely cover the time frame of one general application period monitoring Hidden applications and “submarines” With some search strategies you might accidentally miss relevant publications. E.g. using IPCs in search profile increases stringency…. but might overlook applications that are located in exceptional classes. Another issue are unpublished US applications. Solution:try a search with excluding your IPCs of choice (“NOT”) High numbers of hits Solution:check search profile for sources of “background noise”check efficiency of family sortgo back to database indexwith full-text databases, limit search to selected fields (title, claims, abstract, …)increase stringency – further delimitation possible?reduce truncationsreduce acronymsuse IPCscreate sub-searches Step 7 – Have positive control references up your sleeve Hold back at least one internal positive control (publication) that should be found by the search strategy. If the positive control(s) was not found, improve the search strategy. Step 8 – Ensure availability of specialist expertise for special topics and tasks Some types of FTO searches, like on bio-sequences, chemical structures or statistical analysis (competitive intelligence) – require specialized tools, special sources as well as particular knowledge and expertise of the analyst. It is vital to have all three in place! Step 9 – Carefully interpret results Here is a list of my recommendations with interpreting results … Step 10 – Stay up-to-date To my opinion, it is not sufficient to just state FTO at a certain time point. It needs to be watched. So, monitoring comes into game. Most professional database providers offer alert functions for a given search profile, which automatically drop you a note to your mailbox once a new piece of information is available. It is a quick win to use this functionality. In addition, current awareness searches might be needed at larger intervals to complete the full picture. This approach also allows you fine tuning or search strategies, resp. the adjustment to a changed “football field”. Special: 10 steps to keep down your costs This post is based on a presentation first given at the C5’s European FTO Congress, Munich, November…

Since the late 1960’s up to the end of 2013, eNova was the Corporate Product Literature Database of Novartis and its ancestors. But in fact it was much more than that. Over many years of continuous improvements, eNova had evolved to the most sophisticated, mature and powerful information source on real-world product behavior. Providing an outstanding high level of “digestion” of source data, eNova was able to answer very specific questions regarding clinical findings and medical evidences on Novartis products 24/7 and within just a few minutes … where alternative methods needed hours to days. During my time at Novartis, I was responsible for the content of eNova which was systematically and continuously picked out of the scientific literature and conference abstracts and analyzed. I was the owner of the corresponding Novartis-specific guidelines for information classification and analysis, and continuously improved and streamlined the rule sets to assure the expected level of quality. I cared for the quality and stability of corresponding eNova content creating and updating processes. In addition, I was in charge for (internal) customer relations, user support, and user training. CLIENT:Novartis Pharma AG(as a Novartis employee)PROJECT TIME FRAME: November 2008 – December 2013 READ MORE…

In 2013, I initiated and promoted the development and implementation of “eNova QuickAnswers”, a quick and easy access to standard product-related answers for marketing and medical information colleagues at Novartis. “QuickAnswers” was finally realized as search tool within eNova and as website widget which could be implemented on any intranet or Sharepoint site Last not least the team decided to additionally develop a QuickAnswers iOS app for internal use. I supported the team with migrating the QuickAnswers concept and functionality to the principles of an app. The result successfully passed user acceptance tests, Novartis risk assessment, and was rolled-out to the internal app store soon before due date. The eNova QickAnswers iPhone/iPad app was one of the very first Novartis-internal iOS apps, providing unique and mobile insights on real-world product behavior. CLIENT:Novartis Pharma(as a Novartis employee)PROJECT TIME FRAME: 2013 READ MORE…

With a so-called “bibliographic search” you are looking for the abstract or full-text of a scientific publication. This means, you already have at least some citation information on the publication, like author name(s), publication year, title, journal name, volume#, issue#, and/or page#. There are some known traps and pitfalls with bibliographic searches, that I would like to share with you. 6 pitfalls for bibliographic searches … 1. Always assume a typo Generally assume typos in either the database record of the publication, or your notes, or the original publication. 2. Do not use special characters If the known publication title you would like to search for includes any special characters, like hyphens, colons, commas, semicolons, brackets, Greek symbols and so on and so forth, use only those parts of the title for your search which do not include any of those. Example:”Oral fingolimod (FTY720) in relapsing-remitting multiple sclerosis (RRMS): 2-Year αData efficacy results; the phase III FREEDOMS I trial”should be searched as”Oral fingolimod” AND “multiple sclerosis” AND “efficacy results” AND “phase III FREEDOMS I trial” However, some literature databases handle brackets, hyphens & co. quite well. When they are phrased. Example:”Oral fingolimod (FTY720) in relapsing-remitting multiple sclerosis (RRMS)” By the way. In literature databases non-Latin characters (Greek symbols e.g.) are normally translated to the corresponding Latin character (α -> a) or written out (α -> alpha). Similar for local characters, like the French accents (à, á, â) that most likely will be used just as “a”. 3. Do not trust publication titles Even if the known title of a publication can be the quickest way to identify the reference, always doubt it. If you do not find anything with it, it does not necessarily mean that the publication is not there. The source, where you have it from might have included an error, or there could be an accidental typo. Also think about the already mentioned different notations for Greek symbols, special characters, numbers (3, III, three) or abbreviations as well as differently use blanks, that are all potential variations resp. sources of mismatches. If you cannot pass on searching the title, the solution might be to not use the complete but just a fragment of it, which seems to be more valid (= less opportunities for variations) . Examples:”Oral fingolimod (FTY720) in relapsing-remitting multiple sclerosis (RRMS): 2-Year αData efficacy results; the phase III FREEDOMS I trial”could be searched in the title field as”Oral fingolimod (FTY720) in relapsing-remitting multiple sclerosis” 4. Use author’s last names only For “Jean-Paul Sartre” you would find the following alternative writings in scientific literature databases: Sometimes you find even in a single database notation variations of the same author’s name. So, the only stable and consistent values are the author’s last names. 5. Use sparse search values only If you know the full citation data, a search with the first authors last name, the publication year and the first page number alone in most cases will be sufficient and bears minimum risk only for mistakes and typos. Examples: 6. Avoid journal names Search for journal names only if there is no other opportunity to identify. But keep in mind that there might be variations of the journal name like “Proceedings of the National Association of Science”, “Proc Nat Assoc Sci”, and “PNAS”. Better limit by clearer values, like volume number, issue number, publication year, first page number … without using the journal name. So, and now just enjoy your next search! Try those 6 simple rules, and failure should be…

The major challenge for most IP workers is to know where and how to retrieve up-to-date, high-quality patent as well as patent-related information. Well, for simple searches regarding a known patent number, inventor, assignee, head title, etc. there are already a couple of easy-to-use Internet sources provided by national and international patent authorities. For example, esp@cenet (EPODOC), DEPATISnet and the USPTO databases. Another promising source for basic searches – especially in the context of drug development – is DrugPatentWatch. But this one – as the ones following now – unfortunately is not for free. For more complex information research, like comprehensive FTO, patent infringements, intended patent revocations, patent portfolio analysis, etc., more suitable tools for executing efficient and in the end successful searches are needed. In those cases patent experts consult highly specialized databases provided by database hosts like STN, Lexis-Nexis, Dialog and others. What is a ‘database host’? Hosts give a whole set of databases by various producers a virtual home. Their major advantages are that … The hosts major disadvantages are that they are not for free, and that you need to be trained in their specific retrieval languages. But these retrieval systems are essential for using the most powerful search and analysis tools. The hosts are already aware of that problem, and they try to win even those customers that are not used to retrieval languages. For example, they offer more and more search masks via Web interfaces. But to be honest … a search mask will never really be able to provide the same versatile functionalities a retrieval language does. What host should I use? Most hosts set priority to a specific field of information. STN concentrates on scientific and literature information (biotech, pharma, chemistry, engineering, material science, etc.), Dialog on business and market information, and Lexis-Nexis on law and legal information. Interestingly, most hosts offer patent literature as this branch of specialist information is one of the most lucrative … shame to him who thinks evil of it. Delphion (formerly IBM patent server, now member of the Thomson Derwent Group) is the only host that offers just patent databases without the option to do cross-research with non-patent databases, but with extensive analysis tools. You should also have closer look to the type of clearing procedure. With Dialog for example, you pay a flat fee in advance that expires after a year, independently if you used your account or not. Others, like STN Classic, calculate database usage time plus document royalties. Others, like STN Easy, have no time costs but slightly higher document royalties. Our recommendation for starting with host information searches regarding Life Science topics would be ‘STN Easy’, as this retrieval surface is more easy to use for beginners and the costs are comprehensible. Finally, if you say “no, I do really not need to do also THAT”, you may consult a professional information searcher, called infobroker or information broker. Information brokers are experts in retrieving specialist information from various sources. Most of them are specialized to branches of businesses, and are organized in associations like the AIIP (Association of Independent Information Professionals) or the German DGI (Deutsche Gesellschaft für Informationswissenschaft und Informationspraxis). In future posts I will go more into detail on pros&cons of specific databases and on proper strategies to get the most out of your research. Look forward! Revised version of the article “Identifying High-Quality Patent Information”, originally published in June 2004 by Inside-Lifescience, ISSN…