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- Federal Circuit Patent Bulletin: Bayer Pharma AG v. Watson Labs., Inc.
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Rather, the Examiner must first set forth the underlying facts and reasoning leading to a conclusion that a disclosure or statement in the Background section constitutes a prior-art admission. IP News Wire. Patent Application Publication No. See the Opinion here. Facebook 0 Twitter 0 Likes. Managing Editor: Cynthia M.
Bouchez, Ph. Patent No. This case concerned Millennium Pharmaceuticals in its multiple lawsuits against multiple defendants in ANDA litigation. Millennium Pharmaceuticals, Inc. Sandoz , Inc.
July 17, In addition, there are claims to a lyophilized cake, method of preparation of the new compound and its reconstitution of the lyophilized mixture with a pharmaceutically acceptable carrier. It was known in the art that the base compound bortezomib had chemotherapeutic effects but never was approved by the FDA due to its instability, rapid degradation in liquid formulations and general insolubility. The inventor tried to develop twenty-five liquid formulations but failed in overcoming the stability and solubility problems that plagued researchers in the field.
Finally, the inventor and associated researchers turned to using lyophilization i. Such a process in the presence of mannitol, a known bulking agent was utilized in order to prepare a finalized formulation and was not intended to change the chemical structure of the active pharmaceutical ingredient.
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Unexpectedly, a new chemical ester compound was formed during the process and had substantial improvement in dissolution and stability. A teaching or suggestion in the prior art that the intended result would occur is needed in formulating a finding of obviousness even, if at first glance, the process used may be routine. As the following shows, it remains important to find a teaching or suggestion in the prior art that a given result would occur even in seemingly routine processes because the intended results may be surprising and unexpected.
First, there was no teaching or suggestion in the prior art that a new chemical compound would be created during lyophilization, a process not intended to change chemical properties, and solve the problems that inhibited development of bortezomib in oncology. Thus, it is important for patent attorneys to discuss with the inventors on recognizing whether certain experimental results are unexpected in relation to the expectations of the prior art. General motivation for a person of ordinary skill insufficient to find obviousness in many cases.
As the following shows, a general motivation to use a known process, in certain cases, can be insufficient to find a particular claimed chemical compound produced using a known process as obvious. Bortezomib is a lead compound for consideration in an obviousness determination on whether a person of ordinary skill would have the reason or motivation to modify it to make a claimed compound with a reasonable expectation of success.
However, a specific motivation to modify bortezomib using the known pharmaceutical process with a reasonable expectation of success was lacking in this case. For instance, although a general motivation to modify pharmaceutical products using lyophilization and a process of adding bulking agents was present, no specific motivation to modify bortezomib was shown in this case. For instance, there was no teaching or suggestion in the references to produce the claimed mannitol ester having the unexpected properties of improved stability and solubility by specifically lyophilizing bortezomib and using mannitol as a bulking agent for bortezomib.
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In fact, stabilization of a particular compound by ester formation was unpredictable, because such process was compound-specific, and a person of ordinary skill expected that an ester would block a portion of the bortezomib molecule, rather than expecting that the ester compound to disassociate in the bloodstream effectively. Thus, it is important for patent attorneys and inventors, when possible, to recognize why a specific motivation to modify a lead compound with a reasonable expectation of success is lacking.source link
Federal Circuit Patent Bulletin: Bayer Pharma AG v. Watson Labs., Inc.
This is extremely important if they want to successfully overcome rejections in the USPTO and succeed in litigation in the future. Inherency in the context of obviousness still requires that the claimed invention be expected by a person of ordinary skill. Inherent obviousness cannot be based on what the inventor thought, and, in addition, the results in a particular case may not be inherently obvious depending on what was expected by a person of ordinary skill.
Incidentally, more recently, in Honeywell International Inc. Mexichem , the Federal Circuit reaffirmed the foregoing principle on focusing on what a person of ordinary skill would have expected. Honeywell International Inc. Mexichem Appeal No. The court also emphatically asserted:.
What it takes to Prove a Motivation to Combine
In addition, examiner needs to show that one of ordinary skill would have had a motivation to combine the references with a reasonable expectation of success. The evidence on the record showed that there was unexpected stability of the claimed HFOyf with PAG lubricants and a person of ordinary skill would have expected that combining reactive and unstable HFO refrigerants and unstable PAG lubricant would, in fact, result in a degradation reaction due to peroxide formation.
Thus, it is important for patent attorneys and inventors to recognize in situations even when conventional processes are used, such results, although inherent, may be unknown, and therefore, unexpected!
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The following will discuss the foregoing factors mentioned by the court in Millennium Pharmaceuticals. When unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected when compared with the closest prior art. For instance, the district court was incorrect in requiring Millennium to compare improve stability, solubility, and dissolution properties of the lyophilized mannitol ester of boretezomib with a glycerol bortezomib ester mentioned in U.
The Adams patent generically identified glycerol as one amongst a list of ten compounds for boronate esters, rather than specifically disclosing or actually identifying the glycerol ester in the Adams Patent. Moreover, the Adams Patent did not disclose stability or solubility of any ester compound. Accordingly, Millennium was not required to create the glycerol ester, where the product had not been created in the prior art. Thus, it is important for patent attorneys and inventors to compare only unexpected results with only prior art that is known.