thalomidlogoIn 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 lymphoma impaired 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 that “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.”

It is interesting that the same drug that caused a catastrophe of the 1960’s with many children born with severe birth defects due to their mothers’ use of the drug, is now a miracle drug, helping to alleviate their suffering of illnesses from AIDS to cancer.

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.

The premise behind the claim of misappropriation of ideas is that when a party misappropriates another person’s confidential idea or some other type of property, the law imposes an obligation on that party to pay the other restitution for its improper use.

Generally, the test for determining whether the law will imply an obligation to pay for a confidentially submitted idea is when “a person communicates a novel idea to another with the intention that the latter may use the idea and compensate him for such use, the other party is liable for such use and must pay compensation if:

(1) the idea was novel;
(2) it was made in confidence to the defendant; and
(3) it was adopted and made use of by the defendant in connection with his own activities.

A misappropriation claim, unlike a contract-based claim, only can arise from the taking of an idea that is original or novel because the law of property does not protect against the appropriation of that which is free and available to all. Anyone may use ideas in the public domain freely.

While Jacobson now claims that she disclosed the information to Celgene on a confidential basis, there is no evidence that anyone agreed to keep any information secret or not to use the information.

Even if there was some sort of implied obligation of confidentiality on Celgene, Jacobson’s pleading states that she told another patient about using thalidomide and that patient asked for and received the drug from the Multiple Myeloma Institute’s staff.  Certain the information was available to – if not created in whole or in part by – Folkman and Barlogie.

In addition, all the pertinent information was certainly disclosed on publication of the New England Journal of Medicine article and the Celgene Annual Report. It could be that any novelty of the treatment was lost early on and the information had fallen into the public domain.

We’ll keep you posted on developments.

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6 Comments

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    This complaint has a lot of strikes against it. I think it’s little more than an attempt to use the threat, however slight, of a big money judgment, plus bad PR (attained through some of the silly articles we’ve seen) to force Celgene to make a significant settlement offer.

    Jacobsen did work 15 years at a top law firm, and is represented by a decent firm, but still, her case appears to fall apart quickly on several grounds.

    First: her own complaint alleges that her original contribution is more than ten years old. While the date the statute of limitations begins to run on a claim can be argued, the court is unlikely to find that she is welcome to bring her claim 12 years after her alleged contribution.

    Second: there appears to be no “privity” with Celgene. She appears not to have spoken directly to Celgene until 2000, when it was well down the road on MM. She previously spoke to Folkman and then Bart Barlogie. This is why in point #43 she refers to Barlogie as her “agent,” as she is trying to create a contractual relationship with Celgene where there is none. In reality, if she has any claim at all, it is against Entremed, where Folkman worked. It defies logic that in November 1997, Folkman would have pointed her to Celgene, since Entremed was at the time developing thalidomide on its own, until it sold all rights to Celgene more than a year later.

    Third: If there ever was a composition of matter patent for thalidomide, it expired decades ago. Anyone is free to develop their own version of thalidomide. Celgene has some “use” patents for thalidomide; if they cover its use in MM, then it is not Jacobsen’s “novel idea” and if they don’t, then Jacobsen was free to develop it on her own.

    It appears to me that Jacobsen made some contribution to advancing thalidomide in MM, but not one that the law provides compensation for. So she instead sought compensation as a matter of fairness. Company CEOs had lunch with her, and may have discussed a board seat, but when that didn’t happen, she decided she wanted cash. And given the claims on her Website, I’d guess that she pressed for a monetary payment in the tens of millions of dollars, and they refused, and finally stopped talking to her, knowing that this lawsuit was coming, and now she has conjured up the best complaint she could and hope it’s enough to pressure the company into a big settlement.

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    Please note that “Mark”, the above posters, is a Celgene shareholder who has a vested interest in seeing Ms. Jacobsen’s claim fail.

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    Yes, I have been a Celgene stockholder since 1998. And I am also a lawyer with 15 years’ experience, most of it managing litigation. And who I am doesn’t change the fact that this claim is being brought 12 years after the idea was allegedly first advanced, and there appears never to have been a direct relationship between the plaintiff and Celgene.

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    No, they should not.

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    […] » Patent Baristas » Should Patient’s Suggestions for Treatments Be Compensated? […]

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    It is obvious in light of the above article, that Ms. Jacobsen’s intention in administering the drug to her husband was just to save his life/treat him of the disease. So there was no obligation of confidentiality on part of Celgene. And now, after seeing huge sums of money involved, anyone would try to get a pie for it. When we rather see it from a different perspective of practically what happened, Celgene did indeed use the idea suggested by Ms. Jacobsen and thy are making huge sums of money from it. What could potentially be a settlement between the two parties that instead of paying any penalty, Celgene should pay for the idea of Ms. Jacobsen. We can relate it to the idea of Mc. Donalds.