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Public Citizen Comments to USPTO on Proposed Modifications to Rules of Practice for Patent Proceedings

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Comments from Public Citizen in Response to the U.S. Patent & Trademark Office’s Request for Comment on Patent Trial and Appeal Board Rules of Practice for Briefing Discretionary Denial Issues, and Rules for 325(d) Considerations, Instituting Parallel and Serial Petitions, and Termination Due to Settlement Agreement, No. PTO-P-2023-0048

Public Citizen is a consumer advocacy organization with more than 500,000 members and supporters and a fifty-year history protecting the public’s interest before federal agencies, Congress, and the courts. The Access to Medicines program advocates for access to prescription drugs in the United States and internationally. As such, we and our members have a strong interest in preserving and strengthening the accessibility and effectiveness of proceedings for challenging invalid patents at the Patent and Trial Appeal Board (PTAB).

The PTAB plays a critical role in the public’s ability to mitigate the harmful effects of invalid patents, particularly in the pharmaceutical sector. Evidence shows that the PTAB’s capacity to cancel wrongly granted patents helps combat inflated prescription drug prices in this country. Empirical research by Professor Charles Duan, a member of the Public Patent Advisory Committee, shows that IPRs leading to the cancellation of invalid pharmaceutical patents result in significant drug price reductions, generating financial savings and benefits to health and wellbeing.[1]

We write to express our strong support for the proposed regulations. These regulations represent a significant step towards a system that more fairly balances the public’s interest in eliminating invalid patents and industry concerns. By keeping the PTAB’s focus on the merits of a petition when deciding institution, these regulations align with Congress’s intent when it created these proceedings as well as efforts to address the drug pricing crisis today. If implemented effectively, they have the potential to contribute to making medicine more affordable for people who need it.

In particular, we wish to emphasize our support for aspects of the proposal that:

  1. Preserve the ability of “any person” to file a petition for review, as provided by the America Invents Act. (See 35 U.S.C. § 311(a)).
  2. Make a petition’s merits the primary factor in the PTAB’s decision to institute a proceeding.  (See Proposed 37 CFR § 42.108).
  3. Define serial petitions as petitions that challenge at least some of the same claims (instead of the same patent) as a previous challenge by the same patent owner (instead of any entity). (See Proposed 37 CFR § 42.2)
  4. Require that a joint motion for termination of a proceeding, filed before or after institution, must be accompanied by any written settlement agreement, which enhances transparency and oversight of unfair, anticompetitive practices in pre-institution settlement agreements. (See Proposed 37 CFR 42.74).

We commend the USPTO for the direction it has chosen in promulgating these regulations and look forward to engaging in the future on their implementation. Ensuring that PTAB proceedings remain accessible and effective supports innovation, competition, and public health. Thank you for your commitment to the patent system and your consideration of the public’s interest.

Sincerely,
Public Citizen

[1] Charles Duan, On the Appeal of Drug Patent Challenges, 72 Am. U. L. Rev. 1177, 1191-1207 (2023).

 

Protest of Cheniere Sabine Pass

By Tyson Slocum

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Sabine Pass—owned by Cheniere Energy and the private equity firms Blackstone Inc. and Brookfield Asset Management—applied for authorization to export an additional 899.46 billion cubic feet per year (Bcf/yr) of Liquified Natural Gas (LNG) from its Stage 5 expansion of its existing facility located at the Louisiana and Texas border. When added to its current capacity, Sabine Pass would have a total export capacity of 2,561.4 Bcf/yr.

The Cheniere/Blackstone/Brookfield request must be rejected as the additional requested export authorization threatens domestic supply shortages and will result in higher and more volatile domestic energy prices, and therefore is not in the public interest. Read the full filing here: SabinePass

Comments on New Jersey’s Proposed Rule on Sexual Misconduct Education and Prevention

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Public Citizen submitted comments supporting a proposed New Jersey rule for physician education about sexual misconduct prevention and patient right to an observer. We also called for improving the rule by (1) ensuring adequacy of educational programs, (2) extending patient right to a trained observer to all clinical encounters and mandating use of trained observers during sensitive examinations in all health care settings, (3) promoting independence of observers, (4) replacing use of board-mandated observers for abusive physicians with more effective measures to protect patients, and (5) educating patients about proper sensitive examination.

Comments at the FDA’s Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees

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In comments at the Food and Drug Administration’s (FDA’s) public meeting, “Optimizing FDA’s Use of and Processes for Advisory Committees,” Public Citizen urged the FDA to (1) maintain or perhaps even expand voting questions as a central feature of advisory committee meetings; (2) release publicly available briefly materials five to seven business days before the date of the advisory committee meeting, not, as is typically the case now, no later than two full business days before the meeting; and (3) reduce to zero, with rare exceptions, the number of voting members of advisory committees who are granted waivers to participate despite having an otherwise disqualifying financial interest.

Public Citizen Testimony to the Texas Senate Committee on Natural Resources & Economic Development

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To: Chairman Brian Birdwell and the Members of the Senate Committee on Natural Resources & Economic Development
CC: Sen. Judith Zaffirini, Sen. Carol Alvarado, Sen. César Blanco, Sen. Kelly Hancock, Sen. Bryan Hughes, Sen. Lois W. Kolkhorst, Sen. Borris L. Miles, Sen. Kevin Sparks 

Via hand delivery and by email. 

From: Adrian Shelley, Public Citizen
Re: Overcoming Federal Incompetence 

Dear Chairman Birdwell and Members of the Committee: 

Public Citizen appreciates the opportunity to offer this testimony. There are many examples of federal competence providing billions of dollars in health, safety, and environmental benefits to Texans. Perhaps the best example of a federal law, competently enacted with the cooperation of the states, yielding massive public health benefits, is the Clean Air Act. 

The Clean Air Act saves hundreds of thousands of lives. 

The Clean Air Act Amendments of 1990 have prevented hundreds of thousands of deaths and achieved a benefit-cost ration of 30-to-1.1 1 Houston went from having up to 200 high ozone days a year to only 20 or 30. 2023, the hottest year in recorded history, saw an increase in ozone days to 53.2 In Houston, when ozone increases from 70 to 90 ppb for just one day, heart attacks that day increase by 4% and asthma attacks increase that day by 21%?3 Houstonians and Texans in our other nonattainment areas need the continued cooperation of state and federal governments to save us from air pollution. 

 The new fine particulate matter (PM2.5) National Ambient Air Quality Standards will provide nationwide health benefits of up to 4,500 avoided premature deaths, 800,000 avoided cases of asthma symptoms, and 290,000 avoided lost workdays. By 2032 the net health benefits of the new fine PM standard will reach $46 billion, with a benefit/cost ratio of 77 to 1.4 Again, state and federal cooperation is needed to implement this standard. The health benefits for Texans will easily reach into the billions of dollars. For example, the public health costs of air pollution in Central Texas is estimated at $3.8 billion each year, with $3.3 of that caused by particulate matter.5

Extreme weather costs hundreds of lives and hundreds of billions of dollars. 

Texas is the most vulnerable state to extreme weather events, which includes hurricanes, floods, wildfires, droughts, and winter storms. 46 percent of all billion-dollar disasters in the United States have impacted Texas. That’s 179 of 387 events since 1980.6 Many of these extreme weather events are made more likely by climate change.7

 A few examples of extreme weather events that have impacted Texas are:  

Drought: the 2022 drought caused almost $8 billion in direct agricultural losses, including $2.1 billion among cotton farmers, and nearly $17 billion in total losses, according to the Comptroller’s office.8
Winter Storm Uri: caused at least 246 deaths9 and up to $130 billion in damages.10
Hurricane Harvey: more than 100 deaths, damage estimated at $150 – 180 billion.11
Wildfires: The Panhandle wildfires this February caused three deaths and more than $1 billion in damage.  

 Wildfires and Well Plugging 

The Panhandle Wildfires in February were the largest in Texas history.12 Losses from the Panhandle fires also included: 

  • More than one million acres burned 
  • Hundreds of water wells 
  • 15,000 cattle 
  • 138 homes 

The House Investigative Committee on the Panhandle Wildfires noted that these fires occurred outside of Texas traditional wildfire season.13 Unusually high temperatures, low humidity, and high winds were to blame. Although the House report doesn’t attribute these conditions to climate change—and indeed, does not mention climate change at all—the National Oceanographic and Atmospheric Administration does.14  

The investigative report identified decaying utility poles and neglected oil wells as the most common causes of wildfires. The report refers to the Railroad Commission’s oversight of marginal, or “stripper” wells as, “grossly deficient.”15

The Railroad Commission was able to double its annual well plugging target from 1,000 to 2,000 with more than $60 million per year in federal funding from the Infrastructure Investment and Jobs Act. The table below includes the well plugging allocation each fiscal year, the state contribution from Account 5155, and the federal allocation, which for 2024-2025 includes funding form the Bipartisan Infrastructure Act16 and the Infrastructure Investment and Jobs Act. 

Well Plugging in the Railroad Commission’s Budget17

Year  Allocation  Acct. 5155  Federal  Target 
FY 2020  $53,493,886  $77,260,636  $7,202,000  1,400 
FY 2021  $55,797,266  $77,817,750  $7,202,000  1,400 
FY 2022  $55,951,658  $59,021,334  $6,860,000  1,000 
FY 2023  $56,151,742  $59,989,019  $6,860,000  1,000 
FY 2024  $125,940,858  $77,728,084  $68,671,300  2,000 
FY 2025  $126,490,870  $71,170,183  $69,760,000  2,200 

 

Chemical Safety 

 The EPA’s Risk Management Program rule was finalized earlier this year. The rule brings much needed updates to the EPA’s chemical safety program18, including:18 

  • Requiring approximately 1,500 chemical plants across the country to evaluate safer technologies. 
  • Allowing the EPA to gather and share information about new, safer designs. 
  • Creating a publicly searchable database of information on RMP facilities. 

 Texas, and especially Houston, will benefit significantly from the rule. It’s been estimated that Houston experiences a chemical accident every six weeks.19 The table below lists some of the significant chemical incidents in Texas over the last decade.  

 

Significant Chemical Accidents in Texas 2013 – 20232020 

 

Date  Company  Event  Location  Casualties 
5/15/23  Marathon  Explosion   Galveston Co.  1 dead, 2 hospitalized 
5/5/23  Shell/Pemex   Deer Park Refinery Fire  Deer Park  9 injured 
9/29/22  NRG Energy  WA Parish chemical leak  Fort Bend  6 hospitalized,100 evaluated 
6/8/22  Freeport LNG  Explosion and 450 foot fireball  Freeport   
1/24/2020  Watson Manf.  Chemical plant explosion  north Houston  3 dead 
1/29/2020  Chesapeake  Oil well blow out  Burleson Co.  3 dead 
11/27/2019  TPC Group  Chemical plant explosion  Port Neches  50,000 evacuated 
7/31/2019  ExxonMobil  Fire  Baytown  66 workers injured  
4/2/2019  KMCO  Explosion and fire  Crosby  1 dead, 2 injured 
3/18/2019  ITC  3-day tank fire and chemical spill  Deer Park   
8/31/2017  Arkema  Chemical explosion in Harvey  Crosby   
11/15/2014  DuPont  Chemical leak  La Porte  4 killed 
4/17/2013  West Fertilizer  Fertilizer explosion  West  15 dead, 160-200 injured 

1 https://www.epa.gov/sites/default/files/2015-07/documents/factsheet.pdf
2 https://www.h-gac.com/getmedia/f8e31ae3-7305-4b9c-bfd6-b538139bd237/ITEM-2d-Regional-Air-Quality-Monitoring-October-2023
3 See Ensor, K. B., Raun, L. H. and Persse, D. (2013). A Case-Crossover Analysis of Out-of-Hospital Cardiac Arrest and Air Pollution. Circulation. V127, pp 1192-1199. http://www.ncbi.nlm.nih.gov/pubmed/23406673; Raun, L. H., Ensor, K. B. and Persse, D. (2014) Using community level strategies to reduce asthma attacks triggered by outdoor air pollution: a case crossover analysis. Environmental Health, 13:58. http://www.ehjournal.net/content/13/1/58 Raun, L. and Ensor, KB. 2012. Association of out-of-hospital cardiac arrest with exposure to fine particulate and ozone ambient air pollution from case-crossover analysis results: are the standards protective? James A. Baker III Institute for Public Policy of Rice University. http://bakerinstitute.org/files/594/.
4 https://www.epa.gov/newsreleases/epa-finalizes-stronger-standards-harmful-soot-pollution-significantly-increasing
5 See “CAC Meeting 8/12/2020 Item 6: Consider Participation in EPA’s Particulate Matter Advance Program” memo from Andrew Hoekzema, CAPCOG Director of Regional Planning and Services, to Clean Air Coalition Members (3 August, 2020).
6 https://www.ncei.noaa.gov/access/billion
7 https://www.noaa.gov/news-release/climate-attribution-tools-critical-for-understanding-extreme-events
8 https://www.texastribune.org/2024/06/06/texas-drought-crop-insurance-climate-change/
9 https://www.texastribune.org/2022/01/02/texas-winter-storm-final-death-toll-246/
10 https://www.chron.com/politics/article/Texas-winter-storm-freeze-deaths-financial-cost-16585329.php
11 https://fortune.com/2017/09/03/hurricane-harvey-damages-cost/
12 https://www.house.texas.gov/_media/pdf/committees/reports/88interim/House-Interim-Committee-on-The-Panhandle-Wildfires-Report.pdf
13 See p. 5, https://www.house.texas.gov/_media/pdf/committees/reports/88interim/House-Interim-Committee-on-The-Panhandle-Wildfires-Report.pdf
14 “Research has shown that climate change is likely causing the fire season to start earlier and extend longer. This is attributed to an increase in the number of hot and dry days throughout the year, conditions conducive to wildfires.” National Environmental Satellite, Data, and Information Service, NOAA (7 Mar 2024), https://www.nesdis.noaa.gov/news/fires-rage-across-texas-panhandle
15 See p. 18, https://www.house.texas.gov/_media/pdf/committees/reports/88interim/House-Interim-Committee-on-The-Panhandle-Wildfires-Report.pdf.
16 https://www.rrc.texas.gov/news/010323-federal-well-plugging-data-visualization/
17 General Appropriations Act 2024-2025, p. VI-52 (pdf p. 708), Railroad Commission Strategy C.2.1, p. VI_56, https://www.lbb.texas.gov/Documents/GAA/General_Appropriations_Act_2024_2025.pdf; General Appropriations Act 2022-2023, p. VI-49 (pdf p. 705), Railroad Commission Strategy C.2.1, https://www.lbb.texas.gov/Documents/GAA/General_Appropriations_Act_2022_2023.pdf; General Appropriations Act 2020-2021, p. VI-48 (pdf p. 702), Railroad Commission Strategy C.2.1, https://www.lbb.state.tx.us/Documents/GAA/General_Appropriations_Act_2020_2021.pdf.
18 https://www.houstonchronicle.com/opinion/outlook/article/crenshaw-chemical-risk-management-19399833.php
19 https://truthout.org/articles/houston-suffers-a-petrochemical-disaster-every-six-weeks/
20 https://www.tceq.texas.gov/response/shell-pemex-deer-park; https://www.click2houston.com/news/local/2022/09/29/2-employees-at-generating-station-in-critical-condition-following-chemical-leak/; https://www.bloomberg.com/news/articles/2022-07-12/freeport-lng-blast-created-450-feet-high-fireball-report-shows; https://en.wikipedia.org/wiki/2020_Houston_explosion; https://www.csb.gov/assets/1/6/watson_final_report_2023-06-29.pdf; https://www.thechemicalengineer.com/news/three-killed-in-texas-oil-well-blowout/; https://www.texastribune.org/2020/01/30/texas-plant-reported-increasing-rogue-emissions-explosion/; https://www.texastribune.org/2019/11/27/texas-plant-rocked-explosions-mandatory-evacuations-ordered/; https://www.beaumontenterprise.com/news/article/Report-cites-TPC-Group-for-unauthorized-butadiene-14914367.php; https://www.beaumontenterprise.com/news/article/EXCLUSIVE-Communications-after-TPC-Group-blast-15078676.php; https://www.wsj.com/articles/large-fire-breaks-out-at-exxons-baytown-plant-in-texas-11564594125; https://www.houstonpublicmedia.org/articles/news/2019/04/03/327691/kmco-fire-raises-legal-safety-questions/; https://www.houstonchronicle.com/news/houston-texas/houston/article/New-fire-erupts-at-Deer-Park-plant-as-leaking-13710439.php; https://www.houstonchronicle.com/news/houston-texas/article/dupont-la-porte-leak-deaths-fined-sixteen-million-17915839.php; https://en.wikipedia.org/wiki/West_Fertilizer_Company_explosion

Public Citizen Testimony on Bitcoin Mining to the Texas Senate Committee on Business and Commerce

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The following was delivered to the Texas Senate Committee on Business and Commerce by Adrian Shelley, Texas director of Public Citizen.

Viewpoint in JAMA Internal Medicine: Less Care at Higher Cost-The Medicare Advantage Paradox

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According to a new analysis, published June 10, 2024 in JAMA Internal Medicine, privatized Medicare Advantage plans have raised Medicare’s costs by $612 billion since 2007, including $82 billion in 2023 alone.

The authors are physicians affiliated with Harvard Medical School, the City University of New York’s Hunter College, and Public Citizen’s Health Research Group.

See the article.

See the press release.

Testimony Before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee Regarding Donanemab for the Treatment of Alzheimer’s Disease

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In testimony before the Food and Drug Administration’s (FDA’s) Peripheral and Central Nervous System Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve donanemab for the treatment of Alzheimer’s Disease because the evidence for the drug’s benefits does not outweigh its significant risks.

Letter to OpenAI Urging the Suspension of Voice Mode

By Rick Claypool and Robert Weissman

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Dear Sam Altman and Mira Murati,

We are writing to urge you to suspend indefinitely OpenAI’s Voice Mode feature.

As OpenAI surely knows, there is extensive research suggesting the risks of serious harm that come with deceptive anthropomorphic design. In fully embracing AI anthropomorphism, we believe you are undertaking a reckless social experiment and risking widespread injury.

Your rush to disseminate this technology is dangerous, unnecessary, and inconsistent with OpenAI’s purported priority in advancing AI safety.

Based on the product demonstration, Voice Mode may be the most extreme example of AI anthropomorphism in existence. From the demonstration, we note your characterization of the model’s ability as “intelligence,” the human-sounding voice, the demonstrated ability of the voice to display what appears to be emotion, the apparent empathy and expressiveness displayed by the voice, and the casual and colloquial nature of the voice. Everything about Voice Mode seems designed to lure users into feeling like they are interacting with a genuine human.

While the technology and its human-seemingness are undoubtedly impressive, it is precisely that human-like design which creates such risk. AI systems that employ deceptively human-like design carry unique and substantial risks of injury and harm, as such systems can be used to impersonate real people, manipulate consumer choices, invade user privacy, and induce unearned trust. The technology poses these unprecedented risks to users in general, and vulnerable users in particular.

We’re obviously in the early days of convincingly anthropomorphic AI, but there’s already an abundance of evidence that screams: Halt.

  • Unfair business practices: The Federal Trade Commission (FTC) has warned about businesses employing unfair anthropomorphic design strategies to deceive and manipulate users. Referencing anthropomorphic designs that are far less human-seeming than ChatGPT’s Voice Mode, the FTC warns of chatbots that are “effectively built to persuade and are designed to answer queries in confident language even when those answers are fictional. A tendency to trust the output of these tools also comes in part from ‘automation bias,’ whereby people may be unduly trusting of answers from machines which may seem neutral or impartial. It also comes from the effect of anthropomorphism, which may lead people to trust chatbots more when designed, say, to use personal pronouns and emojis. People could easily be led to think that they’re conversing with something that understands them and is on their side.”
  • Privacy violations: Businesses that succeed in using human-like AI design to induce unearned trust – based on the emotional attachment to the AI and sense of the AI as a social actor, rather than its trustworthiness as a tool – can deceptively exploit this trust in order to invade user privacy. Marketing research going back decades shows that users are likelier to divulge personal information to a chatbot if they feel it is also sharing information about itself. More recent market research is explicitly focused on improving human-like chatbot design in order to induce increased personal disclosures from consumers, including by making a chatbot appear to have a gender in order to induce connections with consumers. Additional research also shows that users are more willing to share personal information with a conversational AI system when speaking out loud than they are when typing, and that adding linguistic signals that mimic a person engaging in active listening encourages users to divulge even more.
  • Emotional dependence: Voice Mode’s anthropomorphism is likely to lead users to develop deep, emotional attachments. Less sophisticated AI technologies have already induced such relationships, in ways that are often problematic. Google DeepMind researchers point out that “the emotions users feel towards their assistants could potentially be exploited to manipulate or – at the extreme – coerce them to believe, choose or do something they would have not otherwise believed, chosen or done.” Emotional dependence may “interfere with users’ behaviours, interests, preferences, beliefs and values.”

These and related issues – such as enabling the more effective spread of disinformation – are neither minor nor ancillary concerns. They are likely to be serious and pervasive, causing widespread injury, and they follow directly from the human-like design of Voice Mode.

There are other, even more profound risks, many highlighted in the important Google DeepMind paper. These include fundamentally degrading human-human relationships, undermining humans’ ability to accept different points of view and severely worsening social atomization, and deepening social dissatisfaction. The extent to which these risks will be realized is, to be sure, much more uncertain than the dangers we highlighted above. But no one who has lived through the changes wrought by social media should doubt that such deep and troubling hazards are plausible and extremely difficult to reverse or mitigate. More than any other, a firm such as OpenAI – which touts its commitment to safety and alignment – should take seriously these threats and not rush them into widespread use.

We acknowledge that your safety note on Voice Mode states that “we recognize that GPT-4o’s audio modalities present a variety of novel risks” and that your system card will provide greater details on your safety testing. But nothing in what we’ve seen suggests your safety testing and outside review grapples adequately with the enormous risks Voice Mode presents. Given the stakes, we find it impossible to believe that internal testing, with limited external review, can possibly justify the massive social experiment you are poised to inflict on society.

It is noteworthy that Google – a for-profit company that is not governed by a non-profit with a safety and alignment mandate – affirmatively decided not to adopt anthropomorphic voices for its AI assistant.

However, if OpenAI’s Voice Mode gains traction and popularity, it will be difficult for Google and the handful of other leading AI companies not to risk competitive disadvantage and not also adopt human-sounding voices and an anthropomorphic approach to its AI assistant.

There’s still time to put this genie back in the bottle, but not for long. We urge you to suspend Voice Mode and the use of human-sounding voices and attributes for ChatGPT; to reassess future design choices in light of potential harms; and to pledge not to release anthropomorphic AI systems, at least not before there has been extensive and public testing, review and debate of the potential consequences, and conclusive evidence that consequential social harm can be avoided.

Sincerely,

 

Robert Weissman

President

 

Rick Claypool

Research Director, President’s Office

Comment regarding the FDA’s draft guidance on developing treatments for early Alzheimer’s disease

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In this comment to the Federal Register, Public Citizen expresses concern about the FDA’s draft guidance for developing drugs for early Alzheimer’s disease because the proposed definition of early Alzheimer’s disease and the reliance on biomarkers as both a diagnostic tool and a measure of benefit. Moreover, the proposed criteria for the duration of clinical trials and the selection of clinical endpoints are concerning.