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Patent Filing & Litigation

Considering Novelty and Usefulness when Patenting Biotechnology

By January 10, 2022No Comments

Biotechnology Innovation Organization, the industry’s trade organization, keeps its definition of biotechnology simple: “Technology based on biology.” The field encompasses life-changing and life-saving technologies, from detecting and combating disease to growing more nutritious and less vulnerable crops. These products and processes are eligible for patent protection as long as they are novel, non-obvious, and useful—just like other fields of study.

However, the “biology” in biotechnology makes patenting these valuable innovations an IP dilemma. Biotech patents are both controversial and beneficial because of the nature of the field itself. Patenting biotechnology inventions can be a challenge due to:

  • Centuries-old patent laws,
  • Reproduction capabilities of technologies,
  • Varrying complexity of lifeforms,
  • Privatization of traditional knowledge,
  • Biodiversity concerns,
  • Ability to conduct future research,
  • Ethical and religious debates,

…and other concerns. These issues may exist to some extent in other industries. However, many are either unique to or exacerbated when patenting biotechnological inventions. Patent protection allows companies to recover a return on their vast investments in biotech R&D. This incentive exists across industries but, it could be argued, is even more important in biotechnology, where every innovation has the potential to change how we live.

Examining Patentability

Patentability varies from country to country, especially in biotechnology. What is consistent across patent offices is the need to clearly identify novelty and usefulness. These elements of patentability are more complex in biotechnology, requiring additional documentation.


The distinction between an invention and a discovery is hard to define in this field. While it seems to be common sense that no single inventor or assignee should hold a patent on a naturally occurring phenomenon, what if that “biological material” is replicated with a “technical process”? According to the EPO, this type of material is patentable, even “if it previously occurred in nature.” It is up to an applicant to clearly identify how their invention is novel and non-obvious, within the regulations and precedents of the jurisdiction in which they’re applying.


Every patent application must prove the invention at hand is useful enough to be worth patenting. This requirement is magnified when patenting biotechnology. The WIPO states, “exclusive patent rights may be granted only where an appropriate level of concrete and practical use of the biotechnological invention is disclosed in the patent application.” Because of the complexity and unpredictability of biotechnology, more examples and data are required to demonstrate usefulness.

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