[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S4537-S4538]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]





           AFFORDABLE PRESCRIPTIONS FOR PATIENTS ACT OF 2023

  Mr. CORNYN. Madam President, I am glad the Presiding Officer is in 
the Chair because, committed as I know she is to solving real problems, 
the legislation that we are going to pass here momentarily by unanimous 
consent has been 7 years in the making but will actually address the 
problem of high drug prices.
  In the last few years, I have heard, certainly, from my constituents 
in Texas about the struggle to obtain their medication at affordable 
costs. It is not because no treatment exists or because they don't have 
insurance or because it is a brandnew drug that just hit the market. 
Many patients can't afford prescriptions they have been taking for 
years because the prices continue to go up, and there is little 
evidence of anything to justify those price increases.
  I have heard heartbreaking stories about patients leaving their 
prescriptions unfilled simply because they can't afford them, rationing 
doses of blood pressure medication, and traveling across the 
international border to Mexico to get certain medications at lower 
prices. The problem is, when you go to Mexico to get your medication, 
it may look like the same medication you take in the United States, but 
chances are it may well be counterfeit, so that is a real problem in 
and of itself.
  These challenges have been compounded by high inflation under 
President Biden's policies. We know everything has gone up in cost--an 
average of 20 percent over the last 3 years for groceries, gas, rent. 
Just about everything is more expensive today than it was when 
President Biden took office.
  Senators from both sides of the aisle, on a bipartisan basis, have 
offered a number of bills to try to get at this problem of high drug 
prices. One of these is a bipartisan bill that I introduced with 
Senator Richard Blumenthal from Connecticut called the Affordable 
Prescriptions for Patients Act. This legislation addresses one of the 
most egregious practices contributing to high drug prices, which is 
patent abuse.
  Our country offers robust protection for intellectual property. In 
other words, if you are going to do the research and development and go 
to the expense and take the risk associated with creating something new 
and innovative, like a new drug to treat a deadly disease, our laws 
allow the right to sell that drug on an exclusive basis for a period of 
time. I think it is very important to incentivize that sort of 
innovation and research, and it produces lifesaving drugs. We know that 
many companies are unlikely to pour expensive resources into 
discovering new cures if, at the end of it, they can't even recoup 
their own costs, much less make a profit.
  That is where our patent system comes in. It is as old as our country 
is old. The patent system provides a limited time period for the 
manufacturer to be the sole seller in the marketplace before generic 
versions can become available, but some companies are abusing the 
system. They are taking extreme steps to maintain their exclusivity for 
a drug and keep the money rolling in. One way they do this is through a 
practice known as patent thickening. This involves creating intricate 
webs of patents to keep the competition at bay for as long as possible 
because as long as you can continue to sell these drugs on an exclusive 
basis, the money is going to keep coming in, and it will not go generic 
and result in competition from others.
  The Affordable Prescriptions for Patients Act aims to stop this 
anticompetitive behavior and allow new drugs to come to market sooner. 
That is how we improve competition and ultimately lower prices for 
patients without standing in the way of innovation.
  The added benefit to this bill is the Federal savings that it would 
provide for taxpayers. The Congressional Budget Office has estimated 
that this bill would lead to lower Federal spending by $1.8 billion 
over 10 years.
  At a time when our national debt is at an alltime high--approaching 
$35 trillion--anything we can do to help deal with that rising debt I 
think should be regarded as positive. And this is just a savings to the 
Federal Government for Medicare and Medicaid. There will, undoubtedly, 
be significant savings for consumers who have private health insurance 
on top of that.
  This bipartisan legislation checks every box. It protects innovation; 
it increases competition; and it saves money for taxpayers and 
consumers. Most importantly, it lowers prices at a time when many 
patients are seeing their drug prices go up and up and up--apparently, 
without end.

  I can't imagine why anybody would oppose such a piece of legislation. 
Election day is 4 months away, and the Senate is only scheduled to be 
in session for 20 days between now and then, including today. Patients 
in Texas and across the country are asking their elected 
representatives to do something to address these high drug prices, and 
it is time for the Senate to deliver.
  Madam President, as in legislative session, I ask unanimous consent 
that the Senate proceed to the immediate consideration of Calendar No. 
22, S. 150.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The senior assistant legislative clerk read as follows:

       A bill (S. 150) to amend the Federal Trade Commission Act 
     to prohibit product hopping, and for other purposes.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on the Judiciary.
  Mr. CORNYN. Madam President, I further ask that the Cornyn substitute 
amendment at the desk be considered and agreed to; that the bill, as 
amended, be considered read a third time and passed; and that the 
motion to reconsider be considered made and laid upon the table with no 
intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 2399) in the nature of a substitute was agreed to, 
as follows:

                (Purpose: In the nature of a substitute)

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Affordable Prescriptions for 
     Patients Act of 2023''.

     SEC. 2. TITLE 35 AMENDMENTS.

       (a) In General.--Section 271(e) of title 35, United States 
     Code, is amended--
       (1) in paragraph (2)(C), in the flush text following clause 
     (ii), by adding at the end the following: ``With respect to a 
     submission described in clause (ii), the act of infringement 
     shall extend to any patent that claims the biological 
     product, a method of using the biological product, or a 
     method or product used to manufacture the biological 
     product.''; and
       (2) by adding at the end the following:
       ``(7)(A) Subject to subparagraphs (C), (D), and (E), if the 
     sponsor of an approved application for a reference product, 
     as defined in section 351(i) of the Public Health Service Act 
     (42 U.S.C. 262(i)) (referred to in this paragraph as the 
     `reference product sponsor'), brings an action for 
     infringement under this section against an applicant for 
     approval of a biological product under section 351(k) of such 
     Act that references that reference product (referred to in 
     this paragraph as the `subsection (k) applicant'), the 
     reference product sponsor may assert in the action a total of 
     not more than 20 patents of the type described in 
     subparagraph (B), not more than 10 of which shall have issued 
     after the date specified in section 351(l)(7)(A) of such Act.
       ``(B) The patents described in this subparagraph are 
     patents that satisfy each of the following requirements:
       ``(i) Patents that claim the biological product that is the 
     subject of an application under section 351(k) of the Public 
     Health Service Act (42 U.S.C. 262(k)) (or a use of that 
     product) or a method or product used in the manufacture of 
     such biological product.
       ``(ii) Patents that are included on the list of patents 
     described in paragraph (3)(A) of section 351(l) of the Public 
     Health Service Act (42 U.S.C. 262(l)), including as provided 
     under paragraph (7) of such section 351(l).
       ``(iii) Patents that--
       ``(I) have an actual filing date of more than 4 years after 
     the date on which the reference product is approved; or
       ``(II) include a claim to a method in a manufacturing 
     process that is not used by the reference product sponsor.
       ``(C) The court in which an action described in 
     subparagraph (A) is brought may increase the number of 
     patents limited under that subparagraph--
       ``(i) if the request to increase that number is made 
     without undue delay; and
       ``(ii)(I) if the interest of justice so requires; or
       ``(II) for good cause shown, which--
       ``(aa) shall be established if the subsection (k) applicant 
     fails to provide information required section 351(k)(2)(A) of 
     the Public Health Service Act (42 U.S.C. 262(k)(2)(A)) that 
     would enable the reference product sponsor to form a 
     reasonable belief with respect to whether a claim of 
     infringement under this section could reasonably be asserted; 
     and

[[Page S4538]]

       ``(bb) may be established--
       ``(AA) if there is a material change to the biological 
     product (or process with respect to the biological product) 
     of the subsection (k) applicant that is the subject of the 
     application;
       ``(BB) if, with respect to a patent on the supplemental 
     list described in section 351(l)(7)(A) of Public Health 
     Service Act (42 U.S.C. 262(l)(7)(A)), the patent would have 
     issued before the date specified in such section 351(l)(7)(A) 
     but for the failure of the Office to issue the patent or a 
     delay in the issuance of the patent, as described in 
     paragraph (1) of section 154(b) and subject to the 
     limitations under paragraph (2) of such section 154(b); or
       ``(CC) for another reason that shows good cause, as 
     determined appropriate by the court.
       ``(D) In determining whether good cause has been shown for 
     the purposes of subparagraph (C)(ii)(II), a court may 
     consider whether the reference product sponsor has provided a 
     reasonable description of the identity and relevance of any 
     information beyond the subsection (k) application that the 
     court believes is necessary to enable the court to form a 
     belief with respect to whether a claim of infringement under 
     this section could reasonably be asserted.
       ``(E) The limitation imposed under subparagraph (A)--
       ``(i) shall apply only if the subsection (k) applicant 
     completes all actions required under paragraphs (2)(A), 
     (3)(B)(ii), (5), (6)(C)(i), (7), and (8)(A) of section 351(l) 
     of the Public Health Service Act (42 U.S.C. 262(l)); and
       ``(ii) shall not apply with respect to any patent that 
     claims, with respect to a biological product, a method for 
     using that product in therapy, diagnosis, or prophylaxis, 
     such as an indication or method of treatment or other 
     condition of use.''.
       (b) Applicability.--The amendments made by subsection (a) 
     shall apply with respect to an application submitted under 
     section 351(k) of the Public Health Service Act (42 U.S.C. 
     262(k)) on or after the date of enactment of this Act.
       (c) Medicare Improvement Fund.--Section 1898(b)(1) of the 
     Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended by 
     striking ``$0'' and inserting ``$1,800,000,000''.

  The bill (S. 150), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.
  Mr. CORNYN. Madam President, I yield the floor.

                          ____________________