Patent Law

Should Patient?s Suggestions for Treatments Be Compensated?

By Stephen Albainy-Jenei

In 1995, Beth Jacobson?s late husband, Dr. Ira Wolmer was diagnosed with multiple myeloma; an incurable blood cancer that develops in the bone marrow. Ms. Jacobson, a lawyer, devoted her efforts to identify treatment options for her husband, which led her to request that he be treated with Thalomid, Celgene’s brand name for thalidomide.

While Dr. Wolmer did not respond to treatment and later died, thalidomide has become a major treatment against multiple myeloma and Celgene has grown into a $24 billion company. Jacobson has now brought a lawsuit against the Celgene Corporation (Jacobson v. Celgene Complaint) based on what she claims is Celgene’s misappropriation of her idea for treating multiple myeloma with thalidomide and she wants $300,000,000 plus 25% of future profits.

Multiple myeloma is the second most common blood cancer after non- Hodgkin’s lymphommpaired production of normal antibodies, increased susceptibility to bacterial infection, and hypercalcemia. Dr. Wolmer was treated at the Myeloma Institute by a team of doctors, led by Dr. Bart Barlogie.

In Ms. Jacobson?s research on alternative treatments, one researcher told her about Dr. Judah Folkman, a researcher at Harvard Medical School who has theorized that cancer may be treated by retarding angiogenesis, the growth of blood vessels that feed tumors. One of the substances under study in Dr. Folkman’s laboratory was thalidomide.

Ms. Jacobson claims that she suggested the idea of using thalidomide to treat her husband’s multiple myeloma because of the similarities she perceived between leukemia and multiple myeloma and that Dr. Folkman told her that he had never thought of the idea. (other versions say that Dr. Folkman suggested thalidomide but he died last year).

After her conversation with Dr. Folkman, Ms. Jacobson got Dr. Barlogie to treat her husband with thalidomide, which was obtained from Celgene. Dr. Barlogie got FDA approval to administer thalidomide to Dr. Wolmer on an experimental basis. Unfortunately, Dr. Wolmer died despite the treatment.

Later, physicians at the Myeloma Institute used thalidomide to treat another patient and this time, thalidomide worked and the patient had a near complete remission. Dr. Barlogie and others then conducted a clinical trial, the results of which were published in the New England Journal of Medicine and showing that “thalidomide had substantial antitumor activity in patients with advanced myeloma.”

The article was dedicated to the memory of Dr. Wolmer and expressly acknowledged Ms. Jacobson’s idea of using thalidomide to treat multiple myeloma and stated; “We are indebted to Beth Wolmer for her persistence in recommending the clinical evaluation of thalidomide in the treatment of multiple myeloma.” In addition, Celgene’s 1999 Annual Report stated that the 1999 clinical trial for the treatment of multiple myeloma with thalidomide along with its publication in the New England Journal of Medicine was a “seminal event in the commercialization of Thalomid.”

Thalomid (thalidomide) and a related drug, Revlimid, generate $2.2 billion a year for Celgene.  Ms. Jacobson would now like a big pile of cash claiming the idea of treating multiple myeloma with thalidomide was novel and that no one in the medical community was using the drug for this purpose before Ms. Jacobson’s discovery.

We’ll keep you posted on developments.

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Full post as published by Patent Baristas on August 27, 2009 (boomark / email).