Leo Pharma v. Rea: Fleshing Out “Obvious to Try” Combinations

 Category: 103
Obvious to Try?
By: Jesus Hernandez, Blog Editor/Contributor  
TitleLeo Pharma. Prod., Ltd., v. Rea, No. 2012-1520 (Fed. Cir. Aug. 2013).
Issue"[W]hether, in light of the prior art references [not specifically addressing the problem of the ‘013 patent] and objective indicia of nonobviousness, the claimed invention would have been obvious to a person of ordinary skill in the art at a time just before the time of invention.” Leo Pharma. at *11 (text added).
Holding“In light of the lack of expectation of a successful result, the failure of the prior art to provide direction, and the substantial number of intervening years between the publication of the prior art and the ’013 patent’s filing date, this invention is not simply a case of '‘picking and choosing’ from a list in order to achieve a compatible and non-deleterious preparation' […]. Because the problem was not known, the possible approaches to solving the problem were not known or finite, and the solution was not predictable, it would not have been obvious for a person of ordinary skill to make the claimed invention.” Id. at *18-19.

Procedural History“This appeal arises from an inter partes reexamination of U.S. Patent No. 6,753,013 (the ’013 patent). The ’013 patent is owned by Leo Pharmaceutical Products, Ltd. (Leo Pharmaceuticals) and challenged by third party requester Galderma R&D. “ Leo Pharma., at *1.

Legal Reasoning (Rader, C.J., O'Malley, Reyna)
Obvious to Try Analysis
Problem was Not Known"As an initial matter, an invention can often be the recognition of a problem itself. See Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 381 F.3d 1371, 1377 (Fed. Cir. 2004) (“There can of course arise situations wherein identification of the problem is itself the invention.”). Here, the prior art either discouraged combining vitamin D analogs and corticosteroids in a single formulation, or attempted the combination without recognizing or solving the storage stability problems associated with the combination." Leo Pharma. at *11.
Possible Approaches to Solving the Problem were either not Known or not Finite"This court and obviousness law in general recognizes an important distinction between combining known options into 'a finite number of identified, predictable solutions,' KSR, 550 U.S. at 421, and '‘merely throwing metaphorical darts at a board’ in hopes of arriving at a successful result,' Cyclobenzaprine, 676 F.3d at 1071 [...]. While the record shows that, as early as 1995, the prior art indicated that both vitamin D analogs and corticosteroids were effective treatments for psoriasis, see J.A. 610, 6237, that same prior art gave no direction as to which of the many possible combination choices were likely to be successful. Instead, the prior art consistently taught away from combining vitamin D analogs and corticosteroids." Id. at *18.
Solution not Predictable"Here, the 'background of useful knowledge'— including the prior art relied on by the Board—was published decades before the ’013 patent: Turi issued in 1978, Dikstein issued in 1986, and Serup was published in 1994. The elapsed time between the prior art and the ’013 patent’s filing date evinces that the ’013 patent’s claimed invention was not obvious to try. […] It took over a decade—after Dikstein’s disclosure of the benefits of combining vitamin D and corticosteroid treatments into one formulation—for Dikstein’s formulations to be tested for storage stability. And, until the advancement made by the inventors of the ’013 patent, no one had proposed a new formulation that would be storage stable. " Id. at *17.
Objective Indicia of Nonobviousness
Objective Indicia and Hindsight"This case illustrates a good reason for considering objective indicia as a critical piece of the obviousness analysis: Objective indicia “can be the most probative evidence of nonobviousness in the record, and enables the court to avert the trap of hindsight.” Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1310 (Fed. Cir. 2010) (internal quotation marks omitted). Here, the objective indicia of nonobviousness are crucial in avoiding the trap of hindsight when reviewing, what otherwise seems like, a combination of known elements." Leo Pharma. at *20.
Objective Indicia of Nonobviousness Cut Against an Obvious to Try Combination
Unexpected Results“During reexamination, the inventors of the ’013 pa- tent submitted test results that analyzed the Dikstein and Serup formulations. The inventors found that the formulations disclosed by Dikstein and Serup result in significant degradation of the vitamin D analog and corticosteroid. See J.A. 1041–46 (testing formulations in Serup); J.A. 1625–27, 2152–2154 (testing formulations in Dikstein). The inventors also tested an improvement of Serup using Turi, by replacing Serup’s solvent with POP-15-SE, and still found significant degradation of the corticosteroid component. See J.A. 1045–46. These test results are a strong indication that the ’013 patent’s combination of known elements yields more than just predictable results.” Leo Pharma., at *20-21.
Commercial Success“[T]he commercial success of Leo Pharmaceutical’s Taclonex® ointment is a testament to the improved properties of the ’013 patent’s claimed invention.“ Id. at *21.
Long Felt Need“The record also shows evidence of long felt but unsolved need, i.e., the need for a single formulation to treat psoriasis. The length of the intervening time between the publication dates of the prior art and the claimed invention can also qualify as an objective indicator of nonobviousness. [...] Here, the researchers were aware of the benefits of using both vitamin D and corticosteroids in the treatment of psoriasis as early as 1986. See, e.g., Dikstein col. 1, ll. 9–16. And Turi, upon which the Board relied to make its case, issued in 1978. Yet, it was not until the ’013 patent’s filing in 2000—twenty-two years after Turi and fourteen years after Dikstein—that the solution to the long felt but unsolved need for a combined treatment of vitamin D and cortico-steroid was created. The intervening time between the prior art’s teaching of the components and the eventual preparation of a successful composition speaks volumes to the nonobviousness of the ’013 patent.” Id. at *21-22.
Other: FDA Approval“Taclonex® is the first FDA-approved drug to combine vitamin D and corticosteroids into a single for- mulation for topical application. While FDA approval is not determinative of nonobviousness, it can be relevant in evaluating the objective indicia of nonobviousness. See Knoll Pharm. Co., Inc. v. Teva. Pharm. USA, Inc., 367 F.3d 1381, 1385 (Fed. Cir. 2004). Here, FDA approval highlights that Leo Pharmaceutical’s formulation is truly storage stable, something that the prior art formulations did not achieve.” Id. at *21.
Dicta on the importance of objective indicia of nonobviousness in adversarial proceedings“When an applicant appeals an examiner’s objection to the patentability of an application’s claims for obviousness, the PTO necessarily has the burden to establish a prima facie case of obviousness which the applicant then rebuts. […] However, during inter partes reexamination, the Board is reviewing evidence of obviousness—including objective indicia—submitted by two adversarial parties for the claims of an issued patent. Thus, the Board should give the objective indicia its proper weight and place in the obviousness analysis […].” Leo Pharma., at *19-20.
© 2000-2019, Journal of the Patent & Trademark Office Society
Disclaimer & Privacy Policy