PHOSITA Can Bridge Gaps with Reasonable Success Under Result-Effective Variable Doctrine

On March 5, the U.S. Court docket of Appeals for the Federal Circuit (CAFC) issued a precedential choice in Pfizer Inc. v. Sanofi Pasteur Inc. affirming decrease rulings by the Patent Trial and Attraction Board (PTAB) that invalidated Pfizer’s patent claims and denied motions to amend (MTA). Though the Federal Circuit vacated the PTAB’s MTA denials with respect to 2 patent claims, the ruling provides new contours to the appellate court docket’s case legislation on obviousness in ways in which might have an effect on corporations which can be patenting chemical innovations with claimed numerical ranges.

Pfizer appealed to the Federal Circuit following rulings from 5 inter partes evaluate (IPR) proceedings petitioned by Sanofi Pasteur, the vaccine division of French pharmaceutical firm Sanofi. These IPR proceedings challenged all claims of Pfizer’s U.S. Patent No. 9492559, Immunogenic Compositions Comprising Conjugated Capsular Saccharide Antigens and Makes use of Thereof, which claims compositions frightening an immune system response to be used in pneumococcal vaccines like Pfizer’s Prevnar. The PTAB’s last written choices in these IPR proceedings invalidated all challenged claims of the ‘559 patent for obviousness. The PTAB additionally denied Pfizer’s MTAs after discovering that Sanofi and fellow petitioner Merck had proven obviousness for Pfizer’s proposed substitute claims.

End result-Efficient Variable Doctrine Can Be Utilized Even When Parameters Are Unknown

On enchantment, Pfizer challenged rulings associated to Sanofi’s asserted prior artwork references: U.S. Patent Application No. 20110195086 (Merck-086); and PCT Patent Application Publication 2007/071711 (GSK-711). Merck-086 discloses immunogenic compositions with distinct polysaccharide conjugants wherein S. pneumoniae serotypes, together with 22F, is conjugated to a provider protein. GSK-711 discloses S. pneumoniae vaccines having capsular saccharide antigens, with saccharides derived from S. pneumoniae serotypes which will embrace a saccharide conjugant of 22F.

Of Pfizer’s challenges to the PTAB’s determinations on obviousness, the Federal Circuit first handled the PTAB’s software of the “result-effective variable doctrine.” Beneath this doctrine, an overlap between a claimed vary and numerical vary disclosed by the prior artwork creates a presumption of obviousness. This presumption may be rebutted by the patent proprietor with proof that the given parameter was not acknowledged as result-effective. Pfizer contended on enchantment that the PTAB erred in making use of this doctrine in any respect because of the undisputed incontrovertible fact that neither GSK-711 nor Merck-086 discloses a molecular weight for the claimed serotype 22F conjugate.

Because the Federal Circuit defined, the truth that the result-effective variable doctrine creates a presumption of obviousness when an overlap in numerical ranges seems doesn’t imply that the doctrine is just relevant when an overlap exists. The appellate court docket famous that optimization analyses for obviousness determinations repeatedly think about the motivations of an individual having bizarre ability within the artwork (PHOSITA) to mix prior artwork references with the power to bridge any gaps within the prior artwork whereas retaining an affordable chance of success.

Citing to the 1977 ruling in In re: Antonie by the Federal Circuit’s predecessor, the U.S. Court docket of Customs and Patent Appeals, the CAFC famous that it’s not improper to think about whether or not a parameter lacking from the prior artwork would have been result-effective. Though Pfizer offered opposite proof to the PTAB that glycoconjugate molecular weight requires case-by-case experimentation and is thus unpredictable, the Federal Circuit dominated that the alleged unpredictability was not at problem in instances, akin to the current enchantment, the place the strategy of manufacturing glycoconjugates is mostly acknowledged as routine.

Hausdorff Discloses Claimed End result Throughout Vary of Serotypes Not Present in Merck-086

Pfizer additionally challenged the PTAB’s dedication that it will have been apparent for a PHOSITA to include glycoconjugates claimed within the prior artwork to attain immunogenic impact within the composition claimed by Pfizer’s ‘559 patent. Pfizer pointed to the prior artwork’s lack of disclosure that the claimed glycoconjugates had been truly examined or made, thus making it inconceivable to find out that the claimed glycoconjugates would have been anticipated to “elicit useful antibody,” because the declare time period “immunogenic” was construed by the PTAB.

Citing to its 2007 choice in Pfizer v. Apotex, the Federal Circuit reiterated that ““a rule of legislation equating unpredictability to patentability . . . . can’t be the correct customary for the reason that expectation of success want solely be affordable, not absolute.” Due to this fact, the PTAB’s conclusion {that a} PHOSITA would have had an affordable chance of success concerning the immunogenic impact of the prior artwork disclosed glycoconjugates was not unreasonable, explicit in Pfizer’s current case the place the immunogenic properties of the particularly claimed serotypes have lengthy been acknowledged.

Through the IPR proceedings, Pfizer filed MTAs to substitute proposed claims that added limitations protecting a “2-log enhance” (100-fold) above baseline antibody ranges. The PTAB decided that this and different proposed substitute claims had been apparent in mild of each GSK-711, Merck-086 and U.S. Patent Application 20120237542 (Hausdorff). On enchantment, Pfizer alleged that the Merck-086 reference offers clear proof that the claimed 2-log enhance wouldn’t have been apparent, as a result of that reference doesn’t disclose the claimed outcome throughout all 14 serotypes as recited by Pfizer’s proposed declare. Nevertheless, the Federal Circuit discovered the claimed outcome for the remaining 13 serotypes disclosed by Hausdorff, creating an affordable chance of success in combining prior artwork references.

Case Remanded to PTAB to Correctly Analyze Claimed End result Utilizing Glycoconjugates

The Federal Circuit did, nonetheless, vacate the PTAB’s dedication that proposed claims 48 and 49, which embrace the extra 2-log enhance limitation with beforehand claimed glycoconjugates, had been apparent in mild of the prior artwork. The PTAB’s ruling included no evaluation particular to the glycoconjugate limitations within the proposed claims and whether or not it will have achieved the claimed 2-log enhance outcome with these claimed glycoconjugates. Thus, this portion of the PTAB’s ruling was remanded with instructions to handle this problem.

Lastly, the Federal Circuit denied Pfizer’s argument that the method of Director evaluate violated notice-and-comment rulemaking guidelines below the Administrative Procedures Act (APA). Noting that this problem has already been addressed in non-precedential choices, the Federal Circuit discovered no prejudice to Pfizer, making the alleged procedural failure below the APA innocent.