FTC Voices Support for March-In Rights on Patents to Help Control Drug Prices

The Federal Trade Commission (FTC) has announced its support of the federal government’s use of “march-in rights” as a mechanism to control the price of pharmaceuticals. The National Institute of Standards and Technology (NIST) late last year issued its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” that would fundamentally change the use of march-in rights by allowing the government to exercise price control under the Bayh-Dole Act, which the FTC announced its support for last week. This shift is the latest effort by federal agencies to lower drug prices in the wake of President Joe Biden’s Executive Order on Promoting Competition in the American Economy.

Read the full Alert on the Duane Morris LLP website.

Senator reiterates FTC warnings regarding inhaler patents in Orange Book

Senator Tammy Baldwin (D-WI) sent letters this week to companies warning of improper Orange Book listings of patents for inhalers, following up on the FTC’s focus on potential anticompetitive harm of improper listings. According to Senator Baldwin’s letters, the recipients of the letters were warned by the FTC in November regarding the listing of inhaler patents, but have not removed the patents from the Orange Book. The letters follow an investigation launched earlier this month by the Senate Committee on Health, Education, Labor, and Pensions (of which Senator Baldwin is a member) into the prices of inhalers.

March-In Rights Imperatives: A CLE Webinar from Ryan C. Smith, Ph.D.

“Has your institution received government funding? Is government funding behind your patents? Are you licensing patents that were developed with government support? If so, you really should listen to this informative webinar. Your rights and economic interests could be dramatically impacted by March-In Rights.”

Discover the nuances of March-In Rights in patent law through a recent presentation by Duane Morris partner, Ryan C. Smith, Ph.D.

To access the presentation, follow this link.

FTC and DOJ Finalize 2023 Merger Guidelines

Today, the Federal Trade Commission (“FTC”) and Department of Justice (“DOJ”) (collectively, the “Agencies”) jointly released the 2023 Merger Guidelines .  The 2023 Merger Guidelines outline the “factors and frameworks the agencies utilize when reviewing mergers and acquisitions,” including both horizontal and vertical transactions. The 2023 Merger Guidelines finalize the draft merger guidelines that were released in July 2023 and effectively update and replace the 2010 Horizontal merger Guidelines and Vertical Merger Guidelines that were issued in 2020 and later rescinded by the FTC in 2021. The 2023 Merger Guidelines are not law, but past merger guidelines have been persuasively cited by courts, and they give insight as to how the Agencies view the competitive impact of transactions.

Given the Agencies’ focus on competition in the Life Sciences space, companies should be aware of all of the factors and frameworks outlined in the 2023 Merger Guidelines. In particular, certain components of the 2023 Merger Guidelines reflect recent enforcement trends, including the threshold for when the Agencies consider certain transactions presumptively illegal, an emphasis on elimination of potential entrants in concentrated markets, a focus on how transactions will affect access to products or services used by rivals, an examination of whether a transaction furthers an already-dominant market position or is part of a trend towards consolidation, and concerns with both cross-ownership and common ownership in firms that have competitive relationships.

Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction

On December 11, 2023, Sanofi released a statement that it will terminate its proposed $755 million licensing agreement with Maze Therapeutics (Maze) shortly after the Federal Trade Commission (FTC) issued an administrative complaint and authorized filing a complaint for preliminary injunction in the United States District Court for the District of Massachusetts to block the deal.

Under the terms of the proposed licensing agreement between Genzyme Corporation, a wholly-owned subsidiary of Sanofi, and Maze, Sanofi would acquire an exclusive license to Maze’s glycogen synthase 1 products and related technology, including its candidate MZE001, a drug in development to treat the potentially fatal genetic order Pompe disease. According to a statement by Jason Coloma, Ph.D., Maze’s CEO, the FTC’s challenge “is the first time ever the FTC has moved to block a license of a Phase 1 investigational medicine.” The challenge seems consistent, however, with revised draft merger guidelines proposed by the FTC and Department of Justice that indicate that transactions “should not entrench or extend a dominant position” by, for example, “[e]liminating a nascent competitive threat.”

Continue reading “Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction”

Bayh-Dole Act March-In Rights Part of White House Plan to Lower Drug Prices

Following enactment of the Inflation Reduction Act, which provides for Medicare drug price negotiations, the White House has announced new actions to lower drug costs, including the release of a proposed framework for agencies to exercise march-in rights under the Bayh-Dole Act to promote public accessibility to tax-payer-funded drugs. If adopted, the framework would make it easier for the government to exercise march-in rights and would impact the value of license rights to government-funded inventions.

Read the full Alert on the Duane Morris LLP website.

FDA Pushes Back Enforcement Deadline for MoCRA Facility Registration and Product Listing Requirements

Today, FDA announced updated guidance regarding its MoCRA rollout.

FDA  does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.

To read the full text of this post by Kelly Bonner,  please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog.

Federal Trade Commission Issues Notice Letters Regarding Allegedly Improper Orange Book Listings

On November 7, 2023, the Federal Trade Commission (“FTC”) announced that it had issued notice letters to 10 life sciences companies regarding 100 patents that the FTC contends are improperly listed in the Orange Book, the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. The announcement comes of the heels of the FTC’s policy statement warning drug companies that improper listing of patents in the Orange Book could violate Section 5 of the FTC Act. Pursuant to the FTC’s policy, the companies have 30 days to either withdraw or amend their listings or certify under penalty of perjury that the listings are proper.

The FTC believes that improper listings in the Orange Book could constitute an unfair method of competition under Section 5 of the FTC Act because a patent listed in the Orange Book could lead to a statutory stay that generally blocks the introduction of competing products for 30 months. According to the FTC, costs associated with challenging patents could frustrate innovation and/or market entry. The FTC has said that even a brief delay in generic entry harms consumers in the form of artificially high drug prices.

We will be watching how companies choose to respond to the recent notice letters and the policy’s impact on Orange Book listings and competition with respect to brand drugs going forward.

Boston Partner Daniel Pierce Interviews Treventis CEO Chris Barden

Daniel R. Pierce, Corporate and IP partner in the Boston office, recently spoke with Chris Barden, CEO of firm client Treventis, about his background, his company’s research into misfolded proteins to develop cures for central nervous system diseases like Alzheimer’s, as well as Chris’ thoughts and experience at the BIO Conference.

Can you tell us a little bit about your background and how you ended up CEO of an emerging life science company?

Sure. My background is really in computational science. I did a lot of work in university looking at how computers could be used to solve problems in chemistry. I did a Ph.D. in computational chemistry, where I was looking at molecules with five atoms in them and getting all kinds of gory details. I decided, after doing that, I really wanted to do something a little bit more practical. So that’s where I got into working in drug discovery.

I’ve been doing work in drug discovery projects for the better part of 20 years now, looking at central nervous system infectious diseases as well as developing cancer drugs. I’m pleased to be involved in a number of projects that have developed pre-clinical candidates, and Treventis is one of the main engines for us to be able to move those things along.

In terms of Treventis, could you talk a little bit about how the company was formed and your experience there?

Treventis was, from day one, operating multinationally, which is a little bit unusual. We had a management team that actually left a Nasdaq-traded pharmaceutical company to be the founding C-suite executives at Treventis. And then we had a pretty big contingent of scientists working in Canada that were developing our concepts and drug design.

I started on the R&D side and then got more involved in trying to manage the Canadian side of the operation. Ultimately, I took the reins from the former CEO, and have been in this current role for seven years or so, driving the company.

Treventis focuses on central nervous system diseases, particularly looking at misfolded proteins as a cause of Alzheimer’s disease. Can you talk about what misfolded proteins are and why they are the focus of your therapeutic research?

Misfolded proteins are essentially proteins that are found in the body that have some part of them, or all of them, that don’t stay in a particular shape.

When we look at most proteins in the body, they get formed and then they fold in a certain way and they more or less stay in that shape for their entire biological lives. But, these misfolded proteins are shapeshifters, and because they can change their shape, sometimes they get into a shape which allows them to basically begin to polymerize. They begin to build copies of themselves and aggregate to make these really big clumps of protein. This is most notorious in Alzheimer’s disease, with the amyloid plaque seen in the brain.

A lot of the drugs that are coming onto the market right now are specifically looking at that amyloid plaque. But there’s also a protein called tau, which is important, and that’s one of the focuses of Treventis. We’re working on ways to keep the tau protein from misfolding, and hopefully we’ll have some disease-modifying potential in Alzheimer’s disease.

One of the ways that Treventis develops its drug candidates is by utilizing your proprietary Common Conformational Morphology technology. Can you talk a little bit about what it is?

Common Conformational Morphology, or CCM, is a concept that we developed fairly early on in the company, and we’ve been developing over the decade-plus that Treventis has been around. CCM looks at the lack of information that we normally have about what a misfolded protein’s three-dimensional shape really is and tries to build computer models that will simulate that. We use those computer models as hypotheses for experiments that we can do to try to demonstrate that the model has some validity. Utilizing that virtual model of the misfolded protein, we then do drug discovery work.

It’s similar to a conventional drug campaign. Typically, if you had an enzyme and you were trying to make an enzyme inhibitor, you would try to crystallize the enzyme so you could see where your inhibitor needed to bind. Misfolded proteins don’t crystallize. That’s the main reason why you need some other approach, and CCM is our unique approach to do this.

Did this approach lead to the development of promising compounds that you’ve used or that you’re leveraging in your partnership with Takeda?

Oh, yes. We’ve developed several classes of compounds using CCM in looking at compounds that affect beta amyloid and compounds that affect TDP that affect alpha synuclein potentially in Parkinson’s disease, and most notably for this Takeda collaboration, compounds that affect the misfolding of tau. So we’ve made compounds that we have not only demonstrated bind to this tau protein and affect its misfolding, but also have effects on the misfolding in animal models of the disease as well. This is the approach which allows for these potential drugs to slow down the production of misfolded proteins, and that should mean that there’s some disease-modifying effects. This is, I think, what really captured the imagination of the Takeda neuroscience team when we began working with them. We are going to continue that collaboration to arrive upon the chemical matter that is really going to be the compound that goes into the clinic for this program.

Lastly, I know you were recently in Boston for the BIO Conference, and that’s something that you’ve done many years before. Can you talk a little bit about what it was like to be here for BIO and the value for companies like Treventis that are early stage to be there?

BIO is always an exciting and exhausting time of year, and it’s never more so than when it’s in Boston. BIO, even before COVID, is really the preeminent networking event for the pharmaceutical industry. It’s a “must-do” for emerging biotech companies to be able to make those connections face to face.

I think the thing that many people wouldn’t get from all of the banners and crowds and the big event things is how much it’s really focused on one-on-one meetings. Most of the conversations that I was having at BIO really were sitting at a table with one or two or three other people from some other company and discussing our respective companies, and just trying to have as many quality meetings as possible, face to face.

This interview was published in the Autumn 2023 Boston Office Happenings newsletter.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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