Avoiding hindsight in non-obviousness determination: case law review of pharmaceutical patents and guidance from the KSR v Teleflex decision

ABSTRACT

Introduction: Hindsight bias is the tendency to estimate an outcome once it is known. Legal systems are often prone to hindsight bias. In patent law, the non-obviousness or inventive step is the most critical determinant of patentability and often subjected to hindsight bias.

Areas covered: Scholarly literature confirms the existence of hindsight bias in different patent systems. This communication hence addresses factors, which lead to hindsight bias specifically in chemical and pharmaceutical arts, guidance from the case law that can be helpful in avoiding hindsight bias in non-obviousness determination.

Expert opinion: The Supreme Court in 2007, advocated a more expansive and flexible approach to where the Teaching Suggestion or Motivation test could come from. In the case of chemical and pharmaceutical active compounds, the considerations such as i) was there sufficient motivation to modify the lead compound and arrive at the claimed compound and its properties, ii) was there a reasonable expectation of success to achieve the claimed property and other such considerations highlighted in this review may contribute to avoid hindsight bias in non-obviousness determination.

KEYWORDS:

• Patent
• pharmaceutical invention
• hindsight
• non-obviousness
• US patent law
• patent law
• chemical inventions

Acknowledgments

The authors wish to take this opportunity to express our deep gratitude to CSIR – Unit for Research and Development of Information Products (URDIP), Pune, India and Academy of Scientific and Innovative Research (AcSIR), India for providing us with the required technical facility support and opportunity to work on this research topic.

Article highlights

• Legal systems such as patent law are often prone to hindsight bias.

• Hindsight bias assumes greater significance during non-obviousness assessments.

• United States Federal Circuit: Teaching, Suggestions, Motivation (TSM) test guards against hindsight bias in non-obviousness determinations.

• United States Supreme Court: TSM test cannot be regarded as the sole test in determining non-obviousness of inventions.

• Unpredictable nature of inventions pertaining to chemical, pharmaceutical, and biological arts assists in defending hindsight bias during patent prosecution or later during an invalidity defence.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.