Patent Strategy 101

Insights from a Webinar by Dr. Zachary S. Wiersma

This article is adapted from a webinar presented in September 2025 by Zachary S. Wiersma, Ph.D., an associate attorney at Armstrong Teasdale LLP.

For scientific entrepreneurs, few topics are more important than a strong patent strategy. However, for the non-initiated, the patent world can be confusing. Dr. Zach Wiersma brings his experience as a Ph.D. in chemistry and a seasoned experienced patent agent to his current role at Armstrong Teasdale LLP. In a recent webinar with Analytical Chemistry Startups he shared a framework for thinking through patent decisions systematically.

His firm’s patent prosecution practice serves some of the world’s largest companies, university tech-transfer programs, research facilities, and technology incubators. The team includes more than 50 lawyers and patent agents registered to practice before the U.S. Patent and Trademark Office or the European Patent Office. They work across an extraordinarily diverse range of technologies—from ablation technology and aerospace design to wind energy and wound care, spanning diagnostic systems, chemical formulations, data storage, pharmaceutical compositions, robotics, and hundreds of other specialized areas.

Wiersma organized his presentation around six fundamental questions: Who, What, When, Where, Why, and How. Together, these questions form a practical framework for building patent strategy from the ground up.

Who: Understanding Entities and Fee Structures

Before you file your first application, it's essential to understand how the USPTO classifies applicants. This classification directly impacts your filing costs, and applying to  the right category can save thousands of dollars.

The patent system recognizes three entity types. Large entities—typically major corporations—pay full fees with no discounts. Small entities, which include universities, non-profit research organizations, and startups with fewer than 500 employees, receive approximately 60% discounts on USPTO fees. This is where most early-stage companies will find themselves. Micro entities receive the most substantial discount at 80% off standard fees, but the qualification requirements are strict. To qualify as a micro entity, you must be an inventor who has filed fewer than five patent applications and whose gross income is less than three times the median U.S. household income. 

The data tells a compelling story. Over the past decade, both micro and small entity filings have represented significant portions of USPTO applications, demonstrating how critical these fee structures are to individual inventors and startups entering the patent system.

What: Patent Rights and Strategic Considerations

Understanding what a patent actually provides is foundational to any IP strategy. Patents provide the inventor or applicant with a monopoly—a set of exclusive rights for a limited period of time in exchange for public disclosure of the invention.

Here's the crucial distinction that trips up many first-time filers: owning a patent does not confer the right to practice or use the invention. Instead, it provides the right to exclude others from making, using, selling, or importing the invention for the term of the patent (20 years in the United States). This right can be sold, licensed, mortgaged, assigned, transferred, given away, or even abandoned, making patents versatile business assets beyond their protective function.

Before filing any application, startups need to ask several strategic questions: What is the purpose of this application? What is the end goal? Should we even be filing this application at all?

Filing for a patent is not the only way to protect an invention. An alternative method is trade secret protection, which can offer indefinite protection without the costs and public disclosure requirements of patents. However, a tradeoff is the requirement of maintaining actual secrecy. The decision between patent protection and trade secret protection is one that deserves careful consideration.

Patent strategy generally falls into three categories. An offensive strategy focuses on protecting your own intellectual property with appropriately scoped claims. A defensive strategy aims to cover competitors' IP, creating barriers that prevent them from dominating key markets. A marketing strategy recognizes that patents strengthen company valuation and credibility, particularly when courting investors or negotiating partnerships.

Types of Patent Applications

The U.S. patent system offers several application types, each serving different strategic purposes.

U.S. Provisional Applications provide a one-year runway to file a non-provisional application. These applications establish a filing date but do not mature into issued patents themselves. They serve as a "holding place" for a later non-provisional or utility application. A provisional application includes a specification with figures when needed, but no claims are required.

U.S. Non-provisional/Utility Patent Applications offer 20-year protection from the filing date. These are the applications examined by the USPTO that can mature into issued patents. They include a complete specification with figures when needed, plus formal patent claims.

U.S. Design Patent Applications provide 15-year protection for any new and nonobvious ornamental design for an article of manufacture. These patents protect only the appearance of an article, not its structure or function. Design patents allow for only one claim, and the term is based on the date of grant. A notable change occurred on May 13, 2015, when the term shifted from 14 to 15 years.

U.S. Plant Patent Applications cover asexually reproduced distinct and new varieties of plants, offering 20-year protection. This category includes algae and fungi but excludes bacteria.

When: Timing Your Patent Strategy

The patent process follows a predictable arc: from that initial "Eureka!" moment through invention disclosure, patent application, assignment of rights, patent grant, and potentially licensing. But understanding when to file—and what happens once you do—requires careful attention to both legal requirements and practical realities.

The fundamental rule is straightforward: file prior to any public disclosure of your invention. The exceptions are narrow and specific—you can disclose under a nondisclosure agreement or other confidentiality arrangements without jeopardizing your rights, but these protections must be in place before disclosure occurs.

You should file when the invention is defined in sufficient detail that someone skilled in the art could repeat it. The invention does not have to be perfected, and you don't have to test all possible embodiments before filing. What matters is whether the disclosure is enabling—whether it teaches enough for reproduction.

The invention disclosure form becomes your key documentation tool. It captures the technical details and establishes when the invention was conceived, providing the foundation for your patent application.

Patience is mandatory in patent prosecution. The process typically takes 18 to 60 months or longer in the USPTO from filing to grant. During this time, your application exists in "pending" status.

Publication typically occurs 18 months after filing, making your application—and the technology it describes—publicly visible. For startups operating in competitive markets or stealth mode, this public disclosure can be problematic. You can request non-publication to keep your application secret for competitive purposes, though this decision may affect damages available for later infringement claims.

The foreign patent process varies significantly by country. Some jurisdictions follow procedures similar to the U.S., while others operate quite differently. The expenses can be substantial—translations, separate U.S. counsel and foreign counsel, and local filing fees all add up. Some countries require no prosecution at all; patents effectively "grant" upon filing, with validity determined only if challenged in litigation later.

Where: Application Filing Strategy

Patents are territorial by nature, requiring separate protection in each jurisdiction where you want enforceable rights. This reality forces startups to make strategic decisions about geographic coverage early in the process.

The fundamental questions are practical: Where will we plan to sell products? Do we have a plan and strategy to protect our IP in those countries? Remember that separate patent offices mean separate protection—your U.S. patent provides no coverage in Europe or Asia.

Foreign associates become critical partners in this process. Do we have foreign law firms in target countries who can assist with prosecution? What will they cost? How do we enforce our rights in those countries if infringement occurs? These questions should be answered before filing, with a clear plan in place for each application. Being aware of the costs upfront prevents unpleasant surprises during the national phase.

International Filing Strategy

The Patent Cooperation Treaty (PCT) offers a streamlined approach to international protection. A PCT application provides a unified procedure for filing patent applications to protect patentable inventions in each of the 153 contracting states, which include the United States, European Patent Office countries, Japan, China, and most major economic regions.

However, it's essential to understand what the PCT does not do. A PCT application will not result in the grant of an “international patent.” In fact, there is no such thing as an international patent. Instead, the PCT provides a single filing date and defers the expensive process of nationalizing your application in individual countries.

After filing a PCT application, you eventually enter the national phase, where the application may be “nationalized” in any participating country you choose. Alternatively, patent applications may be filed directly in individual countries without using the PCT route.

Why: Competitive Strategy

Patent strategy extends far beyond filing your own applications. Understanding the competitive landscape—who holds what rights, where vulnerabilities exist, and what opportunities remain unexplored—often matters more than the strength of your own portfolio.

Competitor Awareness

Are we aware of who else is operating in or around our fields? This seemingly simple question demands systematic attention. Have we done our due diligence to see what IP competitors may have? Are they litigious companies known for aggressive enforcement, or do they tend toward licensing and partnerships?

Strategic claiming requires anticipating competitor moves. What products might they move into, and how do we block them with our claiming strategy? Equally important: How easily could they navigate around our claims to achieve a similar result as our patented inventions? If your claims are too narrow or obvious to design around, they provide little practical protection.

Freedom to Operate

Freedom to operate (FTO) analysis addresses a fundamentally different question than patentability. You might have a perfectly novel, non-obvious invention that qualifies for patent protection, yet still be unable to commercialize it without infringing someone else's existing patents.

Are we aware of IP owned by competitors? Have we compared our products to the competitors' IP? FTO clearance asks: Are we clear to operate, or do existing patents block our path? If obstacles exist, can we make modifications to our product design or process that would avoid infringement while maintaining commercial viability?

Validity Assessments

Competitor patents aren't necessarily as strong as they appear. How strong are the granted patents of our competitors? How likely are the pending claims in their applications to actually grant? These questions often arise as a follow-up to FTO analysis when you've identified potentially problematic IP.

Can we create invalidity positions for any patents that might block us? Inter Partes Review (IPR) provides a powerful tool for challenging patent validity. If we had to, could we file an IPR and win? An IPR is a trial proceeding conducted at the Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims in a patent, but only on grounds that could be raised under §§ 102 or 103 (anticipation and obviousness), and only on the basis of prior art consisting of patents or printed publications.

The proceeding is instituted upon a showing that there is a reasonable likelihood that the petitioner would prevail with respect to at least one claim challenged. This represents a proactive strategy—you can develop an invalidity position to save for a rainy day or use as a negotiation tactic when discussing licensing or settlement.

Whitespace Analysis

Whitespace analysis uses research to uncover new opportunities to target. It provides a comprehensive landscape of areas that have been targeted by existing patents and, critically, which areas haven't been explored yet.

This analysis serves multiple purposes: enhancing competitor awareness, identifying potential licensing opportunities, informing your own use and enforcement strategies, and using the data to try combinations and products that haven't been done before. By mapping what's already protected, you can spot gaps where innovation remains unclaimed, potentially revealing entirely new product directions or R&D strategies.

How: Special Programs and Acceleration Options

The USPTO offers several programs that can either reduce costs or accelerate examination for qualifying applicants. Understanding these options can provide significant advantages, particularly for resource-constrained startups.

The USPTO Pro Bono Program serves inventors earning less than three times the federal poverty level, connecting them with volunteer patent attorneys who can assist with the application process at no charge. 

Track One Prioritized Examination aims to complete prosecution within 12 months rather than the typical 18 to 60-month timeline. The program requires additional fees: $4,200 for large entities, $1,680 for small entities, and $840 for micro entities. 

Petition to Make Special allows small entities to request expedited examination under certain qualifying circumstances. These include applicant age, health conditions, or inventions addressing specific subjects of public importance like energy efficiency or cancer treatment.

The Climate Change Mitigation Pilot Program provides faster examination until the first office action for inventions that demonstrably contribute to reducing greenhouse gas emissions or addressing climate change. This program recognizes the societal value of environmental innovations.

The Patent Prosecution Highway (PPH) Program enables accelerated examination based on corresponding prosecution in other patent offices. If your application has received favorable examination results in a participating foreign office, you may be able to fast-track examination in the U.S. (or vice versa), leveraging work already completed by another office.

Case Studies

Seeing these principles in practice helps clarify how patent strategy evolves with company growth and changing competitive circumstances.

Startup A: Diagnostic Analysis Instrumentation

This company initially took a conservative approach, filing limited patents focused on methods of making their instrumentation. Over time, they implemented a comprehensive overhaul of their IP strategy built around regular IP disclosure meetings where technical teams systematically shared emerging innovations with counsel.

They conducted whitespace analysis to identify unexplored areas in their technology landscape and shifted their focus toward different markets that showed promise. The result was a new generation of patent applications covering next-generation technologies, creating a more forward-looking and strategically positioned portfolio.

Startup B: Pharmaceuticals

This pharmaceutical company, operating in the pre-approval phase, understood that regulatory timelines would extend for years. They built a comprehensive global patent portfolio early, recognizing that international coverage would be essential for their business model.

They leveraged this global patent portfolio to secure foreign partnerships, using their IP position as a key asset in negotiations. As the competitive landscape evolved, they shifted to filing defensive patents designed to block competitors and strengthen their negotiating position in potential licensing discussions.

Summary

As Wiersma emphasized throughout his presentation, patent strategy is multi-faceted. There is no one-size-fits-all approach that works for every company, technology, or market situation. What matters most is recognizing that patent prosecution requires consistent strategic evaluation—not a single decision at founding, but an ongoing process of assessment and adaptation as your technology, competitive landscape, and business objectives evolve.

The six questions—Who, What, When, Where, Why, and How—provide a framework for that continuous evaluation, ensuring that your patent strategy remains aligned with your broader business goals and competitive realities.