Legal insights
Analysis from the front lines of IP & technology law.
Our attorneys write about the developments shaping intellectual property—from the PTAB and the Federal Circuit to the practical realities of protecting fast-moving technology.
Hatch-Waxman Toolkit: Notice Letters, Complaints, and Settlement Considerations
Working templates for Hatch-Waxman practice on both sides. It includes an Orange Book and exclusivity analysis worksheet, a certification decision matrix, a Paragraph IV notice letter with a confidential access offer, a brand 45-day tracker, an ANDA complaint outline, a protective order provision set, a section viii carve-out review and launch materials scrub, an induced infringement evidence log, an IPR estoppel analysis, an at-risk launch memorandum, a settlement term sheet, and an antitrust justification memorandum. Each carries drafting notes on what the document is doing, what the other side will do with it, and where each side most often fails. A closing table collects the clocks that govern the framework and what each runs from. Adapt every template to the product, the patents, and the applicable regulatory pathway.
Hatch-Waxman Litigation: The Orange Book, Paragraph IV Certifications, and the 30-Month Stay
The Hatch-Waxman Act built a litigation system on top of a drug approval statute, and it works by making a paper filing an act of patent infringement. This article explains how the Orange Book listing regime, the four certification options, and the 30-month stay fit together, why a generic filer sues itself into court by sending a notice letter, and what the safe harbor of Section 271(e)(1) does and does not protect. It covers the 180-day exclusivity that drives first-filer behavior, the skinny-label carve-out and the induced infringement exposure that follows it, reverse-payment settlements after FTC v. Actavis, and the counterclaim Caraco created for delisting. It closes with the strategic decisions each side makes and when.
Hardware Supply Toolkit: Manufacturing Agreements, Quality Terms, and Transition Plans
This toolkit provides the working documents of a hardware supply relationship, ordered by when they are used. It opens with a supplier diligence questionnaire built around the questions that actually predict trouble, a term sheet identifying the five provisions worth real negotiating capital, and contract architecture language that stops purchase orders from overwriting the agreement. It supplies a tooling schedule and the unconditional release clause that makes ownership meaningful, forecast zone and allocation terms, a quality agreement outline, a change control form naming plant relocation, and an epidemic failure clause carved out of the liability cap. Later tools cover a supply chain compliance rider, a supplier scorecard, an adequate assurance letter, a termination and transition notice, and a transition project plan. Each item is annotated with the failure it prevents.
Government Data Demand Toolkit: Legal Process Review, Objections, and Notification
This toolkit supplies the working documents a law enforcement response function runs on, in the order it uses them. It provides an intake log, a validation form that catches the defective third of demands, a one-page routing decision tree, and a scope negotiation script that resolves more demands than litigation does. It then gives objection letters for the recurring cases—a subpoena seeking content, a civil subpoena, a section 1782 application, and a foreign government demand—plus an emergency request verification form built around the callback rule that defeats fraudulent requests. Later tools cover nondisclosure order tracking and the customer notification that follows expiry, a preservation tracker, a production cover letter and review sheet, a transparency report template, and the contract clauses the whole program depends on. Each item is annotated with the failure it prevents.
Governing a Controlled Company: A Practical Guide
Governing a controlled company is a different job from governing a widely held one, because the usual accountability mechanism—the stockholder vote—does not work. This guide sets out the architecture that substitutes for it: how to compose a board that a court will respect, how to build a standing conflicts committee before it is needed, how to run a related-party transaction program that survives a books-and-records demand, and how to handle controller compensation. It covers the ongoing administration of a dual-class structure, including sunset monitoring, permitted transfer administration, and disclosure consistency. It closes with succession, the hardest problem a controlled company faces and the one most often deferred.
Going-Private Transaction Checklist
A controller going-private transaction survives litigation or fails on a sequence of decisions made in the first three weeks, most of which are procedural rather than economic. This checklist runs the transaction in order, from the controller's opening letter through committee formation, adviser retention, negotiation, disclosure, and closing mechanics. It flags the ab initio timing requirement, the independence inquiry that listing standards do not answer, and the disclosure items most often omitted. Each section is written to be worked through with dates and initials rather than read.
Going Public: The IPO, the Direct Listing, and What Is Left of the SPAC
Going public is a liability event with a financing attached, and the structures available differ mainly in who bears that liability and who buys the shares. This article explains the registration architecture that governs all of them, the near-strict liability of Section 11 and the due diligence defense that shapes the entire process, and what Omnicare requires of statements of opinion. It then compares the three routes—the underwritten offering, the direct listing after Slack Technologies v. Pirani resolved the tracing question, and the de-SPAC as it exists after the enforcement and market corrections—on the terms that actually distinguish them. It covers the S-1 workstreams, financial statement requirements, the emerging growth company accommodations, communications rules and the quiet period, and lockups. It closes with the public company obligations that begin the day after and the readiness work that should precede everything.
Going Public Toolkit: S-1 Workstreams, Diligence, and Underwriting Terms
This toolkit provides the working documents of an initial public offering, weighted toward the readiness work that determines the timetable. It opens with a readiness assessment scorecard, a financial statement gap analysis built around auditability and staleness, and a capitalization audit that finds the undocumented grants before underwriter diligence does. It supplies a timetable template that assumes a realistic review period, a workstream matrix with named owners, a diligence request list, and a backup binder specification for every factual claim in the prospectus. Later tools cover an opinion statement test applying Omnicare, a risk factor drafting standard, a communications policy running through the lockup, a comment response format, a governance decision memorandum for the choices that last decades, underwriting agreement terms, and a first-quarter readiness calendar. Each item is annotated with the failure it prevents.
Global Patent Portfolio Toolkit: Filing Calendars, National Phase Instructions, and Cost Models
This toolkit provides the working documents that run an international patent program, in the order the program uses them. It supplies a master filing calendar keyed to the priority date, a one-page invention disclosure form engineers will actually complete, a jurisdiction strategy template, and a national phase decision memo that presents ten-year cost rather than entry cost. It also includes an instruction letter to foreign associates that gives business context instead of "please advise," a translation review protocol, an annuity reconciliation worksheet, a portfolio review sheet with real abandonment criteria, a five-year cost model, and a docket transfer protocol for firm changes and acquisitions. Each item carries an annotation explaining the decision behind it and the failure it prevents. Adapt the templates; do not adapt the dates.
Fund Formation Checklist: A Practical Checklist
This checklist runs the full arc of a private fund launch, from the structuring decisions that constrain everything downstream to the first hundred days of operating the fund. It covers exclusion selection and the counting problems each one carries, the entity chain, the ERISA plan asset and commodity pool analyses that get missed, and the adviser registration determination. It then walks the document set, the service providers, the offering exemption mechanics, side letter and MFN administration, closing and equalization, and the recurring compliance calendar. Each item is phrased so it can be marked done, and the ones that are routinely forgotten are flagged.
FRAND Toolkit: Declarations, License Offers, and Rate-Setting Evidence
Working templates for standard-essential patent practice on both sides. It includes a standards exposure register, a supplier licensing inquiry, an implementer willingness response, a patent holder notice letter, an essentiality analysis worksheet, a top-down valuation model, a comparable license normalization table, a supported counter-offer, an escrow and security notice, a negotiation log built for the willingness record, an ITC public interest submission outline, a license term sheet, an arbitration proposal, and a supply agreement indemnity provision. Each carries drafting notes on what a neutral will credit and where each side most often fails. Several templates are designed to be prepared months before they are needed, because the willingness record is built long before any tribunal reads it. Adapt everything to the standard, the portfolio, and the applicable SSO policy and governing law.
FRAND Commitments, Injunctions, and Rate Setting: How Standard-Essential Patents Get Priced
A FRAND commitment is a promise made to a standards body about patents that do not yet exist, to licensees who are not yet identified, at a price nobody has agreed. This article explains how that promise is enforced: what the commitment is as a matter of contract, who can enforce it, the hold-up and hold-out problem it addresses on both sides, and why injunctions against a willing licensee sit uneasily with it. It covers the two dominant valuation methodologies—comparable licenses and top-down apportionment—the royalty base dispute, the essentiality problem, and the negotiation framework courts have built around good faith. It closes with what an implementer and a patent holder each need to do, and when.