What’s the Problem? CAFC reverses PTAB for identifying the problem to be solved in finding combined references analogous when the burden was properly on the Petitioner
| May 11, 2023
Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc.
Decided: May 9, 2023
Before Reyna, Mayer and Cunningham. Opinion by Cunningham.
Summary:
The Court reverses a PTAB final written decision finding all challenged claims of Safoni’s patent unpatentable as obvious over prior art. The Court held that Mylan improperly argued a first prior art reference is analogous to another prior art reference and not the challenged patent. Therefore Mylan failed to meet its burden to establish obviousness premised on the first reference since the Board’s factual finding that the first reference is analogous to the patent-in-suit is unsupported by substantial evidence.
Background:
Mylan filed an IPR against Sanofi’s RE47,614 (“the ‘614 patent”) alleging its unpatentability in light of a combination of three prior art references: (1) U.S. Patent Application No. 2007/0021718 (“Burren”); (2) U.S. Patent No. 2,882,901 (“Venezia”); and (3) U.S. Patent No. 4,144,957 (“de Gennes”). Claim 1 of the ‘614 patent is directed to a drug delivery device with a spring washer arranged within a housing so as to exert a force on a drug carrying cartridge and to secure the cartridge against movement with respect to a cartridge retaining member, the spring washer has at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.
Mylan asserted that Burren with Venezia taught the use of spring washers within drug-delivery devices and relied on de Gennes to add “snap-fit engagement grips” to secure the spring washer. Burren and Venezia were both within the field of a drug delivery system. However, de Gennes was non-analogous art being directed to a clutch bearing in the automotive field. Sanofi argued that the combination was improper because de Gennes was non-analogous art. Mylan responded that de Gennes was analogous in that it was relevant to the pertinent problem in the drug delivery art and cited to Burren as providing a problem which a skilled artisan may look to extraneous art to solve.
The PTAB found that Burren in combination with Venezia and de Gennes does render the challenged claims unpatentable relying on the “snap-fit connection” of de Gennes as equivalent to the “fixing elements” of the ’614 patent. Sanofi appealed.
Discussion:
In its appeal, Sanofi argued that the PTAB “altered and extended Mylan’s deficient showing” by analyzing whether de Gennes constitutes analogous art to the ’614 patent when Mylan, the petitioner, only presented its arguments with respect to Burren (i.e. other prior art). Mylan countered that the Board had found de Gennes as analogous art because there was “no functional difference between the problem of Burren and the problem of the ‘614 patent.”
In its review of the law governing whether prior art is analogous, the CAFC noted that “we have consistently held that a patent challenger must compare the reference to the challenged patent” and, citing precedent, noted that the proper test is whether prior art is “reasonably pertinent to the particular problem with which the inventor is involved.” The CAFC expanded thereon stating:
Mylan’s arguments would allow a challenger to focus on the problems of alleged prior art references while ignoring the problems of the challenged patent. Even if a reference is analogous to one problem considered in another reference, it does not necessarily follow that the reference would be analogous to the problems of the challenged patent…[broad construction of analogous art]… does not allow a fact finder to focus on the problems contained in other prior art references to the exclusion of the problem of the challenged patent.
The Court re-emphasized that the petitioner has the burden of proving unpatentability and that they have reversed the Board’s patentability determination where a petitioner did not adequately present a motivation to combine.
Conclusion:
The CAFC concluded that the Board’s decision did not interpret Mylan’s obviousness argument as asserting de Gennes was analogous to the ’614 patent, but rather improperly relied on de Gennes being analogous to the primary reference, Burren. As such, Mylan did not meet its burden to establish obviousness premised on de Gennes; and therefore, the Board’s factual finding that de Gennes is analogous to the ’614 patent is unsupported by substantial evidence. The Court reversed the finding of obviousness.
Take away:
- Relying on non-analogous art to support an obviousness contention requires looking at the problems the inventor of the patent-in-issue would find pertinent not those set forth in other relied upon prior art. Arguments that a problem solved by non-analogous art should focus on the inventor of the patent-in-issue as recognizing the problem to be solved not generally problems recognized in the art.
- Petitioner’s in IPRs should be cautious relying on the PTAB formulating an argument outside of those clearly set forth in their filings. Extrapolation of Petitioner’s arguments by the PTAB can open the possibility of a reversal based on lack of substantial evidence.
THE PTAB’S IPR INSTITUTION DECISION IS FINAL AND NONAPPEALABLE
| April 6, 2021
CyWee Group LTD. v. Google LLC
Summary:
CyWee appealed the PTAB’s final decision on three grounds. First, CyWee argued that the PTAB erred in concluding that Google disclosed all real parties in interest. However, the CAFC noted that the CAFC is precluded from reviewing this challenge because the PTAB’s determination on this issue is final and nonappealable. Second, CyWee argued that the CAFC should terminate and dismiss the IPR proceedings because the APJs were appointed in violation of the Appointments Clause. The CAFC rejected this challenge because the APJs were constitutionally appointed as of the date that the Arthrex decision was issued. Finally, a prior cited by Google (Bachmann) is not an analogous art. However, the CAFC held that Bachmann is reasonably pertinent to the particular problem with which the inventor is involved, and that this reference does not have to be reasonably pertinent to every problem facing a field to be analogous prior art. Therefore, the CAFC affirmed that the PTAB’s determination that the challenged claims would have been obvious in view of Bachmann.
Details:
Google LLC (“Google”) petitioned for IPR of claims 1 and 3-5 of U.S. Patent No. 8,441,438 and claims 10 and 12 of U.S. Patent No. 8,552,978, asserting that those claims are unpatentable as obvious in view of U.S. Patent No. 7,089,148 (“Bachmann”).
The PTAB instituted IPR and found that those claims would have been obvious. CyWee appeals.
CyWee’s first argument
CyWee argues that the PTAB erred in concluding that Google disclosed all real parties in interest, as required by 35 U.S.C. §312(a)(2)[1].
The CAFC found that the CAFC is precluded from reviewing this challenge because the PTAB’s determination on this issue is final and nonappealable under 35 U.S.C. §314(d)[2] because this issue “raises an ordinary dispute about the application of an institution-related statute.”
CyWee argued that CyWee attempts to challenge the PTAB’s denial of CyWee’s post-institution motion to terminate the proceedings in view of newly found evidence.
However, the CAFC found that CyWee’s request is nothing more than a request for the PTAB to reconsider its institution decision, which is final and nonappealable.
CyWee’s second argument
CyWee argues that the CAFC should terminate and dismiss the IPR proceedings because the APJs were appointed in violation of the Appointments Clause.
However, the CAFC rejected this challenge because the APJs were constitutionally appointed as of the date that the Arthrex decision[3] was issued, and because the Arthrex decision was issued before the final decisions in this case. Therefore, the CAFC found that those final decisions were rendered by constitutional panels.
CyWee’s third argument
CyWee argues that Bachmann is not an analogous art.
However, the CAFC found that the PTAB’s conclusion is supported by substantial evidence because the PTAB determined that (1) “improving error compensation with an enhanced comparison method” was of “central importance” to the inventors, and that (2) Bachmann was reasonably pertinent to this problem because Bachmann “illustrates collection of data from the same kinds of sensors” and “correct[s] for the same kinds of errors that were of concern to the inventor[s].”
Therefore, the CAFC found that Bachmann is reasonably pertinent to the particular problem with which the inventor is involved.
Furthermore, the CAFC noted that a reference need not be reasonably pertinent to every problem facing a field to be analogous prior art, but rather need only be “reasonably pertinent to one or more of the particular problems to which the claimed inventions relate.” Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 1361 (Fed. Cir. 2020).
Finally, the CAFC noted that “a reference can be analogous art with respect to a patent even if there are significant differences between the two references.” Donner, 979 F.3d at 1361.
Takeaway:
- The PTAB’s decision on whether to institute an IPR proceeding is final and nonappealable.
- The Supreme Court heard the oral argument in the Arthrex case on March 1, 2021. Two questions before the Court are (1) whether APJs are properly appointed, and (2) if they are not properly appointed, whether removing employment protections corrects the defect.
- A reference need not be reasonably pertinent to every problem facing a field to be analogous prior art, but rather need only be “reasonably pertinent to one or more of the particular problems to which the claimed inventions relate.” A reference can be analogous art with respect to a patent even if there are significant differences between the two references.
[1] 35 U.S. Code § 312 – Petitions
(a) Requirements of Petition. – A petition filed under section 311 may be considered only if –
(2) the petition identifies all real parties in interest;
[2] 35 U.S. Code § 314 – Institution of inter partes review
(d) No Appeal. – The determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.
[3] Arthrex, Inc. v. Smith & Nephew, Inc., 941 F.3d 1320 (Fed. Cir. 2019): “The APJs were actually “principal officers” under the Appointments Clause, and that the APJ appointment provisions of the AIA creating the PTAB were unconstitutional because the APJs were not appointed by the President and confirmed by the Senate, as is required for “principal officers.””
Tags: administrative patent judge > Analogous Art > appointment clause > inter partes review > real party in interest
What Do a Resealable Cartridge for Low Pressure Liquid Chromatography and a Soda-Pop Bottle and Cap Have In Common?
| September 23, 2014
Scientific Plastic Products, Inc., v. Biotage AB.
September 10, 2014
Panel: Newman, Moore and Wallach. Opinion by Newman. Dissent by Moore.
Summary
The CAFC affirmed the Patent Trial and Appeal Board’s decision that all claims of the three disputed patents held by Scientific Plastic Products, Inc. (SPP) would have been obvious.
The CAFC held that the cited references, King and Strassheimer, both of which related to the sealing of a beverage container, were available as prior art against the claimed resealable cartridge for low pressure liquid chromatography (LPLC).
The CAFC held that although the cited reference Yamada failed to explicitly disclose a leakage problem, by “providing for the presence of an O-ring,” Yamada implicitly acknowledged that there is the potential for a leak. Further, the CAFC concluded that the inventors, in the patents in question, identified that the potential for leaks is a “known problem.”
Accordingly, the CAFC found adequate reason for one of ordinary skill in the art to turn to King or Strassheimer to improve the sealing arrangement set forth in Yamada.
