The Federal Circuit recently reviewed the requirements of obviousness analysis, and in a precedential opinion, vacated a lower court finding of nonobviousness, along with fundamental error in the lower ruling.
Janssen Pharmaceuticals owns various patents on paliperidone and salts and conjugates of the compound.[i] Paliperidone is a pyridopyrimidine[ii] used in treating schizophrenia,[iii] having the structure;[iv]
The compound is a major active metabolite of resperidone, an antipsychotic compound developed in the 1990s.[v] It was originally formulated for oral administration, but problems with treatment adherence resulted in development of other treatment regimens.[vi] Conjugating paliperidone to an ester results in the compound dissolving slowly from musculature.[vii] Janssen Pharmaceuticals marketed a formulation of paliperidone palmitate as Inviga™.[viii]
In 2017 Teva Pharmaceuticals filed an abbreviated new drug application for a generic version of the drug and subsequently initiated litigation for patent infringement of the ‘906 patent.[ix] Janssen’s ‘906 patent covered a dosing regimen for paliperidone palmitate comprising administration of intramuscularly in the deltoid or gluteal muscle, starting with a loading dosing regimen over a one-month period.[x] Subsequent claims cover maintenance dosing.[xi] Notably, the use of paliperidone and dosing were known prior to the filing of the ‘906 patent.[xii] The prior art relied upon for an obviousness rejection must be “analogous to the claimed invention.”[xiii]
In response to the litigation, Teva challenged the various asserted claims were, among other things, obvious.[xiv] As recounted by the court, obviousness is a question of law relying on factual determinations on “(1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the pertinent art; and (4) any secondary considerations of non-obviousness.”[xv] The test is flexible, permitting the fact-finder to incorporate inferences and creativity of one of ordinary skill in the field.[xvi]
After recounting the prior art asserted by Teva, the Federal Circuit noted that the claims dictate the scope of what must be shown to invalidate a claim for obviousness- finding where the claims are directed to a patient population, there is no requirement to show safety or efficacy for a general population, even if regulatory approval requires such a showing.[xvii] The Federal Circuit found this error impacted the analysis and factfinding.[xviii] Further, the analysis must give weight to the deductive perspective or creativity of a person of ordinary skill in the field,[xix] as well as the background knowledge, and the effect on motivations to combine references or modify references.[xx] Moreover, the considerations of other agencies, such as the FDA’s safety and efficacy requirements, are not to be imported into claims without recitation of those requirements.[xxi]
Finally, the Federal Circuit noted that any evidence of nonobviousness must be evaluated in light of one of ordinary skill in the field and against the closest prior art.[xxii] The analysis does not take into account the convention wisdom or the field generally, nor the applicant’s understanding or surprise.[xxiii] As a further note, using a known technique, method, or prior art elements based on their known function supports a motivation to combine. The combination does not need to be the best option, just a suitable option.[xxiv] The obviousness requirement is one of the most amorphous in patent law, as it requires a comparison of the claims to the prior art through the lens of one of ordinary skill in the art.[xxv] The findings supporting an analysis must be explicitly stated,[xxvi] but the flexibility of the requirement commonly causes difficulty in defining obviousness. The clarification provided by Janssen Pharma. Inc. is useful in defining the nexus required between the prior art and claims and the evidence of nonboviousness.
[i] See, Francois, et al. (U.S. Pat. 6,555,544); Vermeulen, et al. (U.S. Pat. 9,439,906); Haspeslagh, et al. (U.S. Pat. 9,394,354); Haspeslagh, et al. (U.S. Pat. 9,012,648); Gopal, et al. (U.S. Pat. 10,143,693).
[ii] https://pubchem.ncbi.nlm.nih.gov/compound/115237, last accessed Apr. 11, 2024.
[iii] INVEGA (paliperidone) Extended-Release Tablets Prescribing Sheet. Titusville, NJ: Janssen Pharma. Inc.; 2007.
[iv] https://pubchem.ncbi.nlm.nih.gov/compound/115237#section=2D-Structure, last accessed Apr. 11, 2024.
[v] Janssen Pharma., Inc. v. Teva Pharma USA, Inc., Case Nos. 2022-1258, 2022-1307, slip opinion at 6 (Fed Cir. Apr. 1, 2024)
[vi] Id. at 6-7.
[vii] Id. at 6.
[viii] Id. at 2-3.
[ix] Id.; U.S. Food and Drug Administration ANDA Approval Letter for ANDA 211149 (July 6, 2021) (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211149Orig1s000ltr.pdf, last accessed Apr. 12, 2024).
[x] See, Vermeulen, et al. (U.S. Pat. 9,439,906); claim 1
[xi] See, Vermeulen, et al. (U.S. Pat. 9,439,906); claim 2
[xii] Janssen Pharma., Inc., page 9.
[xiii] Netflix, Inc. v. DIVX, LLC, 80 F.4th 1352, 1358 (Fed. Cir. 2023) (citing In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)).
[xiv] Id. at 2.
[xv] Id. at 15 (citing ZUP, LLC v. Nash Mfg., Inc., 896 F.3d 1365, 1371 (Fed. Cir. 2018)).
[xvi] Id.
[xvii] Id. at 16-17.
[xviii] Id. at 17-18.
[xix] Id. at 20.
[xx] Id. at 21.
[xxi] Id. at 22.
[xxii] Id. at 31 (citing Forest Labs., LLC v. Sigmapharm Labs., LLC, 918 F.3d 928, 937 (Fed. Cir. 2019); Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014); Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 970 (Fed. Cir. 2006).
[xxiii] Id.
[xxiv] Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1380 (Fed. Cir. 2023) (citing Intel Corp. v. Qualcomm Inc., 21 F.4th at 784, 799–800 (Fed. Cir. 2021)).
[xxv] See, KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 127 S.Ct. 1727, 1734 (2007) (citing Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18, 86 S.Ct. 684 (1966)).
[xxvi] In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329 (Fed. Cir. 2006) (citing In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998)).
