Do patents make drugs more expensive? And what role does intellectual property play in getting new medicines from the lab bench to patients?

The questions have never been more timely. Biopharmaceutical innovation sits at the center of some of our biggest public policy debates. Drug pricing, access, generic competition, university research, venture funding, AI-driven discovery, follow-on research, and the future of biotech startups. And in the middle of those debates, patents are often reduced to slogans like patent monopolies and ever-greening and are assigned the political blame for high drug prices and limited patient access to medical breakthroughs.

But the real system is much more complicated. Modern drug development is extraordinarily expensive, uncertain, regulated, and risky. A promising discovery may begin in a university lab, move through a startup, require venture financing, depend on partnerships with larger pharmaceutical companies, survive years of clinical testing, and then still face manufacturing approval, reimbursement, safety monitoring, and market adoption hurdles.

Along that path, intellectual property is not just a prize at the end. It can be the asset that allows investment, collaboration, disclosure, licensing, specialization, and commercialization to happen in the first place. At the same time, the public has a legitimate interest in access, affordability, competition, and generic entry. So the policy challenge is understanding how the system works, what incentives are actually doing, and what can go wrong when lawmakers, courts, and pundits oversimplify the trade-offs.

This is a big conversation, but the through line is simple. If we want more medicines, better medicines, and broader access to medicines, we need to understand the innovation system clearly before we start rewriting the rules.

** Special Guest: Dr. Bo Heiden **

To help us truly understand the critical role of patent protections in the biopharmaceutical ecosystem and what prevailing narratives mean for investors, startups, and biotech R&D, we’re sitting down with Dr. Bo Heiden, one of the leading thinkers working at the intersection of intellectual property, innovation strategy, and life sciences policy. Dr.  Heiden is the co-director of the Eira Initiative, a project out of the Berkeley Policy Institute, the Executive Director for the Tusher Strategic Initiative for Technology Leadership at Berkley’s Haas School of Business, the Co-Director of the Center for Intellectual Property (CIP) at University of Gothenburg, and the Co-Chair of the Technology, Innovation, and Intellectual Property program at the Classical Liberal Institute at the NYU School of Law.

** Episode Overview **

⦿ Drug price and access concerns, as they pertain to patents.
⦿ The economic realities that make drug development a uniquely risky investment problem.
⦿ The CliffsNotes history of why the modern biotech system emerged so strongly in the United States.
⦿ What policymakers often miss in narratives around evergreening and patent monopolies, and how those narratives may now be pushing policy in directions that could undermine the very startup and R&D ecosystem we all depend on for advancements in medicine.
⦿ The Supreme Court’s recent Hikma decision and what it means for skinny labels, induced infringement, and generic competition.
⦿ Practical takeaways on two of the hottest areas in the market: AI-driven drug discovery and the evolving GLP-1 regulatory and generic landscape.

** Mossoff Minute: America's 250th and the Democratization of Invention  **

In this month's Mossoff Minute, Professor Adam Mossoff discusses the democratization of invention sparked by American independence.

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When most people think or speak generally about patents, they’re really talking about utility patents – or patents that are primarily concerned with how an invention is used and how it works. But as it turns out, this is just one specific type of patent on the complete menu of options available for protecting your innovations. Another option, called a design patent, exists to – additionally or alternatively – protect the appearance of your invention. 

And whether you find yourself in an either/or or a both situation, it’s important to consider all tools at your disposal in covering every uniquely protectable functional and visual aspect of your inventions. This is often referred to as building a moat around your business. In this month’s IP Market Insights Newsletter, former guest of the podcast, Louis Carbonneau, wrote that:

"Morningstar’s research has consistently shown that companies with wide economic moats — those with defensible advantages expected to last 20 years or more — dramatically outperform those without. When Buffett said he looks for 'economic castles protected by unbreachable moats,' he wasn’t being quaint".

** Episode Overview **

Design patents play a critical role in your broader portfolio and in making your moat as wide and unbreachable as possible. This is why we’ve enlisted the help of our very own Dr. Tiffany Miller to guide us through all of the do’s and don’ts. As you’ll hear today, Tiffany has some very unique and practical insights into how even the most nuanced aspects of design patents can significantly impact infringement cases.

⦿ The definition, term, and features of design patents.
⦿ How design patents compare with utility patents.
⦿ Obviousness implications for the patent office and the courts – including what to possibly make of the courts wiping the case law slate clean on design patent obviousness back in 2025.
⦿ And some really great interactive panel discussions around real-world design patent examples and how courts have weighed in on patentability.

** Mossoff Minute: Loss of American Leadership  **

In this month's Mossoff Minute, Professor Adam Mossoff discusses the unfortunate loss of American leadership on the international stage in terms of defending the fundamental rights and rules for how we protect patents. 

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Willful infringement is a patent law concept that applies when someone infringes a patent knowingly or with reckless disregard for the patent holder’s rights. It goes beyond accidental infringement, often involving a deliberate choice to use protected work despite awareness of the rights holder. With unintentional infringement, the infringer can still be required to pay damages, negotiate a license, or face an injunction to halt the infringing activities. If the infringement is deemed willful, however, this can lead to significantly increased damages, sometimes up to three times the original amount. 

This is something that patent holders need to be keenly aware of – both offensively and defensively. If found for infringement, is simply knowing about the competitor’s patent enough? What if it turned up in search results when examining prior art for your own invention? On the other side, if you’ve discovered that a competitor is infringing on you, what steps should you take to ensure that they’ve been clearly put on notice? The answers to these questions could mean millions. 

** Guest Host **

Tamany Vinson Bentz is our guest co-host today. Tamany is the founder of California IP Law, where she currently focuses on developing customized IP portfolios for businesses of all sizes. Prior to managing her own firm, she spent 20 years as a litigator in big law as a partner at both Venable and DLA Piper. 

** Episode Overview **

Tamany and Dave lead today's discussion with our all-star patent panel, delving deeply into all things willful infringement. Along the way, they discuss:

⦿ Willful infringement prior to two 2016 SCOTUS cases.
⦿ How the SCOTUS cases shaped assessment of willful infringement.
⦿ How this has been playing out in more recent cases, and what has and has not been viewed as willful or egregious.
⦿ And some practical tips on how and where to communicate notices if you feel like your patent rights are being infringed.

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Patent abandonment is the premature relinquishment of patent rights for an invention. Abandonment can happen voluntarily for various strategic and cost reasons, but can also happen silently and unintentionally. It can happen before the right is even granted in the case of public disclosure. But it can also happen after the patent has been granted at many key points in its otherwise useful life and window of exclusivity. Like with other property rights, securing your patent isn’t the end of the line in maintaining that property right. Like property taxes for land and annual registration for automobiles, patents have deadlines and fees that, if not properly managed, can lead to loss of that right. And in all cases – whether abandoned intentionally or by accident - the invention becomes part of the public domain, and the rights holder's exclusivity window to prevent others from using, making, and selling the invention is terminated short of the otherwise expected 20–year term. 

** Episode Overview **

Fortunately, with careful management, the problem can be avoided entirely. And for many unintentional cases, if caught quickly enough, there are remedies for reviving your rights. To help unpack all of this and conquer your fears of abandonment, Albert Du, Patent Strategist and Chief Mindfulness Counselor at Aurora, leads today's discussion with our all-star patent panel, delving deeply into all things patent abandonment and revival. Along the way, Al and the panel:

⦿ Provide a general overview of the utility patent lifecycle to help better frame key points at which abandonment can occur
⦿ Discuss the types of abandonment and the statutes governing each
⦿ Break down when and how to revive an abandoned patent
⦿ And as always, offer countless practical pointers to keep in mind before, during, and after patent prosecution to help avoid what can at best be a costly legal process – and at worst, a complete loss of patent rights. 

** Related Past Episodes  **

⦿ Public disclosure and the on-sale bar
⦿ International patents
⦿ Software patents
⦿ Patent Prosecution Highway
⦿ Continuation practice

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What are your options for protecting inventions across Europe? In this month’s episode, we’re taking a journey across the pond with a discussion on European Patent Practice. This episode is part two of a series we’re doing on International Patenting and follows Ashley’s exceptional Travel Guide to Foreign Protection from earlier this season. 

Even in a globalized economy, patents are still nationalized documents. For example, a U.S. patent only grants the right to exclude others from making, using, selling, and importing the claimed invention within the United States. It has no bearing on activities in Europe, Canada, Mexico, China, or anywhere else in the world. To restrict activities there, you will typically need a patent granted in each relevant country. This can boil down to filing and prosecution on a per-country basis. However, those seeking protection in Europe do have some additional options for a single application granting protection in multiple nations.

** Guest Host:  Dr. Will Doherty **

To help navigate the very complicated European landscape, we reached out to a good friend of Aurora’s—Dr. Will Doherty of Albright IP. And we’re so glad we did. In this episode, Will puts on an absolute masterclass on European patent practice.

Beyond being a great teacher with a sharp sense of classic British humor, Will is an experienced Chartered British Patent Attorney, European Patent Attorney, and IP Litigator. As a Patents Director at Albright, he prepares, files, and prosecutes patents with great success in a wide range of technical sectors globally, in addition to handling patent infringement matters. Will is a member of and regulated by IPReg, the independent professional regulatory body in the UK for Patent and Trademark Attorneys. He is also a long-standing member of the Chartered Institute of Patent Attorneys in the UK and the European Patent Institute. Will’s academic background is in Chemistry, with a doctorate in Physical and Theoretical Chemistry. 

** Episode Overview **

⦿ European patent process, EPO participating countries, key players in the system, and how it all compares to USPTO and PCT processes. 
⦿ Strategic considerations around filing in individual countries vs. using EPO, translation implications, cost considerations, fee timelines, filing timeline implications, market alignment, and rights enforcement.
⦿ Interplay with newer Unitary Patents and the Unitary Patent Court.
⦿  Key practitioner takeaways, including some insightful claim drafting tips for medical-type applications, which are viewed very differently in Europe than in the U.S.

** Mossoff Minute: Price Controls on Standardized Technologies  **

In this month's Mossoff Minute, Professor Adam Mossoff is discussing an issue that could cause huge problems in Europe and for the global innovation economy, more broadly. 

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In this month’s episode, we’re talking about patent marking – and its massive implications on your ability to collect on infringement damages.  

We’ve all seen patent numbers on physical products. Much like their copyright and trademark cousins, these designations are far from cosmetic. And instead serve a statutory requirement to provide public notice about your protected intellectual property. In the case of patent marking, not only does it reduce the risk of infringement because you are informing potential infringers of the patent's existence, but the notice also marks the point in time from which you can go back to for collecting on awarded damages. As the panel will discuss today, American patent law operates on a simple principle: mark your products with patent numbers, or watch your damages disappear.  

** Episode Overview **

Kristen Hansen, Patent Strategy Specialist at Aurora, leads today's discussion with our all-star patent panel, delving deeply into the Do’s and Don’ts for patent marking – both physical and virtual, for US and abroad. Along the way, Kristen and the panel discuss:

⦿ Patent Marking basics
⦿ Legal requirements for patent marking
⦿ Benefits and best practices for marking
⦿ A real-life case cautionary tale 
⦿ Implications for worldwide marking

** Mossoff Minute: Coke Morgan Stewart's Patent Reforms **

In this month’s minute, Professor Adam Mossoff celebrates the accomplishments of Acting USPTO Director Coke Morgan Stewart. Her tireless efforts over the past months are helping to light the path back toward reliable and effective patent rights for innovators across the country and in the global economy.

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Whether you’re a founder looking to take the next fundraising steps beyond bootstrapping, an aspiring angel investor looking to understand the risks of seed investing, or even a practitioner hoping to get a better grasp of how this all works hand-in-hand with patent strategy, today’s topic provides an incredible springboard into the high risk, high reward world of strategic fundraising for early-stage startups. 

** Guest Host: Charlie Pascal **

To help us with the specifics, we’ve enlisted the assistance of Charlie Pascal. Charlie is the founder and principal attorney at Pascal Advisory LLC, where he’s spent the last decade focused primarily on working with early-stage tech and life science companies to navigate the legal complexities of everything from the pre-incorporation cocktail napkin stage to helping founders pick teams and build a board, on through our focus today, which is advising on all of the funding rounds from friends and family on through venture capital. Much like Aurora does with many of our early-stage clients, Charlie functions as what you can essentially think of as fractional general counsel for companies that aren't yet ready or able to engage full-time in-house legal counsel.

** Episode Overview **

Charlie and the panel discuss:

⦿ The various routes and rounds of fundraising available to early-stage companies.
⦿ How patents can play into each and how differences in business models can significantly impact patent strategy. 
⦿ As a founder, what goes initially into projecting a budget for fundraising needs, and later, how to think about valuation.
⦿ How to get the most out of your patents when it comes to valuation and approaching investors.
⦿ And great pro tips on some surprising sharp corners related to things like preferred stock, down rounds, the investor payout waterfall, and the very commonly used and freely downloadable SAFE equity agreement created by Y-Combinator.

 ** Related Content **

⦿ What Investors Want in Patents: https://www.aurorapatents.com/blog/what-investors-want-in-patents-with-sridhar-iyengar
⦿ Government Grants and Patent Rights: https://www.aurorapatents.com/blog/government-grants-and-patent-rights
⦿ Key Considerations for IP Diligence: https://www.youtube.com/watch?v=oeeAmgAMtQA

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In today’s global economy, the importance of international patent protection cannot be overstated. Your invention could be conceived of with a workforce distributed across several continents. Your manufacturing could happen in Asia or India, while your products are shipped into and distributed from ports in the target markets of the largest economies across the globe. Would be competitors and infringers could be next door neighbors or perhaps across the pond. But as you’ll learn today, there is no such thing as an International Patent – no one global patent that protects you everywhere. Instead, patents are jurisdictional property rights. For example, a U.S. patent only grants the right to exclude others from making, using, selling, and importing the claimed invention within the United States. It has no bearing on activities performed in Canada, Mexico, China, or anywhere else in the world. To restrict activities there, you will need a patent granted in each of those countries.

So, how do you choose where to file? How long do you have to decide? What pathways exist for filing internationally? How do you pursue international protection in an intentional, strategic, cost-effective manner that won’t break the bank? And what should you be thinking about now, while drafting your patent to set yourself up for the greatest odds of success once on the international stage?

** Episode Overview **

Dr. Ashley Sloat, Aurora’s very own international patenting tour guide, leads today's discussion with our all-star patent panel, traveling from the U.S. to Europe, Africa, India, East Asia, Australia, and everywhere in between, exploring the intricacies and nuances of ensuring your patent rights are protected everywhere it matters. Along the way, Ashley and the panel discuss:

⦿ Reasons for pursuing international protection.
⦿ How to choose locations with a cost-effective international strategy.
⦿ Foreign filing deadline and strategy pointers.
⦿ The most common pathways for foreign protection including, the Patent Cooperation Treaty, the Paris Convention, the European Patent Convention, Unitary Patents, and the African Regional Intellectual Property Organization.
⦿ Things you need to be thinking about well in advance, in terms of drafting your patent and the international dangers of public disclosure.
⦿ And even some considerations for how political happenings like tariffs, trade wars, and Brexit can impact your patent strategy.

** Mossoff Minute: A Friend to Inventors **

In this month’s minute, Professor Adam Mossoff discusses Secretary of Commerce Howard Lutnick's remarks at the National Inventors Hall of Fame Induction Ceremony, and what this positively signals for the near future of innovation policy.

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In this month’s episode, we’re getting high on innovation with a deep dive into cannabis patents! 

As more and more states relax restrictions on both medical and recreational uses of marijuana and hemp, the U.S. cannabis industry is projected to reach $50 billion in sales this year and over $74.6 billion by 2032! This rapid growth is happening despite immense challenges brought on by a complex and conflicting web of legal disparities between federal and state laws. These legal challenges include limited access to financial institutions and the inability to transport products across state lines, but what about patents? THC – the primary psychoactive compound in cannabis – was deemed a Schedule One drug under the Controlled Substances Act of 1970. This is the most restrictive category for drugs in the eyes of the federal government. And unlike most other property rights, patents fall squarely within federal jurisdiction. So what does this mean for inventors in the space hoping to protect their cannabis-related innovations?

** Guest Host: James Gourley **

For the answer, we turned to *the* expert in this space. There have only been five or so cannabis patent infringement cases ever filed in the United States, and our guest host today has worked on two of them. James Gourley is a partner at Carstens, Allen & Gourley, LLP, and a registered patent attorney with the United States Patent and Trademark Office. James served on the Dallas Bar Association's Intellectual Property Section Board before moving to Denver. He is a member of the State Bar of Texas and Colorado and is admitted to practice in the U.S. District Courts for the Northern, Southern, Eastern, and Western Districts of Texas, the District of Colorado, the Fifth Circuit Court of Appeals, and the United States Supreme Court. James has been a pioneer cannabis IP law and brings incredible depth of expertise, based on first-hand experience, to our conversation.

** Episode Overview **

⦿ Cannabis at the molecular level, specifically THC and CBD, and how the subtle differences underscore the complexity of cannabis legality.
⦿ The present legal framework around cannabis and the challenges that come via a patchwork of conflicting state and federal laws.
⦿ Cannabis IP issues surrounding obtaining and asserting both patents and trademarks, including insights from the cases James has personally litigated.
⦿ Patent prosecution strategies to help ensure your rights are enforceable in a federal court.

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If a court stripped away your property rights, wouldn’t you at least want an explanation? The answer is obvious, but the reality is appalling. The practice of revoking patent rights on appeal without explanation has been happening to inventors at the Federal Circuit Court of Appeals (CAFC) at an alarming rate. In over 43% of PTAB cases on appeal at the CAFC, inventors receive a single-word response – “AFFIRMED” – rather than an opinion. This practice is referred to as the application of Rule 36 and, in cases involving the PTAB, amounts to the seizure of property from an administrative agency without any reasoning provided by a constitutionally created Article III court. 

Based on the findings of our guests today, who are taking this very issue up with the Supreme Court, Rule 36 violates clear statutory requirements, raises Constitutional questions, and defies a rich history of court precedent. Gene Quinn has said that this Federal Circuit Court practice is “placing America’s inventors under siege,” and friend of the podcast and former Chief Justice of the Federal Circuit, Paul Michel, has called this practice a “dereliction of duty” that “warrants immediate Supreme Court scrutiny.” Our guests this month – Jeff Parker, Amit Vora, and Juliette Fassett – are fighting hard to make that happen. 

** Our Guests **

ParkerVision has filed a petition for a writ of certiorari with the Supreme Court and recently submitted a reply brief in an attempt to get the Supreme Court to take up this innovation-crippling practice. In the coming days, the justices are scheduled to discuss the petition in private conference, where they will vote on whether to take the case.

To help us unpack Rule 36 practice and what ParkerVision is hoping to do about it, Dr. Ashley Sloat and I have enlisted the assistance of the three people closest to this case and its implications:

⦿ Jeffrey Parker, CEO of ParkerVision – an absolute pioneer in wireless technology.
⦿ Amit Vora, appellate litigator at Kasowitz Benson Torres, representing ParkerVision in its petition for cert with the Supreme Court.
⦿ Juliette Fassett from the Fair Inventing Fund, advocating for inventors’ rights. Juliette is an inventor herself, with over 30 years of experience building consumer product companies.

** Referenced Links **

⦿ ParkerVision's Cert: https://www.supremecourt.gov/DocketPDF/24/24-518/331105/20241104163210189_No.%2024-_____%20Petition.pdf
⦿ Why Patents Exist w/ Professor Mossoff: https://www.aurorapatents.com/blog/why-patents-exist-with-adam-mossoff

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