Biotech Insights - December 2025

Prosecuting Bispecific Antibody Patents Worldwide: A Fine-Dining Guide for Patent Chefs

By: Benjamin Pelletier

Introduction

A client calls and says, “We’re cooking up a bispecific antibody. We want to mix and match binding sequences like a molecular gastronomy tasting menu. Some will go into CAR-T dishes. And of course, we want patents everywhere—from the United States to Latin America to the Persian Gulf. What ingredients do you need?”

If this sounds familiar, welcome to the Michelin-starred madness of bispecific antibody (bsAb) patenting, where every jurisdiction is a different kitchen with its own rules, recipes and temperamental food critic extraordinaire—aka patent examiner.

Claim Language: Mise en Place Matters

The fundamental ingredient of any antibody claim is the binding domain—your CDR sequences. Whether you’re plating heavy/light chain pairings or serving heavy-chain-only tapas, a proper patent menu should include:

• The exact CDR set (the “signature dish”);
• A 95% identity variant of the variable region (the “seasonal variation”); and
• The full variable region at 100 percent identity (the “chef’s original”).

For multispecific antibodies with unusual architecture—binding units tucked between domains like amuse-bouches between courses—describe each polypeptide subunit from N-terminus to C-terminus. Identify each binding unit by target, format, location and CDR composition. Don’t forget any mutations that affect effector function, heterodimerization or purification—these are your secret sauces.

Round it out with full-length sequence claims: the tasting menu from first bite to final dessert.

For CAR-T dishes, treat the extracellular binding domain as the key flavor component. If a jurisdiction refuses claims involving “cells,” simply present the CAR or its encoding polynucleotide—same dish, just as a deconstructed bento box.

Supporting Data: Restaurant Critics are Everywhere

Patent offices, especially in Europe, want evidence—not promises—that your new antibody sequence tastes better than the prior art. Novelty alone won’t win you a star. You will need data showing technical effect, such as:

• Stronger binding (umami!);
• Better specificity (no off-notes);
• Improved epitope targeting (precise plating);
• Agonism/antagonism shifts (controlled seasoning);
• Therapeutic improvements (the customer feels great afterward);
• Reduced toxicity (no one gets food poisoning); or
• Changes in ADCC/CDC (enhanced “bite”).

Since more jurisdictions are adopting Europe’s standards, gather your data early—before the examiners start acting like judges on a culinary competition show and saying you only made 11 of the 12 requested opera cakes.

Method-of-Treatment Claims: International Menu Translations

In the U.S., you can serve method-of-treatment claims straight from the kitchen. Elsewhere, the maître d’ insists on Swiss-type claims, first-medical-use phrases or second-medical-use formats. Write your specification like an international menu so you can plate whichever format each jurisdiction demands.

Prosecution Strategy: Avoiding Double-Patenting Kitchen Chaos

Each country’s patent prosecution is its own kitchen, complete with its own version of double-patenting health codes. A reliable recipe:

1. Serve the product claims first—those reciting both binding units by sequence.
2. Then bring out the broader platform claims—those featuring only one binding unit by sequence, and generically referencing the other, e.g., “a second binding unit that binds to a tumor associated antigen (TAA).”
3. Add provisos to the platform claims to carve out combinations already claimed in the parent, e.g., “…provided the second binding unit does not bind Target 2.”

It is the patent equivalent of keeping two dishes distinct so the reviewer does not accuse you of serving the same entrée twice.

Conclusion

Prosecuting bsAb patents is like running a high-end kitchen: you need precise ingredients (claims), impeccable flavor combinations (data) and a menu tailored to each region’s preferences (jurisdictional formats). But above all, stay close to your development team—they’re the sous-chefs who know what is really cooking. The sooner you start collaborating, the less likely you will have a kitchen fire during your dinner service!

Key California M&A Considerations for Life Sciences Businesses: Part 1

By: Martin Florman, Paul Tobin and Daniel Dubyak

Whether you plan on “doing business” in California, selling a business in California, acquiring a business that is a California entity or merging with a business that is in California, the process may appear straightforward. However, business owners, including those in the life sciences industry, commonly overlook multiple issues and considerations related to California.

This is the first article in a two-part series addressing a few key items that life science business owners should consider when dealing with a merger or acquisition in California. Part 1 addresses approval mechanics, corporate governance requirements, minority protections, dissenters’ rights, California’s permit and fairness hearing process and the quasi-California corporation “long-arm” regime. Part 2 will address dispute resolution considerations, the enforceability of restrictive covenants and tax issues that frequently affect deal structure and negotiation.

• Separate Class-Vote Requirement for Shareholder Approvals. In California, a majority vote of all the outstanding shares taken as a whole is not sufficient for approval of a merger; a majority of each class must approve. Moreover, the Cal. Corp. Code does not contain any provision allowing California corporations to waive the separate class-vote requirement. Consequently, any shareholder or group of shareholders holding the majority of one class of shares can potentially block a proposed merger transaction, notwithstanding the transaction’s approval by the corporation’s board of directors and other shareholders holding the majority of the corporation’s outstanding shares on a combined basis.

• Number of Directors for Board Approvals. The number of directors must be either a specified number or a range identifying an acceptable minimum and maximum number of directors. Subject to certain exceptions (outlined below), the minimum number in a range cannot be less than three and the maximum number cannot exceed the minimum by more than two times the minimum minus one (e.g., not less than three nor more than five). There may be one director only if there is one shareholder. Additionally, there may be two directors only if there are no more than two shareholders. Consequently, if an entity that is formed in California is not in compliance with Cal. Corp. Code § 212(a) prior to entering into a merger or acquisition, that entity may not have obtained the proper approval to enter into a merger or acquisition.

• Prohibition on Cash-out of Minority Shareholders. The Cal. Corp. Code prohibits “freeze-outs” or “cash-outs” of the minority shareholders by the majority shareholders. § 1101 of the Cal. Corp. Code requires the unanimous approval of all other target shareholders for a merger if, at any time prior to the merger, the ultimate purchaser of the California target corporation became an owner of more than 50 percent but less than 90 percent of the target’s outstanding shares. The Cal. Corp. Code does allow for the possibility of completing the merger without the unanimous approval of the minority shareholders if the California Commissioner of Corporations approves the fairness of the merger at a hearing, but most purchasers would rather avoid the additional delay and uncertainty of a hearing. However, if the purchaser holds more than 90 percent of the target’s outstanding shares prior to the merger, it can complete a short-form merger without any need for separate minority-shareholder approval (as is the case in Delaware). Consequently, any shareholder or group of shareholders that are not the shareholder(s) holding more than 50 percent but less than 90 percent can potentially block a proposed merger transaction, notwithstanding the transaction’s approval by the corporation’s board of directors and shareholder(s) holding more than 50 percent but less than 90 percent.

• Dissenting Shareholders’ Rights in Merger Transactions. A shareholder of a California target corporation who opposes a merger transaction can demand that the corporation purchase its shares for “fair market value.” The California Court of Appeal has ruled that in no event can a dissenting shareholder make a claim for monetary damages out of its opposition to the merger (Busse v. United Panam Fin. Corp., 2014 WL 60551 (Cal. App. 4th Dist. Jan. 8, 2014)). However, if the merger is a short-form merger involving two parties under common control, a dissenting shareholder can sue under § 1312(b) of the Cal. Corp. Code to rescind the merger. Consequently, if the dissenting shareholder and the corporation do not agree on whether it is entitled to exercise its appraisal rights or on the fair market value of its shares, the shareholder can bring an action in court to resolve those questions.

• § 25142 Permit and Hearing Process. A purchaser’s shares issued and exchanged in connection with an acquisition transaction need to be registered with the Securities and Exchange Commission, unless the issuance is exempt from federal and state registration. However, in California, registration may not be necessary, even if an exemption under § 4(2) or Regulation D is not available. California is one of a few states to have its own permit and hearing process for the qualification of the securities to be issued and exchanged in an acquisition transaction. The permit and fairness hearing process can be used if either the purchaser or the target is incorporated in California or has a meaningful presence in California. This process is favored by California practitioners under the appropriate circumstances, including but not limited to companies involved in a merger or acquisition transaction that has high federal registration costs (the process provides a fast and cost-efficient alternative to federal registration, saving companies hundreds of thousands of dollars in federal registration costs). Under this procedure, a purchaser wishing to issue shares in connection with an acquisition transaction can apply for a permit from the California Commissioner of Corporations and request the commissioner to hold a hearing to determine the fairness of the terms and conditions of the issuance and exchange of shares. After completing the fairness hearing and receiving approval from the commissioner, the purchaser may qualify for the following exemptions: (i) registration under § 3(a)(10) of the Securities Act of 1933, (ii) certain requirements for corporate merger transactions under Cal. Corp. Code §§ 1101, subd. (b), 1101.1 and 1113, subd. (c), and/or (iii) the requirement for approval by 90 percent of the outstanding shareholders before or after the board approves the sale, lease, conveyance, exchange, transfer or disposal of all (or substantially all) of its assets under Cal. Corp. Code § 1001. The § 25142 permit and hearing process typically saves a purchaser the significant time and expense necessary for registration and should be considered if available.

• § 2115 of the Cal. Corp. Code – Long-arm Statute and Quasi-California Corporations. § 2115 of the Cal. Corp. Code purports to require certain private corporations incorporated in foreign jurisdictions to comply with various requirements of the Cal. Corp. Code normally applicable only to corporations incorporated in California. A foreign private corporation is subject to § 2115 if (i) more than half its business during its latest full income year is conducted in California, as measured by a statutory formula weighing assets, payroll and sales factors, and (ii) more than 50 percent of its outstanding voting securities are held of record by California residents. To these “quasi-California corporations,” § 2115 attempts to apply a host of Cal. Corp. Code provisions to the exclusion of the law of the jurisdiction in which the corporation is incorporated. Consequently, this often complicates a deal involving a private target that is headquartered or otherwise has a significant presence in California but is incorporated elsewhere, because it forces the parties to comply with potentially conflicting laws of California and the target’s state of incorporation.

This above list covers just a few of the key issues and considerations. California’s approval mechanics, minority protections, state-specific securities and quasi‑California rules can materially affect feasibility, timing and deal terms—particularly for life sciences companies with complex cap tables and regulatory timelines. In Part 2, we turn to dispute‑resolution planning, the enforceability of restrictive covenants and California‑specific tax considerations that frequently drive structure and negotiations. Stay tuned for Part 2 to see how these issues interact with—and build upon—the topics covered above.

Strategies to Consider with USPTO's New Fast-Track Examination Pilot Program

By Kalyani Joshi Jeffrey Morton Ph.D.

On Oct. 27, 2025, the U.S. Patent and Trademark Office (USPTO) announced it is offering a Streamlined Claim Set Pilot Program in an effort to further accelerate examination of currently pending applications with a limited number of claims. This Pilot Program supplements the Track One program, which remains in place.

To qualify, a patent applicant must file a timely petition to make special under this new Pilot Program. Based on the limited information in the Federal Register Notice that announced the Pilot Program, there are some unanswered questions about the Pilot Program, but the essentials are as follows:

• The applicant must have filed an original (non-reissue), noncontinuing utility application before Oct. 27, 2025. Importantly, national stage applications filed under 35 U.S.C. § 371 are not eligible.
• A petition to make special must be filed prior to the issuance of a first office action (which includes a written restriction requirement). As noted in the Federal Register Notice, the USPTO will generally dismiss petitions filed after the application has been docketed to an examiner at the time the petition is up for decision.
• The application must contain no more than one (1) independent claim, and no more than ten (10) total claims. A preliminary amendment may be filed before or with the petition to qualify for the Pilot Program.
• The application cannot contain multiple dependent claims, and the dependent claims must be directed to the same statutory class of invention as the independent claim.
• No inventor/joint inventor can be named as the inventor/joint inventor on more than three (3) other nonprovisional patent applications in which a petition under this Pilot Program has been filed.
• Any non-publication request must be rescinded.

The Pilot Program will accept petitions through Oct. 27, 2026, or until each Technology Center that examines utility applications has docketed at least 200 applications into the Pilot Program. The petition to make special must be filed with a $150 fee ($60 for small entities).

Applications accepted by the USPTO into the Pilot Program will receive expedited examination for the first office action only; after the first office action (including any written restriction requirement), the application will return into the examiner’s regular docket. The agency may consider as non-responsive any later amendments that violate the Pilot Program’s claim limits or dependency format.

Comparison to the Track One Prioritized Examination Program

While both the Pilot Program and the Track One Prioritized Examination Program (Track One) offer avenues for expedited examination, there are a few key differences of note between these programs.

Notably, Track One has broader eligibility requirements. It accepts a maximum of four independent claims, 30 total claims and no multiple dependent claims at the time the USPTO reviews the request to participate in the Track One program. Furthermore, Track One accepts original, non-provisional utility and plant patent applications – including, for example, continuation applications that are not eligible for the new Pilot Program.

While the fees for the Track One are significantly higher (currently $4,515 for a large entity; $1,806 for a small entity), an application receives prioritized examination during the full course of prosecution under Track One – unlike the Pilot Program, which offers a faster examination speed through the first office action only.

Strategic Considerations

The Pilot Program may prove to be useful for a patent applicant that has a smaller budget, a focused claim set and would benefit from an expedited patent prosecution.

Startups or smaller companies may benefit from rapid allowance through the Pilot Program for an application meant to prove up or launch new products, help raise capital by spurring investor confidence or to get patent protection ahead of various licensing agreements. While Track One offers fully expedited examination, the Pilot Program provides a lower cost option to applicants that:

1. May not have the resources to file under Track One; or
2. Are operating in the early stages of a new market and may not see the value of expediting examination past the first office action.

Applicants should consider whether filing under the Pilot Program may be sufficient for a lead embodiment – for example, for a life science company, a lead compound. Expedited allowance of that lead embodiment, followed by continuation application filings for the remaining (and potentially broader) embodiments may be an ideal avenue to rapid commercialization of lead products, while still maintaining patent protection for other embodiments and the ability to delay prosecution if needed. The slower examination rate of the Pilot Program relative to the Track One may also be ideal for applicants looking for initial feedback from the USPTO while maintaining sufficient time to craft a broader patent family through such continuation applications for other embodiments.

Though the Pilot Program is limited to applications filed before Oct. 27, 2025, because applicants may file a preliminary amendment to present an eligible claim set under the Pilot Program, applicants should carefully review their pending applications to identify potential embodiments that may benefit from review under the Pilot Program, as well as fallback embodiments in the application to pursue later in prosecution.

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