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<h4>Resolution Details</h4>
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<strong>Company:</strong>
<p>Johnson &amp; Johnson</p>
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<strong>Year:</strong>
<p>2026 </p>
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<strong>Issue Area:</strong>
<p>Corporate Governance </p>
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<strong>Focus Area:</strong>
<p>Independent Board Chairs </p>
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<strong>Status:</strong>
<p>Filed</p>
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<h2>Resolution Text</h2>
<p><strong>RESOLVED</strong>: Shareholders request that the Board of Directors adopt an enduring policy, and amend the governing documents as necessary in order that 2 separate people hold the office of the Chairman and the office of the CEO as soon as possible.</p>
<p><strong>SUPPORTING STATEMENT</strong>:</p>
<p dir=”ltr”>The Chairman of the Board shall be an Independent Director. A Lead Director shall not be a substitute for an independent Board Chairman.<br>&nbsp;<br>The Board shall have the discretion to select an interim Chairman of the Board, who is not an Independent Director, to serve while the Board is required to seek an Independent Chairman of the Board on an accelerated basis. This policy could be phased in when there is a contract renewal for our current CEO or for the next CEO transition although it is better to adopt it now.</p>
<p dir=”ltr”>An independent Board Chairman&nbsp;at all times improves corporate governance by bringing impartiality, objective oversight, and external expertise to board decisions, mitigating conflicts of interest, enhancing transparency, and boosting shareholder confidence.&nbsp;</p>
<p dir=”ltr”>This detached perspective allows the chairman to focus on&nbsp;shareholder interests,&nbsp;strengthen management accountability, and provide critical checks and balances, ultimately contributing to long-term sustainability and credibility.&nbsp;</p>
<p dir=”ltr”>This may be a particularly good time to consider the merits of this proposal. Johnson &amp; Johnson stock was at $186 in 2022 and was at only $191 in late 2025 despite a robust stock market.</p>
<p dir=”ltr”>Unfavorable news reports regarding Johnson &amp; Johnson emerged in 2025.&nbsp;</p>
<p dir=”ltr”>In October 2025, a Los Angeles jury ordered J&amp;J to pay a historic $966 million verdict to the family of a woman who died from mesothelioma. The verdict, which includes $950 million in punitive damages, is the largest single-plaintiff talc award since the company began facing lawsuits for asbestos-contaminated talc. As of October 2025, there were 67,000 product liability cases pending against J&amp;J.<br><br>In March, a federal judge ordered J&amp;J to pay $1.64 billion after a jury found its subsidiary, Janssen, guilty of violating the False Claims Act. The ruling concerned misleading marketing practices for two HIV drugs, Prezista and Intelence.<br><br>In March 2025, a federal bankruptcy judge again dismissed J&amp;J’s attempt to use a subsidiary to resolve its talc liabilities through bankruptcy. This was J&amp;J’s third failed attempt to use this controversial “Texas Two-Step” maneuver, and it forces J&amp;J to face the thousands of lawsuits in court.<br><br>In September 2025, the U.S. Food and Drug Administration issued a warning letter to J&amp;J subsidiary Janssen Vaccines for significant quality control and manufacturing practice violations.&nbsp;<br><br>J&amp;J acknowledged that the loss of patent exclusivity for its blockbuster drug Stelara created a significant headwind in its third-quarter 2025 earnings.&nbsp;<br><br>J&amp;J estimated in April 2025 that existing and potential tariffs would cost it approximately $400 million, with the majority coming from China.</p>

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<div class=”views-field views-field-nothing”><span class=”field-content”> John Chevedden</span></div><div class=”views-field views-field-title views-field-field-shareholder”><span class=”field-content”>Chevedden Corporate Governance</span></div>
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<strong>Company:</strong>
<p>Johnson &amp; Johnson</p>
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<strong>Year:</strong>
<p>2026 </p>
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<strong>Issue Area:</strong>
<p>Health </p>
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<strong>Focus Area:</strong>
<p>Chemicals/Toxins </p>
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<strong>Status:</strong>
<p>Filed</p>
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<h2>Resolution Text</h2>
<p><strong>WHEREAS</strong>: &nbsp;Exposure to toxic PFAS poses significant health, safety, reputational, litigation, and long-term financial viability concerns for companies and consumers alike. PFAS, known as “forever chemicals,” accumulate in the environment and human bodies, leading to a range of serious health and environmental impacts. Health harms include cancer, immune dysfunction, reproductive harm, and developmental issues, amplifying long-term liability and reputational concerns.[1]&nbsp;</p>
<p><strong>PFAS Contamination in Contact Lenses&nbsp;</strong></p>
<p>Johnson &amp; Johnson contact lenses were tested in a recent PFAS study. The study’s EPA certified lab detected alarming levels of organic fluorine, a marker for PFAS, in the Company’s Acuvue Oasys with HydraLuxe 1-Day lenses and Acuvue Vita Astigmatism Senofilcon C lenses, ranging from 5,537 PPM to 6,096 PPM of organic fluorine, two of the four highest levels in the study.[2] This study received media attention, which increased consumer awareness and concern over the products’ PFAS toxicity.[3]&nbsp;</p>
<p><strong>Legal, Financial, and Regulatory Risks of PFAS Are Accelerating&nbsp;</strong></p>
<p>Growing evidence of significant PFAS-related public health and environmental harm has led to mounting litigation and costly settlements, including industry payouts as high as $850 million.[4] Johnson &amp; Johnson is already facing legal consequences, including two class action lawsuits for failing to warn consumers about dangerous PFAS levels in its Band-Aid products.[5]&nbsp;</p>
<p>At the same time, PFAS regulations are rapidly expanding.[6] Notably, New York, Maine, and Washington have banned PFAS in children’s products, raising litigation risk for Johnson &amp; Johnson, as 14.5% of all children under 17 years wear contact lenses.[7] As health protection regulations on PFAS expand, the company faces escalating risks, including lawsuits.</p>
<p><strong>Shareholders Need Transparency to Assess Market Risk&nbsp;</strong></p>
<p>Johnson &amp; Johnson’s Health for Humanity Report pledges “to support a healthy environment and the resilience of our business, we focus our efforts ([on]…improving the environmental performance of our product portfolio [and] partnering to advance sustainable healthcare.”[8] Yet, the Company has not disclosed how it plans to address PFAS in its product portfolio.&nbsp;</p>
<p>The Company’s failure to address high PFAS presence in its products, including Acuvue contact lenses, may result in high environmental cleanup fees, export bans, insurability concerns, lawsuits, and, most significantly, harm to consumer and environmental health, disrupting the resilience of our Company’s business.&nbsp;</p>
<p>In a competitive marketplace increasingly demanding safe products and reduced harm to human and environmental health, shareholders seek information on how Johnson &amp; Johnson plans to manage and reduce the presence of PFAS in its products or otherwise mitigate mounting risks.</p>
<p><strong>BE IT RESOLVED</strong>: &nbsp;Shareholders request that Johnson &amp; Johnson issue a public report, at reasonable cost and omitting proprietary information, disclosing if and how the Company plans to manage the environmental and health risks associated with PFAS chemicals in its products.&nbsp;</p>
<p>[1] https://www.pfas.des.nh.gov/health-impacts&nbsp;</p>
<p>[2] https://mamavation.com/health/pfas-contact-lenses.html&nbsp;</p>
<p>[3] https://www.theguardian.com/environment/2023/may/09/contact-lenses-pfas-forever-chemicals&nbsp;</p>
<p>[4] https://www.wlf.org/2020/01/31/publishing/the-2020-outlook-for-pfas-chemical-litigation-an-expanding-target-zone/&nbsp;</p>
<p>[5] https://topclassactions.com/lawsuit-settlements/lawsuit-news/johnson-and-johnson-class-action-lawsuit-and-settlement-news/another-class-action-claims-band-aid-products-contain-pfas/&nbsp;</p>
<p>[6] https://www.saferstates.org/bill-tracker/?toxic_chemicals=PFAS&nbsp;</p>
<p>[7] https://www.optometrists.org/childrens-vision/guide-to-childrens-eye-exams/can-kids-wear-contact-lenses/&nbsp;</p>
<p>[8] https://healthforhumanityreport.jnj.com/2024/_assets/downloads/johnson-johnson-2024-health-for-humanity-report.pdf, p.28</p>

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<div class=”views-field views-field-nothing”><span class=”field-content”> Cailin Dendas</span></div><div class=”views-field views-field-title views-field-field-shareholder”><span class=”field-content”>As You Sow</span></div>
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Resolution Details

Company:

Johnson & Johnson

Year:

2025

Issue Area:

Health, Human Rights & Worker Rights

Focus Area:

Access & Affordability, Human Rights, Pharmaceutical Prices and Access

Status:

Filed

Resolution Text

            RESOLVED, that shareholders of Johnson & Johnson (“J&J”) urge the board of directors to oversee conduct of human rights due diligence (“HRDD”) to produce a human rights impact assessment (“HRIA”) covering J&J’s operations, activities, business relationships, and products related to access to medicines. The HRIA should be prepared at reasonable cost and omitting confidential and proprietary information and made available on J&J’s web site. The HRIA should describe actual and potential adverse human rights impacts identified; identify rightsholders that were consulted; and discuss whether and how the results of the HRIA will be integrated into J&J’s operations and decision making.

Supporting Statement

            J&J has adopted a Position on Human Rights (“Position”) in which it commits to “respecting internationally recognized human rights throughout [its] own operations and across [its] value chain.”[1]Article 12.1 of the International Covenant on Economic, Social, and Cultural Rights “recognize[s] the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.”[2]Access to medicines is a key element of the right to health. Target 3.8 of Sustainable Development Goal 3 assesses progress toward “access to safe, effective, quality and affordable essential medicines and vaccines for all.”[3]

 

The Position recognizes the salience of access to medicines. Specifically, J&J says it “aim[s] to advance sustainable and equitable patient access to medicines” and “strives to achieve broad and timely access to [its] medical products at sustainable prices that aim to be locally affordable.”[4]

 

J&J claims to “have due diligence processes and management systems in place across [its] business to identify and address potential and actual human rights impacts.”[5] But the specific HRDD examples J&J provides involve supplier human rights risks;[6] there is no indication that J&J has applied an HRDD process to its own operations, including pricing and access. Even as to supplier issues, J&J has not disclosed any HRIAs produced as a result of its HRDD. 

 

Some of J&J’s actions appear to undermine its commitment to the human right to health and access to medicines. Subsidiary Janssen sued to invalidate the Inflation Reduction Act’s (“IRA’s”) provision authorizing limited Medicare drug price negotiations.[7] A trade association to which J&J belongs[8] lobbied against the IRA,[9] contributed millions to defeat a California pricing measure,[10] and supported a group that fought to repeal Obamacare.[11]

 

J&J touts its ranking in the Access to Medicine Index (“AtMI”) as evidence of its commitment to access. The AtMI, however, only focuses on low- and middle-income countries (“LMICs”) and medicines for diseases that occur mainly in LMICs. Additionally, AtMI assesses “policies, plans and practices that should improve access to medicines” but not actual affordability.

 

Comprehensive HRDD that includes access to medicines would enable J&J to identify human rights impacts of its own operations, such as shortcomings in access programs and funding of harmful lobbying efforts.

 

 

[1]  https://www.jnj.com/about-jnj/policies-and-positions/our-position-on-human-rights, at 1

[2]   www.ohchr.org/en/instruments-mechanisms/instruments/international-covenant-economic-social-and-cultural-rights; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605313/

[3]  www.un.org/en/development/desa/population/migration/generalassembly/docs/globalcompact/A_RES_70_1_E.pdf

[4]  https://www.jnj.com/about-jnj/policies-and-positions/our-position-on-human-rights, at 6

[5]  https://www.jnj.com/about-jnj/policies-and-positions/our-position-on-human-rights, at 3

[6]  See https://healthforhumanityreport.jnj.com/2023/_assets/downloads/johnson-johnson-2023-health-for-humanity-report.pdf?h=Ka9OvM1t, at 40

[7]  https://www.biopharmadive.com/news/johnson-johnson-lawsuit-ira-drug-pricing-xarelto/688377/

[8]  https://s203.q4cdn.com/636242992/files/doc_downloads/Gov_Docs/PE/2022-trade-associations.pdf

[9]  https://www.mmitnetwork.com/aishealth/spotlight-on-market-access/pharma-spent-record-amount-on-lobbying-in-2022-pbms-are-now-in-spotlight-2/

[10]  https://www.npr.org/sections/health-shots/2017/12/18/571206699/in-election-year-drug-industry-spent-big-to-temper-talk-about-high-drug-prices

[11]  https://www.nytimes.com/2018/07/27/business/the-stealth-campaign-to-kill-off-obamacare.html

 

 

Resolution Details

Company:

Johnson & Johnson

Year:

2024

Issue Area:

Health

Focus Area:

Pharmaceutical Patents, Pharmaceutical Prices and Access

Status:

Filed

Resolution Text

RESOLVED, that Johnson & Johnson (“JNJ”) shareholders ask the Board of Directors to establish and report on a process by which the impact of extended patent exclusivities on product access would be considered in deciding whether to apply for secondary and tertiary patents. Secondary and tertiary patents are patents applied for after the main active ingredient/molecule patent(s) and which relate to the product. The report on the process should be prepared at reasonable cost, omitting confidential and proprietary information, and be made public.

SUPPORTING STATEMENT: Intellectual property protections on branded drugs play an important role in maintaining high prices and impeding access. When patent protection on a drug ends, generic manufacturers can enter the market, reducing prices. But branded drug manufacturers may try to delay generic competition by extending their exclusivity periods. 

In part because of this behavior access to medicines is the subject of consistent and widespread public debate in the U.S. A 2021 Rand Corporation analysis concluded that U.S. prices for branded drugs were nearly 3.5 times higher than prices in 32 OECD member countries.[1] The Kaiser Family Foundation has “consistently found prescription drug costs to be an important health policy area of public interest and public concern.”[2]

This high level of concern has driven policy responses. The Inflation Reduction Act empowers the federal government to negotiate some drug prices, and in fact some have argued it enacts significant patent reform, specifically around the issue this proposal seeks to understand. This comes from one important provision stating that the only drugs that can be considered for price negotiations are those with no generic competition, thus discouraging extended patent exclusivities.

One law firm asserts that “prevailing in a patent infringement lawsuit against a forthcoming competitor may no longer be as valuable for a branded drug company because high-expenditure single-source drugs are at risk of being selected for price negotiation if there is no generic or biosimilar competitor on the market.”[3]

Additionally, there are 5 U.S. Senate bipartisan bills all aimed at addressing this issue:

Ensuring Timely Access to Generics Act of 2023 (S. 1067)
Expanding Access to Low-Cost Generics Act of 2023 (S. 1114)
Increasing Transparency in Generic Drug Applications Act of 2023 (S. 775)
Preserve Access to Affordable Generics and Biosimilars Act of 2023 (S. 142)
Stop STALLING Act of 2023 (S. 148)

Specifically, JNJ sells Remicade, a biologic drug that treats inflammatory disorders. Although biosimilar competitors have now launched,[4] Remicade has been cited as an example of a patent thicket, with over 100 patents.[5] With AbbVie, JNJ jointly markets cancer treatment Imbruvica, which had 165 patent applications and 88 granted patents as of July 2020.[6] 

In our view, recent policy changes and reputational hits around bedaquiline availability[7] shows that a more thoughtful process could bolster JNJ’s reputation and help avoid regulatory blowback resulting from high drug prices and perceptions regarding abusive patenting practices.

[1]  https://www.rand.org/news/press/2021/01/28.html

[2]  https://www.kff.org/health-costs/poll-finding/public-opinion-on-prescription-drugs-and-their-prices/

[3] https://www.akingump.com/en/insights/alerts/the-impact-of-the-inflation-reduction-act-of-2022-on-pharmaceutical-innovation-patent-litigation-and-market-entry

[4]  See https://www.sec.gov/ix?doc=/Archives/edgar/data/0000200406/000020040622000022/jnj-20220102.htm, at 25.

[5]  See https://www.bloomberg.com/news/articles/2017-09-07/this-shield-of-patents-protects-the-world-s-best-selling-drug

[6]  http://www.i-mak.org/wp-content/uploads/2020/08/I-MAK-Imbruvica-Patent-Wall-2020-07-42F.pdf

[7] https://msfaccess.org/msf-calls-commitment-pharma-corporation-jj-not-enforce-extended-patents-lifesaving-tb-drug-main

 

Resolution Details

Company:

Johnson & Johnson

Year:

2023

Issue Area:

Health, Inclusiveness

Focus Area:

Access & Affordability, Racial Justice

Status:

Withdrawn for Agreement

Resolution Text

To combat systemic racism, corporations should recognize and remedy industry- and company-specific barriers to everyone’s full inclusion in societal and economic participation. Racial gaps cost the U.S. economy an estimated $16 trillion over the past twenty years.1 Closing the Black- and Hispanic-white wealth gaps could add 4-6% to U.S. GDP by 2028.2

More than one year after many companies made commitments to racial justice, the practical outcomes remain unclear. Fifty corporate pledges totaling $49.5 billion were characterized as falling short of addressing systemic racism after an August 2021 analysis.3 Shareholders lack independent assessments that racial equity strategies are impactful, address appropriate topics, and unlock growth.

Addressing systemic racism and its damaging economic costs demands more than a reliance on internal action and assessment. Audits engage companies in a process that internal actions alone may not replicate; unlocking hidden value and uncovering blind spots that companies may have to their own policies and practices. Company leaders are not diversity, equity, and inclusion experts and lack objectivity. Crucially, a racial justice audit examines the differentiated external impact a company has on minority communities.

Given the many companies across sectors embroiled in race-related controversies, any company without a comprehensive third-party audit and plan for improvement of its internal and external racial impacts could be at risk.4 Companies such as Facebook, Starbucks, Blackrock and Citi have committed to such audits, and practitioners have developed guidelines.5

Healthcare companies especially have a history with, and an ongoing struggle to address, disparate racial impacts.

We applaud the decision to discontinue sales of talcum-based powder worldwide in 2023. However, we are concerned that the structures that enabled the decisions that eventually led to nearly 40,000 plantiffs suing the company still remain. 

In addition, the recent criticism the company received for reportedly prioritizing export of COVID-19 vaccines from South Africa to wealthier nations over the fulfillment of its contract to distribute the vaccines locally, suggests a troubling blind spot.6

Resolved, shareholders urge the board of directors to oversee a third-party audit (within a reasonable time and at a reasonable cost) which assesses and produces recommendations for improving the racial impacts of its policies, practices and products, above and beyond legal and regulatory matters. Input from stakeholders, including civil rights organizations, employees, and customers, should be considered in determining the specific matters to be assessed. A report on the audit, prepared at reasonable cost and omitting confidential/proprietary information, should be published on the company’s website.

1 https://ir.citi.com/NvIUklHPilz14Hwd3oxqZBLMn1_XPqo5FrxsZD0x6hhil84ZxaxEuJUWmak51UHvYk75VKeHCMI%3D
2 https://www.mckinsey.com/industries/public-and-social-sector/our-insights/the-economic-impact-of-closing-the-racial-wealth-gap
3 https://philanthropynewsdigest.org/news/corporate-pledges-for-racial-justice-fall-short-analysis-finds
4 https://www.nytimes.com/2020/06/06/business/corporate-america-has-failed-black-america.html
5 https://www.bloomberg.com/news/articles/2021-08-05/how-aclu-veteran-laura-murphy-audited-facebook-s-race-problem?sref=cdlcj118 6 https://apnews.com/article/europe-africa-business-health-coronavirus-pandemic-b2797c07c6233c28bdd43827b55789bf

  

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Resolution Details

Company:

Johnson & Johnson

Year:

2023

Issue Area:

Health

Focus Area:

Access & Affordability, COVID-19/Coronavirus, Pharmaceutical Prices and Access

Status:

Vote

Vote Percentage:

31.80%


Johnson & Johnson Access to COVID-19 Products – Proxy Exempt Solicitation


Resolution Text

RESOLVED that shareholders of Johnson & Johnson (“JNJ”) ask the Board of Directors to report to shareholders, at reasonable expense and omitting confidential and proprietary information, on whether and how JNJ subsidiary Janssen’s receipt of government financial support for development and manufacture of vaccines and therapeutics for COVID-19 is being, or will be, taken into account when engaging in conduct that affects access to such products, such as setting prices.

SUPPORTING STATEMENT

COVID-19 continues to cause deaths, long-term health consequences and economic disruption for millions of people. Vaccines and therapeutics are essential tools to reduce mortality, and vaccines can reduce the emergence of more transmissible and vaccine-resistant variants.

Janssen received more than $2 billion in US government funding for COVID-19-related vaccine research, development and manufacturing.[1] The government also provided $152 million for Janssen and a partner to develop COVID-19 therapeutics.[2]

JNJ has been distributing its COVID-19 vaccine on a “nonprofit” basis, but that commitment is limited to “emergency pandemic use.”[3] JNJ has not clarified what “nonprofit” means when the government funds a portion of the research and development costs, nor what prices the company will charge and which access measures will be applied post-emergency pandemic if people continue to need vaccines and boosters. This Proposal asks JNJ to explain how the contribution from public entities affects its actions, including pricing determinations, that impact access to COVID-19 products.

JNJ’s approach to access to its vaccine has led to high profile public criticism, generating reputational risks for JNJ and its investors.[4] Shareholders should understand how JNJ is accounting for public funding in its current and future pricing strategies for its COVID-19 products to evaluate the reputational risks and understand company mitigation measures. The company’s reports do not explain how government funding was integrated into its access strategy. JNJ’s disclosures are insufficient to enable investors to gauge the material risks that JNJ could face for securing substantial public funding without commensurate policies and practices to promote broader and sustained vaccine access.

Refusing to voluntarily account for how public funding plays a role in JNJ’s access determinations also risks potential increased regulation and oversight. If the federal government cannot trust JNJ to voluntarily provide sustainable, equitable, and timely access to a vaccine benefiting from substantial public funding, the government may introduce rules and policies, including through future public funding agreements, that mandate how JNJ should commercialize relevant products. This effectively removes control and decision-making authority from the company. Policymakers are scrutinizing the role of public funding in medicine pricing and access strategies, and public funding is already a factor in how the US government will negotiate drug prices.[5] This could also lead to governments asserting greater control over other aspects of the industry’s business, including non-pandemic medical technologies, leading to long-term regulatory risks for company operations.

We urge shareholder to vote FOR this proposal.

[1] https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx

[2] https://www.reuters.com/article/health-coronavirus-usa-funding/factbox-u-s-pours-billions-into-development-of-coronavirus-vaccines-tests-idINL4N2D32T5

[3] https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic

[4] https://www.nytimes.com/2021/08/16/business/johnson-johnson-vaccine-africa-exported-europe.html; https://www.nytimes.com/2022/02/08/business/johnson-johnson-covid-vaccine.html

[5]https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%20APPENDIX%20v3.pdf; https://aspe.hhs.gov/sites/default/files/private/aspe-files/263451/2020-drug-pricing-report-congress-final.pdf; https://www.congress.gov/bill/117th-congress/house-bill/5376/text

  

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Resolution Details

Company:

Johnson & Johnson

Year:

2023

Issue Area:

Health

Focus Area:

Anti-Competitive Practices, Pharmaceutical Patents, Pharmaceutical Prices and Access

Status:

Vote

Vote Percentage:

14.42%


Johnson & Johnson Patents and Access – Proxy Exempt Solicitation


Resolution Text

RESOLVED, that shareholders of Johnson & Johnson (“JNJ”) ask the Board of Directors to establish and report on a process by which the impact of extended patent exclusivities on product access would be considered in deciding whether to apply for secondary and tertiary patents. Secondary and tertiary patents are patents applied for after the main active ingredient/molecule patent(s) and which relate to the product. The report on the process should be prepared at reasonable cost, omitting confidential and proprietary information, and published on JNJ’s website.

SUPPORTING STATEMENT: Access to medicines, especially costly specialty drugs, is the subject of consistent and widespread public debate in the U.S. A 2021 Rand Corporation analysis concluded that U.S. prices for branded drugs were nearly 3.5 times higher than prices in 32 OECD member countries.[1] The Kaiser Family Foundation has “consistently found prescription drug costs to be an important health policy area of public interest and public concern.”[2]

This high level of concern has driven policy responses. The Inflation Reduction Act empowers the federal government to negotiate some drug prices.[3] State measures, including drug price transparency legislation, copay caps, and Medicaid purchasing programs, have also been adopted.[4] The House Committee on Oversight and Reform (the “Committee”) launched a far-reaching investigation into drug pricing in January 2019.[5]

Intellectual property protections on branded drugs play an important role in maintaining high prices and impeding access. When patent protection on a drug ends, generic manufacturers can enter the market, reducing prices. But branded drug manufacturers may try to delay generic competition by extending their exclusivity periods.

Among the abuses described by the Committee’s December 2021 report is construction of a “patent thicket,” which consists of many “secondary patents covering the formulations, dosing, or methods of using, administering, or manufacturing a drug”; they are granted after the drug’s primary patent, covering its main active ingredient or molecule, has been granted.[6] In June 2022, citing the impact of patent thickets on drug prices, a bipartisan group of Senators urged the U.S. Patent and Trademark Office to “take regulatory steps to . . . eliminate large collections of patents on a single invention.”

JNJ sells Remicade, a branded biologic drug that treats inflammatory disorders. Although biosimilar competitors have now launched,[7] Remicade has been cited as an example of a patent thicket, with over 100 patents.[8] With AbbVie, JNJ jointly markets cancer treatment Imbruvica, which had 165 patent applications and 88 granted patents as of July 2020.[9]

In our view, a process that considers the impact of extended exclusivity periods on patient access would ensure that JNJ considers not only whether it can apply for secondary and tertiary patents but also whether it should do so. A more thoughtful process could, we believe, bolster JNJ’s reputation and help avoid regulatory blowback resulting from high drug prices and perceptions regarding abusive patenting practices.

[1]  https://www.rand.org/news/press/2021/01/28.html

[2]  https://www.kff.org/health-costs/poll-finding/public-opinion-on-prescription-drugs-and-their-prices/

[3]  https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/

[4]  https://www.americanprogress.org/article/state-policies-to-address-prescription-drug-affordability-across-the-supply-chain/

[5]  https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%20APPENDIX%20v3.pdf, at i.

[6]  https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%20APPENDIX%20v3.pdf, at 79.

[7]  See https://www.sec.gov/ix?doc=/Archives/edgar/data/0000200406/000020040622000022/jnj-20220102.htm, at 25.

[8]  See https://www.bloomberg.com/news/articles/2017-09-07/this-shield-of-patents-protects-the-world-s-best-selling-drug

[9]  http://www.i-mak.org/wp-content/uploads/2020/08/I-MAK-Imbruvica-Patent-Wall-2020-07-42F.pdf

  

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