Asked in Patents (Intellectual Property)

Q: What makes the length of the patent protection too short?

The approval date for a drug named BIKTARVY is 02/07/2018 and the date of the first-expiring patent is 11/04/2020. Meaning the amount of time between the approval date of the drug and the date of the first-expiring patent is 2 years, 8 months and 29 days. Why would it be too short and not a length of 20 years? what factors may be affecting the length of protection?

4 Lawyer Answers
Floyd Edwin Ivey
Floyd Edwin Ivey
Answered
  • Patents Lawyer
  • Kennewick, WA

A: The term for a patent currently is 20 years from the date of filing.

Bernard Samuel Klosowski agrees with this answer

Kevin E. Flynn
Kevin E. Flynn
PREMIUM
Answered
  • Patents Lawyer
  • Chapel Hill, NC

A: PATENT TERM

Patent term is more confusing than it should be.

Old rules were that patents had a term of 17 years from when they issued. New rules are that apply to patent applications filed after June 8, 1995 are 20 years from the first non-provisional patent application. Applications pending on June 8, 1995 get to choose between the old and new rules so it is possible that something could pop out with a 17 year term that was filed before June 8, 1995 but that is pretty rare.

So you ignore the filing date of the provisional application (if any) and look to the oldest non-provisional patent application in the chain of priority. Some applications claim priority back to an earlier non-provisional application via a divisional application, continuation application, or continuation-in-part application.

There are several things that can change this default 20 year term

1) Patent Term Adjustment -- These are bonus days added to the end of the term to make up for the Patent Office being slow in doing their job. This is printed on the patent.

2) Patent Term Extension -- There are extra days added to things undergoing certain types of regulatory review such as review of a new drug at the FDA. The thought is that patent days should not tick off the clock while you are not allowed to sell the product.

3) Sometimes two patent applications are deemed similar by the patent office and they tie the end date of the second application to the end date of the first application. This is called a terminal disclaimer and rarely has a huge impact due to the new 20 year rule.

4) The patent owner has the option of disclaiming the rest of the patent term. This rarely happens but could if the patent owner was worried about an antitrust charge from maintaining a blatantly invalid patent.

5) Some patents become toothless as the claims are deemed invalid or unenforceable in litigation.

6) The patent may expire early if the patent owner does not pay a renewal fee by start of years 4, 8, and 12. This fee is called a maintenance fee. You can see the status using Public PAIR or you can check at https://fees.uspto.gov/MaintenanceFees.

My assumption is that in this case, the patent owner wanted one more set of claims from a family of patent applications that were filed many years before and were kept alive by always having a patent pending from that family. So they received one final patent with a short term but this was in parallel to one or more patents from the same family with a longer term.

I hope that this helps.

Kevin E Flynn

FLYNN IP LAW

Bernard Samuel Klosowski and Timothy John Billick agree with this answer

Bernard Samuel Klosowski
Bernard Samuel Klosowski
Answered
  • Patents Lawyer
  • Greenville, SC

A: I agree my colleague Mr. Ivey and would add that it's 20 years from filing of the earliest filed utility patent application (if priority is claimed) and 15 years for a design patent. Additionally, delays in prosecuting the patent by the applicant can affect the patent term ("patent term adjustment"); e.g., applicant requesting to suspend prosecution, or in a more drastic case, having to petition to revive an inadvertently abandoned application due to a missed deadline.

Timothy John Billick agrees with this answer

Peter D. Mlynek
Peter D. Mlynek
Answered
  • Patents Lawyer
  • Moorestown, NJ

A: Actually, this is a very common question, and a problem for the pharmaceutical industry, including my clients, deal on daily basis.

Although it is correct generally the term of a patent is 20 years from the earliest priority date, things are not so simple in pharmaceutical arena. For example, given that it takes many years to develop a new drug, especially if it is a new chemical entity, having a 20-year term is not workable in an industry where patents are everything. The problem is that the FDA takes as much time as is needed to approve the drug, and for that reason, under Hatch-Waxman, a vast portion of the drugs listed in the Orange Book has the patent term extended under 35 U.S.C. § 156. Further, there is also pediatric exclusivity (PED) under which the FDA cannot approve an aNDA under BCPA, an orphan drug exclusivity (ODE) under 21 C.F.R. 316.31, a 3-year change exclusivity under 21 C.F.R. § 314.108, a 180-day first aNDA exclusivity, etc.

Many practitioners in pharma-biotech space do not calculate or provide the patent term to clients without doing a significant amount of work.

If you wish, I'd be happy to take a look at this case for you.

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