“Product Literature Database” (PLD) … what the heck is this?

zur deutschen VersionPharmaceutical 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:

  1. Professional literature databases are quite expensive with a market dominated by few providers only, which sometimes behave like monopolists.
    (And to make an early clear statement: no, PubMed clearly does not qualify, especially due to its lack of comprehensiveness and poorly finished content.)
  2. It is very time-consuming to find precise and significant answers by searching and analyzing scientific literature. And the cheaper the source, the more (expensive) human workload is needed.

 

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.

  1. PLDs need long-term view and sustainability. But currently lived management approaches in pharma enterprises are more near-term and quite volatile. Without a strategic integration, a PLD is always in danger falling victim to a short-term budget or structural decision, similar to other internal services. But in contrast to other internal services, such a decision is much more fatal for a PLD, as it cannot be just shut-on again once negative side effects become obvious.
  2. PLDs save money in the in the field. What a fatal dilemma. As a central service, PLD costs are budgeted with a (global) business unit, which does not necessarily benefit itself by the service. On the other hand, corresponding cost savings, e.g. by higher productivity, cut costs for external providers, synergy effects, etc. pp. are effective within the whole organisation, with completely different business units. As a result, budget and benefit are organizationally decoupled. Overall, the enterprise has a tremendous advantage and cost savings by the PLD. But unfortunately this full picture view is less and less shared with individual budget decisions.
  3. PLDs are IT, they are not. Effective PLDs certainly need a powerful IT infrastructure, databases, and more. Unfortunately, this bears the risk to rashly assign PLDs to the IT department. To be very honest, to my opinion that is the wrong place. I also need a PC to work efficiently and powerful, but I am far away from being a software engineer. For me, a clever PLD implementation includes a clear localization within business, at least within a well-established linking function between business and IT.
  4. PLDs are strong as central functions. Only then they can fully exert resulting synergistic effects. In contrast, there seem to be frequent “waves” with in pharmaceutical enterprises to distribute tasks over the whole organisation. The underlying thought is “we save money at Global (e.g. for the PLD), and the work is shared by all”. Funny thought … unfortunately with fatal implications on productivity of associates.
  5. PLDs are designed by information experts for information experts. True, and there are historical reasons. But this approach does not fit to todays reality within pharmaceutical enterprises anymore. During the past 10-15 years, pharma has consequently reduced the number of educated information professionals. As a result, todays users of PLDs are more and more subject matter experts (e.g. medics) without explicit expertise in using professional information tools. And honestly spoken, I so far have not seen many PLDs which serve those new user groups regarding usability adequately.

 

Fazit

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 keyboards.

How to maximise the effectiveness of your FTO research – Checklist

post20141107Information 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 …

  1. Asking questions will be crucial for success
  2. Include non-patent literature
  3. Choose the right information sources
  4. Dare to get external support
  5. Know peculiarities of sources
  6. Know peculiarities of content
  7. Have positive control references up your sleeve
  8. Ensure availability of specialist expertise for special topics and tasks
  9. Carefully interpret results
  10. Stay up-to-date

 

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.

  • What is the scope? What kind and dimensions of freedom do you need?
  • What do you really need to know? And how can you delimitate the search?
  • Who could have worked with the technology?
  • What sources of information should be considered beyond literature?
  • What databases need to be used and where do you find them?

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:

  • scientific literature databases are bibliographic (abstract) only
  • scientific literature can be searched efficiently only by year but not by date
  • citation analysis (who, where) can give you additional hint for your overall search

 

Step 3 – Choose the right information sources

There are public sources, e.g. for patent literature, like esp@cenetUSPTODEPATISnet, and with other national patent authorities.

Pro’s

  • free of charge
  • quickly accessible via the internet
Con’s

  • limited search opportunities
  • limited 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-processing
  • added value (indexing, reviewing)
  • extensive and effective search functions
  • crosslinks between different databases
  • option of multi-file searches
  • substantial service and support
    (e.g. helpdesk, trainings, documentation)
Con’s

  • considerable costs (royalties)
  • professional search tools need
    training & 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 …

  1. Does the external specialist demonstrate a provable level of professionalism, experience and reliability?
  2. Does the external specialist in addition to information research expertise also provide a particular competence in the technological field or subject of the project?
  3. How will your communication be organized?
  4. How is information security ensured?
  5. Do you have a confidentiality/non-disclosure agreement in place?

 

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.

  • database characteristics – consider differences in data origin, processing, update modes, and – subsequently – findability
  • database coverage – consider differences regarding the types of documents covered, the time period covered, publication regions covered, and languages covered
  • database language – consider different languages of content

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 keywords
  • use character masking
  • e.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 keywords
  • truncate 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 sort
  • go back to database index
  • with full-text databases, limit search to selected fields (title, claims, abstract, …)
  • increase stringency – further delimitation possible?
  • reduce truncations
  • reduce acronyms
  • use IPCs
  • create 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 …

  1. summarize results by family sort and/or removal of duplicates
  2. benefit from report functionalities of tools – e.g. text file export for printout or table export for subsequent sorting and easier post-processing
  3. keep references to full-text documents – e.g. links to free EPO, USPTO or JPO documents
  4. consider peculiarities of source database(s) of results – e.g. a full-text search does not necessarily give better results or ensure completeness

 

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

  1. Invest time in the preparation of your search strategy.
  2. Invest time in the preparation of your search strategy.
  3. Invest time in the preparation of your search strategy.
  4. In advance to database searches “play” with the index.
  5. If your search strategy does not work properly within the databases, stop immediately and go back to step 1.
  6. Do a multi-file search, put cheap databases first in the row.
  7. Avoid search steps for date or region.
  8. Be as stringent as useful.
  9. Use standardized preview formats for display of hits.
  10. Use family sort and duplicate remove.

 


 

This post is based on a presentation first given at the C5’s European FTO Congress, Munich, November 2006.

Checklist on pitfalls with bibliographic searches

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 relapsingremitting multiple sclerosis (RRMS): 2Year 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 relapsingremitting 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 relapsingremitting 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 relapsingremitting multiple sclerosis”

4. Use author’s last names only

For “Jean-Paul Sartre” you would find the following alternative writings in scientific literature databases:

  • Sartre Jean-Paul
  • Sartre Jean Paul
  • Sartre, Jean-Paul
  • Sartre; Jean-Paul
  • Sartre, J-P
  • Sartre, J.-P.
  • Sartre J.-P.
  • Sartre JP
  • Sartre, JP
  • Sartre, Jean
  • Sartre Jean P.
  • Sartre, Jean-P.

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:

  • author last name and starting page number (and publication year if necessary) might be sufficient already
  • volume, starting page and publication year might be sufficient already
  • volume, issue and starting page number might be sufficient already

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 history.

Does Google already control your business?

zur deutschen VersionYou would be surprised (and shocked) by how many people use Google as the major or even sole information source for daily business. In the worst case for business-critical decisions. And many of those are actually convinced that Google serves their needs. The problem simply is that you never know what you do not know.

OK … no bashing! … Google is not bad. Assumed that you always keep in mind what kind of tool you are working with and use it properly. Google suggests to give an answer, but factually it does not. Google only provides sources (= webpages) of answers.

But there is a limitation with the ranked sorting of the Google results. The hits on top of the list neither necessarily give a reliable answer nor a comprehensive answer nor the right answer at all. The webpage with the best answer (or the right one at all) can be hidden somewhere on page #5 or #11 of the results. And – let’s be honest – with many searches people do not go beyond page 1-2 of the Google results.

This is no issue when a you are looking for a movie you would like to see with your girl friend, or the map of the zoo, or the true age of Lady Gaga. But it is bad for business and potentially threatening the existence of a company when decisions are based on superficial Google use. You give the responsibility for your business … to a biased ranking algorithm not under your control.

Well, this constraint and menace is not new. But sometimes people take the bait to disregard, owing to a general tendency to concede time pressure, to oversimplify and to prefer quick answers instead of sound ones. But now, the well-known “soft” evidence once again has been proven by hard facts. A recent study by Nadja Hariri on the patented Google PageRank mechanism found that …

  • documents ranked by users as most relevant were on positions 5 (most), 1, 2, 18, 20, and 36 – so, do not trust the ranking
  • the mean values for the precision for most relevant documents were nearby between 38.82% and 31.18% on pages 1-4 – so, do not ignore results down the list
  • altogether, the correlation between user’s and Google’s rankings was rather low
  • “it is better for users of the search engines, especially Google, to examine at least three or four pages of the retrieved results”

Hariri’s conclusion: “users evaluate retrieved information in such a subjective way that search engine ranking cannot be in complete accordance with their views of relevance”. Search tools are simply far away from being able to equivalently replace human brains. While a decade has gone by, Hariri still is hooking up with Hawking et al. (1999) who stated that “the standard of document ranking produced by public web search engines is by no means state-of-the-art”.

So, watch out! Do not trust search engine rankings. And take care that Google is not taking your business into his hands.

P.S.: Please allow me to anticipate expected criticism. Could those results be biased by surrounding cultural conditions? The study was done at one location only. And – this frank note has to be allowed –  at a location not expressly known for goodwill regarding the US including US-based services. Well, sure, some influence can never be completely excluded. But Hariris’s findings are support by a series of earlier studies. And, by the way, it is also in line with my own decent but extensive experiences.

How to find high-quality patent information?

zur deutschen VersionThe 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-NexisDialog 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 …

  • hosts give access to professional databases which cover improved, high-quality, reliable patent information,
  • hosts provide a common searching surface that enables the user to simultaneously search a bundle of selected databases,
  • you can always decide yourself which database(s) out of the whole set will be used,
  • the data fields are harmonized between the databases,
  • the data between different databases are crosslinked,
  • and there is just one bill.

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 1610-0255.