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.

LitigationGovernment Enforcement

Bringing or Defending a Qui Tam Case: A Practical Guide

This guide runs a False Claims Act matter from both sides, in the order events actually occur — which for a defendant means beginning before it knows a case exists. It covers recognizing the signals of a sealed qui tam, responding to a civil investigative demand, issuing a hold that reaches the systems where the evidence lives, and running an internal investigation that finds the company's own facts before the government asks about them. It then addresses the two records that decide most cases: the contemporaneous interpretation file that answers scienter after Schutte, and the agency payment history that answers materiality after Escobar. Later steps cover the presentation to the government during the seal, the motion to dismiss, discovery, settlement and its collateral terms, and parallel criminal exposure. Separate steps set out the relator's path and the compliance work that should precede all of it.

Casey Scott McKaySeptember 5, 202629 min read

Intellectual PropertyTrademarks

Brand Licensing Toolkit: License Terms, Quality Programs, and Audit Rights

This toolkit supplies the working documents of a brand licensing program, from the term sheet to the termination notice. It includes an annotated term sheet, model quality control and approval clauses with the drafting reasoning behind each, a product specification schedule outline, a submission and approval form, and a royalty report template designed so the numbers can actually be checked. It also provides an audit demand letter, a licensee scorecard, a franchise law screening memo, a notice of non-conformity and a termination and sell-off notice, a control file index, and a rider for international licenses. Each item is annotated with the failure it prevents, because most licensing failures are operational rather than legal. Adapt the language; keep the architecture.

Casey Scott McKaySeptember 5, 202618 min read

Intellectual PropertyPatents

BPCIA Patent Exchange Checklist: A Practical Checklist

A working checklist for the BPCIA information exchange and the litigation that follows, organized by the statutory day counts. It covers the applicant's pre-filing estate mapping, process design-around, and exclusivity computation, then the dance decision and each step of the exchange with its deadline and its consequence. Later sections address the immediate action, the 180-day notice, the preliminary injunction that replaces the automatic stay, the confidentiality regime and its gaps, the interchangeability decision, at-risk launch analysis, and settlement structuring. A closing section covers the parallel regulatory, PTAB, manufacturing, and commercial tracks. Every item is written so that a "no" tells you what to do next.

Casey Scott McKaySeptember 5, 20269 min read

CorporateCorporate Governance

Books-and-Records Toolkit: Demand Letters, Production Protocols, and Confidentiality Orders

This toolkit supplies the operative documents of a books-and-records matter in drafting-ready form, annotated with the failure each provision prevents. For the stockholder it provides a full demand letter with a purpose statement and bounded categories, a stockholder list demand, and a second-request letter seeking electronic communications. For the company it provides a preservation hold notice, a response letter that negotiates rather than refuses, and a completeness statement. A confidentiality and use agreement with an incorporation-by-reference clause, a production protocol, and a privilege log format complete the set. The annotations focus on the handful of terms that determine whether a production is usable and whether a later complaint survives.

Casey Scott McKaySeptember 5, 202613 min read

CorporateCorporate Governance

Books-and-Records Demands: Section 220, Proper Purpose, and the Documents You Actually Get

A books-and-records demand is the cheapest and most consequential tool a stockholder has, and Delaware has spent two decades calibrating how much it should yield. This article explains what a stockholder must show to obtain inspection, how the "credible basis" standard actually operates, and why the scope fight now matters more than the entitlement fight. It works through the categories of documents courts order produced, the increasingly contested question of when emails and text messages are available, the confidentiality restrictions that accompany production, and the incorporation-by-reference consequence that makes produced documents part of a later complaint. It then covers the defense side, where the strategic question is rarely whether to produce but how much, how fast, and on what terms. Worked examples follow a demand from letter through production and into the derivative complaint it enables.

Casey Scott McKaySeptember 5, 202628 min read

CorporateCorporate Governance

Books-and-Records Demand Checklist

A books-and-records demand succeeds or fails on details that are easy to get right and easy to overlook. This checklist covers the stockholder's side from standing evidence through category drafting and service, then the company's side from the day-one preservation hold through the honest assessment, the board briefing, and the scope negotiation. Separate sections cover the production itself, including privilege handling and the completeness statement, and the post-production steps for each side. It also covers stockholder list demands and director inspection demands, which run on different rules. A red-flag section identifies the defects that cost weeks.

Casey Scott McKaySeptember 5, 20269 min read

Business and CorporateMergers and Acquisitions

Board Sale Process Checklist: A Practical Checklist

A working checklist for a board selling the company, sequenced the way a reviewing court will read the record. It begins with the standard of review determination and the conflicts mapping that must happen in week one, then covers committee formation and empowerment, advisor selection and conflicts disclosure, the market check, projections discipline, negotiation, deal protections, and the proxy. A separate section walks the MFW sequence for controller transactions, where an ordering error forfeits the protection entirely. Closing sections address private company adaptations, the documentation file, and a pre-signing sign-off. Every item is written so that a "no" tells you what to do next.

Casey Scott McKaySeptember 5, 202611 min read

Intellectual PropertyPatents

Biosimilar Litigation Toolkit: Disclosure Lists and Preliminary Injunction Briefing

Working templates for BPCIA practice on both sides. It includes a patent estate mapping worksheet, a process design-around record, a dance decision memorandum, a manufacturing process disclosure scope guide, a supplemental confidentiality agreement, a sponsor patent list format, detailed statement outlines for both sides, a list exchange worksheet, a 180-day notice, preliminary injunction and opposition outlines with an irreparable harm evidence plan, an at-risk launch memorandum, a settlement term sheet, and a day-count calendar. Each carries drafting notes on what the document does, what the other side will do with it, and where each side most often fails. A closing day-count calendar ties the statutory deadlines to the parallel regulatory, PTAB, and commercial tracks. Adapt every template to the product, the patent estate, and the regulatory posture.

Casey Scott McKaySeptember 5, 202618 min read

Intellectual PropertyPatents

Biologics and the BPCIA: The Patent Dance, Biosimilar Approval, and Exclusivity

Congress gave biologics their own version of Hatch-Waxman and made almost every part of it different. This article explains the Biologics Price Competition and Innovation Act: the abbreviated 351(k) pathway, the twelve-year reference product exclusivity, the interchangeability designation, and the elaborate private information exchange known as the patent dance. It covers what the Supreme Court held in Sandoz v. Amgen about whether the dance is enforceable and when the 180-day notice of commercial marketing may be given, why biosimilar makers face patent thickets rather than a short Orange Book list, and how preliminary injunction practice replaced the automatic stay. It closes with the strategic decisions each side makes and why so few of these cases reach judgment.

Casey Scott McKaySeptember 5, 202629 min read

Government ContractsBid Protests

Bid Protests at GAO and the Court of Federal Claims: Standing, Timeliness, and the Record

A bid protest is federal litigation conducted on a clock measured in days, on a record the agency assembles, in a forum you must choose before you know what happened. This article explains the three forums and how they differ, who has standing to protest, and the timeliness rules that dispose of more protests than the merits ever do. It covers the CICA automatic stay and why the five- and ten-day windows govern the entire strategy, the standard of review and the prejudice requirement, and how a protest is actually decided on a paper record with almost no discovery. It then works through the common protest grounds, the corrective action that resolves most successful protests, the jurisdictional traps for size protests and task orders, and the position of the awardee who intervenes. A running example follows one company through a protest it filed and one it defended.

Casey Scott McKaySeptember 5, 202629 min read

Government ContractsBid Protests

Bid Protest Toolkit: Protest Grounds, Agency Reports, and Corrective Action

This toolkit supplies the working documents of a bid protest, from the debriefing request sent on day one to the costs claim filed after a sustained decision. It includes a protest calendar that separates the merits deadline from the shorter automatic stay window, a same-day debriefing request letter, a structured debriefing question set, a forum selection matrix, and a catalog of protest grounds ranked by how often they produce relief. It then provides a GAO protest outline, an evaluation comparison table that makes disparate treatment visible, an agency report review protocol, a comments outline, an intervenor filing outline, a corrective action assessment, and a protest costs claim template. A final tool is the one-page playbook a contractor should adopt before the next unsuccessful-offeror notice arrives. Each item is annotated with the failure it prevents.

Casey Scott McKaySeptember 5, 202616 min read

Government ContractsBid Protests

Bid Protest Checklist: A Practical Checklist

This checklist runs a bid protest by the clock, because the clock is what decides most of them. It opens with the first day — the debriefing request and the one-page calendar that separates the merits deadline from the shorter automatic stay window — then covers debriefing preparation, the standing and timeliness screens, and the forum decision. Later sections cover drafting the protest, the protective order, a working method for reading the agency report, the comments and supplemental protest round, corrective action, and the decision and costs claim. Separate sections give the awardee's intervention checklist, the specialist tracks for size and task order protests, the pre-award protest, and the playbook a contractor should have written before the notice arrives. Every item is written so a "no" tells you what to do next.

Casey Scott McKaySeptember 5, 202612 min read