The document discusses the factors that determine the length of a patent. The base term for a patent is 20 years from the date of filing. However, this can be adjusted based on several factors. For pharmaceutical patents, the length may be extended to account for time spent in clinical trials and FDA review. Patent term extensions allow for half the clinical trial time and all FDA review time to be added, up to a maximum of 5 years. Additionally, 6 months can be added for pediatric drug testing. These extensions aim to provide an effective patent term of around 14 years after FDA approval. Understanding these various factors is important for pharmaceutical executives to assess patent value and protection timelines.

1. Patent Terms
How long until a patent expires?

2. 2
Knowinghowlongapatentlastsiscriticaltounderstandingthevaluethe
productitsupports.
Executivesshouldhaveakeenawarenessofthepatentlifeleftforeachof
theirkeyproducts,andshouldunderstandthelengthofpatentprotection
thatmayapplytoproductsindevelopment.
Whilepharmaceuticalexecutivesusuallyrelyontheirpatentattorneys,inside
thecompanyorout,totellthemthelengthofapatent,itcanbeveryhelpful
tounderstandthefactorsthatdeterminethelengthofapatent. Thisis
especiallytruesincesomefactors,suchas extensions,arenotdeterminable
forcertainuntilwellafterthepatentisfiled.

3. As we walk through each of the factors, I think you will find each factor to be relatively
straightforward. Listen for the terminology that applies to each factor, but more important is to
understand how each factor is computed, which is probably going to be a lot easier to
remember. You can always refresh on the terminology if you understand the concepts.
3

4. The most basic factor is the "base term" of the patent, which, in the United States, the European
Union, the United Kingdom and essentially all other relevant markets is 20 years from the date of
filing.
So, lets start with that, and then start folding in the exceptions and complications, many of which
can be very useful.
5a

5. So, 20 years might not sound bad at all, that is quite a long time. However, consider that the
Filing Date is when the patent application is first submitted to the patent office. Doing that does
not ensure that a patent is issued, and it can take quite a while for the patent office to get around
to reviewing the patent and deciding whether or not to grant the patent. So, a good bit of the 20
years can be eaten up waiting for the patent office to take action. Generally, expect that patent
office review will take about 3 years, so the time you have left after the patent is granted is usually
closer to 17 years. In fact, for many years in the United States, patents were granted with a base
term of 17 years after grant. So, the current system results in about just as long of a patent.
5a

6. So, you might say that it is not fair to have the length of your patent depend upon the speed of the
patent office. And, Congress agreed and the next factor we will review is known as "patent term
adjustment" which adds time to the base term if the patent office did not meet two deadlines.
The first deadline I am going to talk about is the one that I think is most expected. For this
element, the expectation that the patent office should grant of deny the patent within 3 years was
acted upon, so that if they do not meet that deadline, then whatever time more than three years is
added onto the end of the patent. As we can see here, if it took four years from the Filing Date to
the grant, then one year is added onto the Base Term as a Patent Term Adjustment.
5b

7. The other deadline is that the patent office should start the review of the patent within 14 months
after the Filing Date. Thus, if the patent office does not even look at your patent application for a
full two years after your file it, the difference between 14 months and 24 months, id est 10 months,
gets added to the Base Term, even if they are very fast and grand the patent before the 3 years
from the filing date is up.
5b

8. With both elements of patent term adjustment, the adjustment will not be granted if the delay is
the fault of the patent applicant For instance, if there is a fee owed, and the applicant is late
paying it, however many days late they are will be deducted from any adjustment. The same is
true if the applicant fails to respond to questions from the examiner in a timely manner. Thus, the
actual adjustment is computed by the patent office which notifies the applicant after the patent is
granted.
8

9. So, in addition to "Patent Term Adjustment", for pharmaceutical patents there is also a factor
called "Patent Term Extension"
Patent term extension is meant to ensure that pharmaceutical companies still have a good amount
of time left on their patents after spending years in clinical trials and in FDA review of the New
Drug Application.
Patent Term Extension has two elements as well, and the sum of the two elements is the amount of
the extension.
9

10. The two elements of "Patent Term Extension" are based upon two time periods:
The first is the amount of time from the submission of the IND, which you should know is the
"approval" of the investigational new drug application, and the submission of the NDA. The
patent holder gets credit for ½ of that clinical investigation time.
The second time period is the review time, from the submission of the NDA to the approval of the
NDA. The patent holder gets credit for all of that review time.
10

11. For the first element, the clinical investigation time, it should be noted that FDA does not really
"approve" of INDs, but there is a letter of "no objection" allowing clinical trials under the IND to
proceed. So, receipt of that letter is the start time of that time period. And, it is important to
understand that with NDA filings, the FDA has a process for "accepting" and NDA, so in FDA
parlance an NDA is not filed until it is accepted. However, for purposes of computing these time
periods, it is the actual providing the NDA package to FDA that marks the end of the investigation
period and start of the Review Period.
11

12. Patent Term Extension is limited in two ways.
First of all, the total extension is capped at five years. This limit can actually be reached. If FDA
review of the NDA is about 1 year, then if the clinical trial phase lasts 8 years the cap would be
reached. However, certainly everyone would hope that the clinical trial phase would not be that
long.
The second limit is that the extension cannot extend the patent beyond 14 years after NDA
approval. Thus, the maximum you should generally expect a product to have patent protection is
14 years. Of course, if a company is very fast, spends money before the patent is approved, and
moves quickly through clinical trials, a longer period of protection is possible. However, consider
the pre-clinical work needed just to submit an IND, getting more than 14 years would be
unusual.
12

13. So, the length of the Investigation Period is somewhat in the control of the patent holder company,
so that if they go slowly in the clinical trials they get a bigger extension. However, recall that
credit is only given for ½ of the Investigation Period, so every month of additional time in clinical
trials is two weeks less of time with an approved product on the market with patent protection,
presuming the NDA gets approved. Thus, the system does not reward delay, but does limit its
cost.
13

14. Credit for - ½ of testing time (IND effective date to submission of NDA)
plus - all of review period (initial submission of NDA to approval)
5c
PatentTermExtension:

15. 6 months for completed pediatric investigation plan
• Elect to apply to patent or exclusivity
• Qualifies even if PIP does not support indication
5d
PediatricInvestigationPlan:

16. Supplement Protection Certificate (SPC)
Up to 5 years for pharmaceutical testing and development
Additional 6 months in EU for completed Pediatric Investigation Plan (“PIP”)
16
EuropeandUK
20yearsfromdateoffiling

17. So, those are the basic elements of the length of a patent.
Please see our course on patent sequencing for a discussion of provisional patents, and strategies to
get the most out of your ideas.
Other course titles:
Provisional Patents and Sequencing Filings
Types of Pharmaceutical Patents
17

18. Pharmaceutical Patent Fundamentals
August 2022
Pharming Teams – Patents and Exclusivity
Thanks for Watching: