{"id":104,"date":"2022-01-01T00:46:35","date_gmt":"2022-01-01T00:46:35","guid":{"rendered":"http:\/\/pharmatopo.com\/?p=104"},"modified":"2022-12-02T22:12:39","modified_gmt":"2022-12-02T22:12:39","slug":"lessons-learned-documenting-your-intellectual-property-and-defending-it","status":"publish","type":"post","link":"https:\/\/pharmatopo.com\/index.php\/2022\/01\/01\/lessons-learned-documenting-your-intellectual-property-and-defending-it\/","title":{"rendered":"Lessons Learned: Documenting Your Intellectual Property and Defending It"},"content":{"rendered":"\n

Stuart R. Gallant, MD, PhD<\/strong><\/p>\n\n\n\n

Some readers may not have had the opportunity to be deposed by the opposing counsel from a pharmaceutical company.  Here is what that experience is like, and here is what you can do to protect yourself and your company.  Think of this post as taking a lesson from Noah\u2014build your ark before<\/em> the rains come.<\/p>\n\n\n\n

During preparation for a trial involving intellectual property, the opposing counsel will request (and may be legally entitled to) all emails, PowerPoint decks, reports, lab notebooks, and other documents related to the patents or trade secrets at issue.  By the time you are deposed, opposing counsel may have had a year or more to digest this material.  In addition, they will have their own technical experts providing commentary and analysis.  And, if you are not the first employee of your company to be deposed, opposing counsel may have talked to your colleagues prior to questioning you.<\/p>\n\n\n\n

Fortunately, your counsel will have reviewed all the relevant documents (documents that you may have not seen for years).  Ideally, counsel will provide you an organized set of the key documents\u2014just the most important emails and reports, rather than the entire trove of thousands of pages provided to opposing counsel.  Of course, there is a risk that your counsel will ignore an important email, that you would have recognized as pivotal, but they thought was insignificant.  At the end of the day, you probably don\u2019t have the time to look at everything, so you trust your lawyers.<\/p>\n\n\n\n

During the deposition, you will be the focus of everyone\u2019s attention in a way that can be unnerving\u2014mostly because you are not convinced that everyone has your best interest at heart.  Opposing counsel will ask you a series of questions, often centered on the documents.  Hopefully, you will be prepared to answer those questions.  Here are some things you can do to be prepared.<\/p>\n\n\n\n

Years in Advance<\/strong><\/p>\n\n\n\n

I will readily admit that I came of age before widespread use of electronic laboratory notebooks, but the principles are more or less the same however you collect your data, so this discussion will pretend that we all work on paper [1, 2].  Laboratory notebooks are very valuable\u2014they contain the holy trinity of science (data, interpretation, and credit).  \u201cCredit\u201d (who did what work) is incredibly important in the world of intellectual property.  To run a good notebook, you should do the following:<\/p>\n\n\n\n

  1. Make plans:  write out the concept of the experiment.  Or, what I do is type it out in a Word document, print it, and tape it into the notebook.<\/li>
  2. Make observations:  take written data as you run the experiment and paste printed results into the notebook.  Use it like a diary.  There\u2019s no such thing as using too many notebooks.<\/li>
  3. Write your conclusions:  things like, \u201cI didn\u2019t expect to run that experiment at such a cold temperature, but the yield was better\u2014this is worth following up.\u201d<\/li>
  4. Sign the pages as soon as you can after finishing an experiment.<\/li><\/ol>\n\n\n\n

    I did not realize how important signed notebooks were until I became involved in pre-trial discovery for the first time.  I thought somehow that once we scanned the notebooks and they became electronic records, the original paper notebooks became insignificant.  In fact, the lawyers are very interested in the paper notebooks, and they will want them to be shipped to their offices in the case of litigation.<\/p>\n\n\n\n

    Some other helpful documents are:<\/p>\n\n\n\n

    • Technical Reports:  write technical reports to synthesize and summarize topics like:  process development, manufacturing campaigns, testing procedures.  Sign the reports and archive them with version numbers so that you can go back and create a new version if you do more work in a particular area.<\/li>
    • Vendor Reports:  frequently development labs return PowerPoint decks as a deliverables.  I like to convert labs that I work with to writing Vendor Reports.  I send them an experimental plan for each bite of work (whatever they will be doing for the project in the next month).  The experimental plan is written in such a way that they can append their data, format it, add some conclusions, and sign it.  The Vendor Reports can be rolled up into Technical Reports pretty easily.  (Obviously, this is not such a big deal in GMP labs where reports are a cultural totem, but many projects start out at small non-GMP labs.  Correctly documenting early development work has a big impact on the intellectual property record.)<\/li><\/ul>\n\n\n\n

      Notebooks, Vendor Reports, Process Descriptions, and Technical Reports all becomes part of the Project Knowledge which will be the subject of a future post. Work with your counsel to establish your company’s Intellectual Property Plan<\/em> (a topic within the previous Drug Development Plan post).<\/p>\n\n\n\n

      Months in Advance<\/strong><\/p>\n\n\n\n

      Again, the central conceit of this post is that you are preparing to be deposed.  Months in advance of your deposition, you will begin to review documents with your attorneys.  You may have two teams:<\/p>\n\n\n\n

      • The Intellectual Property Team:  these lawyers and paralegals will comb through all you documents (the notebooks and reports, the emails, the PowerPoint, the patent documents…) to put together what happened\u2014or at least what happened as closely as they can construct it.<\/li>
      • The Litigation Team:  these lawyers and paralegals prepare to represent you in court.  Their view isn\u2019t as minute as the IP Team, it\u2019s more big picture.  They want to be prepared to tell the story to a jury in language the jury can understand.  It\u2019s most likely that the matter will settle before trial, but a trial is always a possibility.<\/li><\/ul>\n\n\n\n

        If something seems to be missing, raise it with the IP Team.  \u201cI used to provide status updates to my boss on Fridays.  Can you look for the updates from May and June of that year?\u201d  The IP Team will have everything in a big electronic database, and they can find things that you haven\u2019t seen in years.  A lot of what they find you will have forgotten.<\/p>\n\n\n\n

        Work with counsel to help the Litigation Team tell the story.  You will know your little part of the story, but you may not know what other scientists did (or did not do).  So, trust your counsel to tell the big story (the entire project), and work with them to tell your part (what you saw, heard, and did).<\/p>\n\n\n\n

        Weeks in Advance<\/strong><\/p>\n\n\n\n

        The time spent awaiting deposition may be stressful for you, so don\u2019t be shy about doing things to relieve the stress.  You can write out a list of most likely questions and review the answers so that names and dates are easy to recall.  But, remember to leave those notes at home on the day of your deposition.  A lawyer once told me a story about a scientist who brought flash cards to her deposition, resulting in an argument over whether the flash cards were legally discoverable.<\/p>\n\n\n\n

        On the Day of Deposition<\/strong><\/p>\n\n\n\n

        On the day of the deposition, you will walk in feeling as naked as you ever have as a scientist (no comforting PowerPoint deck, no notes, just you in your interview suit).  Once they have you mic\u2019d and the camera is recording, try to relax.  You will have two sets of lawyers (your lawyers and the opposing counsel) hanging on your every word.  A few things that can help are:<\/p>\n\n\n\n

        • Develop a discipline of answering every question the same way:  1) watch opposing counsel while they state the question (\u201cHow was it decided to use pressure homogenization to recover the inclusion bodies?\u201d), 2) restate the question in your head; this has three benefits:  it ensures that you understand the question, it prevents you from rushing into an answer, and it prevents you from appearing stressed, 3) answer only the question asked, as briefly and directly as possible.<\/li>
        • Don\u2019t assume that the opposing counsel knows what they are talking about or doing.  They have a lot to master in what for them is a short period of time.  They may have been in preparation for months, but most lawyers have several legal matters running concurrently, so you have not been the only matter in front of opposing counsel.  They are essentially on a fishing expedition.  If they get off on a tangent, it isn\u2019t for you to bring them back on topic or correct their misunderstandings.  Continue to answer exactly what they ask, and no more.<\/li>
        • Don\u2019t let opposing counsel intimidate you.  They may say in a very loud assertive way, \u201cStrike as nonresponsive.\u201d  What they mean is that they didn\u2019t get the answer they wanted.  But, it\u2019s your<\/em> testimony, so you should say what you feel<\/em> is the correct answer.  Your counsel will defend you if necessary.<\/li>
        • Because the opposing counsel is looking for sound bites (i.e., statements that they can bring up later in court), you are helping them when you speculate.  If you don\u2019t know the answer to a question, say that you don\u2019t know\u2014don\u2019t speculate<\/em>.  When you try to answer questions beyond your own personal knowledge, your answers could be incorrect, but more importantly, they could be embarrassing for your side.<\/li>
        • Don\u2019t be shy about asking for breaks\u2014direct questioning can be pretty tiring.  A bathroom break can be very helpful.  Also, stay hydrated, you\u2019ll be talking a lot.<\/li><\/ul>\n\n\n\n

          Finally, once your deposition is over and you are walking out with your counsel, ask for feedback, \u201cHow did I do?\u201d  Hopefully, you will get the answer back, \u201cWe had a good day.\u201d<\/p>\n\n\n\n

          [1] Kanare, H. M.  Writing the Laboratory Notebook<\/em>, American Chemical Society Press (1985).<\/p>\n\n\n\n

          [2] Canfield, M. R.  Field Notes on Science and Nature<\/em>, Harvard University Press (2011).<\/p>\n\n\n\n

          Disclaimer:  PharmaTopoTM<\/sup> provides commentary on topics related to drugs.  The content on this website does not constitute technical, medical, legal, or financial advice.  Consult an appropriately skilled professional, such as an engineer, doctor, lawyer, or investment counselor, prior to undertaking any action related to the topics discussed on PharmaTopo.com.<\/p>\n","protected":false},"excerpt":{"rendered":"

          Stuart R. Gallant, MD, PhD Some readers may not have had the opportunity to be deposed by the opposing counsel from a pharmaceutical company.  Here…<\/p>\n","protected":false},"author":2,"featured_media":105,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[17],"tags":[30,21,31,20],"class_list":["post-104","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-patent","tag-deposition","tag-intellectual-property","tag-laboratory-notebook","tag-patent"],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/i0.wp.com\/pharmatopo.com\/wp-content\/uploads\/2022\/01\/Gavel.jpg?fit=1755%2C775&ssl=1","_links":{"self":[{"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/posts\/104","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/comments?post=104"}],"version-history":[{"count":6,"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/posts\/104\/revisions"}],"predecessor-version":[{"id":132,"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/posts\/104\/revisions\/132"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/media\/105"}],"wp:attachment":[{"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/media?parent=104"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/categories?post=104"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmatopo.com\/index.php\/wp-json\/wp\/v2\/tags?post=104"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}