Yes, an exception exists to the general rule that only the product is analyzed when dealing with product-by-process claims.
In fact, this occurred in a recent case heard at the Patent Trial and Appeal Board (PTAB). IPR2016-00006 (SteadyMed LTD (SteadyMed) v. United Therapeutics Corporation (UTC)).
UTC owned a product-by-process patent on a chemical composition treprostinil. SteadyMed essentially claimed that UTC's patent was invalid, since the product claimed in the UTC patent had already been disclosed in an earlier patent to one Phares (i.e., SteadyMed's assertion was that UTC's patent had been "anticipated" by Phares).
UTC, in response, admitted that treprostinil was disclosed by Phares, but argued that the treprostinil produced by Phares exhibited differences in overall purity than that produced by the product of UTC's claimed. UTC urged the PTAB to uphold their patent on the grounds that the steps in the recited process created structural and functional differences not present in the product described by Phares.
Although the PTAB acknowledged that an exception applies when process steps recited in a claim impart structural and functional differences to the claimed product, they could not find any such structural or functional differences between the UTC product and that disclosed by Phares. They thus invalidated the UTC patent.
More information on this case can be found at the Jones Day website:
www.ptablitigationblog.com/product-process-claims-invalid-process-not-impart-structural-functional-differences/#page=1
In fact, this occurred in a recent case heard at the Patent Trial and Appeal Board (PTAB). IPR2016-00006 (SteadyMed LTD (SteadyMed) v. United Therapeutics Corporation (UTC)).
UTC owned a product-by-process patent on a chemical composition treprostinil. SteadyMed essentially claimed that UTC's patent was invalid, since the product claimed in the UTC patent had already been disclosed in an earlier patent to one Phares (i.e., SteadyMed's assertion was that UTC's patent had been "anticipated" by Phares).
UTC, in response, admitted that treprostinil was disclosed by Phares, but argued that the treprostinil produced by Phares exhibited differences in overall purity than that produced by the product of UTC's claimed. UTC urged the PTAB to uphold their patent on the grounds that the steps in the recited process created structural and functional differences not present in the product described by Phares.
Although the PTAB acknowledged that an exception applies when process steps recited in a claim impart structural and functional differences to the claimed product, they could not find any such structural or functional differences between the UTC product and that disclosed by Phares. They thus invalidated the UTC patent.
More information on this case can be found at the Jones Day website:
www.ptablitigationblog.com/product-process-claims-invalid-process-not-impart-structural-functional-differences/#page=1
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