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`Galderma Laboratories, LP v. Tolmar, Inc., 737 F. 3d 731 - Court of Appeals, Federal Circuit 2013 - Google Scholar
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`734
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`737 F.3d 731 (2013)
`GALDERMA LABORATORIES, L.P., Galderma S.A., and Galderma Research and Development,
`S.N.C., Plaintiffs-Appellees,
`v.
`TOLMAR, INC., Defendant-Appellant.
`No. 2013-1034.
`United States Court of Appeals, Federal Circuit.
`December 11, 2013.
`*734 Charles E. Lipsey, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Reston, VA, argued for plaintiffs-
`appellees. With him on the brief were Howard W. Levine, Sanya Sukduang, Cortney B. Casp, and Victoria S. Lee, of
`Washington, DC.
`Thomas P. Steindler, McDermott Will & Emery LLP, of Washington, DC, argued for defendant-appellant. With him on the
`brief were Jeffrey R. Gargano and Keith M. Stolte, of Chicago, IL.
`Before NEWMAN, BRYSON, and PROST, Circuit Judges.
`PROST, Circuit Judge.
`In this patent infringement case, Tolmar, Inc. challenges the district court's holding that the claims of U.S. Patent Nos.
`7,579,377 (`377 patent); 7,737,181 (`181 patent); 7,834,060 (`060 patent); 7,838,558 (`558 patent); and 7,868,044 (`044
`patent), which are owned by Galderma Laboratories, L.P., Galderma S.A., and Galderma Research and Development,
`S.N.C. (collectively, "Galderma") are not invalid under 35 U.S.C. § 103. We find that the district court erred in finding the
`claims of the asserted patents not invalid as obvious. Accordingly, we reverse.
`I. BACKGROUND
`
`This Hatch-Waxman case is based on Tolmar's filing of an Abbreviated New Drug Application ("ANDA") seeking
`approval to market a generic version of Differin® Gel, 0.3%, which is a topical medication containing 0.3% by weight
`adapalene approved for the treatment of acne. On January 21, 2010, Galderma sued Tolmar in the United States
`District Court for the District of Delaware, alleging that Tolmar's ANDA product infringed certain claims of the '377 patent.
`Galderma subsequently filed amended complaints alleging infringement of each of the asserted patents. After a bench
`trial, the district court ruled against Tolmar on several issues of which only invalidity under 35 U.S.C. § 103 is at issue in
`this appeal.
`A. Patented Technology
`
`The asserted patents include both composition claims and claims directed to methods of treating acne using
`pharmaceutical compositions. At trial, Galderma alleged infringement of claims 35 and 36 of the '181 patent, claims 24
`and 27 of the '060 patent, claim 5 of the '558 patent, and claims 40 and 41 of the '044 patent.[1] Each of the asserted
`claims requires an aqueous gel or cream that includes 0.3% by weight of adapalene. The asserted claims also recite
`one or more inactive excipients included in the gel or cream. Claim 5 of the '558 patent is representative:
`5. A topically applicable pharmaceutical composition comprising 0.3% by weight of [adapalene] relative to
`the total weight of the composition, effective for the treatment of acne, formulated into a topically
`applicable, pharmaceutically acceptable medium therefor, said composition being in the form of a
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`topically applicable, pharmaceutically acceptable aqueous gel comprising at least one carbomer gelling
`agent and wherein the sole anti-acne ingredient is adapalene.
`B. Prior Art
`
`735
`
`736
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`Below, Tolmar based its obviousness argument primarily on three pieces of prior art: U.S. Patent No. 4,717,720 ("Shroot
`'720 patent"), U.S. Reissue No. 34,440 *735 ("Shroot '440 patent"), and the Differin® 0.1% Gel Data Sheet ("Data
`Sheet").
`The Shroot '720 patent specifically discloses and claims adapalene along with other inventive compounds. Col. 3 ll. 9-
`10; col. 4 ll. 29-37; col. 9 ll. 39-54; col. 19 l.17col. 20 l. 19. Four of the seven composition examples in the Shroot '720
`patent disclose adapalene as the active ingredient, in concentrations of 0.001%, 0.1%, and 1%. Col. 16 ll. 35-53; col. 17
`ll. 20-52. The specification of the Shroot '720 patent states repeatedly that the inventive compounds are useful for the
`treatment of acne. See col. 4 ll. 53-59; see also col. 5 ll. 49-53. Moreover, the specification states that the inventive
`compounds can be used in concentrations "preferably between 0.01 and 1 weight percent, based on the total weight of
`the composition." Shroot '720 patent col. 5 ll. 61-64. Finally, the Shroot '720 patent indicates that the inventive
`compounds "are less irritating than known retinoids of analogous structure." Col. 4 ll. 48-51. The Shroot '440 patent is
`largely similar to the Shroot '720 patent, but also contains claim 4, which recites a preferred range of 0.01 to 1% for
`cosmetic compositions which include the inventive compounds, e.g., adapalene, as the active ingredient. Shroot '440
`patent col. 20 ll. 15-18. Notably, prior to their expiration, the Shroot patents were listed in the FDA's Orange Book as
`covering Galderma's prior art Differin® 0.1% Gel as well as Differin® Gel, 0.3%.
`The Data Sheet is the product insert for Galderma's earlier launched adapalene product. The Data Sheet discloses
`0.1% adapalene as a treatment for acne. It also discloses all but one of the inactive ingredients listed in the asserted
`claims. Other than the dosage of adapalene, the only difference between the claimed formulations and the formulation
`taught by the Data Sheet is that the Data Sheet discloses "poloxamer 182," while certain asserted claims list "poloxamer
`124."
`In addition to the Shroot patents and the Data Sheet, Tolmar provided other relevant evidence. For instance, a 1989
`article by Jamoulle et al. describes the use of a lotion containing 0.3% adapalene in an animal model to determine
`whether adapalene was suitable for the treatment of acne. The authors concluded from this test that adapalene was
`"particularly suitable for the treatment of acne." J.A. 13063. A series of other prior art articles demonstrate that 0.03% and
`0.1% adapalene products were effective against acne and well tolerated. These articles include: Verschoore et al.,
`Efficacy and Safety of CD 271 Alcoholic Gels in the Topical Treatment of Acne Vulgaris, 124 British J. of Derm. 368-71
`(1991) ("Verschoore 1991"); Alirezai et al., Comparative Study of the Effectiveness and Tolerance of 0.1 and 0.03
`Percent Adapalene Gels and of a 0.025 Percent Tretinoin Gel in the Treatment of Acne, 123 Ann. Dermatol. Venereol.
`165-70 (1996) ("Alirezai 1996"); Allec et al., Skin Distribution and Pharmaceutical Aspects of Adapalene Gel, 35(6) J.
`Am. Acad. of Dermatol. S119-25 (1997) ("Allec 1997").
`The prior art also teaches the use of 0.3% adapalene for other conditions without intolerable irritability. See Verschoore
`et al., Adapalene 0.1% Gel Has Low Skin Irritation Potential, 36(6) J. Am. Acad. of Dermatol. S104-09 (1997)
`("Verschoore 1997"); Goldfarb, Using Adapalene to Treat Photodamage, Supp. to Skin & Aging 4-7 (Nov.2000)
`("Goldfarb Article"); Goldfarb et al., Photographic Assessment of the Effects of Adapalene 0.1% and 0.3% Gels and
`Vehicle on Photodamage Skin, 14 (Supp.1) J. Eur. Acad. Dermatol. Venerol. 315 (2000) ("Goldfarb Abstract"); Euvrard,
`"How Adapalene Can Treat Actinic Keratoses," Supp. to Skin & Aging 12-15 (Nov. *736 2000) ("Euvrard 2002").[2] There
`was also an indication in the prior art that dermatologists preferred other retinoids to adapalene at least in part because
`they were available in multiple concentrations whereas adapalene was only available in one. Bershad et al., Topical
`Retinoids in the Treatment of Acne Vulgaris, 64 (Supp.2) Cutaneous Med. for the Practitioner 8-19 (Aug.1999) ("Bershad
`1999"). Finally, the prior art indicated that many skilled artisans believed at the time of the invention that 0.1% was the
`optimal concentration of adapalene for the treatment of acne. See Verschoore 1997; Allec 1997; Czernielewski et al.,
`Adapalene Biochemistry and the Evolution of a New Topical Retinoid for Treatment of Acne, 15 (Supp.3) J. Eur. Acad.
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`Dermatol. Venerol. 5-12 (2001) ("Czernielewski 2001").
`II. OBVIOUSNESS
`
`The determination of invalidity for reasons of obviousness under 35 U.S.C. § 103 is a legal conclusion based on
`underlying facts. Graham v. John Deere Co., 383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). Following a bench
`trial, we "review the district court's factual findings for clear error and its conclusions of law de novo." Winner Int'l Royalty
`Corp. v. Wang, 202 F.3d 1340, 1344-45 (Fed.Cir. 2000).
`Factual considerations that underlie the obviousness inquiry include the scope and content of the prior art, the
`differences between the prior art and the claimed invention, the level of ordinary skill in the art, and any relevant
`secondary considerations. See Graham, 383 U.S. at 17-18, 86 S.Ct. 684. Relevant secondary considerations include
`commercial success, long-felt but unsolved needs, failure of others, and unexpected results. KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398, 406, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007); In re Soni, 54 F.3d 746, 750 (Fed.Cir.1995). Because
`patents are presumed valid, Tolmar was required to prove that the asserted claims were obvious by clear and
`convincing evidence. See Microsoft Corp. v. i4i Ltd. P'ship, ___ U.S. ___, 131 S.Ct. 2238, 2242, 180 L.Ed.2d 131 (2011).
`Tolmar presents an obviousness case that is both straightforward and potent. At the time of the invention, adapalene
`was a known compound and the prior art Shroot patents disclose topical adapalene compositions for the purpose of
`treating acne in a preferred range of 0.01%-1%, including several exemplary formulations containing adapalene in
`various concentrations. The asserted claims are directed to 0.3% topical adapalene compositions for the treatment of
`acne, which fall within the concentration range disclosed in the Shroot patents. Thus, the Shroot patents disclose all of
`the limitations of the asserted claims, except for a precise teaching of 0.3% adapalene and the specific inactive
`ingredients of the asserted claims. The specific inactive ingredients of the asserted claims are, however, taught by the
`Data Sheet.
`The Data Sheet discloses each of the inactive ingredients, except for poloxamer 124. However, the district court found
`poloxamer 124 equivalent to poloxamer 182, which is disclosed in the Data Sheet. Moreover, the district court held that
`"the record evidence establishes that the inactive ingredients in the claimed formulations [were] routine and obvious,
`and, therefore, non-inventive." Galderma Labs., L.P. v. Tolmar, Inc., 891 F.Supp.2d *737 588, 645 (D.Del.2012).
`Notably, on appeal, the parties do not dispute the obviousness of the inactive ingredients of the formulation. Rather, the
`sole dispute between the parties is whether it was obvious to use a 0.3% adapalene composition for the treatment of
`acne. Accordingly, Tolmar argues that the asserted claims are obvious because they claim nothing more than the use of
`an old compound for a known purpose in a concentration that falls within a range disclosed in the prior art as preferred
`for that purpose.
`Tolmar buttresses its obviousness argument with other relevant evidence. This evidence includes a study that used a
`lotion containing 0.3% adapalene in an animal model to determine that adapalene was "particularly suitable for the
`treatment of acne." J.A. 13063. Additionally, the prior art showed that 0.03% and 0.1% adapalene products were suitable
`for the treatment of acne and that 0.3% adapalene products were suitable for the treatment of other conditions without
`intolerable irritability. Moreover, the prior art indicated that dermatologists desired acne treatments that came in varying
`concentrations. According to Tolmar, this provides further motivation to select a 0.3% adapalene composition for the
`treatment of acne.
`The district court rejected Tolmar's obviousness case, finding that Tolmar "failed to establish, by clear and convincing
`evidence, that the claimed inventions would have been obvious to a person of ordinary skill at the time of the invention."
`Galderma Labs., 891 F.Supp.2d at 637. In reaching this conclusion, the district court relied heavily on evidence showing
`that increasing the dose of adapalene was likely to increase the incidence of certain side effects and evidence showing
`that 0.1% was considered the optimal adapalene concentration for the treatment of acne. Id. at 641-42. In addition, the
`court found "that at least two secondary considerations, unexpected results and commercial success, additionally
`support the determination that the asserted claims are not invalid due to obviousness." Id. at 642-44.
`
`737
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`Prior to addressing the obviousness of the asserted claims, we note an error in the district court's obviousness analysis.
`The district court framed the obviousness inquiry as requiring Tolmar to provide motivation in the prior art to triple the
`concentration of adapalene from 0.1% to 0.3%. Id. at 638. Tolmar carried no such burden. Rather, Tolmar, like all those
`who seek to prove claims obvious, was required to show that "the differences between the claimed invention and the
`prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the
`claimed invention to a person having ordinary skill in the art to which the claimed invention pertains." 35 U.S.C. § 103.
`Nothing in the statute or our case law requires Tolmar to prove obviousness by starting with a prior' art commercial
`embodiment and then providing motivation to alter that commercial embodiment. See KSR, 550 U.S. at 419, 127 S.Ct.
`1727 ("In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the
`avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is
`obvious, it is invalid under § 103."). This is particularly true where, as here, the prior art teaches a range that
`encompasses both the prior art commercial embodiment and the claimed invention.
`The relevant dispute in this case is thus not over whether the prior art discloses all of the claim elements or over the
`motivation to combine the prior art references. Rather, the dispute is whether there was motivation to select the claimed
`0.3% adapalene composition in the disclosed *738 range. In these circumstances, where there is a range disclosed in
`the prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee to come
`forward with evidence that (1) the prior art taught away from the claimed invention; (2) there were new and unexpected
`results relative to the prior art; or (3) there are other pertinent secondary considerations. See Novo Nordisk A/S v. Caraco
`Pharm. Labs., Ltd., 719 F.3d 1346, 1352-54 (Fed. Cir.2013).
`Accordingly, Tolmar having demonstrated that the prior art taught a range of concentrations of adapalene for the
`treatment of acne that encompasses the claimed 0.3% adapalene composition, we now examine the district court's
`findings with respect to the factors listed above to determine whether the claims are invalid as obvious. The ultimate
`burden of proving obviousness rests with Tolmar.
`A. Teaching Away
`
`Despite express teachings in the Shroot patents indicating that adapalene would be useful in concentrations preferably
`between 0.01% and 1%, the district court found that the prior art taught away from a 0.3% adapalene composition. The
`district court based its conclusion primarily on two related grounds.[3] First, according to the district court, the prior art
`taught "away from the selection of 0.3% adapalene for the treatment of acne, because of dose-dependent increases in
`side effects." Galderma Labs., 891 F.Supp.2d at 641 n. 8. And second, the prior art taught that 0.1% was the optimal
`concentration of adapalene for the treatment of acne. Id. at 641-42. We leave undisturbed the district court's findings that
`increasing the dose of adapalene would result in a concomitant increase in side effects and that 0.1% was the optimal
`concentration of adapalene for the treatment of acne at the time of the invention. However, to the extent the court found
`that these facts taught away from the claimed invention, it clearly erred.
`A reference may be said to teach away when a person of ordinary skill, upon reading the reference,
`would be discouraged from following the path set out in the reference, or would be led in a direction
`divergent from the path that was taken by the applicant. A reference does not teach away, however, if it
`merely expresses a general preference for an alternative invention but does not criticize, discredit, or
`otherwise discourage investigation into the invention claimed.
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed.Cir. 2009). With respect to the prior art
`teachings of dose-dependent side effects, the district court relied on the Verschoore 1991 and Alirezai 1996 articles,
`which show that the increase in adapalene concentration from 0.03% to 0.1% resulted in an increase in side effects.
`Neither of these articles mentions 0.3% adapalene compositions, nor do they expressly teach away from the claimed
`invention. The district court inferred that these references taught away from a further tripling of the adapalene
`concentration. We cannot agree with this inference.
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`These articles show increased side effects associated with 0.1% adapalene as *739 compared to 0.03% adapalene, yet
`they failed to discourage even the use of 0.1% adapalene. To the contrary, as the district court found, 0.1% was the
`optimal concentration of adapalene at the time of the invention. Galderma Labs., 891 F.Supp.2d at 641-42. Moreover,
`there is nothing in either of these references to indicate that increasing the concentration to 0.3% would be unproductive,
`nor do these articles indicate in any way that the side effects would be serious enough to dissuade the development of a
`0.3% adapalene product. Therefore, the Verschoore 1991 and Alirezai 1996 articles fail to teach away from the claimed
`invention.
`The district court relied on the Allec 1997, Verschoore 1997, and Czernielewski 2001 articles to demonstrate that 0.1%
`was the standard or optimal concentration of adapalene for the treatment of acne. The court concluded that this fact
`teaches away from 0.3% adapalene compositions. It does not. "A reference does not teach away ... if it ... does not
``criticize, discredit, or otherwise discourage' investigation into the invention claimed." DePuy Spine, 567 F.3d at 1327
`(citing In re Fulton, 391 F.3d 1195, 1201 (Fed.Cir.2004)). A teaching that a composition may be optimal or standard does
`not criticize, discredit, or otherwise discourage investigation into other compositions. Accordingly, the Allec 1997,
`Verschoore 1997, and Czernielewski 2001 articles do not teach away from the claimed invention.
`B. Unexpected Results
`
`The district court found that the comparable tolerability of 0.1% and 0.3% adapalene was unexpected in view of the prior
`art, since a skilled artisan would have expected that tripling the concentration of adapalene would have resulted in a
`clinically significant increase in side effects. Galderma Labs., 891 F.Supp.2d at 642-44. While we agree that this result
`was unexpected, it does not constitute an unexpected result that is probative of nonobviousness.
`Unexpected results that are probative of nonobviousness are those that are "different in kind and not merely in degree
`from the results of the prior art." Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed.Cir.2004) (citation
`omitted). Results which differ by percentages are differences in degree rather than kind, where the modification of the
`percentage is within the capabilities of one skilled in the art at the time. See In re Harris, 409 F.3d 1339, 1344
`(Fed.Cir.2005) (finding increased efficacy, measured by percentages, to be a difference of degree and not of kind); In re
`Budde, 50 C.C.P.A. 1491, 319 F.2d 242, 246 (1963) (finding no unexpected results where ranges of reaction time and
`temperature constituted only a difference in degree rather than in kind); In re Aller, 42 C.C.P.A. 824, 220 F.2d 454, 456-
`57 (1955) (finding no unexpected results where improved yields over the prior art, measured by percentages, reflect a
`difference in degree, not in kind). Thus, where an unexpected increase in efficacy is measured by a small percentage, as
`here, and the evidence indicates that skilled artisans were capable of adjusting the percentage, the result constitutes a
`difference in degree, not kind. So too, where an increase by a percentage is expected but not found, that result is also
`likely only a difference in degree. In this case, the expected result was an increase, by some percentage, in the
`prevalence of certain side effects. The failure of that percent increase to materialize, though unexpected, constitutes only
`a difference in degree from the prior art results. Accordingly, the comparable tolerability of 0.1% and 0.3% adapalene
`does not indicate that the asserted claims are non-obvious.
`*740 C. Commercial Success
`
`"Evidence of commercial success... is only significant if there is a nexus between the claimed invention and the
`commercial success." Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311-12 (Fed.Cir.2006). "When a patentee can
`demonstrate commercial success, usually shown by significant sales in a relevant market, and that the successful
`product is the invention disclosed and claimed in the patent, it is presumed that the commercial success is due to the
`patented invention." J.T. Eaton & Co. v. Atlantic Paste & Glue Co., 106 F.3d 1563, 1571 (Fed.Cir.1997). However, "if the
`feature that creates the commercial success was known in the prior art, the success is not pertinent." Ormco Corp., 463
`F.3d at 1311-12; see also J.T. Eaton, 106 F.3d at 1571 ("[T]he asserted commercial success of the product must be due
`to the merits of the claimed invention beyond what was readily available in the prior art").
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`740
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`The district court found that "[t]he commercial success of Galderma's 0.3% adapalene product also supports a finding of
`nonobviousness." Galderma Labs., 891 F.Supp.2d at 644. The district court gave two reasons for its finding. First,
`Differin® 0.3%, Galderma's commercial embodiment of the claims, "quickly gained and maintained market share —
`even in the face of an overall declining market and decreasing promotional expenditures, and while facing competition
`from generic 0.1% adapalene formulations." Id. Second, the court found "that Tolmar (along with another ANDA filer,
`Actavis) seeks to enter the market precisely because Differin® 0.3% has been commercially successful." Id. We discuss
`these findings in reverse order.
`The mere fact that generic pharmaceutical companies seek approval to market a generic version of a drug, without more,
`is not evidence of commercial success that speaks to the non-obviousness of patent claims. Plainly, Tolmar believes
`that it can make a profit selling a generic version of the claimed invention. This is likely true in all Hatch-Waxman cases,
`if not all patent cases generally. However, that fact tells us very little about the level of commercial success of the
`patented invention relative to the prior art or the extent to which the commercial success of the branded drug is "due to
`the merits of the claimed invention beyond what was readily available in the prior art." J.T. Eaton, 106 F.3d at 1571. As
`such, it does not support a finding of non-obviousness.
`The court also relied on the fact that Differin® Gel, 0.3% quickly gained and maintained market share to find commercial
`success. We do not disturb this finding. However, we note that it is of limited value in determining whether or not the
`presently asserted claims are obvious. "Commercial success is relevant because the law presumes an idea would
`successfully have been brought to market sooner, in response to market forces, had the idea been obvious to persons
`skilled in the art." Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1376 (Fed.Cir. 2005). Where "market entry by
`others was precluded [due to blocking patents], the inference of non-obviousness of [the asserted claims], from evidence
`of commercial success, is weak." Id. at 1377. This principle applies forcefully to the present case.
`The now expired Shroot patents blocked the market entry of 0.3% adapalene products until their expiration in 2010, long
`after Galderma invented 0.3% adapalene compositions of the asserted claims. As such, no entity other than Galderma
`could have successfully brought to 0.3% to market prior to 2010. Like the commercial *741 success described in Merck &
`Co., the commercial success of Differin® Gel, 0.3% is of "minimal probative value." Id. at 1376. Accordingly, we conclude
`the district court erred in adjudging this factor as confirming its conclusion of nonobviousness.
`III. CONCLUSION
`
`For the foregoing reasons, we hold that claims 35 and 36 of the '181 patent, claims 24 and 27 of the '060 patent, claim 5
`of the '558 patent, and claims 40 and 41 of the `044 patent are invalid as obvious. We therefore reverse the district
`court's finding that the claims are valid.
`
`REVERSED.
`NEWMAN, Circuit Judge, dissenting.
`Without doubt, the question of obviousness here presented is a close call. However, when the question is close, when it
`turns on findings and interpretations of biologic and medicinal evidence, when the application of law to fact invokes the
`policy of the patent statute to advance the useful arts, then the findings and rulings of the trial court warrant particular
`attention on appellate review.
`Here, the district court fully explored the evidence relating to whether it would have been obvious to increase by 300%
`the concentration of the active ingredient adapalene without increasing its known adverse side effects. The district judge
`held an eight-day bench trial, heard thirteen live witnesses including expert witnesses of stature and experience, and
`received evidence and argument from both sides. The court issued an opinion with over 50 pages on the issue of
`obviousness, finding the facts and weighing the evidence and applying the law with thoughtful explanation and
`reasoning.[1]
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`My colleagues on this panel give scant attention to the district court's analysis, instead making their own findings, and
`applying flawed procedural and substantive law. My colleagues do not identify clear error in the district court's findings;
`instead they distort the burdens of proof and production, ignore the applicable standard of proof and rely on their own
`factual determinations and creative theories of law, and eradicate the patent.
`The district court ruled that there was not clear and convincing evidence of invalidity. By contrast, my colleagues
`announce their rule whereby a broad teaching that includes the patented invention removes the statutory presumption of
`validity, and without more establishes obviousness. See maj. op. at 737-38 ("where there is a range disclosed in the
`prior art, and the claimed invention falls within that range, the burden of production falls upon the patentee ..."). Although
`the majority mentions the requirement of clear and convincing evidence of invalidity, the majority presumes that the prior
`art establishes invalidity, and places on the patentee the burden of establishing patentability based on "secondary
`considerations." The majority goes on to impose a new and unprecedented view of these considerations.
`For example, although the panel majority concedes that there are unexpected results for the concentration selected by
`the patentee, see maj. op. at 739 ("we agree that this result was unexpected"), my colleagues do not require the patent
`challenger to show any reason in the prior art (or common sense) for selection of this embodiment with its unexpected
`properties. Rather, they hold that unless a skilled artisan was not "capable of adjusting the percentage," id., the extent of
`the change in percentage (here 300%) and the unexpected *742 results and properties are irrelevant to patentability.
`In refusing to credit any of the demonstrated "secondary considerations" my colleagues foreclose patentability to a vast
`body of improvement patents. In the field of medicaments, the denial of patentability for improvements is a disincentive to
`the development of such improvements. The losers are those afflicted with disease. I respectfully dissent.
`
`DISCUSSION
`
`Particularly for close questions of patentability, the district court's findings and assessments of credibility and weight of
`evidence, and the district court's application of law to found facts, compel appellate attention. The role of the trial court in
`considering the evidence that each party provides through examination and cross-examination of witnesses and
`documents, with judicial elaboration and interaction, cannot be matched on appeal. As the Supreme Court stated in
`Anderson v. Bessemer City, "duplication of the trial judge's efforts in the court of appeals would very likely contribute only
`negligibly to the accuracy of fact determination at a huge cost in diversion of judicial resources." 470 U.S. 564, 574-75,
`105 S.Ct. 1504, 84 L.Ed.2d 518 (1985).
`Clear and convincing evidence is required to overcome the statutory presumption of validity of a duly granted patent.
`See 35 U.S.C. § 282 (a patent is presumed valid); Cardinal Chem. Co. v. Morton Int'l, 508 U.S. 83, 93 n. 15, 113 S.Ct.
`1967, 124 L.Ed.2d 1 (1993) (invalidity must be proved by clear and convincing evidence). Here the panel majority does
`not provide clear and convincing evidence of invalidity. Instead, the majority discards the trial judge's findings on the
`premise of a presumption of invalidity that the majority applies to "selection" inventions, that is, inventions within a known
`class or range of technology, for which the majority discards the established procedural and substantive burdens. The
`majority makes its own factual findings, and writes new law.
`In contrast to the panel majority's dismissive analysis, the district court's findings reflect careful examination of all of the
`evidence. Nonetheless, my colleagues conclude that the selection of a 300% increase in dosage was obvious, after the
`unexpected properties of the increase were discovered by this patentee. I summarize some of the evidence before the
`district court, whose findings well support the conclusion that invalidity on the ground of obviousness was not
`established by clear and convincing evidence:
`
`I T
`
`HE PRIOR ART
`
`https://scholar.google.com/scholar_case?case=5700967401803944370&q=galderma+labs+v+tolmar&hl=en&as_sdt=40000003
`
`7/14
`
`MYLAN PHARMS. INC. EXHIBIT 1048 PAGE 7
`
`
`
`7/30/2015
`
`Galderma Laboratories, LP v. Tolmar, Inc., 737 F. 3d 731 - Court of Appeals, Federal Circuit 2013 - Google Scholar
`In this Hatch-Waxman case, Tolmar, Inc. seeks to invalidate Galderma's patents on the commercially successful acne
`medication whose active ingredient is the retinoid adapalene in 0.3% concentration. There was