The Impact of Wyeth on Patent Terms

In January 2010, the Federal Circuit held that the Patent Office had been undercalculating the patent term adjustments (PTA) owed to patentees because of USPTO delays during prosecution. About 80% of issued patents receive some term adjustment. The Wyeth case did not directly impact the calculation of which cases receive an adjustment, rather the decision operates to lengthen the adjustment for those already eligible.

In order to measure the impact of the change in calculation, I compared the calculated patent term adjustment for two sets of recently issued utility patents. The first set comes from January 5, 2010 (before the Wyeth decision) and the second set comes from April 27, 2010 (after the Wyeth decision). For each set, I used all utility patents issued on the given date.

The chart below shows that the change has been substantial. The average PTA grant has increased by six-months — jumping from 14–months to 20–months. (Note — these averages only include patents with an adjustment). One patent in the April 2010 group was adjusted more than eight years and over 500 patents had term-adjustments of more than three years.

These days, any discussion of the US 20–year patent term must consider real impact of these adjustments.

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22 thoughts on “The Impact of Wyeth on Patent Terms

  1. “In your experience, these noble customer-pleasing attributes are characteristic of large insurance companies?”

    They come closer than many at the PTO. They are certainly more prompt than the PTO or FDA.

  2. The difference is that the insurance company, while protecting itself from the liability claims by saying “no” when the data does not show safety and effectiveness, otherwise tries to please the customer with efficiency, courtesy, etc.,

    In your experience, these noble customer-pleasing attributes are characteristic of large insurance companies?

  3. ianae,(Is that a misspelling of inane?) In my proposal, the prevention comes from the insurance company’s screening and review of clinical trial data submitted to them by the pharma companies, completely analogous to the current situation. The difference is that the insurance company, while protecting itself from the liability claims by saying “no” when the data does not show safety and effectiveness, otherwise tries to please the customer with efficiency, courtesy, etc., things that the monopoly government provides only sporadically.

  4. Make it a bunch of insurance companies that insure against product liability claims on pharma, with a reasonable cap on their liability. If they approve a drug that turns out to be unsafe or uneffective, they pay claims to the folks hurt.

    According to a recent FDA study, an ounce of prevention can be as therapeutically effective as 16 ounces of insurance payments.

  5. Ought to privatize the FDA, too. Make it a bunch of insurance companies that insure against product liability claims on pharma, with a reasonable cap on their liability. If they approve a drug that turns out to be unsafe or uneffective, they pay claims to the folks hurt. The pharma companies would not be allowed to market product without an insurance policy. The terms of the policy would require payments that are enough to discourage the insurance companies from insuring and allowing drugs to come to market if they are unsafe or ineffective, but not enought to cripple the insurance companies and put them out of business. The insurance companies and the pharma companies negotiate their own premiums.

  6. Up until recently, the Patent Office was the rarity in government that not only paid for itself, but was a source of revenue for other government programs.

    It would be interesting to see what would happen if the function were not only privatized, but multiple vendors were vetted. Unfortunately, I think what would be spawned would be something along the lines of the military-industrial complex, wherein the government would be inclined to make sure that more than one vendor would be available and any perceived competitive benefits would be rather imaginery.

    Perhaps less meddling is better.

  7. The beauty of competition coupled with a profit motive is that the competitors bust their butts to make the profit.

    On balance, I prefer not having a privatized PTO that competes with other privatized PTOs to be an attractive forum for patent applicants.

  8. “since American Cowboy’s suggestion still provides no focus on a quality and timely examination.”

    That problem cannot be made to go away as long as USPTO has a monopoly on the examination and granting of patents. The beauty of competition coupled with a profit motive is that the competitors bust their butts to make the profit. When you are the only game in town, it ain’t gonna happen. Sorry, but that is one of the sad facts of life of having government (i.e. the monopoly) do stuff for you.

  9. More and more PTA may be awarded with the new RCE docketing procedures. Examiners no longer have a deadline for acting on an RCE, but PTA accrues after 4 months.

  10. Has anyone here been successful in reaching the PTA help line at the USPTO (Office of Patent Legal Administration)? I have left 5 or 6 messages and never got a call back. I got through one time, was put on hold and then a few minutes later, got hung up on.

    Rather than bore anyone with details, I’d like to chat with someone who has had experience with post-NOA abandonment delays attributable to the Applicant.

    I can be reached at sale-gugcs-1716761846@craigslist.org

    (To keep my info private, your email goes through a Craigslist Wanted Ad for a Kappos Time Machine. Your emails to this address will reach me.)

    Thanks

  11. but not more than 30 years from earliest effective filing date.

    Yeah – that’s the ticket – We already have the quo (publication), let’s give less quid – you get 17 years* (chuckle chuckle)from the time we eventually issue you a patent.

    *less any time we take to meander in getting you a patent right, since American Cowboy’s suggestion still provides no focus on a quality and timely examination. This would also take care of that troublesome violation of promises to act in a timely manner. We guarantee with one hand and take it away with the other – Sweet!

  12. Wouldn’t it be a whole lot easier and make more sense just to go back to 17 years from issuance?

    It would seem we’re about 80% of the way back there already.

  13. Red,

    Any real determined defendant doesn’t have to wait even now – With publication, those watching their art-space can defend well before a patent issues. Being “wrong” at twice the speed impacts this ability too (not favorably).

  14. See what happens when we try to adopt those lousy rules from Europe? Complication, confusion and waste. Wouldn’t it be a whole lot easier and make more sense just to go back to 17 years from issuance?

    You could prevent Lemelson abuses by saying something like, “but not more than 30 years from earliest effective filing date.”

  15. “Being “wrong” at twice the speed only means that you have released a crappy patent twice as fast”

    It also means more time to invalidate it during litigation, where it must face a determined defendant with a real stake in the outcome, instead of an examiner.

  16. Defining “quality” as a speedy throughput, without actually having a truly quality examination will only make everything worse.

    Being “wrong” at twice the speed only means that you have released a crappy patent twice as fast.

  17. So far my largest PTA increase has been from 822 days to 1523 days. Several others have been right around one year.

  18. About 80% of issued patents receive some term adjustment.

    Which is all well and good for those large, well-capitalized drug companies who would rather have term at the end than the beginning, but bad for their customers and bad for other patent applicants who find 80% of applications taking this long to issue.

    It only serves to underscore how bad the examination backlog at the PTO has become, and how urgently it needs fixing.

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