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William Feldman

@wbfeldman.bsky.social
1.5K followers 232 following 29 posts

Lung & ICU doctor | Faculty @harvardmed & @PORTAL_Research | Ethics Co-Chair @BrighamWomens

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Reposted by William Feldman
The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · 30/04/2025
New on FirstView: "Patent Thickets and Product Hops: Challenges and Opportunities for Legislative Reform" by @wbfeldman.bsky.social explains the strategies pharmaceutical manufacturers use to limit generic competition — and how to overcome them. #GenericDrugs www.cambridge.org/core/journal...
Independent Article
Patent Thickets and Product Hops: Challenges and Opportunities for
Legislative Reform
William B. Feldman
Brigham and Women’s Hospital and Harvard Medical School
Abstract
Two key strategies that brand-name pharmaceutical manufacturers employ to limit generic competition are patent thickets and product hops.
The former strategy entails obtaining numerous patents on peripheral features of products (not just the active ingredients), and the latter
involves shifting active ingredients into reformulations with new patent protection that can extend periods of market exclusivity. These
strategies have become particularly problematic for drug-device combinations like inhalers and glucagon-like peptide-1 receptor agonists,
which contain pharmaceutical compounds that are sold together with their delivery devices. The Senate Judiciary Committee moved three
bipartisan bills out of committee during the last legislative session aimed at facilitating more timely generic competition. Although these bills
offer a valuable step forward, more is needed to limit the sort of patent gamesmanship that has become pervasive in the US pharmaceutical
industry. Such reforms should include routine reexamination by the US Patent and Trademark Office of patents submitted for listing with the
Food and Drug Administration (FDA), a greater role for the FDA in reviewing such listings, limits on the number of patents that brand-name
firms can assert when suing for infringement following patent challenges, stronger incentives for patent challenges, and more flexibility for the
FDA to approve complex generic drugs.
Keywords: patent thickets; product hops; inhaler; GLP-1 receptor agonist; Food and Drug Administration
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William Feldman @wbfeldman.bsky.social · 28/02/2025
So, even if you are unwilling to trade environmental benefit for cost, which I definitely get, the choice will not even exist in these types of cases, which is all very frustrating!
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William Feldman @wbfeldman.bsky.social · 28/02/2025
So there will only be the expensive version of Breztri (with longer patent protection and slower generic competition). And this will be bad for patients, much like the CFC-to-HFA transition.
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William Feldman @wbfeldman.bsky.social · 28/02/2025
Breztri is a good example. Will likely be the first MDI with a novel propellant in the US. AstraZeneca will pull the older version once the newer one is released for financial rather than regulatory reasons (with no ban on the horizon).
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William Feldman @wbfeldman.bsky.social · 28/02/2025
I hear you. I think keeping prices down is absolutely a priority--and sadly not where we are headed. The switch to novel propellants will be so lucrative for manufacturers and, in a some cases, there will be no lower-cost version that remains on the market.
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Reposted by William Feldman
Nick Hopkinson @copddoc.bsky.social · 22/02/2025
Key message here is that there is actually little conflict between good care and the environment. The most effective asthma care is also best for the environment. -reduces the need to use reliever medication -reduces the number of acute exacerbations www.nice.org.uk/news/article... #RespEd #LungSky
nice.org.uk
New joint guideline recommends prescribing combination treatments for people with newly diagnosed asthma
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William Feldman @wbfeldman.bsky.social · 22/02/2025
Thanks as ever to Gregg Furie for his work and collaboration on these issues.
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William Feldman @wbfeldman.bsky.social · 22/02/2025
But one thing is clear: Only structural reform, and not individual decisions by even committed physicians, can ensure that patients with chronic respiratory disease have access to safe, effective, sustainable, and affordable therapy.
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William Feldman @wbfeldman.bsky.social · 22/02/2025
There are no easy answers here. We discuss some policy solutions in the piece.
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William Feldman @wbfeldman.bsky.social · 22/02/2025
...Loss of product exclusivity through patent expiration currently poses a much greater risk to revenue than climate related risks.” As with the last propellant transition, patients may be caught in the middle.
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William Feldman @wbfeldman.bsky.social · 22/02/2025
Here’s how AsraZeneca described the financial upside it sees: “Transitioning to new low GWP propellants as part of our Ambition Zero Carbon strategy will mitigate the financial risks posed to our MDI-based respiratory portfolio (e.g. Symbicort)…
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William Feldman @wbfeldman.bsky.social · 22/02/2025
New low carbon-inhalers are now under development, but these will be expensive and may be on-patent into the 2030s/2040s. Manufacturers earned billions from the last propellant transition (CFCs to HFAs) and could earn even more during this next round.
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William Feldman @wbfeldman.bsky.social · 22/02/2025
Many also have links to the tobacco industry; Phillip Morris International purchased an inhaler manufacturer in 2020 despite uproar by physicians.
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William Feldman @wbfeldman.bsky.social · 22/02/2025
Metered-dose inhalers are potent greenhouse gas emitters. Dry powder inhalers are better for the environment but are not suitable for all patients and not always available on formularies.
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William Feldman @wbfeldman.bsky.social · 22/02/2025
Our latest in @nejm.org on the dilemmas of treating patients with chronic lung disease. www.nejm.org/doi/full/10....
nejm.org
The Moral Injury of Inhaler Prescribing | NEJM
Many inhalers that are vital for patients with asthma or COPD are associated with societal harms that can worsen the very diseases the products are designed to treat. How can this dilemma be resolved?
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Reposted by William Feldman
Aaron Mitchell @thewonkologist.bsky.social · 14/02/2025
Physicians who receive money from inhaler manufacturers prescribe more inhalers in the future. New findings from Hasan Nadeem, @wbfeldman.bsky.social &co: pubmed.ncbi.nlm.nih.gov/39937634/
pubmed.ncbi.nlm.nih.gov
Association Between Industry Payments and Prescription of Inhaled Medications - PubMed
Association Between Industry Payments and Prescription of Inhaled Medications
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Reposted by William Feldman
The Washington Post @washingtonpost.com · 10/02/2025
United Health Group’s pharmacy benefit manager, Optum Rx, stopped covering Cole Schmidtknecht’s “life-changing” inhaler, suit alleges.
washingtonpost.com
Man dies of asthma attack after inhaler cost skyrockets to more than $500
United Health Group’s pharmacy benefit manager, Optum Rx, stopped covering Cole Schmidtknecht’s ‘life-changing’ inhaler, suit alleges.
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Reposted by William Feldman
Program On Regulation, Therapeutics, And Law (PORTAL) @handle.invalid · 11/02/2025
🔎 New in JAMA IM: Avik Ray, @wbfeldman.bsky.social & colleagues assess the comparative effectiveness of diabetes drugs in COPD patients. They find GLP-1s & SGLT-2s are associated with lower risks of moderate or severe COPD exacerbations vs. DPP-4s during follow-up: jamanetwork.com/journals/jam...
Glucose-Lowering Medications and Risk of Chronic Obstructive Pulmonary Disease Exacerbations in Patients With Type 2 Diabetes, JAMA Internal Medicine.
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Reposted by William Feldman
Tahir Amin @tahiramin.bsky.social · 05/02/2025
Democrats can win back some of the public’s trust by building an agenda around game-changing ideas *if* they address systemic issues like patent abuse at their root, rather than continuing to settle for legislation that is watered down and incremental at best. 1/8 🔗 www.nytimes.com/2025/02/01/o...
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Reposted by William Feldman
Adam Raymakers @araymakers.bsky.social · 31/01/2025
🚨 Just out today (online)! 🚨 Our results show that a common argument against #QALYs (based on the use of subgroup analyses) is not justified with empirical data. With co-authors: @leah-rand.bsky.social , @wbfeldman.bsky.social, & @akesselheim.bsky.social from @portalresearch.org.
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Reposted by William Feldman
Dr Matt Sawyer Health, people & planet @healthpeopleplanet.bsky.social · 09/01/2025
Treating COPD with DPI triple therapy had slightly lower exacerbation rates than with MDI triple therapy (about 7-9% lower). Better for patients, better for planet! Mimms write up www.mims.co.uk/triple-inhal... and BMJ paper www.bmj.com/content/387/...
mims.co.uk
Triple inhalers in COPD: no outcome disadvantage with low-carbon option, study suggests
Patients using a triple combination dry powder inhaler had a slightly lower rate of COPD exacerbations than those using a high-carbon metered-dose inhaler, a retrospective study has found.
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 30/12/2024
Dry powder inhaler shows similar effectiveness and safety to metered-dose inhaler, w numerous implications including that environmentally-friendly prescribing in this case is also clinically equivalent -- led by @wbfeldman.bsky.social of @portalresearch.org in BMJ: www.bmj.com/content/387/...
bmj.com
Comparative effectiveness and safety of single inhaler triple therapies for chronic obstructive pulmonary disease: new user cohort study
Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler,...
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William Feldman @wbfeldman.bsky.social · 30/12/2024
Great to work on this piece with Samy Suissa, @akesselheim.bsky.social. Jerry Avorn, Max Russo, Sebastian Schneeweiss, and Shirley Wang. @portalresearch.org
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William Feldman @wbfeldman.bsky.social · 30/12/2024
Particularly given the added climate impact of metered-dose inhalers, health systems designing formularies and setting treatment guidelines may consider steps to increase use of fluticasone-umeclidinium-vilanterol relative to budesonide-glycopyrrolate-formoterol.
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William Feldman @wbfeldman.bsky.social · 30/12/2024
We found that budesonide-glycopyrrolate-formoterol was associated with a slightly higher incidence of moderate or severe COPD exacerbations compared to fluticasone-umeclidinium-vilanterol in patients with COPD treated in routine clinical care.
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William Feldman @wbfeldman.bsky.social · 30/12/2024
There are two single-inhaler triple therapies available in the US: one a metered-dose inhaler (budesonide-glycopyrrolate-formoterol, Breztri Aerosphere) and the other a dry powder inhaler (fluticasone-umeclidinium-vilanterol, Trelegy Ellipta).
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William Feldman @wbfeldman.bsky.social · 30/12/2024
By way of background: Metered-dose inhalers are associated with 20-times the greenhouse gas emissions as dry powder inhalers--with emissions in the US equivalent to roughly 550,000 cars on the road each year. www.commonwealthfund.org/blog/2023/hi...
commonwealthfund.org
A Hidden Contributor to Climate Change — Asthma Inhalers
The U.S. health care system could reduce emissions from asthma inhalers and mitigate their negative impact on population health.
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William Feldman @wbfeldman.bsky.social · 30/12/2024
I'm excited to share a new study out today in @bmj.com comparing the two single-inhaler triple therapies on the US market. Brief thread below! www.bmj.com/content/387/...
bmj.com
Comparative effectiveness and safety of single inhaler triple therapies for chronic obstructive pulmonary disease: new user cohort study
Objective To compare the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once daily dry powder inhaler,...
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 21/12/2024
Pre-holiday PPV: Fed Circuit in Teva v Amneal follows recommendation in amicus brief written by @wbfeldman.bsky.social and Sean Tu of @portalresearch.org, affirming delisting of improper inhaler patents from OB and helping promote timely generic competition: fedcircuitblog.com/wp-content/u...
fedcircuitblog.com
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William Feldman @wbfeldman.bsky.social · 20/12/2024
We filed an amicus brief in the case to underscore the problems of device-only patent listings. More info below. @akesselheim.bsky.social @seansst5.bsky.social t5.bsky.social @portalresearch.org www.linkedin.com/posts/willia...
linkedin.com
William Feldman, MD, DPhil, MPH on LinkedIn: Amicus Brief in Teva vs. Amneal
On Friday, we submitted an amicus brief in Teva vs. Amneal. Teva is suing Amneal for infringing its device-only patents on ProAir HFA (albuterol). This case…
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William Feldman @wbfeldman.bsky.social · 20/12/2024
Important win today for the generic drug industry and patients with asthma and COPD. The Federal Circuit ruled that Teva's patents on the delivery device of its ProAir HFA inhaler were impermissibly listed in the Orange Book. patentlyo.com/patent/2024/...
patentlyo.com
Orange Book Device Patent Listings: Understanding Teva v. Amneal
by Dennis Crouch In a major decision clarifying the scope of Orange Book patent listings, the Federal Circuit has ruled …
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 13/12/2024
The wrong ways and right ways to reform the FDA in the new administration - new in Health Affairs Forefront from me and Josh Sharfstein: www.healthaffairs.org/content/fore...
healthaffairs.org
Will The New Administration’s FDA Be A Threat Or An Opportunity For The Public's Health? | Health Affairs Forefront
As various reform ideas are proposed, the organized medical and scientific community will need to work with the new leadership at the FDA to promote positive change–and oppose initiatives that undermi...
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 02/12/2024
New Perspective in NEJM models the impact of recent proposals by USPTO and Congress to try to clear thickets of questionably innovative drug patents. Awesome graphics! With @portalresearch.org's Sean Tu, Bernard Chao, Ryan Whalen: www.nejm.org/doi/abs/10.1...
nejm.org
Clearing Dense Drug-Patent Thickets | NEJM
Proposed reforms from the U.S. Patent and Trademark Office and Congress could work in tandem to prevent patent thickets by targeting strategies that impede market entry of generic and biosimilar drugs.
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William Feldman @wbfeldman.bsky.social · 28/11/2024
Some really interesting bits here on med non-adherence and the pharmaceutical supply chain. Definitely worth a listen for the latest on what Amazon pharmacy is up to.
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William Feldman @wbfeldman.bsky.social · 26/11/2024
+1
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William Feldman @wbfeldman.bsky.social · 26/11/2024
Would be glad to join this group! I work on pharmaceutical pricing and patenting of asthma/COPD meds in the US.
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William Feldman @wbfeldman.bsky.social · 26/11/2024
+1
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Reposted by William Feldman
Program On Regulation, Therapeutics, And Law (PORTAL) @handle.invalid · 26/11/2024
New in JGIM: Dongzhe Hong & coauthors discuss the results of a physician survey on antibiotic prescribing preferences. They find clinicians prioritize clinical outcomes over other factors like patient cost or risk of antibiotic resistance in deciding which antibiotic to prescribe. #idsky
doi.org
National Survey of Factors Associated with Physician Antibiotic Prescribing Preferences - Journal of General Internal Medicine
Background The development of new infectious disease therapies has become a public health priority given the suboptimal efficacy and adverse effects with current drugs for some patients. Understanding...
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 26/11/2024
New from Dongzhe Hong, @wbfeldman.bsky.social, Metlay, Powers [@portalresearch.org]: Physicians considering new abx prioritize clear evidence of drug efficacy and safety over public health or econ factors like resistance or OOP costs: link.springer.com/article/10.1...
link.springer.com
National Survey of Factors Associated with Physician Antibiotic Prescribing Preferences - Journal of General Internal Medicine
Background The development of new infectious disease therapies has become a public health priority given the suboptimal efficacy and adverse effects with current drugs for some patients. Understanding...
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 26/11/2024
New JAMA Special Communication from @ojwouters.bsky.social, Sean Tu, Matt Vogel and @wbfeldman.bsky.social at @portalresearch.org: comparison of small molecule and biologic drugs show no clear rationale for greater legal protections for biologic drugs: jamanetwork.com/journals/jam...
jamanetwork.com
Legal Protections for Biologics vs Small-Molecule Drugs in the US
This Special Communication analyzes and compares development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment...
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William Feldman @wbfeldman.bsky.social · 25/11/2024
New paper out at @jamacurrent.bsky.social led by @ojwouters.bsky.social on the empirical assumptions underlying differential protection for biologics & small-molecule drugs. Upshot: We found no good evidence supporting differential treatment by FDA (or under IRA). jamanetwork.com/journals/jam...
jamanetwork.com
Legal Protections for Biologics vs Small-Molecule Drugs in the US
This Special Communication analyzes and compares development times, clinical trial success rates, research and development costs, patent protection, market exclusivity periods, revenues, and treatment...
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William Feldman @wbfeldman.bsky.social · 24/11/2024
@vinguptamd.bsky.social @colleenmfarrell.bsky.social @robyncohenmd.bsky.social @pedlungdoc.bsky.social
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William Feldman @wbfeldman.bsky.social · 21/11/2024
We are hiring new fellows and faculty in PORTAL. Please reach out if interested! And spread the word.
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Reposted by William Feldman
Ben Rome @benro.me · 21/11/2024
🎙️New NEJM audio interview recapping where we are with Medicare price negotiation and how to think about the results from the first 10 drugs. #healthpolicy #medsky @portalresearch.bsky.social www.nejm.org/do/10.1056/N...
nejm.org
Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act. | NEJM
Audio Interview from the New England Journal of Medicine — Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act.
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William Feldman @wbfeldman.bsky.social · 21/11/2024
I'm very much looking forward to serving on a panel at this event hosted by the FDA and Center for Research on Complex Generics focused on the transition to lower emission inhaler propellants. Registration still open! www.complexgenerics.org/education-tr...
complexgenerics.org
Navigating the Transition to Low Global Warming Potential Propellants - The Center for Research on Complex Generics (CRCG)
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG) In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop.
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 21/11/2024
Check out the new NEJM audio interview with @bnrome.bsky.social about the outcomes and future prospects of Medicare drug price negotiation under the Inflation Reduction Act after 1 year - from @portalresearch.bsky.social: www.nejm.org/do/10.1056/N...
nejm.org
Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act. | NEJM
Audio Interview from the New England Journal of Medicine — Interview with Benjamin Rome on the results of the initial round of drug-price negotiation under the Inflation Reduction Act.
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Reposted by William Feldman
Aaron Kesselheim @akesselheim.bsky.social · 19/11/2024
New from @portalresearch.bsky.social incl Dan Carpenter and @wbfeldman.bsky.social: Reviewing how political actors can undermine public vaccine confidence by studying case of COVID19 vaccine roll-out...and how effects can persist. See doi.org/10.1215/0361...
doi.org
Does Policy Uncertainty Boost Vaccine Hesitancy? Political Controversy, the FDA and COVID-19 Vaccine Hesitancy in Fall 2020 | Journal of Health Politics, Policy and Law | Duke University Press
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