Judges decide meaning of “Therapeutically Effective”
I found this recently on Bill Heinze’s IP Updates Weekly:
In Amgen, Inc. v. Hoechst Marion Roussel, Inc. (August 8, 2006) the Federal Circuit disagreed with the district court’s construction of “therapeutically effective amount” in claim 1 of the patent …
According to Circuit Judge Schall:
Based on a reading of the claims in light of the specification, it appears that the patentee used the words “therapeutically effective” in order to broadly claim a pharmaceutical composition with a wide range of effects. Those effects do not necessarily include curing disease in humans. … the patentee noted that recombinant EPO, like that found in the claimed invention, “is the first therapeutic product which can be used to effectively treat hundreds of thousands of patients who suffer from anemia and other disorders involving low red blood cell counts.” In our view, this statement merely lists some of the uses of the invention, without restricting the scope of the invention. . . .
The dissenter wrote:
Significantly, I note that the words “therapeutically effective” are conventionally employed in the pharmaceutical arts to indicate that the claimed pharmaceutical product has utility in the treatment of a human disease where such treatment tends to cause the “healing” or “curing” of the disease.
He went on to say that the patent should reference the particular classes of patients for whom the drug would be “therapeutically effective.”
I agree with the majority here, to the extent that they define “therapeutically effective†as not necessarily including “curing.†In my experience in basic science research and its involvement in medicine, “therapeutically effective†generally describes an effect that can be contrasted with treatment with placebo – ie, the amount of the drug that has beneficial effects that proves to be significantly different from effects in patients treated with placebo (an inactive substance).
For example, a depressed patient must take a 20mg paxil pill per day to realize its beneficial effects that build up in the system. If the patient cuts the pill into halves or quarters, that dosage would be below the “therapeutic dosageâ€, and any positive effects are probably placebo effects, and not from the active substances in the pill. Further, notwithstanding how a patient gains such beneficial effects, it is arguable whether scientists and doctors have discovered how to “cure†depression (I’d say not), but surely they have found treatments (including electroconvulsive therapy) that are “therapeutically effective.â€
Another interesting example occurs during surgery offered to Parksinsons patients, where stimulating electrodes are implanted into a patient’s subthalamic nucleus in the brain. First recording electrodes are lowered to determine location using firing characteristics (rhythm, speed) of neurons the electrode records along the way. This electrophysiological technique is used along with neuroimaging for correct placement of the stimulating electrode. However, sometimes these methods do not work, and the neurosurgeon must guess the proper location for the stimulating electrode, often by turning on the stimulating electrode and watching for therapeutic effects. They often watch the patient’s hand to watch for a lessening of the rolling tremble that is characteristic of Parkinsons patients. If they find such beneficial effects, they leave the electrode in its place. Thus, these neurosurgeons are by no means “curing†Parkinsons disease, but they have found a treatment that is “therapeutically effective.â€
Two things bother me about the dissenter’s note. One is that he uses “healing†and “curing†as synonyms. To me, healing is much more of a process and does not necessarily end in being free from negative effects. A woman may emotionally “heal†from her husband’s death, but that does not mean that she ever is able completely separate herself from the life she once shared with him. The other is that he uses the term “pharmacological arts.†Anyone may correct me if I am wrong, as I am not a pharmacologist by training, but that sounds like an outdated term and makes me think about alchemists.
The dissenter raises an interesting point about patent specificity though. Should someone with a new product have to specify exactly what uses a product can be put to, and exactly who may benefit from its use? The majority seems to take a broad view, allowing more sweeping patents to come to light. But, the dissenter would require a list of diseases or classes of patients with such diseases that the drug may treat. It is well known in the patent field that one person may hold the patent to a compound, and another may hold the patent to a use or a function of the compound. To what extent should this be true? Construing it broadly would encourage R&D into the original compound, but narrow construction would enable people to brainstorm more uses for a compound, and allow compounds to be researched more thoroughly and brought to their full potential.
My last point: should judges trained only in law be allowed to make these types of decisions? Could either of these judges can think of such examples or counterexamples of what may be considered (or not) “therapeutically effective?†It must be quite frustrating for inventive scientists, scientifically-trained lawyers who help write the patents, and the scientifically-trained agents at the PTO to have these patents constructed by untrained judges.
August 9, 2006 2:15 pm 2 Comments
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