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WORKING UP TO BIOLAW
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Senniger Powers Applies Existing Laws to Complicated Issues
By Linda F. Jarrett
The more technical our world becomes, the more diverse and complicated the issues.
Biolaw applies existing laws to the
problems rising out of these issues involving science and its applications.
For over 80 years, the law firm of Senniger Powers has been working up to biolaw and, now, is the largest intellectual property firm in Missouri and the surrounding area.
Intellectual Property is the body of law that protects products of the intellect, whether they are patents, trade secrets or copyrights, says Senniger Powers managing partner Ed Hejlek.
In March 2005, PatentRatings LLC ranked Senniger Powers second for 2004, nationally, based upon quality of patents in the biotech area which includes pharmaceuticals. The firm has ranked in the top ten nationally for the past three years.
TAXOL AND THE YEW TREE
Hejlek is well-schooled in the intellectual property area, having worked with Florida State University to obtain patents relating to the cancer-fighting drug, Taxol.
 Ed Hejlek, managing partner,
Senniger Powers |
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“Taxol is a chemotherapeutic drug which is a natural occurring compound,” Hejlek says. “It was discovered in the bark of the yew tree about 40 years ago. The National Cancer Institute wanted the drug brought into the marketplace and they were looking for someone to do it. Florida State University licensed their technology to Bristol Meyers Squibb who then commercialized the drug.”
The problem, Hejlek says, was that the yew tree, grown in the Pacific Northwest, was an extremely slow-growing tree. “The thought was they would end up denuding the Northwest of the yew tree in a few years in order to get enough bark for a clinical trial which pitted the environmentalists against those in need of a new cancer drug.
“What the University invented, and this is where I came in,” Hejlek says, “was a way to make Taxol from a commonly-occurring related compound found in the twigs and leaves of these trees. This is a renewable source since you collect leaves instead of stripping the bark of the tree.”
Bristol Meyers Squibb licensed that process from the university who used the money to spin off taxol derivatives, every one of them ready for patents. Hejlek has been working 16 years with FSU on Taxol-related technology.
THE PATENT PROCESS
Hejlek says, “You have to understand the dynamics of what it takes to get a drug into the marketplace. Millions are required to get a drug successfully through clinical trial phases and Federal Drug Administration approval, and no one is going to spend that kind of money unless they have an assurance of exclusivity. Patents provide that exclusivity.”
Patents, he says, run 20 years from the earliest filing date of the patent application. Patents are vital to new pharmaceutical development because people have to be given a fair return on their investment.
“Otherwise, why would you be the one to invest many millions of dollars to develop a drug if a generic could follow immediately on your heels?” he asks.
However, even though companies have patents on the drugs, generic companies have the right to test the validity of a patent.
“On one hand,” Hejlek says, “We have pharmaceutical companies as clients who patent their drugs for a period of exclusivity. We have other clients who are considering generic alternatives to patented drugs and we will work with those companies to evaluate the validity of the patent estate around the patented drug.”
In exchange for a patent, an inventor has to disclose how to make and use the compound in enough detail to allow competitors to reproduce the compound with only routine experimentation. While these competitors are prevented from legally making and marketing that drug, they can study it and, perhaps, make one better.
“This is called ‘leap frogging,’” Hejlek says. “When you have people who bring out a patented drug, other competitors will analyze it and see if there are any compounds outside the patent which might be just as efficacious or even more. The patent system requiring full and complete disclosure of what the invention is, how to make and use it, and even the best mode of doing it enables other people to improve upon it, and science advances as a result.”
WHO OWNS WHAT?
Another biolaw issue would be ownership and control regarding the right to privacy. Does a patient own or control information received by a professional, and can research be done without the patient’s consent?
Hejlek gave the example of a person who had litigated under these circumstances.
“A woman took her cats to a well-known animal virologist at the U.C. Davis School of Veterinary Medicine,” he says. “She believed her cats were infected with a virus similar to the human AIDS virus. The virologist analyzed blood samples taken from the cats, was able to determine the source of the problem, and pursued patent protection for methods of detecting and isolating the virus as well as a method for vaccinating cats against the virus.
“So, the question is, “he says, “Is the woman who brought in her cats the owner because she owned the cats and she said something is wrong? Ethically, who has ownership rights? You, as the donor, or the person who analyzed the tissue or fluid and derived the invention from this analysis?”
Hejlek said the woman was not judged to be the inventor. “The general consensus is that the person who conceives the invention is the owner. And she did not conceive any means for isolating or detecting the virus or for vaccinating cats.”
To understand further the complexities of this issue, Hejlek gave the example of a person going to work for a large, research-oriented company. Such companies typically require their research scientists to assign to the company any inventions made in the course of their employment.
“Another example,” Hejlek says, “would be if the principal or CEO of a small corporation made an invention. Even in the absence of an agreement, such individuals may have a fiduciary duty to assign it to the company.”
A third circumstance would be where people have “material transfer agreements.
He explains, “This is where I will agree to transfer this material to you for certain purposes. In exchange, you agree to do or not do certain things with it. One of the conditions could be if you make any discoveries that are derived from the use of this material, I would own them.”
This could go right back to the woman with the cat or any person seeking medical attention. However, patients would have to have the foresight to take this agreement with them to the doctor obligating anyone obtaining material from them and making a discovery to assign it back to the patient.
Hejlek laughs. “Of course, that’s on everybody’s mind when they’re sick and go to the doctor. I’m sick, I don’t feel well, and I know you want to analyze this fluid sample, and
I’d be happy to oblige provided you sign
this agreement!”
Biolaw covers many areas, and this is but one small part. Everyday we see examples from the Terry Schaivo case to stem cell research. It only promises to get more interesting. |
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