"As Seen in GEN" Volume 3, Number 3, May/June 1983
First Commercial Patents on Monoclonals Awarded to Ortho for Nine New Antibodies
By Ginna Sulcer
Companies large and small are quietly conducting clinical research to claim territory in the burgeoning business of monoclonal antibodies. The stakes are high—an estimated $728 million world market by 1985 for monoclonal products and procedures. As the competition heats up, Ortho Pharmaceutical Corp. has established a major new beachhead.
In October , the Johnson & Johnson subsidiary of Raritan, N.J., won the first patents issued to a commercial enterprise for monoclonal antibodies. Previous patents on monoclonal antibodies were held by universities.
A panel of nine monoclonal antibodies patented by Ortho Pharmaceutical is being sold for research purposes by Ortho Diagnostic Systems, Inc., also a J&J affiliate, under the trademark Ortho-Mune. The patent that protects Ortho-Mune covers monoclonal antibodies which identify subclasses of lymph cells in the human immune system by their biological function and stage of maturation. These antibodies enable clinicians to measure the proportion of various types of lymphocytes in the blood to indicate quickly and precisely the state of a patient’s immune system.
Monoclonal antibodies which can identify T cells by pedigree are not only invaluable tools in basic immunological research, but they have a broad array of potential diagnostic and therapeutic applications. Their initial impact in the diagnostics business will be seen as they replace polyclonal antibody preparations, which are produced from the blood of animals or human donors and contain many antibodies irrelevant to the diagnosis. Immunodiagnostics now comprises 20 percent, or $250 million, of the U.S. medical diagnostics industry.
Because the diagnostic testing business is well-defined, test kits using monoclonal antibodies should move rapidly from the research laboratories to the marketplace, improving or replacing existing tests. Monoclonal antibodies already are used to identify the level of maturation of immune system cells to classify malignancies such as leukemias and lymphomas for effective therapy.
In its patent application, Ortho successfully claimed that monoclonal antibodies which specifically identify characteristic sites on the surface of T cells are a novelty.
Because of the potential for profit, the broadly-descriptive patents granted to Ortho eventually may be challenged in court. Competitors also selling monoclonal antibodies targeted to the components of the immune system may have to license the process for producing T cell markers from Ortho Pharmaceutical Corp.
Some monoclonal antibodies are currently being used in clinical studies to monitor patients undergoing immunosuppressive therapy, such as cancer patients, patients who suffer from immunodeficiency states, such as rheumatoid arthritis, and most recently, the newly-discovered disease AIDS (acquired immune deficiency syndrome).
Only 13 monoclonal products now have FDA clearance for in vitro, or out-of-the-body diagnostic tests, but the market is expected to explode to nearly $4 billion within a decade. In the meantime, there is a basic research market for monoclonal antibodies which includes major research institutions, medical schools and clinicians studying autoimmune diseases, cancer and renal transplantation. The market for precision reagents in research alone is projected to be $40 million by 1992.
Market growth will depend upon clinical utility. The extent to which physicians accept the monoclonals as useful in measuring the size of various lymphocyte populations for specific disease states will determine how much the market will grow.