## Facts

- Merck owned U.S. Patent No. 2,703,302 claiming vitamin B12-active compositions obtained by recovering “elaboration products” from fermentation by specified microorganisms (Schizomycetes, Torula, Eremothecium) within defined potency ranges.
- Olin, through a division, marketed a vitamin B12 product (“Rubramin”) and obtained the B12-active material from another manufacturer rather than making it via the patented process.
- Merck sued for infringement of the patent’s product claims; the process claims were withdrawn because Olin did not practice the claimed process.
- The district court held the product claims invalid as claiming a “product of nature” and for “lack of invention.”
- Merck appealed.

## Issues

1. Whether the claimed vitamin B12-active fermentation compositions are unpatentable “products of nature” or patent-eligible compositions of matter.
2. Whether the product claims are invalid for “lack of invention” in view of prior art concerning liver extracts, vitamin B12, and related knowledge about B12 activity.

## Decision

- The Fourth Circuit reversed the district court’s judgment of invalidity.
- The court held the asserted product claims valid.
- The court rejected the view that the claims merely covered vitamin B12 as it exists in nature.
- The court also rejected the finding of “lack of invention,” concluding the claimed compositions constituted a patentable advance over the prior art.

## Legal Principles

- A composition derived from natural sources may be patent-eligible when the claim is directed to a human-made product that does not exist in nature in the claimed form and is made available as a distinct, useful composition.
- “Product of nature” analysis turns on what the patent claims: claiming a specific recovered fermentation composition with defined potency characteristics differs from claiming a natural substance in the abstract.
- In assessing “lack of invention” (nonobviousness in modern terms), prior art must make the claimed standardized, commercially useful composition reasonably apparent; recognition of a natural factor and existence of crude extracts do not necessarily render a specific, potent, recoverable fermentation-derived composition unpatentable.

## Conclusion

The Fourth Circuit upheld patent protection for vitamin B12-active compositions recovered from specified microbial fermentations, reasoning that the claims covered a distinct, human-made composition with defined potency and pharmaceutical utility rather than an unpatentable natural product, and that the prior art did not negate patentability on “lack of invention” grounds.


Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958)