Biotech Insights - Spring 2026

April 16, 2026

Biotech Insights - Spring 2026

Sharon Crane Ph.D., Kayla Cristales, Daniel Dubyak, Martin Florman, Jeffrey Morton Ph.D., Luke Nguyen, Paul Tobin Haynes Boone + Follow Contact LinkedIn Facebook X ;) Embed

Regulatory Overview: Post-Approval Changes to Marketed Drugs

The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternative to the injection currently on the market. Whether relating to drug labeling, dosage form or containers, each change to an NDA must be reported to the FDA. But how? The exact reporting requirements can vary widely, depending on the severity of the change.

Changes to NDAs can be categorized as major changes, moderate changes or minor changes, depending on the change’s potential to adversely affect the “identity, strength, quality, purity, or potency of the drug product,” as adverse effects on the quality of a drug product can impact the product’s safety or efficacy. For major and moderate changes, the FDA typically expects the sponsor to file a supplemental NDA, while minor changes only need to be reported in the drug’s next annual report.

Changes with a substantial potential to adversely affect a drug product’s safety or efficacy require prior approval from the FDA before implementing the change. For example, this could include:

• A change in the primary packaging components for any drug product when the primary packaging components control the dose delivered to the patient (e.g., the valve or actuator of a metered-dose inhaler)
• A change from a prefilled syringe to another container closure system for sterile drug products
• Certain efficacy supplements (i.e., new indication or patient population)

• Changes to clinical pharmacology section based on new/modified clinical data
  Moderate changes—those with a moderate potential to impact a drug’s safety or efficacy—can be implemented 30 days after FDA receives the supplement (as long as the FDA does not inform the applicant that prior approval is required). Alternatively, some moderate changes can be implemented upon notification to the FDA, but if FDA disapproves of the change, the manufacturer must cease distribution. 1 This may include:

• Changes in the size or shape of a drug container

• Strengthening or adding a contraindication, warning or precaution

• Adding specifications for further assurance a manufactured drug will have its purported quality
  Finally, minor changes are those likely to have only a minimal impact on a drug’s safety or efficacy and only need to be included in the applicants’ next annual report. This may include:

• Adding or changing a container closure cap (i.e., from metal to plastic)

• Changing a label’s layout or making editorial changes

• Changing the manufacturing site for product labeling
  While most changes can be reported by way of a supplemental NDA or an annual report, the FDA may ask a sponsor to submit an NDA for the proposed change for certain changes. 2 For example, if a drug product changes the dosage form or route of administration of a drug, the FDA typically expects an original NDA to be filed. As such, a product changing from an injectable form to a tablet or capsule form—like Wegovy—would be expected to file an original NDA to effectuate the change. The exception is if the change in dosage form or route of administration can be accomplished with the drug remaining quantitatively and qualitatively identical in composition. 3

Of course, this only briefly covers the long-list of potential changes to a drug product. Sponsors considering any change to a previously approved drug should fully assess the regulatory requirements for implementing the change to avoid delays in marketing the updated product.

1 FDA Guidance: Changes to an Approved NDA or ANDA (Apr. 2004).

2 FDA, Webinar: So, Your NDA Was Approved – Now What?! (2020) (at 25:50).

3 See FDA Guidance: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (Dec. 2004).

Federal Circuit’s Holding on Patent Eligibility for Engineered Host Cells Dovetails With PERA

U.S. Supreme Court opinions in Mayo Collaborative Services v. Prometheus Laboratories, Inc. 1, Association for Molecular Pathology v. Myriad Genetics, Inc. *2*** and Alice Corporation Pty. Ltd. V. CLS Bank International et al. 3, have left the Court of Appeals for the Federal Circuit grappling with the metes and bounds of patent subject matter eligibility, including the eligibility of nucleic acid sequences.

The United States Court of Appeals for the Federal Circuit (“Federal Circuit”) recently issued a **** holding in REGENXBIO, Inc. v. Sarepta Therapeutics, Inc., No. 24-01408 (Fed. Cir. 2026) **** that would be consistent with the intent of the Patent Eligibility Restoration Act of 2025 (“PERA”; S. 1546/H.R. 3152). **** Returning to the holdings of the seminal 1980 Supreme Court Chakrabarty case 4, the Federal Circuit held that REGENXBIO’s claims to a host cell containing a nucleic acid molecule encoding an adeno-associated virus (AAV) capsid protein and a heterologous non-AAV sequence were patent eligible under 35 U.S.C. § 101. Rather than overly broadly applying the holdings of the Myriad 5 case, the Federal Circuit instead looked to its holding that “cDNA is not a ‘product of nature’ and is patent eligible under § 101…”

REGENXBIO had sued Sarepta for infringement of U.S. Patent No. 10,526,617 (“the ’617 patent”), which included the following independent claim:

1. A cultured host cell containing a recombinant nucleic acid molecule encoding an AAV vp1 capsid protein having a sequence comprising amino acids 1 to 738 of SEQ ID NO: 81 (AAVrh.10) or a sequence at least 95 percent identical to the full length of amino acids 1 to 738 of SEQ ID NO: 81, wherein the recombinant nucleic acid molecule further comprises a heterologous non-AAV sequence.

Sarepta countered by moving for summary judgment that REGENXBIO’s asserted claims were ineligible for patenting under 35 U.S.C. § 101, and REGENXBIO similarly moved that they were not.

The district court had concluded that the ’617 claims recited natural products and that the Chakrabarty and Myriad cases held that there needed to be a material change in what was claimed versus what was found in nature, and that the nucleic acid components in the asserted claims had not been changed, only combined. The district court maintained that the ’617 claims were more similar to those in Funk Brothers *6*, where different species of bacteria that were not inhibitory of each other, were combined as an inoculation for seeds.

Distinguishing the Funk Brothers case, the Federal Circuit noted:

“In contrast, the claims here are not merely directed to repackaging products of nature. Genetically engineering two nucleic acid sequence from separate species into a single molecule and then transforming a host cell in order to incorporate that new molecule into it—thus fundamentally creating a cell containing a molecule that could not form in nature on its own—is materially different from growing more than one naturally occurring bacteria strain in a culture where none of the bacteria undergo any change from their natural state.” Opinion at 14-15.

Taking the 101 analysis one step further, the Federal Circuit held that a further consideration was “whether the claimed composition has ‘the potential for significant utility’ even if that utility is only implicit – as it clearly is here.” Opinion at 17.

The REGENXBIO, Inc. v. Sarepta Therapeutics, Inc. case is a welcome return to a balanced consideration of the scope and intent of 35 U.S.C. 101. Arguably, it is also consistent with the PERA, which was reintroduced into the Senate on May 1, 2025, by Senator Thom Tillis. PERA aims to address patent eligibility uncertainly by replacing judicial exceptions with specific statutory exclusions, making it clear – in this instance – that nucleic acids and other compounds should be patent-eligible if in a different form than how they occur in nature. Conversely, PERA seeks to achieve an appropriate and predictable balance by codifying that anything that occurs in nature wholly independent and prior to human activity, should not be eligible for patenting. A Congressional hearing on PERA was held on Oct. 8, 2025, and Senator Tillis is anxious to see the bill passed before his retirement from the Senate at the end of 2026.

As we head to publishing, Sarepta has recently filed a petition for en banc rehearing arguing that sequences in the DNA construct in REGENXBIO’s host cell exist in nature without manipulation by human activity and therefore are not eligible for patenting. Sarepta argues that the Federal Circuit decision in would allow the patenting of “routine laboratory steps” resulting in the “monopolization of a fundamental tool of research and development in the field of biotechnology….” The conflicting positions between Sarepta and the Federal Circuit decision are precisely what has led to the unpredictability in what can and cannot be patented. This highlights the need for PERA to define these important issues through sound legislation.

1 566 U.S. 66 (2012).

2 569 U.S. 576 (2013).

3 573 U.S. 208 (2014).

4 Diamond v. Chakrabarty, 447 U.S. 303 (1980).

5 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).

6 Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).

Key California M&A Considerations for Life Sciences Businesses: Part 2

This is the second article in our two-part series addressing a few key issues and considerations that life sciences business owners should consider when dealing with a merger or acquisition in California. Part one covered approval mechanics, board composition, protections for minority and dissenting shareholders, California’s permit and fairness hearing process and the quasi-California corporation statute. Part two addresses dispute resolution provisions, the enforceability of noncompetition and nonsolicitation covenants and tax considerations that commonly influence deal structure and negotiations.

1. Pre-Dispute Waiver of Jury Trial. In Grafton Partners L.P. v. Superior Court, the California Supreme Court unanimously held that contractual pre-dispute waivers of jury trial are unenforceable (36 Cal.4th 944 (2005)). As a result of Grafton, parties cannot waive jury trials simply by including a standard waiver in an agreement before an actual dispute (assuming the agreement is governed by California law). Consequently, parties seeking to avoid a jury trial in the event of future disputes related to a merger or acquisition should ensure that either the agreement is governed by non-California law (such as Delaware or New York, where pre-dispute jury waivers are enforceable) or that a mandatory alternate dispute resolution mechanism is specified.
2. Enforceability of Noncompetition Agreements. Under § 16600 of the California Business and Professions Code (CBPC), any agreement restraining anyone “from engaging in a lawful profession, trade, or business of any kind” is void, unless a statutory exception applies. This limitation has been held to apply broadly and includes both noncompetition and nonsolicitation covenants. The narrow statutory exceptions to the prohibition of noncompetition agreements are set out in §§ 16601, 16602 and 16602.5 of the CBPC. Under these sections, a noncompetition agreement is enforceable only against a seller in connection with any of the following: (i) the sale of the goodwill of a business or the ownership interests in a business; (ii) the sale or dissolution of a partnership or the dissociation of a partner from the partnership or (iii) the sale or dissolution of a limited liability company or the termination of the member’s interest in the limited liability company. Thus, unless the narrow statutory exceptions apply, noncompetition agreements are generally unenforceable in California, even if they contain reasonable time, location and industry limitations. Consequently, parties seeking to enforce a noncompetition agreement involved in a merger or acquisition should ensure that one of the narrow statutory exceptions apply or consider whether the agreement should be governed by non-California law (which may be difficult if the restricted person is a California based employee).
3. California Taxation. California has various taxes that need to be considered when entering into a merger or acquisition. This includes, but is not limited to, the tax impact on all parties when structuring the deal as an asset sale, stock sale, an f-reorganization, etc. The following are a few taxes in California that should be considered:

• S Corporations. California LLCs or corporations that choose S corp. taxation must pay a 1.5 percent state franchise tax on their net income.
• Income. California has nine state income tax rates, ranging from 1 percent to 12.3 percent.
• Capital Gains. California's capital gains tax rates align with its progressive income tax system, ranging from 1 percent to 13.3 percent. The considerations outlined in this two-part series cover only a subset of the issues that can arise in California M&A transactions. Solutions to some of these challenges may involve voting agreements or drag along rights, which function as pre-approvals rather than eliminations of voting rights. Even so, many of these issues can materially complicate negotiations and, in some cases, prevent consummation of a transaction. Life sciences business owners should consult their legal advisors regarding these matters.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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