Rosalyn Yalow’s Patent

And H.R.1127

 

 

WHAT IS THE LINK BETWEEN ROSALYN YALOW’S PATENT AND H.R.1127?

 

   At 6:30 a.m. Oct. 13, 1977, Rosalyn Yalow – physicist, wife, and mother – was sitting at her desk at the VA when Stockholm called.  She was the 6^th woman to win a Nobel science award, the 2^nd in medicine, the first wholly American-educated and the only who was a Jewish homemaker and house wife.[1]

  

   H.R.1127 was introduced into the first session of the 104^th Congress

by Mr. Ganske. of Iowa, for himself and Mr. Wyden of Oregon.  A bill to limit the issuance the patents on medical procedures, H.R.1127 was given the short title of: “Medical Procedures Innovation and Affordability Act.”

 

 

   Would you believe that the link between Rosalyn Yalow’s Patent and H.R.1127 is the Statutory Invention Registration[2]?

 

 

 

ROSALYN YALOW’S PATENT

 

 

   Yalow graduated Hunter College in New York City in 1941 and received her Ph.D. in physics from the University of Illinois in 1945.  In 1947 she became a consultant in nuclear physics to Bronx Veterans Adminstration Hospital.  In 1950 she was appointed assistant chief of the radioisotope service.  Yalow’s work was in the field of nuclear medicine.  Her partner was physician Solomon A. Berson.  Research in diabetes led Yalow and Berson to invent a technique, radioimmunoassay (RIA) that won Yalow the Nobel prize five years after the death of Berson.[3]

 

 

     Since its development in 1959, RIA has become almost as useful as the microscope in medical laboratories.  Yalow and Berson went on to develop similar procedures for measuring other hormones in body tissues.  Today there are RIA’s for 100’s of hormones, viruses, drugs, and other substances of biologic interest.  Some recent uses of RIA reported in the literature include: hepatitis,[4] Lambed-Eaton Myathenic Syndrome,[5] a neurologic disorder, DSM-III major depression,[6] AIDS,[7] and Cyclosporine,[8] a transplant drug.

 

   In 1978 the total profits from RIA procedures ran into the tens of millions of dollars.  They provided a $300 million-a-year market for the companies producing them – but no money profit for Berson or Yalow.  On principle the partners did not patent their their discovery of radioimmune assay (RIA).

 

   Said Dr. Yalow, “In my day scientists did not always think of things as being patentable.  We made a scientific discovery.  Once it was published, it was open to the world.”

 

   Thus, Rosalyn Yalow never obtained a patent on her discovery.

 

 

SIR AND H.R.1127

 

   As stated above, H.R.1127, the “Medical Procedures Innovation and Affordability Act” is a bill to limit the issuance of patents on medical procedures.

 

   The bill contains a single substantive sentence, as follows: “On or after the date of enactment of this Act, a patent may not be issued for any invention or any discovery of a technique, method, or process for performing a surgical or medical procedure, administering a surgical or medical procedure, or making a medical diagnosis, except that if the technique, method, or process is performed by or as a necessary component of a machine, manufacture, or composition of matter or improvement thereof which is itself patentable subject matter, the patent on such machine manufacture, or composition of matter may claim such technique, method, or process.”

  

   Of course, any patent attorney worth a shake of salt will see a gigantic loophole in the exception clause virtually nullifying the clause it modifies.  This legislating drafting faux pas will relieve the mind of the run of the mill patent attorney, assuring the practitioner that virtually no incursions limiting the scope of subject matter available for protection will be affected by this legislation.

 

   However, the purpose of this article is to appeal to the exceptional patent attorney who takes seriously the ethical considerations of the work which the attorney performs..

 

   Let us assume that H.R.1127 is enacted in its present form and this attornet consels his client that, if he wishes to adhere to the spirit of the law, as Rosalyn Yalow would wish, the client has an option open other than obtaining a patent.  The client may, rather than obtain a patent, obtain a Statutory Invention Registration, or SIR.  The SIR is a creature of the patent system which provides a shield, but not a sword for the claimant.

 

   One example of a statutory invention registration, apparently obtained for ethical reasons, is found in the author’s previous “Law Works”[9] article regarding transgenic animals.  This is H1065, (the “H” number is the designation assigned by the Patent and Trademark Office to SIR’s) directed to a chicken resistant to avian leucosis virus.  H1065 was obtained in the name of the United States Department of Agriculture, and will allow any farmer to breed the chicken, while preventing another party from obtaining a patent on the chicken and protecting the USDA from infringement actions for disseminating the chicken or information about the chicken.  The author commends the USDA and its patent department for taking this action.

 

CONCLUSION

 

   Rosalyn Yalow won the Nobel Prize for work on radioimmune assay (RIA) which today is worth billions of dollars, yet did not obtain a patent due to ethical considerations.  H.R.1127 the “Medical Procedures Innovation and Affordability  Act” was a bill to limit the issuance of patents on medical procedures.  The bill links the spirit of Rosalyn Yalow to the patent system.  Patent attorneys can obtain Statutory Invention Registrations (SIR’s) instead of patents, in the Rosalyn Yalow, as exemplified by the procurement of the USDA procurement of H1065, a SIR on a virus-resistant chicken.