SmithKline Beecham v. Apotex: The concurrence.
Judge Gajarsa filed a Concurrence in SKB based upon his sua sponte analysis of Section 101. SKB had argued that its claimed compound (PHC hemihydrate) had been seeded in the environment and, once seeded, will naturally contaminate any synthetically made PHC anhydrate.
J. Gajarsa agreed that the manufacture of PHC hemihydrate could be “a natural physical process” occurring “under normal climactic conditions and with no human intervention,” and thus found that it was an unpatentable process of nature.
In short, patent claims drawn broadly enough to encompass products that spread, appear, and “reproduce” through natural processes cover subject matter unpatentable under Section 101–and are therefore invalid.
Finally, the Concurrence derided the Majority’s approach, saying that it has created “unfortunate precedent that will complicate future considerations of the experimental use doctrine.”