NY State Senate Bill 2023-S4513

Current Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

View Actions

	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 03, 2024	referred to health
Jun 10, 2023	committed to rules
May 22, 2023	advanced to third reading
May 18, 2023	2nd report cal.
May 17, 2023	1st report cal.1051
Feb 09, 2023	referred to health

Votes

- May 17, 2023 - Health Committee Vote
  S4513
  
  10
  
  Aye
  
  2
  
  Nay
  
  3
  
  Aye with Reservations
  
  0
  
  Absent
  
  0
  
  Excused
  
  0
  
  Abstained
  - - Health Committee Vote: May 17, 2023
      
      aye (10)
      
      Brouk
      
      Felder
      
      Hoylman-Sigal
      
      Mannion
      
      May
      
      Myrie
      
      Rivera
      
      Salazar
      
      Thomas
      
      Webb
      
      nay (2)
      
      Gallivan
      
      Stec
      
      aye wr (3)
      
      Ashby
      
      Martins
      
      Rhoads

co-Sponsors

2023-S4513 (ACTIVE) - Details

See Assembly Version of this Bill:: A7465
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add Art 2-A Title IV §§282 & 283, Pub Health L
Versions Introduced in 2021-2022 Legislative Session:: S4370, A7245

2023-S4513 (ACTIVE) - Summary

Relates to preserving access to affordable drugs; provides that an agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a pharmaceutical product, shall be presumed to have anticompetitive effects if a nonreference drug filer receives anything of value from another company asserting patent infringement and if the nonreference drug filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the nonreference drug filer's product for any period of time.

2023-S4513 (ACTIVE) - Sponsor Memo

                                 
BILL NUMBER: S4513

SPONSOR: FERNANDEZ
 
TITLE OF BILL:

An act to amend the public health law, in relation to preserving access
to affordable drugs

 
PURPOSE OR GENERAL IDEA OF BILL:

To preserve access to affordable prescription drugs by banning pay-to-
delay agreements.

 
SUMMARY OF PROVISIONS:

Section 1 amends Article 2-a of the public health law by adding a new
title IV to preserve access to prescription drugs by banning pay-to-de-
lay agreements.

Section 2 establishes that if any clause, sentence, paragraph, subdivi-
sion, section or part is found to be invalid or unenforceable, the judg-
ment will not invalidate the remainder of the bill.

Section 3 establishes the effective date.

 
JUSTIFICATION:

Rising prescription drug prices have been devastating to New Yorkers who
depend on prescription drugs to keep them healthy. The growing number of
brand-name and specialty drugs with prices of $100,000 or more has led
many to question whether the costs associated with these products are
defensible or sustainable. The timely availability of generic and biosi-
milar drugs, which increase competition and help lower prices, play an
important role in addressing these concerns.

Brand-name drug manufacturers often file patent infringement lawsuits
against the first generic drug manufacturers to seek FDA approval for
competing generic drugs. Rather than face the costs and uncertainty
associated with litigation, some brand-name and generic drug manufactur-
ers choose to enter into what is known as a pay-for-delay agreement,
where the brand-name drug manufacturers compensates the generic drug
manufacturer for keeping its product off the market for a certain amount
of time. These agreements can be particularly problematic when they
involve the first-to-file generic manufacturer, because no other generic
manufacturer can enter the market until the first-to-file manufacturer
has marketed its product for 180 days.

These pay-for-delay agreements provide financial benefits to drug
manufacturers at the expense of consumers; the brand-name manufacturer
can continue to charge monopoly prices, and the generic company is
compensated for its inaction. The Federal Trade Commission (FTC) esti-
mates that pay-for delay agreements cost American consumers $3.5 billion
per year.

The FTC has found that pay-for-delay agreements prohibit generic entry
for an average of nearly 17 months longer than patent settlement agree-
ments without such payments. In the meantime, consumers must continue
paying brand-name drug prices, which can be as much as 85 percent higher
than the prices of their generic drug counterparts.  Any delay in gener-
ic entry results in a longer period of purchases at the full brand price
and, correspondingly, fewer purchases at less expensive generic prices.
This negatively impacts both consumers and other payers, including
taxpayer-funded health programs, such as Medicaid.

Generic drugs have proven to be one of the safest and most effective
ways for consumers to lower their prescription drug costs, and the use
of generic drugs has been steadily increasing. These drugs should not be
delayed from entering the marketplace.

Patients in New York -- and around the country - are facing unacceptable
costs and a lack of transparency about how medication is priced. For too
long we have allowed pharmaceutical companies to operate under lax regu-
lations at the expense of patients. This bill makes it the presumption
that an agreement resolving or settling a patent infringement claim in
connection to the sale of a pharmaceutical product has anti-competitive
effects if 1) a non reference drug filer receives anything of value from
another company asserting patent infringement and 2) the non-reference
drug filer agrees to forego research, development, manufacturing,
marketing, or sale of the drug for a period of time. The legislation
sets forth civil penalties for individuals who violate or assist in
violating this section to ensure compliance.

 
PRIOR LEGISLATIVE HISTORY:

2021-2022: S4370 / A7245

 
FISCAL IMPLICATIONS:

TBD

 
EFFECTIVE DATE:
This act shall take effect on the sixtieth day after it shall have
become a law.

2023-S4513 (ACTIVE) - Bill Text download pdf

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   4513
 
                        2023-2024 Regular Sessions
 
                             I N  S E N A T E
 
                             February 9, 2023
                                ___________
 
 Introduced by Sen. FERNANDEZ -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health
 
 AN  ACT to amend the public health law, in relation to preserving access
   to affordable drugs
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:

   Section 1. Article 2-A of the public health law is amended by adding a
 new title IV to read as follows:
                                 TITLE IV
                   PRESERVING ACCESS TO AFFORDABLE DRUGS
 SECTION 282. DEFINITIONS.
         283. PRESERVING ACCESS TO AFFORDABLE DRUGS.
   §  282.  DEFINITIONS.  FOR  THE  PURPOSES OF THIS TITLE, THE FOLLOWING
 TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   1. "ANDA" SHALL MEAN ABBREVIATED NEW DRUG APPLICATION AS DESCRIBED  BY
 505(J) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. 335(J).
   2. "ANDA FILER" SHALL MEAN A PARTY THAT OWNS OR CONTROLS AN ANDA FILED
 WITH  THE  FEDERAL  FOOD  AND  DRUG  ADMINISTRATION OR HAS THE EXCLUSIVE
 RIGHTS UNDER THAT ANDA TO DISTRIBUTE THE ANDA PRODUCT.
   3. "AGREEMENT" SHALL MEAN ANYTHING THAT WOULD CONSTITUTE AN  AGREEMENT
 UNDER STATE LAW.
   4.  "AGREEMENT  RESOLVING  OR  SETTLING  A  PATENT INFRINGEMENT CLAIM"
 INCLUDES ANY AGREEMENT THAT IS ENTERED INTO WITHIN THIRTY  DAYS  OF  THE
 RESOLUTION  OR  THE SETTLEMENT OF THE CLAIM, OR ANY OTHER AGREEMENT THAT
 IS CONTINGENT UPON, PROVIDES A CONTINGENT CONDITION FOR, OR IS OTHERWISE
 RELATED TO THE  RESOLUTION  OR  SETTLEMENT  OF  THE  CLAIM.  THIS  SHALL
 INCLUDE, BUT IS NOT LIMITED TO, THE FOLLOWING:
   (A) ANY AGREEMENT REQUIRED TO BE PROVIDED TO THE FEDERAL TRADE COMMIS-
 SION  OR  THE  ANTITRUST  DIVISION  OF  THE  UNITED STATES DEPARTMENT OF
 JUSTICE UNDER THE MEDICARE PRESCRIPTION DRUG, IMPROVEMENT,  AND  MODERN-
 IZATION ACT OF 2003, PUB. L. NO. 108-173;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD09108-01-3

 S. 4513                             2
 
   (B)  ANY  AGREEMENT  BETWEEN  A  BIOSIMILAR OR INTERCHANGEABLE PRODUCT
 APPLICANT AND A REFERENCE PRODUCT  SPONSOR  UNDER  THE  BIOLOGICS  PRICE
 COMPETITION  AND  INNOVATION  ACT  OF  2009,  PUB.  L. NO. 111-148, THAT
 RESOLVES PATENT CLAIMS BETWEEN THE APPLICANT AND SPONSOR.
   5.  "BIOSIMILAR  BIOLOGICAL  PRODUCT  APPLICATION  FILER" SHALL MEAN A
 PARTY THAT OWNS OR CONTROLS A BIOSIMILAR BIOLOGICAL PRODUCT  APPLICATION
 FILED  WITH THE FEDERAL FOOD AND DRUG ADMINISTRATION PURSUANT TO SECTION
 351(K) OF THE PUBLIC HEALTH SERVICE ACT, 42 U.S.C. 262(K), FOR LICENSURE
 OF A BIOLOGICAL PRODUCT AS BIOSIMILAR TO,  OR  INTERCHANGEABLE  WITH,  A
 REFERENCE  PRODUCT,  OR THAT HAS THE EXCLUSIVE RIGHTS UNDER THE APPLICA-
 TION TO DISTRIBUTE THE BIOSIMILAR BIOLOGICAL PRODUCT.
   6. "NDA" SHALL MEAN A NEW DRUG APPLICATION.
   7. "NONREFERENCE DRUG FILER" SHALL MEAN EITHER:
   (A) AN ANDA FILER;
   (B) A COMPANY THAT SEEKS AN ABBREVIATED APPROVAL PATHWAY FOR ITS  DRUG
 PRODUCT UNDER 505(B)(2) OF THE FEDERAL FOOD, DRUG, AND  COSMETIC ACT, 21
 U.S.C. 355(B)(2); OR
   (C)  A  BIOSIMILAR  BIOLOGICAL  PRODUCT  APPLICATION FILER, OR COMPANY
 SEEKING FDA APPROVAL FOR A BIOSIMILAR UNDER 42 U.S.C. 262.
   8. "NONREFERENCE DRUG PRODUCT" SHALL MEAN THE PRODUCT TO  BE  MANUFAC-
 TURED  UNDER  AN ANDA OR AN APPLICATION FILED UNDER SECTION 505(B)(2) OF
 THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. 355(B), THAT IS  THE
 SUBJECT  OF THE PATENT INFRINGEMENT CLAIM, A BIOSIMILAR BIOLOGICAL PROD-
 UCT THAT IS THE PRODUCT TO BE MANUFACTURED UNDER THE BIOSIMILAR  BIOLOG-
 ICAL  PRODUCT APPLICATION THAT IS THE SUBJECT OF THE PATENT INFRINGEMENT
 CLAIM, OR BOTH.
   9. "PATENT INFRINGEMENT" SHALL MEAN INFRINGEMENT OF ANY PATENT  OR  OF
 ANY  FILED  PATENT  APPLICATION,  EXTENSION, REISSUE, RENEWAL, DIVISION,
 CONTINUATION, CONTINUATION IN PART, REEXAMINATION, PATENT TERM  RESTORA-
 TION, PATENTS OF ADDITION, AND EXTENSIONS THEREOF.
   10.  "PATENT  INFRINGEMENT  CLAIM" SHALL MEAN ANY ALLEGATION MADE TO A
 NONREFERENCE DRUG FILER, WHETHER OR NOT INCLUDED IN  A  COMPLAINT  FILED
 WITH  A  COURT OF LAW, THAT ITS NONREFERENCE DRUG PRODUCT OR APPLICATION
 INFRINGES ANY PATENT HELD BY, OR EXCLUSIVELY LICENSED TO, THE  REFERENCE
 DRUG HOLDER.
   11. "REFERENCE DRUG HOLDER" SHALL MEAN EITHER:
   (A) A BRAND HOLDER THAT IS ANY OF THE FOLLOWING:
   (I) THE HOLDER OF AN APPROVED NDA FOR A DRUG PRODUCT APPLICATION FILED
 UNDER  SECTION  505(B)  OF  THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21
 U.S.C. 355(B);
   (II) A PERSON OWNING OR CONTROLLING ENFORCEMENT OF THE  PATENT  LISTED
 IN  THE  APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
 IN CONNECTION WITH THE NDA; OR
   (III) THE PREDECESSORS, SUBSIDIARIES, DIVISIONS,  GROUPS,  AND  AFFIL-
 IATES  CONTROLLED  BY, CONTROLLING, OR UNDER COMMON CONTROL WITH, ANY OF
 THE ENTITIES DESCRIBED IN SUBPARAGRAPH (I) OR (II)  OF  THIS  PARAGRAPH,
 WITH  CONTROL  TO  BE  PRESUMED BY DIRECT OR INDIRECT SHARE OWNERSHIP OF
 FIFTY PERCENT OR GREATER, AS WELL AS THE LICENSEES,  LICENSORS,  SUCCES-
 SORS, AND ASSIGNS OF EACH OF THOSE ENTITIES; OR
   (B)  A  BIOLOGICAL PRODUCT LICENSE HOLDER, WHICH SHALL MEAN ANY OF THE
 FOLLOWING:
   (I) THE HOLDER OF AN APPROVED BIOLOGICAL PRODUCT  LICENSE  APPLICATION
 FOR  A BIOLOGICAL DRUG PRODUCT UNDER SECTION 351(A) OF THE PUBLIC HEALTH
 SERVICE ACT, 42 U.S.C. 262(A);
 S. 4513                             3
 
   (II) A PERSON OWNING OR CONTROLLING ENFORCEMENT OF  ANY  PATENTS  THAT
 CLAIM THE BIOLOGICAL PRODUCT THAT IS THE SUBJECT OF THE APPROVED BIOLOG-
 ICAL PATENT LICENSE APPLICATION; OR
   (III)  THE  PREDECESSORS,  SUBSIDIARIES, DIVISIONS, GROUPS, AND AFFIL-
 IATES CONTROLLED BY, CONTROLLING, OR UNDER COMMON CONTROL WITH,  ANY  OF
 THE  ENTITIES  DESCRIBED  IN SUBPARAGRAPH (I) OR (II) OF THIS PARAGRAPH,
 WITH CONTROL TO BE PRESUMED BY DIRECT OR  INDIRECT  SHARE  OWNERSHIP  OF
 FIFTY  PERCENT  OR GREATER, AS WELL AS THE LICENSEES, LICENSORS, SUCCES-
 SORS, AND ASSIGNS OF EACH OF THOSE ENTITIES.
   12. "REFERENCE DRUG PRODUCT" SHALL MEAN THE PRODUCT TO BE MANUFACTURED
 BY THE REFERENCE DRUG HOLDER AND INCLUDES BOTH BRANDED DRUGS OF THE  NDA
 HOLDER  AND  THE  BIOLOGIC  DRUG PRODUCT OF THE BIOLOGIC PRODUCT LICENSE
 APPLICANT.
   13. "STATUTORY EXCLUSIVITY"  SHALL  MEAN  THOSE  PROHIBITIONS  ON  THE
 APPROVAL OF DRUG APPLICATIONS UNDER CLAUSES (II) THROUGH (IV) OF SECTION
 505(C)(3)(E), SECTION 527 OR SECTION 505A OF THE FEDERAL FOOD, DRUG, AND
 COSMETIC  ACT,  21  U.S.C.  355(C)(3)(E), ON THE LICENSING OF BIOLOGICAL
 PRODUCT APPLICATIONS UNDER SECTION 262(K)(7) OF TITLE 42 OF  THE  UNITED
 STATES CODE OR SECTION 262(M)(2) OR (3) OF TITLE 42 OF THE UNITED STATES
 CODE.
   §  283.  PRESERVING  ACCESS  TO  AFFORDABLE  DRUGS.  1.  (A) EXCEPT AS
 PROVIDED IN PARAGRAPH (C) OF THIS SUBDIVISION, AN AGREEMENT RESOLVING OR
 SETTLING, ON A FINAL OR INTERIM BASIS, A PATENT INFRINGEMENT  CLAIM,  IN
 CONNECTION  WITH THE SALE OF A PHARMACEUTICAL PRODUCT, SHALL BE PRESUMED
 TO HAVE ANTICOMPETITIVE EFFECTS AND SHALL BE A VIOLATION OF THIS SECTION
 IF BOTH OF THE FOLLOWING APPLY:
   (I) A NONREFERENCE DRUG FILER RECEIVES ANYTHING OF VALUE FROM  ANOTHER
 COMPANY ASSERTING PATENT INFRINGEMENT, INCLUDING, BUT NOT LIMITED TO, AN
 EXCLUSIVE LICENSE OR A PROMISE THAT THE BRAND COMPANY WILL NOT LAUNCH AN
 AUTHORIZED GENERIC VERSION OF ITS BRAND DRUG; AND
   (II)  THE  NONREFERENCE DRUG FILER AGREES TO LIMIT OR FOREGO RESEARCH,
 DEVELOPMENT, MANUFACTURING, MARKETING, OR SALES OF THE NONREFERENCE DRUG
 FILER'S PRODUCT FOR ANY PERIOD OF TIME.
   (B) AS USED IN SUBPARAGRAPH (I) OF PARAGRAPH (A) OF THIS  SUBDIVISION,
 "ANYTHING  OF VALUE" SHALL BE INTERPRETED BROADLY TO INCLUDE ANY TYPE OF
 CONSIDERATION, VALUE OR BENEFIT A REFERENCE DRUG HOLDER OR  NONREFERENCE
 DRUG FILER COULD POSSIBLY OBTAIN FROM THE AGREEMENT. "ANYTHING OF VALUE"
 SHALL  NOT  INCLUDE  A SETTLEMENT OF PATENT INFRINGEMENT CLAIMS IN WHICH
 THE CONSIDERATION GRANTED BY THE REFERENCE DRUG HOLDER TO THE  NONREFER-
 ENCE DRUG FILER AS PART OF THE RESOLUTION OR SETTLEMENT CONSISTS OF ONLY
 ONE OR MORE OF THE FOLLOWING:
   (I)  THE  RIGHT  TO  MARKET THE COMPETING PRODUCT IN THE UNITED STATES
 BEFORE THE EXPIRATION OF EITHER:
   (A) A PATENT THAT IS THE BASIS FOR THE PATENT INFRINGEMENT CLAIM; OR
   (B) A PATENT RIGHT OR OTHER STATUTORY EXCLUSIVITY THAT  WOULD  PREVENT
 THE MARKETING OF THE DRUG;
   (II) A COVENANT NOT TO SUE ON A CLAIM THAT THE NONREFERENCE DRUG PROD-
 UCT INFRINGES A UNITED STATES PATENT;
   (III)  COMPENSATION FOR SAVED REASONABLE FUTURE LITIGATION EXPENSES OF
 THE REFERENCE DRUG HOLDER BUT ONLY IF BOTH OF THE FOLLOWING ARE TRUE:
   (A) THE TOTAL COMPENSATION FOR SAVED LITIGATION EXPENSES IS  REFLECTED
 IN  BUDGETS  THAT  THE  REFERENCE  DRUG HOLDER DOCUMENTED AND ADOPTED AT
 LEAST SIX MONTHS BEFORE THE SETTLEMENT; AND
   (B) THE COMPENSATION SHALL NOT EXCEED THE LOWER OF THE FOLLOWING:
   (1) SEVEN MILLION FIVE HUNDRED THOUSAND DOLLARS; OR
 S. 4513                             4
 
   (2) FIVE PERCENT OF THE  REVENUE  THAT  THE  NONREFERENCE  DRUG  FILER
 PROJECTED  OR  FORECASTED  IT  WOULD RECEIVE IN THE FIRST THREE YEARS OF
 SALES OF ITS VERSION OF THE REFERENCE DRUG DOCUMENTED  AT  LEAST  TWELVE
 MONTHS  BEFORE THE SETTLEMENT. IF NO PROJECTIONS OR FORECASTS ARE AVAIL-
 ABLE,  THE  COMPENSATION  SHALL  NOT  EXCEED  TWO HUNDRED FIFTY THOUSAND
 DOLLARS;
   (IV) AN AGREEMENT BY THE REFERENCE DRUG HOLDER NOT TO  INTERFERE  WITH
 THE  NONREFERENCE DRUG FILER'S ABILITY TO SECURE AND MAINTAIN REGULATORY
 APPROVAL TO MARKET THE NONREFERENCE DRUG  PRODUCT  OR  AN  AGREEMENT  TO
 FACILITATE  THE NONREFERENCE DRUG FILER'S ABILITY TO SECURE AND MAINTAIN
 REGULATORY APPROVAL TO MARKET THE NONREFERENCE DRUG PRODUCT; OR
   (V) AN AGREEMENT RESOLVING A PATENT INFRINGEMENT CLAIM  IN  WHICH  THE
 REFERENCE  DRUG  HOLDER  FORGIVES  THE  POTENTIAL  DAMAGES  ACCRUED BY A
 NONREFERENCE DRUG FILER FOR AN AT-RISK LAUNCH OF THE  NONREFERENCE  DRUG
 PRODUCT THAT IS THE SUBJECT OF THAT CLAIM.
   (C)  PARTIES  TO AN AGREEMENT ARE NOT IN VIOLATION OF PARAGRAPH (A) OF
 THIS SUBDIVISION  IF  THEY  CAN  DEMONSTRATE  BY  CLEAR  AND  CONVINCING
 EVIDENCE THAT EITHER OF THE FOLLOWING ARE MET:
   (I)  THE  VALUE  RECEIVED  BY THE NONREFERENCE DRUG FILER DESCRIBED IN
 SUBPARAGRAPH (I) OF PARAGRAPH (A) OF THIS  SUBDIVISION  IS  A  FAIR  AND
 REASONABLE  COMPENSATION  SOLELY  FOR  OTHER  GOODS OR SERVICES THAT THE
 NONREFERENCE DRUG FILER HAS PROMISED TO PROVIDE; OR
   (II) THE AGREEMENT HAS DIRECTLY GENERATED PROCOMPETITIVE BENEFITS  AND
 THE  PROCOMPETITIVE  BENEFITS  OF THE AGREEMENT OUTWEIGH THE ANTICOMPET-
 ITIVE EFFECTS OF THE AGREEMENT.
   2. IN DETERMINING WHETHER THE PARTIES TO THE AGREEMENT HAVE MET  THEIR
 BURDEN  UNDER  PARAGRAPH (C) OF SUBDIVISION ONE OF THIS SECTION, A COURT
 OF COMPETENT JURISDICTION SHALL NOT CONSIDER ANY OF THE FOLLOWING:
   (A) THAT ENTRY INTO THE MARKETPLACE COULD NOT HAVE OCCURRED UNTIL  THE
 EXPIRATION  OF  THE  RELEVANT PATENT EXCLUSIVITY OR THAT THE AGREEMENT'S
 PROVISION FOR ENTRY OF THE NONREFERENCE DRUG PRODUCT BEFORE THE  EXPIRA-
 TION  OF  ANY  PATENT EXCLUSIVITY MEANS THAT THE AGREEMENT IS PROCOMPET-
 ITIVE WITHIN THE MEANING OF SUBPARAGRAPH (II) OF PARAGRAPH (C) OF SUBDI-
 VISION ONE OF THIS SECTION;
   (B) THAT ANY PATENT IS ENFORCEABLE AND INFRINGED BY  THE  NONREFERENCE
 DRUG  FILER  IN THE ABSENCE OF A FINAL ADJUDICATION BINDING ON THE FILER
 OF THOSE ISSUES;
   (C) THAT THE AGREEMENT CAUSED NO DELAY IN ENTRY  OF  THE  NONREFERENCE
 DRUG  FILER'S  DRUG PRODUCT BECAUSE OF THE LACK OF FEDERAL FOOD AND DRUG
 ADMINISTRATION (FDA) APPROVAL OF THAT OR OF  ANOTHER  NONREFERENCE  DRUG
 PRODUCT; OR
   (D)  THAT THE AGREEMENT CAUSED NO HARM OR DELAY DUE TO THE POSSIBILITY
 THAT THE NONREFERENCE DRUG FILER'S  DRUG  PRODUCT  MIGHT  INFRINGE  SOME
 PATENT THAT HAS NOT BEEN ASSERTED AGAINST THE NONREFERENCE DRUG FILER OR
 THAT IS NOT SUBJECT TO A FINAL AND BINDING ADJUDICATION ON THAT FILER AS
 TO THE PATENT'S SCOPE, ENFORCEABILITY, AND INFRINGEMENT.
   3.  IN DETERMINING WHETHER THE PARTIES TO THE AGREEMENT HAVE MET THEIR
 BURDEN UNDER PARAGRAPH (C) OF SUBDIVISION ONE OF THIS SECTION,  A  COURT
 OF COMPETENT JURISDICTION SHALL PRESUME THAT THE RELEVANT PRODUCT MARKET
 IS  THAT MARKET CONSISTING OF THE REFERENCE DRUG OF THE COMPANY ALLEGING
 PATENT INFRINGEMENT AND THE DRUG PRODUCT OF THE NONREFERENCE DRUG  FILER
 ACCUSED  OF  INFRINGEMENT  AND  ANY  OTHER  BIOLOGICAL  PRODUCT  THAT IS
 LICENSED AS BIOSIMILAR OR IS AN AB-RATED GENERIC TO THE REFERENCE  PROD-
 UCT.
   4.  (A) THIS SECTION SHALL NOT MODIFY, IMPAIR, LIMIT, OR SUPERSEDE THE
 APPLICABILITY OF THE ANTITRUST LAWS OF THE  STATE  PURSUANT  TO  ARTICLE
 S. 4513                             5
 
 TWENTY-TWO  OF  THE GENERAL BUSINESS LAW, UNFAIR COMPETITION LAWS OF THE
 STATE PURSUANT TO ARTICLE TWENTY-TWO-A OF THE GENERAL  BUSINESS  LAW  OR
 THE  AVAILABILITY  OF DAMAGES OR REMEDIES PROVIDED THEREIN. THIS SECTION
 SHALL  NOT  MODIFY,  IMPAIR,  LIMIT,  OR SUPERSEDE THE RIGHT OF ANY DRUG
 COMPANY APPLICANT TO ASSERT CLAIMS OR COUNTERCLAIMS AGAINST ANY  PERSON,
 UNDER THE ANTITRUST LAWS OR OTHER LAWS RELATING TO UNFAIR COMPETITION OF
 THE FEDERAL ANTITRUST LAW OR STATE LAW.
   (B)  IF  ANY  PROVISION OF THIS SUBDIVISION, AN AMENDMENT MADE TO THIS
 SUBDIVISION, OR THE APPLICATION OF ANY PROVISION  OR  AMENDMENT  TO  ANY
 PERSON  OR CIRCUMSTANCE IS HELD TO BE UNCONSTITUTIONAL, THE REMAINDER OF
 THIS SUBDIVISION, THE AMENDMENTS  MADE  TO  THIS  SUBDIVISION,  AND  THE
 APPLICATION  OF  THE PROVISIONS OF THIS SUBDIVISION OR AMENDMENTS TO ANY
 PERSON OR CIRCUMSTANCE SHALL NOT BE AFFECTED.
   5. (A)(I) EACH PERSON THAT VIOLATES OR ASSISTS  IN  THE  VIOLATION  OF
 THIS  SECTION  SHALL FORFEIT AND PAY TO THE STATE A CIVIL PENALTY SUFFI-
 CIENT TO DETER VIOLATIONS OF THIS SECTION, AS FOLLOWS:
   (A) IF THE PERSON WHO VIOLATED THIS SECTION RECEIVED ANY VALUE DUE  TO
 THAT  VIOLATION,  AN  AMOUNT UP TO THREE TIMES THE VALUE RECEIVED BY THE
 PARTY THAT IS REASONABLY ATTRIBUTABLE TO THE VIOLATION OF THIS  SECTION,
 OR TWENTY MILLION DOLLARS, WHICHEVER IS GREATER; OR
   (B) IF THE VIOLATOR HAS NOT RECEIVED ANYTHING OF VALUE AS DESCRIBED IN
 THIS  SUBPARAGRAPH, AN AMOUNT UP TO THREE TIMES THE VALUE GIVEN TO OTHER
 PARTIES TO THE AGREEMENT REASONABLY ATTRIBUTABLE  TO  THE  VIOLATION  OF
 THIS SECTION, OR TWENTY MILLION DOLLARS.
   (C)  FOR PURPOSES OF THIS SUBDIVISION, "REASONABLY ATTRIBUTABLE TO THE
 VIOLATION" SHALL BE DETERMINED BY THE STATE'S SHARE OF  THE  MARKET  FOR
 THE BRAND DRUG AT ISSUE IN THE AGREEMENT.
   (II) ANY PENALTY DESCRIBED IN SUBPARAGRAPH (I) OF THIS PARAGRAPH SHALL
 ACCRUE  ONLY  TO  THE  STATE  AND  SHALL  BE RECOVERED IN A CIVIL ACTION
 BROUGHT BY THE ATTORNEY GENERAL IN ITS OWN NAME, OR BY ANY OF ITS ATTOR-
 NEYS DESIGNATED BY IT FOR THAT PURPOSE, AGAINST ANY PARTY TO  AN  AGREE-
 MENT THAT VIOLATES THIS SECTION.
   (B)  EACH  PARTY  THAT  VIOLATES  OR  ASSISTS IN THE VIOLATION OF THIS
 SECTION SHALL BE LIABLE FOR ANY DAMAGES, PENALTIES, COSTS, FEES, INJUNC-
 TIONS, OR OTHER EQUITABLE OR LEGAL REMEDIES, INCLUDING, BUT NOT  LIMITED
 TO, RESTITUTION AND DISGORGEMENT, THAT MAY BE JUST AND REASONABLE.  SUCH
 REMEDIES  SHALL  INCLUDE,  BUT  NOT  BE LIMITED TO, ANY REMEDY AVAILABLE
 UNDER ARTICLES TWENTY-TWO OR TWENTY-TWO-A OF THE  GENERAL  BUSINESS  LAW
 AND SECTION SIXTY-THREE OF THE EXECUTIVE LAW.
   (C)  IF THE STATE IS AWARDED PENALTIES UNDER SUBPARAGRAPH (I) OF PARA-
 GRAPH (A) OF THIS SUBDIVISION, IT SHALL NOT RECOVER  PENALTIES  PURSUANT
 TO  ANOTHER  LAW  IDENTIFIED  IN PARAGRAPH (B) OF THIS SUBDIVISION. THIS
 SECTION SHALL NOT BE CONSTRUED TO FORECLOSE THE STATE'S ABILITY TO CLAIM
 ANY EQUITABLE OR LEGAL REMEDY AVAILABLE IN PARAGRAPH (B) OF THIS  SUBDI-
 VISION.
   (D)  AN  ACTION  TO  ENFORCE A CAUSE OF ACTION FOR A VIOLATION OF THIS
 SECTION SHALL BE COMMENCED WITHIN SIX YEARS AFTER THE  CAUSE  OF  ACTION
 ACCRUED.
   § 2. Severability clause. If any clause, sentence, paragraph, subdivi-
 sion,  section  or  part  of  this act shall be adjudged by any court of
 competent jurisdiction to be invalid  or  unenforceable,  such  judgment
 shall not affect, impair, or invalidate the remainder thereof, but shall
 be  confined in its operation to the clause, sentence, paragraph, subdi-
 vision, section or part thereof directly involved in the controversy  in
 which  such  judgment shall have been rendered. It is hereby declared to
 S. 4513                             6
 
 be the intent of the legislature that this act would have  been  enacted
 even if such invalid provisions had not been included herein.
   §  3.  This  act  shall take effect on the sixtieth day after it shall
 have become a law.

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Senate Bill S4513

Sponsored By

Current Bill Status - In Senate Committee Health Committee

May 17, 2023 - Health Committee Vote

Health Committee Vote: May 17, 2023

co-Sponsors

2023-S4513 (ACTIVE) - Details

2023-S4513 (ACTIVE) - Summary

2023-S4513 (ACTIVE) - Sponsor Memo

2023-S4513 (ACTIVE) - Bill Text download pdf

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Senate Bill S4513

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Sponsored By

Nathalia Fernandez

Current Bill Status - In Senate Committee Health Committee

co-Sponsors

Samra G. Brouk

Rachel May

Lea Webb

2023-S4513 (ACTIVE) - Details

2023-S4513 (ACTIVE) - Summary

2023-S4513 (ACTIVE) - Sponsor Memo

2023-S4513 (ACTIVE) - Bill Text download pdf

Comments