This is the Patent Claim At Issue - This Is The One That They Are Fighting Over
United States Patent 4,940,658
Claim 13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.
Very broad - and I would say bordering in "indefinite". The Patent Code requires that
35 U.S.C. 112 Specification.
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
And I don't think claim 13 passes that statutory test.
This is Claim 1 - which really defines their invention. It is not at issue before SCOTUS - and they are collecting royalties. Claim 1 describes the "invention" - and I emphasize "invention" because the US Constitution provides (Article I, Section 8)
To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. and claim 13 doesn't describe an invention.
US Patent 4,940,658
Claim 1
1. A method of assaying for the amount of one or more sulfhydryl amino acid species present in a given sample, said method comprising:
(a) combining said sample with an internal reference standard comprising a known amount of each sulfhydryl amino acid species to be assayed, labelled with a suitable marker;
(b) adding sufficient reducing agent to insure randomization of the labelled and unlabelled sulfhydryl amino acids present;
(c) measuring the relative amounts of labelled and unlabelled sulfhydryl amino acid present for each species with a mass spectrometer;
(d) calculating the ratio of labelled to unlabelled sulfhydryl amino acid present for each species; and
(e) deriving the amount of unlabelled sulfhydryl amino acid present for each species in said given sample.