Building a Strong Patent Foundation

Intellectual Property Strategy in Biotech Startups: Elements of a Robust Patent

Essential elements of a robust patent strategy can safeguard proprietary innovations and drive long-term value.

New ventures are built on trust. To gain the trust of investors the founder of a startup must prove they can act as a fiduciary partner and competent manager. As such, a founder’s first priority must be to establish, develop and defend the primary assets of their company. For information age startups that primary asset is their Intellectual Property (IP). Creating the IP that generates a competitive advantage is only the first step. To found a company that attracts investor interest you must possess both the legal freedom to operate and the power to enforce your rights as a barrier to competition.

A robust patent filing is essential for securing exclusive rights to innovative technologies, allowing a strategic license agreement, attracting early investment and establishing a competitive edge in subsequent developments leading to full commercialization. This is the pivotal foundation for any startup company seeking to survive due diligence processes while moving towards successful commercialization of their assets.

Robust patents begin with solid experimental unpublished data that substantiates the claimed innovations. In biotechnology, where the path from discovery to commercialization is particularly complex, the quality and comprehensiveness of supporting data play a crucial role in the patent strength. Critical decisions must be made by the principals as early as when considering initial publications of their experimental work for academic purposes.

The Elements of a Strong Defense

The quality of a patent claim depends on a spectrum of issues ranging from the quality of the research to the way it will be used and how and when the patent was filed.  It is important to be aware of the hurdles a new entrepreneur will face.

1. Claim Quality: Building from Reliable Experimental Data

Garbage In = Garbage Out. If you want your data to be respected you need to prove its provenance and value. Solid experimental data is fundamental to strengthening patent applications in biotechnology. Patents are rigorously scrutinized for novelty, non-obviousness, and utility—and robust data provides the necessary evidence to meet these criteria. Demonstrating that the invention works as claimed not only substantiates its credibility but also reduces the risk of objections during the patent examination process. Additionally, crafting specific and carefully worded claims is crucial for protecting the invention. Claims define the legal scope of patent protection and determine what others are excluded from doing. Vague or overly broad claims may be rejected or easily circumvented by competitors, which can weaken the patent’s effectiveness [3].

Developing solid and well-structured claims is essential for biotech patent applications because the claims define the precise legal boundaries of the invention’s protection. In the complex field of biotechnology, where innovations often involve intricate biological processes and compositions, carefully crafted claims ensure that all novel aspects of the invention are adequately covered. Well-structured claims prevent competitors from exploiting ambiguities or designing around the patent, thereby strengthening the patent’s enforceability. Additionally, clear and specific claims facilitate a smoother examination process by helping patent examiners understand the invention’s unique features, which can lead to faster approval and stronger protection of the intellectual property [4].

2. Claim Substance: Composition of Matter vs. Method Claims

An innovation’s patentable “strength” generally lies in novelty or uniqueness. An inventor may create a new way of using an existing innovation or they may invent an entirely new device or compound.

Claims that cover new chemical compositions, formulations, biological compounds or devices: “Composition of matter” claims are among the most significant and powerful types of claims in a patent application, especially in the biotechnology and pharmaceutical industries. These claims protect the actual chemical or biological substances themselves, regardless of how they are made or used. By securing exclusive rights to the composition, the patent holder can prevent others from making, using, selling or importing the patented substance without authorization. This broad protection makes composition of matter claims a crucial element for the long-term legal safeguarding of an asset.

The strength of composition of matter claims lies in their wide scope and enforceability. They offer robust defense against competitors because infringement can occur simply through unauthorized possession or use of the patented substance, irrespective of the specific application or method of production. This contrasts with method or process claims, which only cover specific ways of using or making a substance and can be circumvented if competitors develop alternative methods.

While composition of matter claims are highly valuable, they are not the sole important feature of a patent application. The overall strength and commercial value of a patent portfolio also depend on other factors, such as method of use claims, formulation claims and process claims. These additional claims can provide layers of protection by covering specific applications, combinations or manufacturing processes that enhance the utility and marketability of the invention.  A wise founder will add layers of use case patent protection to existing claims.

Furthermore, the quality of the patent’s disclosure—including detailed experimental data and thorough descriptions—is essential for meeting legal requirements like enablement and written description. Competition or market research should not be ignored. This goes beyond the awareness of market conditions and profitability a potential investor will seek. A well-crafted patent application should address potential prior art to withstand validity challenges and should be strategically structured to cover various aspects of the invention in both the past and future use cases.

3. The Government: USPTO and Regulatory Requirements for Patent Filings

Regulators live in a legalistic world and dealing with them usually involves a degree of legal expertise and lots of paperwork.  Whether a manager chooses to hire counsel or enter the fray personally, it is important to be knowledgeable regarding both lingo and process.

Patent applications in the biotechnology sector generally fall into two primary categories.

• Provisional Patent Application (PPA), which serves as an initial filing that secures an early priority date and permits the use of “Patent Pending” designation. While a PPA must include a detailed description of the invention, it does not require formal claims, oath, or declaration. This provisional filing must be converted to a non-provisional application within 12 months.
• Non-Provisional Patent Application, which represents a formal submission that undergoes USPTO examination and must satisfy all statutory requirements to potentially result in an issued patent. The structure of a non-provisional patent application follows a specific prescribed format, beginning with an Application Data Sheet (ADS) that contains essential bibliographic information such as inventor names, correspondence details, and application particulars.

The path and time between these two types can be incidental or it can be night and day. It is important to know what a provisional patent provides and importantly what it does NOT.

4. A Patent Is Not a White-Paper: Understanding Disclosure and Confidentiality

Patent applications and scientific publications serve distinct purposes and cater to different audiences. Scientific publications advance research by sharing experimental findings, while patent applications are legal documents intended to secure exclusive rights.

In terms of content focus, patent applications emphasize defining the invention’s scope through precise claims and providing detailed descriptions to satisfy legal standards like enablement and best mode. They are carefully worded to distinguish the invention from existing technologies and avoid prior art issues.

Scientific publications, however, focus on presenting data, results and interpretations, discussing hypotheses and theories, and adhering to peer review standards that ensure scientific rigor and methodology. Scientific publications typically adopt an academic writing style that may include subjective interpretations and theoretical discussions. They are organized into standard sections like Introduction, Methods, Results, Discussion and References, and allow for an expressive tone that accommodates hypotheses, opinions and speculative ideas.

The structure and style of these documents also differ significantly. Patent applications are formal legal documents that use precise, unambiguous language to minimize ambiguity. They follow sections defined by statute in a prescribed order and maintain an objective tone that focuses on factual disclosure.

Regarding disclosure and confidentiality, patent applications remain confidential until published by the USPTO—usually 18 months after filing—and require full disclosure of all aspects necessary to practice the invention. Scientific publications, on the other hand, make information publicly available upon publication and may omit certain proprietary details or methods to protect sensitive information or due to space constraints.

The legal implications of patent applications and scientific publications are fundamentally different. When a patent application is granted, it establishes enforceable legal rights that give the inventor exclusive control over the use of the invention. This legal protection is specifically determined by the claims outlined in the patent document, not by the descriptive sections. Moreover, patent applicants are bound by a duty of candor, requiring them to disclose all known relevant prior art to the patent office to maintain the integrity of the patent process.

In contrast, scientific publications do not grant any exclusive legal rights to the authors. Their primary focus is on the proper attribution of ideas and ethical reporting of research findings. Scientific papers are assessed through peer review for their scientific merit rather than legal compliance. They aim to share knowledge and contribute to the advancement of the field without establishing proprietary claims over the content.

5. Timing Matters: The Strategic Importance of Timing in Patent Filings

Timing plays a critical role in the patenting process, especially concerning public disclosures. Patent systems generally operate on a “first to file” basis, meaning that the first individual or entity to file a patent application for an invention holds priority over others. Publicly disclosing an invention before filing can jeopardize patent rights in many jurisdictions due to limited or nonexistent grace periods. Such premature disclosure can render an invention unpatentable because it becomes part of the prior art against which novelty and inventiveness are judged.

For scientific publications, researchers often prioritize the rapid dissemination of their findings to advance knowledge and establish precedence in their field. However, publishing results before securing patent protection can have adverse effects on patentability. A scientific publication can serve as prior art against the researcher’s own patent application, potentially hindering or invalidating the ability to obtain a patent. Therefore, coordinating the timing of patent filings with scientific publications is essential to protect intellectual property rights while still contributing to the scientific community.

Lessons Learned

Securing robust patent protection based on solid data and specific claims is foundational for the success of biotech startups. This is a moment when resourceful scientific language needs to be translated into precise legal documentation. It not only safeguards the company’s innovations but also enhances its attractiveness to investors and partners. Understanding and effectively managing the complex patent filing process, while maintaining strategic flexibility, enables startups to maximize the value of their intellectual assets and achieve their business objectives. Biotech companies must work diligently with renown IP legal firms that have been working within this space for several years. These firms are staffed by dual-degree lawyers (e.g., PhD and JD) who are knowledgeable of the scientific matters and fluent on the legal terms required for proper filings. The long term interactions with the USPTO and the PCT filings requires moderate financial resources and intense intellectual input from the senior management team.

The investment in time, resources and expertise required for effective IP management should be viewed not as a burden, but as an essential component of business strategy. In the dynamic biotechnology sector—where innovation drives value creation—a well-executed IP strategy can provide the competitive advantage necessary for long-term success.

CITED
[1] Lievrouw, Leah A. “Biotechnology, intellectual property, and the prospects for scientific communication.” Biotechnology and Communication. Routledge, 2004. 161-188.
[2] Kesselheim, Aaron S., and Jerry Avorn. “University-based science and biotechnology products: defining the boundaries of intellectual property.” JAMA 293.7 (2005): 850-854.
[3] Brower A. Lack of intellectual property protection worldwide threatens US. Biotechs. Biotechnol Healthc. 2006 Feb;3(1):21-2. PMID: 23424332; PMCID: PMC3571038.
[4] Rimmer, Matthew. Intellectual property and biotechnology: biological inventions. Edward Elgar Publishing, 2008.