INTRODUCTION
Executives usually ask these quantitative but high-level questions:
How much money did we spend on patent work this year?
Was that within our IP budget?
How many patent applications did we file this year?
How many patents issued to our company this year?
While those questions touch upon important metrics, this post provides much deeper and more insightful questions to ask, to much more effectively assess your IP team’s performance at building your company’s patent portfolio.
SUMMARY:
Consider these 10 more insightful questions to better assess your patent team's performance:
Has a carefully thought-out patent portfolio-build strategy been presented to me by my IP team?
Have top challenges to patent issuance/enforcement been identified for key innovation areas before R&D priorities/programs are decided?
Has a strategy been presented for overcoming these top challenges?
Have we filed/exclusively licensed high-quality patent applications that give us our best chance for success?
Have key inventions and patent filings/families (owned or licensed) been identified within our portfolio?
Is my IP team executing on our patent portfolio-build strategy?
Has our company put in place foundational IP processes and documents?
Do your patent filing decisions, team, processes, and the contents of your patent applications meet the sub-points of section 1 above?
Are our patent resources/spend focused on your most valuable patent filings?
Are key patents getting issued to cover our most valuable product plans?
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DEEPER CONSIDERATIONS
Let's dig deeper into each of these questions, as well as some additional questions, to help you assess your patent team.
1) Has a carefully thought-out patent portfolio-build strategy been presented to me by my IP team?
For any age biotech company:
Have top challenges to patent issuance/enforcement (and FTO^1) been identified for key innovation areas before R&D priorities/programs are decided?
Has a strategy been presented for overcoming these top challenges?
Have SMART goals been put in place for the IP team/lead that are aligned with this strategy?
Have we filed/exclusively licensed high-quality patent applications that give us our best chance for success? (A more difficult question than many C-suite executives realize).
Are the inventors, CSO, and in-house IP coordinator satisfied that the patent professional team drafting the patent application(s) understands the technology?
CSO’s and IP coordinators are usually good at answering this foundational question.
Is an experienced patent attorney/agent with a proven track record intimately involved with the patent drafting process?
If outside counsel, ensure this attorney/agent is not just a client-relationship partner that is too expensive to spend much time strategizing and reviewing the drafting of your patents.
If in-house patent attorney/agent, ensure that they are deeply involved in drafting/reviewing, not just handing off to outside counsel.
Biotech patent drafting/prosecution has many challenges and experienced patent professionals who have obtained many valuable patents for clients know how to spot and proactively overcome issues to get patents to issuance and to assure you are not surprised by extremely difficult technology patent areas.
Has an experienced patent professional confirmed that sufficient, high-quality R&D experimental data has been generated and included in patent filings to support key claims of appropriate breadth?
Courts continue to hold that life sciences is an unpredictable art, thus;
more working embodiments are helpful;
actual experimental data to support unexpected results is helpful.
Have patent filings/families been drafted proactively, to overcome top identified likely patentability challenges?
Prior art challenges?
Claim breadth/scope challenges?
Patentable subject matter challenges?
See BONUS SECTION for more details re: drafting patent applications to set them up to overcome patentability challenges
Detecting infringement challenges?
Strategies to overcome anticipated challenges should include numerous layers of fallbacks drafted into patent applications.
Thus, high quality life sciences patent applications take more time to draft, disclose well thought out fallbacks, and thus generally are more expensive.
If company is at least 3-5 years old:
Have key inventions and patent filings/families (owned or licensed) been identified?
Often ~10-20% of patent families are key families.
For many companies, key patent filings include some of the earliest patent filings.
However, new key families should arise every few years (or more often depending on size of R&D team) if getting good ROI on R&D spend.
2) Is my IP team executing on our patent portfolio-build strategy?
For any age biotech company:
Has our company put in place foundational IP processes and documents?
See our IP diligence checklist of key IP processes and documents.
Misses in basic processes and documents are a warning for shortcoming with substantive patent portfolio-build filings and strategies, too.
Do your patent filing decisions, team, processes, and the contents of your patent applications meet the sub-points of section 1 above?
If company is at least 3-5 years old:
Are key patents getting issued to cover our most valuable product plans?
Are we prosecuting our owned/exclusively licensed patents in a proactive, creative, and effective manner?
Carefully aligned with proactive/anticipatory drafting of applications highlighted above.
Not getting stuck by repeat rejections from a very difficult examiner.
Experienced creative patent attorneys know a number of advanced patent strategies to help avoid this.
Are we interviewing and building relationships with examiners of key cases?
Is my patent team getting surprised often by unanticipated, difficult-to-overcome patent prosecution rejections.
For prior art rejections, team should have mapped key art and built fallbacks to overcome into applications (see above).
For other patentability issues, should team have anticipated those and identified effective strategies to overcome them, or warned you to stay out of this tech space?
Are your patent resources/spend focused on your most valuable patent filings?
A process should be in place and executed by your patent team, to assure that patent drafting and prosecution is within budget and focused on your most important cases.
Are we regularly pruning our patent estate of lowest value filings based on our updated business strategy?
Is your company filing enough valuable patent families?
Low numbers of new families may indicate:
R&D innovation/productivity issue?
Patent team not connected tightly enough with R&D team to sense new patentable inventions?
Patent team not thinking aggressively and creatively enough about new innovations?
Company operating in a very difficult-to-protect technical space, but upper management was not warned before significant resources spent in R&D/product development?
BONUS SECTION
Here are some deeper comments for issues re: overcoming common patentability roadblocks, to assess and assist your patent team:
Prior Art Challenges:
Are we aware of key prior art that we will have to overcome?
Have we identified the key technological features of our product/service that will overcome this art?
Have we identified key technical features for our technology?
Have we performed prior art landscaping to identify and map at least easily discovered prior art that teaches those, or highly related, key technical features?
Have we generated unexpected/surprising results, and identified counterintuitive combinations in our inventions.
Have we used Declarations of scientists, and examiner interviews to advance patent prosecution of key cases.
 
Claim Breadth Challenges:
Can at least one of our key technology features be easily modified by a skilled artisan to design around our patents?
Can you remove an element and still get around prior art?
Find different ways to claim the invention that would capture these design-arounds.
Does your key technology feature include a binding element(s) (e.g., antibody/fragment)?
If yes, what is your strategy for obtaining valid patents with meaningful claim breadth to cover these possible design-arounds?
Has your R&D team performed sufficient experiments to support commercially meaningful claim scope?
Patentable subject matter challenges?
Do our key technologies involve molecular diagnostics, software, and/or AI?
If yes, what is your team's strategy for dealing with patentable subject matter challenges?
The solution to this is often tightly linked to overcoming prior art challenges above.
For law of nature rejections, case law and USPTO examples provide guidance for claim language that is more likely to withstand patentable subject matter challenges.
Using a preamble that withstood litigation challenge can increase the validity of your diagnostics claims.
Tracking your claims to USPTO patentable subject matter examples can be helpfulFor life sciences software:
Including an element(s) that integrates an abstract idea into a practical application can be helpful.
Is the software part of a system/device that has real-world uses/outputs?
Claiming more details regarding how your software specifically performs its functions can be helpful.
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^1 Freedom-to-Operate (FTO) considerations are so important in R&D decisions that we mention it here, but this post focuses on patent portfolio build
About DHL
Double Helix Law (DHL) has decades of experience building strong patent portfolios for life science companies. Learn more about DHL and meet the team.
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The content on this website (including all pages, articles, and comments) is not legal advice, and does not and is not intended to form or constitute any attorney-client relationship. The content is not a solicitation for business; it is for educational and entertainment purposes only, and reflects the personal views of the author(s) only and not those of any past, present, or future client of DHL. Any content should be double-checked for accuracy and current applicability, and liability is disclaimed for any error or omission.
3/13/25 Written by EJV