Parke-Davis v. H.K. Mulford
189 F. 95 (1911)
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Rule of Law:
A purified and isolated natural substance is patentable if the purification process makes it a new thing commercially and therapeutically, distinguishing it in kind, rather than just in degree, from its impure state in nature.
Facts:
- Scientists discovered the therapeutic, blood-pressure-raising properties of the suprarenal glands, but early medicinal use relied on dried and powdered glands, which were impure and dangerous for injection.
- Numerous researchers, including Moore, Abel, and Von Furth, attempted to isolate the gland's active principle, producing various compounds and salts, but none succeeded in isolating a pure and stable base.
- Dr. Jokichi Takamine developed a process to isolate the active principle of the suprarenal gland, successfully creating a purified, crystalline, and stable substance he named 'Adrenalin'.
- Takamine's Adrenalin was a significant therapeutic and commercial success, largely replacing the previous impure gland preparations due to its purity and effectiveness.
- H.K. Mulford Co. began producing and selling a competing product called 'Adrin,' which was a purified substance derived from suprarenal glands using a similar process and having nearly identical physiological effects to Adrenalin.
- Takamine secured two patents: No. 730,176 for the purified base (Adrenalin), and No. 753,177 for a stable salt solution derived from the base.
Procedural Posture:
- The complainant, Parke-Davis & Co. (holder of Takamine's patents), filed a suit for patent infringement against the defendant, H.K. Mulford Co.
- The suit was brought in the United States Circuit Court for the Southern District of New York, a federal trial court.
- The complaint alleged that the defendant's product, 'Adrin,' infringed upon claims of U.S. Patent No. 730,176 and U.S. Patent No. 753,177.
- The case proceeded to a hearing before the District Judge for a final decision on the issues of patent validity and infringement.
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Issue:
Is a product patent for a purified, isolated, and commercially useful natural substance valid and infringed by a competitor's substantially similar product?
Opinions:
Majority - Hand, District Judge
Yes, the product patent is valid and infringed. A purified natural substance is patentable when the purification makes it, for every practical purpose, a new thing commercially and therapeutically. Takamine was the first to isolate the active principle of the suprarenal gland as a pure, stable base, distinguishing his invention from prior art which consisted of impure compounds or different chemical salts. While the defendant's product, Adrin, has minor differences in purity and melting point, it is substantially the same substance and infringes upon multiple claims of Takamine's patent for the dry product. Likewise, the defendant's salt solution is 'commercially stable' enough to infringe the second patent, as the term should be construed leniently for a pioneer invention that created enormous therapeutic value. The defendant's argument that the patent is invalid as a mere purification of a natural product fails because Takamine’s work was a distinction 'not in degree, but in kind,' creating a new article of manufacture that was commercially and therapeutically transformative.
Analysis:
This landmark decision by Judge Learned Hand established a foundational principle in U.S. patent law, allowing for the patenting of purified natural products. By rejecting the argument that a purified substance is an unpatentable 'product of nature,' the court created a doctrine that spurred innovation in the pharmaceutical and biotechnology industries. The case set the precedent that isolation and purification can constitute invention if the resulting product has new utility and becomes a 'new thing commercially and therapeutically.' This reasoning has been central to the patentability of isolated hormones, vitamins, antibodies, and, for a time, even isolated DNA sequences.
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