Podcasts about hatch waxman act

This Day in Legal History: Corporations Are “Persons” Under 14th AmendmentOn May 10, 1886, the U.S. Supreme Court delivered a landmark decision in the case of Santa Clara County v. Southern Pacific Railroad Company, fundamentally altering the legal landscape for corporations in the United States. This ruling established that corporations were to be considered "persons" under the Fourteenth Amendment and were thus entitled to equal protection rights under state law. The decision arose from a dispute involving Santa Clara County and the Southern Pacific Railroad, which contested certain tax assessments on the grounds that they were discriminatory against the corporation.The Supreme Court, without directly addressing the issue in the oral argument or written opinion, allowed the notion that corporations were persons for the purpose of the Fourteenth Amendment to stand, based on a headnote by the court reporter, which was not part of the official opinion. This headnote indicated that the Chief Justice had acknowledged corporate personhood in relation to the amendment during the proceedings. Although it did not form part of the decision, this assertion guided future interpretations of corporate rights in the U.S.As a result, the ruling provided corporations with expanded protections that had originally been intended to protect the rights of former slaves. Over time, this interpretation has been used to defend corporations in various legal battles, granting them rights comparable to those of individual citizens in many respects. This includes the right to a trial by jury, the right to protection from unreasonable searches and seizures, and the right to free speech.The implications of the Santa Clara decision have been far-reaching and controversial. Critics argue that it has led to an excessive amount of power being held by corporations, influencing political processes and public policy disproportionately. Supporters, however, see the ruling as essential for ensuring that businesses can operate on a level playing field, free from unfair government interference.The Santa Clara case remains a pivotal point in legal history, frequently cited in discussions about the balance between corporate power and public control. It opened the door to subsequent legal challenges and rulings that continue to shape the interaction between corporations, individuals, and the government in the United States. The ongoing debates surrounding corporate influence in politics and society trace back to this seminal Supreme Court decision, underscoring its significance in American legal history.The Biden administration is considering a proposal by Knowledge Ecology International (KEI) and other groups to use U.S. Code § 1498 to seize patents for the cancer drug Xtandi, manufactured by Astellas Pharma, without paying royalties. This move, aimed at reducing the drug's cost, represents a more aggressive stance toward pharmaceutical pricing, leveraging the government's legal abilities to override private patents under specific conditions. Xtandi, costing over $14,000 monthly for uninsured patients, has been a focal point in debates over drug prices. The proposal suggests that because Xtandi was developed with government grants, existing laws provide a mechanism for the government to authorize generic production without compensating the patent holder. Critics, including former US Patent and Trademark Office head Andrei Iancu, argue that this interpretation distorts patent laws and undermines the Hatch-Waxman Act, which regulates drug patent exclusivities and generic entry. Despite skepticism about the administration adopting this aggressive approach, proponents see it as a viable strategy to control drug prices and alter pharmaceutical company behaviors without the need for compensation, sparking a significant legal and ethical debate on the extent of government intervention in private industry.Cancer Drug Price-Cutting Pitch Mulled by HHS as Industry WaitsThe Biden administration and several civil rights groups, including the ACLU, have filed lawsuits against the state of Iowa to challenge a new law, S.F. 2340, which authorizes the arrest and prosecution of individuals who re-enter the U.S. after deportation. The law, signed by Iowa Governor Kim Reynolds, makes "illegal reentry" into Iowa a criminal offense punishable by up to two years in prison and permits state judges to order deported individuals to return to their home countries. Both the federal government and civil rights organizations argue that this state law unlawfully conflicts with federal immigration law and its established procedures for handling illegal entries and deportations. This Iowa law also fails to exempt individuals with legal status in the U.S., such as asylum seekers and visa holders. This move by Iowa reflects a broader trend among Republican-led states, influenced by similar laws in Texas and recently Oklahoma, aiming to enforce immigration laws due to perceived inaction by the federal government on illegal border crossings. A U.S. appeals court recently blocked a similar law in Texas, citing its inconsistency with federal jurisdiction over immigration matters.Biden administration, civil groups sue Iowa over immigrant arrest law | ReutersElon Musk may be required to provide additional testimony in the SEC's investigation into his $44 billion acquisition of Twitter. During a court hearing in San Francisco, U.S. District Judge Jacqueline Scott Corley considered the SEC's request to compel Musk to testify, following another judge's earlier ruling in favor of the agency. The SEC is investigating whether Musk violated federal securities laws during his 2022 purchase of Twitter, now renamed X, particularly concerning his stock purchases and related public statements and filings. Musk had previously participated in the investigation via two videoconference sessions and had provided documents. His legal representation argued that further testimony would impose an undue burden on him, given his responsibilities to multiple companies. The judge questioned the argument that Musk's busy schedule should exempt him from compliance with securities laws. This legal battle is part of an ongoing feud between Musk and the SEC that dates back to a 2018 incident where Musk tweeted about having funding secured to take Tesla private.Elon Musk may be compelled to testify again in SEC's Twitter takeover probe | ReutersThe American Bar Association (ABA) is considering endorsing alternative pathways to lawyer licensing that do not involve passing the traditional bar exam, signaling a significant shift from its longstanding pro-exam stance. This reconsideration is spurred by a task force formed to evaluate the ABA's existing policies, which since 1921 have primarily supported the bar exam as a requisite for legal practice. The draft policy, set for discussion on May 17, encourages states to develop diverse licensing methods. This change comes in response to actions by states like Oregon and Washington, which have already implemented alternatives such as apprenticeships and skills coursework to bypass the bar exam. The ABA's move aligns with efforts to address racial and socioeconomic disparities in bar exam pass rates, which show significantly lower success rates among minority test takers. The National Conference of Bar Examiners acknowledges the ABA's new direction as it prepares to launch a revised bar exam in 2026, highlighting the ongoing evolution in standards for entering the legal profession.Bar exam alternatives, long out of favor with ABA, make inroads | ReutersThe U.S. Federal Energy Regulatory Commission (FERC) is set to finalize two significant rules aimed at enhancing the planning and funding mechanisms for long-distance electric transmission lines. These rules are designed to facilitate the development of a more robust national power grid and address the increasing demand driven by renewable energy sources and electric vehicles. The first rule mandates regional grid planners to develop at least 20-year plans that consider a broad range of benefits, updating the less effective 2011 guidelines. The second rule potentially allows FERC to issue permits for transmission lines even if they are denied by states, focusing on national interest corridors identified by the Department of Energy.The proposed rules have sparked concerns regarding the traditional role of state regulators in siting and permitting transmission lines and the potential sidelining of competitive bidding processes, which some argue could increase costs and project delays. However, proponents argue that the new rules will facilitate much-needed investment in the transmission infrastructure necessary to meet future energy demands and reduce longstanding disparities in regional transmission capabilities. The discussion is also heavily centered around equitable cost allocation, aiming to distribute costs in alignment with the derived benefits, a topic that has historically been contentious and frequently litigated. These regulatory changes are occurring amidst broader administrative efforts to modernize and expand the U.S. electric grid to support a clean energy future.Transmission Rules to Back Planning of Long-Range Power LinesThis week's closing theme is by Bedřich Smetana.Bedřich Smetana, a towering figure in Czech music, stands as one of the pioneering composers of the 19th century, especially noted for his development of a distinctly Czech musical style. Born on March 2, 1824, in Litomyšl, now part of the Czech Republic, Smetana was a child prodigy in both violin and piano. He grew up immersed in a rich cultural atmosphere that fueled his passion for music, leading him to compose from an early age.His early career was marked by the struggle for recognition, balancing a desire to compose with the need to earn a living as a teacher and conductor. Despite these challenges, Smetana's nationalist spirit found expression in his music, which often incorporated Czech folk themes and stories. By the 1860s, he had established himself as a central figure in Prague's musical life, becoming the principal conductor of the Provisional Theatre, where he championed the cause of Czech music.Smetana's personal life, however, was fraught with tragedy. He suffered the loss of his beloved wife and some of his daughters, and later, he was struck with deafness. Yet, these personal hardships only deepened the emotional depth of his compositions. One of his most famous works, "Má vlast" ("My Country"), is a cycle of six symphonic poems that celebrates the Czech landscape, history, and legends.Among these poems, "Vltava" (known in German as "Die Moldau") is perhaps the most internationally celebrated. It beautifully captures the course of the Vltava River as it flows through the Bohemian countryside, underlining Smetana's mastery of orchestral color and melodic contour. This piece serves as a vivid sonic portrait of the Czech landscape, intertwining folk music with the river's thematic journey through the countryside.Today, as we conclude our week, we turn to this poignant piece from Bedřich Smetana's "Má vlast." Without further ado, "Vltava," or "The Moldau," from Bedřich Smetana's symphonic poems "Má vlast" or "My Country." Get full access to Minimum Competence - Daily Legal News Podcast at www.minimumcomp.com/subscribe

The 1984 Hatch-Waxman Act codified the 505(b)(2) drug approval pathway and allowed the use of studies from a previously approved drug. To be clear, medications approved via this pathway are not generic molecules of the reference listed drug. They may have similar clinical effects and roles in therapy, but they also bring challenges. Dr. Tyler Wood, System Director of Pharmacy Oncology and Biosimilars, and Pharmacy Executive Director, Carolyn Liptak at Vizient, join Gretchen Brummel, Pharmacy Executive Director in the Vizient Center for Pharmacy Practice Excellence and your program host to give an early look.   Guest speakers:  Tyler Wood, PharmD, BCBBS System Director, Pharmacy Oncology and Biosimilars  Providence St. Joseph Health Carolyn Liptak, MBA, BSPharm Pharmacy Executive Director  Vizient    Host:  Gretchen Brummel, PharmD, BCPS  Pharmacy Executive Director  Vizient Center for Pharmacy Practice Excellence    Show Notes:  [00:55-01:34] Dr. Tyler Wood background information  [01:35-03:09] How the 505(b)(2) pathway is intended to work [03:10-04:32] Comparisons can we draw from the biologics approval process [04:33-05:53] What the FDA says about which pathway to use [05:54-07:05] What's changed recently in the approval process [07:06-08:09] Can a 505(b)(2) product be rated as a generic equivalent? [08:10 -09:07] How CMS changes are impacting management [09:08-11:23] What our providers can do to plan and act to address these issues [11:24-12:27] What's most concerning moving forward   Links | Resources:  Applications Covered by 505(b)(2) Hospital Outpatient Prospective Payment System: January 2024 Update MLN Matters® Articles Sign-up CMS.gov ASP Pricing Files CMS.gov What's a MAC Drugs@FDA: FDA-Approved Drugs FDA: Overview of the 505(b)(2) Regulatory Pathway for New Drug Applications HCPCS Level II Coding for 505(b)(2)-Approved Drugs or Biologicals – Frequently Asked Questions   Subscribe Today! Apple Podcasts Amazon Podcasts Google Podcasts Spotify Android RSS Feed  

This week on Second Request, the Hatch-Waxman Act of 1984 laid out a pathway for generic drugs to come to market as patent protections for brand name drugs expire. But brand-name producers have found a way to stave off competition: paying generic producers to delay market entry of their cheaper drugs.

In Hatch-Waxman cases, where is the act of infringement committed, and who commits it? Allison Schmitt (BCLT) and Seth Lloyd (MoFo) discuss the Celgene v. Mylan decision (17 F.4th 1111 (Fed. Cir. 2021)). Featuring Seth Lloyd. SPEAKERS Seth Lloyd, Allison Schmitt Allison Schmitt 00:00 Hello all and welcome to the Berkeley Center for Law and Technology's Expert Series podcast. My name is Allison Schmitt and I'm the director of the Life Sciences Program at BCLT. So today Seth Lloyd from Morrison and Foerster is joining us for our podcast series Beyond the Holding a nuanced look at the Federal Circuit's patents decisions. Thanks so much for joining us, Seth. Happy to have you back. Seth Lloyd 00:20 Yeah, thanks. Awesome. Allison Schmitt 00:22 So today we're going to discuss the November 5th Celgene v. Mylan decision that came down from the Federal Circuit. There's a number of issues to unpack here related to venue and pleading standards. And Seth is going to walk us through all of it. But before we dig into the substance of the decision itself, Celgene discusses a type of case that's different from most of the other cases that we've previously discussed on the podcast. So Celgene arose under the Hatch Waxman Act, which is a complex statutory framework created by Congress, with the goal of streamlining approval of generic drug products in the United States, and creating a framework for the patent challenges to the brand side company's patents prior to marketing the generic drug. So Seth, can you walk us through the background of how these Hatch Waxman cases work so that our listeners can get a sense of how these might be different from the typical patent cases that they're thinking about? Seth Lloyd 01:10 Yeah, I'll give it my best shot. You weren't exaggerating when you said complex, it is a complex statutory framework. But I think there are a few key points to understand for today's case. So in general, as you said, when a completely new drug is coming to market, the party files a new drug application or an NDA, with the Food and Drug Administration. And to get an NDA approved, there's a long process. The parties have to go through clinical studies and and go through several rounds, usually with the FDA to get approval, that tends to be a very lengthy and costly process. And so the Hatch Waxman Act was designed to allow quicker approval for kind of the follow on, so parties who want to market a generic form. So basically the same pharmaceutical formula. But without going through that lengthy process. And what the Hatch Waxman Act allows them to do is to submit an abbreviated new drug application, or an ANDA, as people in the industry call it. And with the ANDA they don't have to submit all the do new clinical trials and submit new data from clinical studies. Instead, they can simply show prove to the FDA that their drug is bio equivalent to an approved drug, it's the same formula, and they can get approval much quicker and with less cost. The part that's going to be relevant to our case today is how does this all work with patents because often, if somebody's come up with a new drug, they've patented the formula or they've patented a new method for using that drug. And so the new drug applicant, that NDA filer will also tell the FDA about any of those patents that covered the drug, or methods of using it, and they'll list those patents in what's called the orange book. Now, later, the company that wants to market the generic version comes along, they have to tell the FDA, what they intend to do with regard to any patents listed in the orange book. They have

Dr. Dean Fanelli advises chemical, pharmaceutical and biotechnology companies on patent portfolio creation and management, counseling, technology transactions, due diligence, and opinion work, including drafting novelty, freedom-to-operate and invalidity opinions. He regularly handles IP issues relating to mergers and acquisitions, including corporate governance and setup, drafting and negotiating asset purchase agreements, licensing agreements, shareholder rights agreements and financing for life sciences companies. Dean also has experience in patent litigation under the Hatch-Waxman Act, developing Paragraph IV litigation strategies as well as biosimilar market and patent assessments.To learn more about Dean visit: www.cooley.com#CivilDiscourse #Conversation #Solutions #ToddFurniss #TFIP #Author #Speaker #Expert #TheSixtyPercentSolution #Ideas #Empathy #Perspective #CommonGround #Society #Business #UnitedStates #Access #Education #Competition #Consumer #Provider #Doctor #Dean #Fanelli #Medicine #Future

To learn more about the Hatch-Waxman Act, click here. To learn more about how biosimilars compare with the generics market, click here. To learn more about the challenges that both the biosimilars and generic markets face, click here.

It’s no secret that the US biosimilar industry has had a slow start in terms of uptake, but much of that setback is due to barriers caused by originator manufacturers taking advantage of current legislation. Although, the Hatch-Waxman Act and the Biologic Price Competition and Innovation Act (BPCIA) established pathways to approval for both generic drugs and biosimilars, there is still much legislative work to be done in order to truly reap the benefits of biosimilars.   We sat down with April Breyer Menon, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago, Illinois, to discuss potential legislation such as The Hatch-Waxman Integrity Act and the Stop Stalling Act that would address barriers to biosimilar market entry.

In this episode, Katherine Eban, investigative journalist and author of Bottle of Lies, illuminates the prevalence of fraud in generic drug manufacturing which brings into question the idea that generics are identical to brand-name drug as we are lead to believe. Katherine walks us through how this widespread corruption came to be, including the shocking story of one particularly egregious (and unfortunately not uncommon) example of an Indian drug company, Ranbaxy, whose business model was completely dependent on falsifying data in their drug applications to the FDA. We then discuss the subsequent investigation into Indian and Chinese drug manufacturing plants which revealed that nearly 80% of them are tainted with fraud. We conclude this discussion on a positive note with i) how individuals can investigate their own drugs to protect themselves ii) an innovative pharmacy attempting to disrupt the market and iii) some ideas on how to reform to the regulations around generic drugs, the FDA, and more.   We discuss: How Peter found Katherine’s book, and what convinced her to investigate the generic drug industry [5:45]; Branded vs. generic drugs: Why they aren’t the same thing [11:15]; The Food and Drug Administration: Why it was originally created and what it does today [20:45]; How the generic drug industry really got its start in the U.S., and the flaw of the Hatch-Waxman Act [28:20]; PEPFAR: How a well-intentioned plan to help Africa with the AIDS epidemic laid the groundwork for corruption [36:30]; The story of Ranbaxy: An Indian drug company whose business model was fraud and deceit [40:45]; How the FDA approves drugs, the impact of “first to file”, and Peter’s tangent on moral corruption [47:30]; A booming generic drug market and the FDA struggling to keep up [57:15]; Dinesh’s internal investigation finds widespread fraud and falsified data inside Ranbaxy [1:00:15]; Presenting the famous SAR document to Ranbaxy’s board of directors which spells out the company-wide fraud [1:09:15]; Dinesh blows the whistle on Ranbaxy which leads to a raid on their US plant [1:19:45]; Formal investigation of Ranbaxy is launched, but the FDA keeps approving Ranbaxy drug applications [1:33:30]; What role does the culture in India play in the high prevalence of fraud in the drug industry? [1:41:00]; The extreme prevalence of data fraud/manipulation in foreign generic drug factories [1:52:30]; Concluding the Ranbaxy story [2:06:15]; How concerned should you be when buying a generic drug from your local pharmacy? [2:11:15]; How to investigate your own drugs for quality to ensure you are getting what you need [2:18:30]; An innovative pharmacy that tests all its drugs for quality [2:24:45]; Reforming the FDA and generic drug industry: Why we need reform and ideas on how to do it [2:27:45]; The importance of taking individual ownership and not waiting for Congress to bail us out [2:34:00]; Closing thoughts from Katherine [2:36:50]; and More. Learn more: https://peterattiamd.com/ Show notes page for this episode: https://peterattiamd.com/katherineeban/ Subscribe to receive exclusive subscriber-only content: https://peterattiamd.com/subscribe/ Sign up to receive Peter's email newsletter: https://peterattiamd.com/newsletter/ Connect with Peter on Facebook | Twitter | Instagram.

You will exactly what the Hatch-Waxman Act is and what it means to the patient and the impact on the pharmaceutical industry. You will hear about a natural herb that I have been taking for pain. And finally you will hear two interviews first Katherin Eban, and secondly lawsuit that has been filed against the generic pharmaceutical companies, which was aired on PBS NewsHour. --- Send in a voice message: https://anchor.fm/susan-hendrix/message

Former Congressman Henry Waxman was recently interviewed for the Clause 8 podcast about how he worked together with Sen. Orrin Hatch to pass the Hatch-Waxman Act and its aftermath.  Congressman… The post Clause 8 Podcast Interview with Co-Author of the Hatch-Waxman Act appeared first on DrugPatentWatch - Make Better Decisions.

Former Congressman Waxman discusses the passage of the seminal Hatch-Waxman Act, recent proposals to improve the balance between rights of brand name pharmaceutical and generic companies, and his 40-year career in Congress.

Robin Feldman of the University of California Hastings College of Law and author of Drug Wars talks about her book with EconTalk host Russ Roberts. Feldman explores the various ways that pharmaceutical companies try to reduce competition from generic drugs. The conversation includes a discussion of the Hatch-Waxman Act and the sometimes crazy world of patent protection.

A case in which the Court held that counterclaims that challenge unpatented uses of generic drugs, even if other approved uses are still under patent, are allowable under the Hatch-Waxman Act.