Dale...
Re: SAFS Patent Protection
In todays WSJ, New England edition, there is a long story about who owns the patent for the drug GBC 590 the drug that SAFS is investigating as a cancer cure.
Seems like there is some questions to who really owns the patent.
Since many do not get the New England edition, I am posting the story below as an FYI.
I still have no position in SAFS. Interesting however is that SAFS closed up today 1 1/2 at 22. With today's story I would have guessed it would have gone down. What do I know!!!
Heard in New England:
SafeScience
Faces Questions
About Drug
----
By Andrew Caffrey
Staff Reporter of The Wall Street Journal
With its anti-cancer drug sparking interest among investors, SafeScience is facing a series of questions about its treatment. Namely: Who created it -- and does it really work?
Until recently, SafeScience was an obscure company that only just reported the first revenue in its eight-year history. That changed in June, when the Boston company issued a statement describing potentially promising results of a Phase I study of its drug GBC-590 on prostate cancer. Within a week, the firm's stock rocketed up nearly 70%. It now trades around $20.
Now two scientists say the drug is based on their research and infringes on their patents. "We know it's ours," says Avraham Raz, director of the Basic Research Division at the Karmanos Cancer Institute in Detroit and a professor at its medical-school affiliate, Wayne State University.
In the past year, Dr. Raz and a colleague have obtained two patents for a drug they now claim SafeScience's chief executive, David Platt, misappropriated when Dr. Platt worked for Dr. Raz as a post-doctoral student 10 years ago.
Meanwhile, the researcher who conducted the Phase I study, Christopher Logothetis, director of the Genitourinary Medical Oncology Department at the M.D. Anderson Cancer Center in Houston, says the study's intent was to see if the drug was safe, which it is. The results are "encouraging," Dr. Logothetis says, but he has "a real problem" with SafeScience's implication the drug was effective. "There's no evidence of efficacy," he argues.
Dr. Platt says the claims that he's infringing on others' intellectual property are ridiculous and motivated by jealousy at SafeScience's recent stock-market success. And he says there's nothing wrong with publishing data suggesting the drug produced promising effects on prostate cancer, even though the study wasn't set up to prove that.
The dispute highlights the sometimes-murky area of ownership of intellectual property that arises from a host of ideas and discoveries before it -- as well as when an employee on a research project is considered a contributor or just hired help.
Both SafeScience and Dr. Raz and his colleague, Kenneth Pienta of the University of Michigan, are pursuing lectins as a possible cure for cancer. Lectins are proteins in a cell that bind to specific sugar molecules. Develop the right molecular strain of sugar molecule, pectin, that attaches itself to a specific lectin in the tumor cell, and you may have a cure for cancer. How? Foreign sources of sugars, such as certain pectins, when introduced to the cancer cell, bind to the lectin and prevent the cell from joining others -- and growing into a larger tumor.
This much is clear: Dr. Raz had a long history of important research on the role of lectins in inhibiting metastasis by the time Dr. Platt went to work at the cancer institute, then known as the Michigan Cancer Foundation, in 1989. The next task was to identify the kind of carbohydrate that would best attach itself to the lectin.
Dr. Platt, now 46 years old, was hired by Dr. Raz to work on a project that was funded by two grants awarded to Dr. Raz. In the experiment, they injected mice with melanoma cancer cells. Then they treated one group with citrus pectin, and another with chemically modified citrus pectin. The result was potentially groundbreaking. Mice treated with unaltered citrus pectin experienced an increase in tumor-cell activity. In the other mice, the treatment of modified citrus pectin "resulted in a marked decrease in the ability of these [cancer] cells to form tumor lung colonization," according to a paper Drs. Raz and Platt published in the Journal of the National Cancer Institute in March 1992.
The journal lists Dr. Raz as the corresponding author, the main point of contact for the article. He says Dr. Platt was working under his direction on his project, using funds Dr. Raz obtained, and therefore Dr. Platt can't claim ownership of the work. "He and my technician did the work, and I wrote the paper," Dr. Raz, 54, says. "That's his job, to do what I tell him."
But in filings with the Securities and Exchange Commission, SafeScience ties its drug to the journal paper, even though the company wasn't founded at the time, and GBC-590 wasn't developed or named until later. "A paper published in the Journal of the National Cancer Institute reported that tumor-bearing mice treated with intravenous solutions of GBC-590 demonstrated complete reduction in metastasizing cancers," the company says in its 1998 annual report.
In an interview, Dr. Platt says the paper cited in the annual report is the one he co-authored with Dr. Raz. "GBC-590 is based on the '92 article with Raz," he says, but now is a "more refined" version.
But, Dr. Pienta argues, "Whatever Platt is claiming as his really doesn't belong to him." Dr. Pienta, director of Urologic Oncology at the University of Michigan Comprehensive Cancer Center in Ann Arbor, was a professor at Wayne State at the time of his earlier work with Dr. Raz.
In 1995, Drs. Pienta and Raz, along with other colleagues, published an article in the Journal of National Cancer Institute detailing how an oral dosage of modified citrus pectin can inhibit metastasis. That paper helped them get a patent for that treatment. SafeScience's SEC filing and Dr. Platt's statements show the company is infringing on the patent, the researchers say. "Any independent patent or rights to that compound really belong to Wayne State," says Dr. Pienta, who with Dr. Raz assigned the patents to Wayne State and the Karmanos Institute.
A Wayne State official says the school will hire a patent attorney to investigate the intellectual-property-rights issue. The Karmanos Institute declines to comment.
Dr. Platt disputes the claims, and in two interviews offered several explanations. Though he was a student working in Dr. Raz's lab, Dr. Platt says, he was more of a collaborator. Between 1981 and 1989, he was a graduate student at Hebrew University in Jerusalem, researching the structure of pectins. Much of his research and published work, according to his resume, was in food chemistry and agriculture, not cancer. But he says his expertise provided the key insight into which molecules would correctly bind to the cancer cells and inhibit cancer growth.
"If anything, they are infringing on me," he says. "I did the data which was published in '92. I thought about it. I designed the molecule. I published the article. Raz had nothing to do with this article. Because he was so famous, I put him on the article. He didn't do the work at all."
In the interview, Dr. Platt also discloses that he filed for a patent on the pectin substance used in the experiment before the article was published in March 1992, but didn't tell Dr. Raz or anyone else at the cancer center. "It was my work. I don't need to explain to anybody," he says.
Dr. Platt's patent attorney, Ronald Citkowski, says his client first filed a patent for the treatment in 1990, and then refiled it in 1993. Mr. Citkowski says Dr. Platt recently won a ruling from the Patent Office's appeal board that should clear the way for a patent on GBC-590. Since Dr. Platt's application predates that of Drs. Raz and Pienta, Mr. Citkowski says, Dr. Platt would have the claim on the intellectual property should he win a patent.
In a later interview, Dr. Platt explains his relationship with Dr. Raz in this way: He says his work in Michigan on pectins "was not related to the work on the grant" Dr. Raz had. That grant, Dr. Platt says, was for defining the genetic sequences of the lectin in question. "It had nothing to do with the word 'pectin.'"
What's more, Dr. Platt says, he had refused to sign over any ownership rights to his work as a condition of employment with Dr. Raz. "I did this work in addition to what I was supposed to do," he says of the research into modified citrus pectin. "On my free time, at night. And, sometimes in the day, I did work on both."
Dr. Raz says Dr. Platt's explanation is "ridiculous." He says he did not have Dr. Platt do gene sequencing, because that's not his specialty. "The work was done on carbohydrates" to prevent metastasis, Dr. Raz says of Dr. Platt's assignment. "One of them turned out to be pectins." Dr. Raz also says that at the time, other scientists at the cancer center, including himself, didn't sign forms turning over rights of their work. "It was an oversight of the administration," he says, "that was corrected after the intellectual-property dispute with Dr. Platt first surfaced in 1994."
How did Dr. Platt switch his research from food chemistry to cancer if Dr. Raz had no role in his work? Mr. Citkowski says Dr. Raz's work "may have channeled" Dr. Platt's "mind" into applying his own work on pectins to Dr. Raz's discoveries on lectins in cancer. "Each one has good reasons for feeling the other guy wants his invention," acknowledges Mr. Citkowski.
Dr. Platt started his own company in late 1992. For years, it languished as it worked on medical and agricultural products designed around Dr. Platt's research into naturally occurring substances, such as carbohydrates. The company later added environmentally safe household-cleaning products to its portfolio.
But the drug developments put SafeScience in the spotlight. On June 24, the company issued a news release on GBC-590 that said the drug was "effective in reducing or stabilizing" the levels of specific antigens that are sometimes viewed as a marker for prostate cancer.
The day before the announcement, SafeScience's stock price was $14. Within a week, it was almost $24. "The fact is," Dr. Platt says, "for eight years, they didn't care at all. Suddenly, when you succeed, they come out of the woodwork."
Although Wayne State officials had long known about Dr. Platt's commercial pursuits, they say they didn't pursue intellectual-property rights against him because Patent Office rules of confidentiality prevented them from finding out just what Dr. Platt supposedly invented. Mr. Citkowski says the institutions dropped intellectual-property claims they made in 1994 after he argued that the work belonged to Dr. Platt.
But now, Dr. Raz says, he is motivated to complain because he's been receiving calls from investors and cancer patients about GBC-590. Dr. Raz says he is concerned that SafeScience "may be misleading the patients" about the potential viability of the drug. Dr. Logothetis, who conducted the Phase I trial for SafeScience, is also concerned. Federal Food and Drug Administration authorized Phase I studies are only supposed to evaluate whether a drug is safe to take at its prescribed level. The study found just that.
But, in its statement, SafeScience reported the drug reduced the levels of prostate-specific antigen, a marker for prostate cancer, in 18 of the 22 patients. Dr. Logothetis says the levels of the antigen marker can fluctuate independent of drug therapy, for reasons scientists don't know. More important, he adds, changes in the antigen levels by themselves don't mean the cancer has abated or worsened. A patient could have lower antigen levels, but the cancer could be getting worse.
Dr. Platt says that Dr. Logothetis "cannot argue with the facts" that the antigen levels went down. A Phase II efficacy-stage trial, which Dr. Logothetis expects to conduct for SafeScience, will try to determine GBC-590's impact on the cancer itself.
interactive.wsj.com
Regards
Bob T. |
