How does commercial availability affect the determination of whether a biological material is known and readily available?

Commercial availability can be a factor in determining whether a biological material is known and readily available, but it’s not always sufficient on its own. According to MPEP 2404.01:

“The Office will accept commercial availability as evidence that a biological material is known and readily available only when the evidence is clear and convincing that the public has access to the material.”

However, the MPEP also notes some limitations:

• A product could be commercially available but only at a price that effectively eliminates accessibility.
• The relationship between the applicant and the commercial supplier is a factor to consider.
• The mere fact that the biological material is commercially available only through the patent holder or their agents doesn’t necessarily mean it’s not readily available, unless there’s reason to believe access would later be improperly restricted.

Therefore, while commercial availability can be evidence of accessibility, it must be evaluated in context to ensure true public access to the biological material.

To learn more:

• biological material
• patent application
• commercial availability
• public accessibility