In June, U.S. Senators Leahy (Democrat) and Cornyn (Republican) (and others) sent a letter to the United States Patent and Trademark Office requesting that the USPTO review practices concerning granting “an excessive” amount of patents on pharmaceuticals, such as biologics, that may be driving up drug pricing costs.
The press release concerning the letter states:
Senators Patrick Leahy (D-VT) and John Cornyn (R-TX) led a
bipartisan letter Wednesday asking the U.S. Patent and Trademark Office to
address an issue that is a significant cause of soaring drug prices.
Senators Richard Blumenthal (D-CT), Susan Collins (R-ME), Amy Klobuchar (D-MN),
and Mike Braun (R-IN) also joined the letter.
The senators explained that drug companies and other large
companies sometimes artificially extend the period in which they can charge
high prices by filing many patents on nearly the same invention, creating a
so-called patent thicket of dozens of patents on a single drug. Those
thickets make any challenge to the patents, or to the drug companies’ pricing
of the covered drug, nearly impossible. Because of the exorbitant cost of
taking on each of the patents in these patent thickets, generic manufacturers
are impeded from entering the market, hurting competition and raising prices for
American consumers. The secondary patents, which are similar to the
originals, often receive less scrutiny from the Patent Office but have an
outsized effect on everyday Americans who struggle to afford expensive
Leahy believes the Patent Office has the ability to address
this abusive practice, and he is asking the agency to take action to rein in
this misuse of the patent system. The letter requests that the Patent
Office look into specific ideas for curbing the abuse and “take regulatory
steps to improve patent quality and eliminate large collections of patents on a
single invention.” The Patent Act clearly states an inventor may obtain
a single patent for a single invention, not dozens. The
senators believe the Patent Office can and should stop these large companies
from undermining the patent system, obstructing appropriate competition,
stifling innovation, and hurting Americans, who end up paying for all of this
at the pharmacy.
The letter contains several ideas
for the USPTO and the public to consider concerning future potential
1. Terminal disclaimers, allowed under 37 C.F.R. 1.321(d),
allow applicants to receive patents that are obvious variations of each other
as long as the expiration dates match. How would eliminating terminal
disclaimers, thus prohibiting patents that are obvious variations of each
other, affect patent prosecution strategies and patent quality overall?
2. Currently, patents tied together with a terminal
disclaimer after an obviousness-type double patent rejection must be separately
challenged on validity grounds. However, if these patents are obvious
variations of each other, should the filing of a terminal disclaimer be an
admission of obviousness? And if so, would these patents, when their validity
is challenged after issuance, stand and fall together?
3. Should the USPTO require a second look, by a team of
patent quality specialists, before issuing a continuation patent on a first
office action, with special emphasis on whether the claims satisfy the written
description, enablement, and definiteness requirements of 35 U.S.C. § 112, and
whether the claims do not cover the same invention as a related application?
4. Should there be heightened examination requirements for
continuation patents, 2 to ensure that minor modifications do not receive
second or subsequent patents?
5. The Patent Act requires the USPTO Director to set a “time
during the pendency of the [original] application” in which continuation status
may be filed. Currently there is no time limit relative to the original
application. Can the USPTO implement a rule change that requires any
continuation application to be filed within a set time frame of the ultimate
parent application? What is the appropriate timeframe after the applicant files
an application before the applicant should know what types of inventions the
patent will actually cover? Would a benchmark (e.g., within six months of the
first office action on the earliest application in a family) be preferable to a
specific deadline (e.g., one year after the earliest application in a family)?
6. The USPTO has fee-setting authority and has set fees for
filing, search, and examination of applications below the actual costs of
carrying out these activities, while maintenance fees for issued patents are
above the actual cost. If the up-front fees reflected the actual cost of
obtaining a patent, would this increase patent quality by discouraging filing
of patents unlikely to succeed? Similarly, if fees for continuation
applications were increased above the initial filing fees, would examination be
more thorough and would applicants be less likely to use continuations to
cover, for example, inventions that are obvious variations of each other?