Developments up to second-filed application relevant to show no double patenting

The Federal Circuit has clarified the relevant timeframe for purposes of determining whether two claimed inventions are patentably distinct or would result in impermissible double patenting.  The court held "the relevant time frame for determining whether a product and process are 'patentably distinct' should be at the filing date of the secondary application."

Here, the product application was filed over a decade before the process application.  The district court originally granted summary judgment of no double patenting based on evidence of developments that came after both applications were filed.  It was unclear whether any of the alternative methods were available before the second application was filed, so the court remanded the case for resolution of that issue.

More detail of Takeda Pharm. Co. v. Doll after the jump.



When compounds in a class have divergent properties, positional isomer not obvious

In a decision Wednesday, the Federal Circuit affirmed a district court's determination that the asserted claims in a pharmaceutical patent were not proven obvious.  As is common in pharmaceutical cases, the defendant filed an ANDA asserting the patent covering the compound and its use was invalid, and in the ensuing infringement suit admitted its proposed generic drug met the claim limitations.  The district court specifically held the prior art did not suggest the closes prior art compound as a potential "lead compound," as the various members of the class of compounds had unpredictable properties rendering the claimed compound's beneficial properties unexpected, and secondary considerations of commercial success and long-felt need confirmed the defendant's failure to prove the claims obvious.  The district court also rejected a separate argument of obviousness-type double patenting based on an expired patent also owned by the patentee.

The Federal Circuit affirmed.  Under Takeda, the court observed obviousness for structurally similar chemical compounds depends on one of ordinary skill in the art selecting the asserted prior art compound as the "lead compound," or the starting point for further experimentation.   Here, the court did not reach the question, as it determined that even if the closest prior art compound was selected, the defendant has not shown obviousness.  There was simply no reason shown why one of ordinary skill in the art would modify even the closest compound to produce the claimed compound (a positional isomer) given the inherent unpredictability of the physical-chemical, biological, and therapeutic characteristics of the individual compounds in the class.  The court also cited its recent Kubin decision, observing there was "no credible evidence that the structural modification was routine."  Further, there was evidence of both commercial success ($2.7 billion in sales) and long-felt need.  As a result, the court affirmed the district court's determination that the claims had not been proven obvious.

Similarly, the court affirmed the finding of no obviousness-type double patenting.  Here, the prior art patent claimed intermittent dosing of compounds in the same class as the claimed compound (to compensate for side effects), whereas the asserted claims are directed to the compound itself (both isolated and in a pharmaceutical composition) and using the compound to treat osteoporosis.  There was no clear and convincing evidence of overlap between the patents, so there was no double patenting.

More detail of Procter & Gamble Co. v. Teva Pharms. USA, Inc. after the jump.


Federal Circuit invalidates Patent on Nobel-Prize winning invention after 50 years of prosecution

In an appeal from the Board of Patent Appeals and Interferences, the Federal Circuit affirmed the Board's rejection of the claims based upon obviousness-type double patenting over previously-granted related patents.  The technical aspects of the invention are complex, but are overshadowed by the procedural aspects of this reexamination.  The majority and dissenting opinions seem to discuss two different cases.  The majority holds the double patenting issue was available in the reexamination under the former § 303 (in part because the rejection at issue was made after the amendment), and the dissent holds the reexamination improper because the issue was previously considered.  The majority holds the expert declarations unpersuasive, but the dissent considers them unrebutted.  In the end, the rejections are affirmed, even though the patents covered an invention that resulted in a Nobel Prize to one of the inventors.

More detail of In re Basell Poliolefine Italia S.P.A. after the jump.


BPAI: when prior art teaches away, expectation of success cannot support obviousness rejection

In a recent precedential decision by the Board of Patent Appeals and Interferences, the board reversed an Examiner's rejections based on double patenting, anticipation, and obviousness.  The Board held the Examiner inappropriately rejected the claims for double patenting because there was insufficient evidence to show the compositions claimed in the prior art possessed the viscosity level claimed in the current application or that they would be obvious variants.  

The Board similarly reversed the anticipation and obviousness rejections.  The Board noted the Examiner did not provide "an adequate basis – based on evidence or scientific reasoning – to support" the argument that the prior art compounds inherently met the viscosity limitation.  Further, the examiner's logic that the compounds were obvious based on the motivation in the art to optimize the viscosity of the prior art formulations was also rejected.  The Board noted that though "the discovery of an optimum value of a variable in a known process is normally obvious," here the cited references all indicated that low viscosity, not the claimed high viscosity, was desirable.  In fact, the Board, citing KSR, highlighted that there still must be a reason to make the asserted modifications to the prior art.  This is particularly the case when the prior art teaches away:

[W]hen the prior art teaches away from the claimed solution as presented here, obviousness cannot be proven merely by showing that a known composition could have been modified by routine experimentation or solely on the expectation of success; it must be shown that those of ordinary skill in the art would have had some apparent reason to modify the known composition in a way that would result in the claimed composition.

More on Ex parte Whalen after the jump.


Invalidity affirmed on double patenting grounds; inequitable conduct finding vacated

In the second of two rulings yesterday, the Federal Circuit found the patent on Toprol-XL® (a drug used to treat hypertension, angina, and congestive heart failure) invalid based on obviousness-type double patenting, affirming summary judgment on the issue. 

The court vacated and remanded the grant of summary judgment of unenforceability due to inequitable conduct, as the district court improperly equated a motivation to deceive with an intent to deceive.  This the court proceeded to this issue even though it had affirmed the invalidity of the patent because it noted that the Federal Circuit has not yet resolved the issue of whether a terminal disclaimer can reinstate the validity of a patent invalid due to obviousness-type double patenting by filing a terminal disclaimer during litigation.

More detail of In re Metoprolol Succinate Patent Litig. after the jump.


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