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Post-KSR Obviousness

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This article discusses changes in the patent law obviousness doctrine after KSR and provides strategy recommendations for protecting biotechnology inventions

This article discusses changes in the patent law obviousness doctrine after KSR and provides strategy recommendations for protecting biotechnology inventions

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Post-KSR Obviousness Post-KSR Obviousness Document Transcript

  • US: BIOTECHNOLOGY PATENTS How biotech patentees can navigate KSR Ewa M Davison and Gary M Myles provide strategies for establishing non-obviousness in the biotechnology and pharmaceutical arts in light of the Supreme Court’s rejection of a rigid TSM test T he US Supreme Court in KSR International Co v Teleflex Inc raised the bar for establishing non-obviousness, arguably the most easily challenged patentabil- ity requirement in the United States. By rejecting the Federal Circuit’s require- One-minute read ment that the prior art contain an express teaching, suggestion or motivation (the In overcoming an obvious- TSM test) to combine the claimed elements of the invention, the Supreme Court ness challenge asserted encouraged an analytical shift towards a framework focusing on the predictability during patent prosecution of the art and reasonable expectation of success. This article explores how this shift or litigation, the patentee may be used to the patentee’s advantage in the fields of biotechnology and pharma- of a biotechnology or phar- ceuticals. maceutical invention must stress the unpredictability of the art and/or Origins of non-obviousness the absence of a reasonable expectation of Despite repeatedly revising the Patent Act after its enactment in 1790, Congress for success. Consequently, although inventions in almost two centuries relied solely on the statutory requirements of novelty and util- these unpredictable fields are more vulnerable ity. Thus, the question of how to further refine patentability was largely left to the to a finding of obviousness post-KSR, several courts. Accordingly, the US Supreme Court in Hotchkiss v Greenwood (1851) cre- factors lend themselves to a strong non-obvi- ated a new condition of patentability, requiring that the invention evidence “more ousness argument. While practitioners can no ingenuity and skill ... than were possessed by an ordinary mechanic acquainted with longer rely on the absence of an express the business”. teaching, suggestion or motivation in the Congress codified the Hotchkiss test in Section 103 of the Patent Act of 1952, prior art to overcome an obviousness chal- labelling the requirement as one of non-obviousness. As the Court later noted in the lenge, the approaches outlined here provide a seminal case Graham v John Deere Co (1966), Hotchkiss had established a practi- roadmap for navigating the post-KSR non- cal test requiring “a comparison between the subject matter of the patent, or patent obviousness framework. application, and the background skill of the calling”. The Section 103 formulation similarly “place[d] emphasis on the pertinent art existing at the time the invention was made and ... [was] implicitly tied to advances in that art”. The Court then elab- orated on this basic non-obviousness framework: Under § 103, the scope and content of the prior art are to be determined; differ- ences between the prior art and the claims at issue are to be ascertained, and the level of ordinary skill in the prior art resolved.... Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc, might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As the Supreme Court more recently explained: “The non-obviousness requirement extends the field of unpatentable material beyond that which could readily be deduced from publicly available material by a person of ordinary skill in the perti- nent field of endeavor” (Bonito Boats, Inc v Thunder Craft Boats, Inc, 1989). Obviousness pre-KSR Following the Graham decision, federal courts attempted to develop general guide- lines – not only to ease non-obviousness analysis, but also to help establish judicial consistency. First, use of hindsight is improper in determining whether a combination is obvi- ous (In re Fine, Fed Cir 1988). To guard against use of hindsight, the Federal Circuit insisted that a claimed combination was obvious only where the prior art contained a teaching, suggestion or motivation to combine the individual elements (Al-Site Corp v VSI Int’l, Inc, Fed Cir 1999). Such a teaching, suggestion, or motivation may be found in the prior art references themselves, the nature of the problem, or the knowledge of those of ordinary skill in the art. Second, the cited prior art need not assure the inventor that a particular combi- nation will meet with certain success. Rather, obviousness requires only a “reason- able expectation of success” (In re O’Farrell, Fed Cir 1988). But, at least until www.managingip.com July/August 2008 79
  • US: BIOTECHNOLOGY PATENTS Statutory non-obviousness requirement 35 USC § 103(a) provides: “A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the sub- ject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” Post-KSR USPTO guidelines emphasize a predictability standard In light of the Supreme Court’s KSR decision, the USPTO issued new rationales for use by its exam- iners in rejecting an invention as obvious: A) combining prior art elements according to known methods to yield predictable results; B) simple substitution of one known element for another to obtain predictable results; C) use of known technique to improve similar devices (methods, or products) in the same way; D) applying a known technique to a known device (method, or product) ready for improve- ment to yield predictable results; E) “obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; F) known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations would have been predictable to one of ordinary skill in the art; G) some teaching, suggestion, or motivation in the prior art that would have led one of ordi- nary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. Source: 72 Fed Reg 57526, 57529 (October 10 2007) (emphasis added). Of particular note is how many of these bases for an obvious rejection centre on the concept of predictability. recently, obviousness could not be established on the basis that claim, for a court can take account of the inferences and creative the claimed combination was “obvious to try” – that is, that steps that a person of ordinary skill in the art would enjoy”. either the inventor (1) varied all the numerous parameters or The Court focused much of its obviousness analysis on pre- choices presented by the prior art until a successful result was dictability: “The combination of familiar elements according to reached, at least where the prior art provides “no indication of known methods is likely to be obvious when it does no more which parameters were critical or no direction as to which of than yield predictable results.” Thus, when determining many possible choices is likely to be successful”; or (2) whether a claimed invention that combines prior art elements explored a promising new technology or approach with only is obvious, “a court must ask whether the improvement is more “general guidance” from the prior art. than the predictable use of prior art elements according to their Third, particular types of evidence aid in the establishment established functions”. Absence of predictability may be estab- of non-obviousness. For example, the Supreme Court indicat- lished by unexpected results, synergy, or teaching away; a com- ed that unexpected or synergistic results constitute particular- bination is also unpredictable if “beyond [the] skill” of one of ly compelling evidence of non-obviousness (United States v ordinary skill in the art. The Court further noted: Adams, 1966; Anderson’s-Black Rock, Inc v Pavement When there is a design need or market pressure to solve a Salvage Co, 1969). The same tends to be true where the prior problem and there are a finite number of identified, pre- art “teaches away” from the claimed combination by identify- dictable solutions, a person of ordinary skill has good rea- ing its disadvantages (United States v Adams, 1966). son to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the The Supreme Court weighs in product not of innovation but of ordinary skill and common In KSR International Co v Teleflex Inc, the Supreme Court sense. In that instance the fact that a combination was obvi- rejected the Federal Circuit’s “rigid” application of the TSM test ous to try might show that it was obvious under § 103. as “inconsistent” with the “expansive and flexible approach” The Court in KSR thus seems to have espoused the “obvi- necessitated by the Graham obviousness framework. Although ous to try” standard long rejected by the Federal Circuit. noting that the TSM test embodied a “helpful insight” and that The new examination guidelines issued by the USPTO in no “necessary inconsistency” existed “between the idea under- light of KSR similarly emphasize that an examiner must lying the TSM test and the Graham analysis”, the Court con- focus on predictability in analyzing an invention’s obvious- cluded that an overly formulaic approach risked “[g]ranting ness during patent prosecution (see box). patent protection to advances that would occur in the ordinary course without real innovation”. Accordingly, although it is still A long dry spell: obviousness post-KSR important to identify a reason motivating a claimed combina- In an unpublished decision issued a mere three days after KSR, tion, an obviousness analysis “need not seek out precise teach- the Federal Circuit affirmed a jury verdict of obviousness ings directed to the specific subject matter of the challenged (Syngenta Seeds, Inc v Monsanto Co, Fed Cir 2007). The www.managingip.com 80 July/August 2008
  • US: BIOTECHNOLOGY PATENTS Moreover, although the 5(S) stereoisomer was significantly more potent than other ramipril stereoisomers, no unexpect- ed result occurred here as the 5(S) stereoisomer’s potency cor- related with its percentage in the prior art mixture. In Pharmastem Therapeutics, Inc v Viacell, Inc, the Federal Circuit concluded that a reasonable jury could not have found non-obvious the challenged patents claiming cryopreserved umbilical cord blood and its use in transplants for hematopoi- etic reconstitution (Fed Cir 2007). The Federal Circuit noted that prior art references suggested both cryopreserving cord blood and using cord blood to effect hematopoietic reconsti- tution, and that one of skill in the art would have had a rea- sonable expectation of success in combining these references. Moreover, the prior art “spelled out” each step required for the cryopreservation and transplantation procedures. At most, therefore, the inventors proved conclusively that stem cells in cryopreserved cord blood were capable of hematopoietic reconstitution. Although “[s]cientific confirmation of what was already believed to be true may be a valuable contribu- tion, ... it does not give rise to a patentable invention” – a find- ing to the contrary would contravene KSR by “[g]ranting patent protection to advances that would occur in the ordinary course without real innovation”. Needle in a haystack: non-obviousness post-KSR In Takeda Chemical Industries, Ltd v Alphapharm Pty, Ltd, the Federal Circuit clarified that “in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner” (Fed Cir 2007). Alphapharm argued that Takeda’s claims to the antidiabetic compound pioglitazone were obvious because: (1) the prior art would have led a chemist to choose the related “com- patent at issue claimed transgenic corn expressing the insecti- pound b” as the lead for further modification; and (2) it cidal protein Bt. To increase expression, patentee Syngenta would have been obvious to try modifying compound b modified the Bt gene so that at least 60% of its nucleotides through homologation and ring-walking, thus creating piogli- consisted of guanine and cytosine. This patent was rendered tazone. Affirming the district court’s finding of non-obvious- obvious, however, by a prior art reference teaching that Bt ness, the Federal Circuit concluded that the obvious-to-try gene expression could be improved in tobacco plants by standard was not satisfied because a chemist would have had increasing guanine and cytosine content, and that this finding no reason to choose compound b for further study. Not only was “equally applicable in other plant species”. Syngenta did “the prior art disclose a broad selection of compounds failed to establish teaching away, absence of a reasonable any one of which could have been selected as a lead com- expectation of success, or unexpected results. pound for further investigation”, but compound b led to The Federal Circuit provided a more instructive opinion in weight and fat increases and thus “exhibited negative proper- Aventis Pharma Deutschland GMBH v Lupin, Ltd, whereby it ties that would have directed one of ordinary skill in the art reversed the district court’s summary judg- ment of infringement (Fed Cir 2007). The Federal Circuit found obvious those claims The KSR decision mandated a shift away from of a pharmaceutical patent relating to the 5(S) stereoisomer of ramipril, an ACE rigid application of the TSM test in assertions inhibitor used for treating high blood pres- of non-obviousness sure, in a form substantially free of other isomers. The prior art contained a mixture of the 5(S) and SSSSR stereoisomers of ramipril; nonetheless, the away from that compound”. Moreover, even if this were not district court, requiring “an explicit teaching to purify the 5(S) the case, non-obviousness could still be established based on stereoisomer”, found the claims valid. Rejecting this reasoning as the unexpectedly decreased toxicity of pioglitazone as com- “precisely the sort of rigid application of the TSM test that was pared to compound b. criticized in KSR”, the Federal Circuit concluded: Most recently, in Ortho-McNeil Pharmaceutical, Inc v if it is known that a desirable property of a mixture derives Mylan Laboratories, Inc, the Federal Circuit found that the in whole or in part from a particular one of its components, district court did not err in finding non-obvious patent or if the prior art would provide a person of ordinary skill claims to an anti-epilepsy drug (Fed Cir 2008). Topiramate, in the art with reason to believe that this is so, the purified a reaction intermediate with anticonvulsive properties, was compound is prima facie obvious over the mixture even discovered by an Ortho-McNeil scientist during his search without an explicit teaching that the ingredient should be for new diabetes treatments. Seeking to market a generic concentrated or purified. form of topiramate, Mylan argued that the claims to this www.managingip.com July/August 2008 81
  • US: BIOTECHNOLOGY PATENTS Strategies for overcoming common obviousness rejections Combination Structural similarity that the prior art, rather than merely provid- The non-obviousness of a composition compris- Where a claimed compound is rejected as ing little or no guidance, actually “teaches ing a combination of compound A and com- obvious over a structurally similar prior art away” from the invention by encouraging a pound B, challenged as obvious over com- compound, the rejection can be most easily different path of investigation. pounds A and B individually disclosed within overcome by demonstrating that the claimed the prior art, may be overcome by demonstrat- compound possesses an unexpected potency Purification ing that the composition possesses an unex- or activity as compared to the prior art com- A claim to a compound rejected as obvious pected activity not attributable to either com- pound. Alternatively, where the prior art dis- over a prior art mixture containing the claimed pound A or B alone. This is usually achieved by closes a large number of compounds but pro- compound may be nonetheless non-obvious showing that the activity of the combination is vides no guidance as to which should be cho- where it was not previously known either: (1) either: (1) entirely new, or (2) a synergistic, as sen for further modification (or what modifi- that the claimed compound was present in the opposed to additive, property. Alternatively, the cations might be desirable), an obviousness prior art mixture, or (2) that the compound was combination may be non-obvious where the rejection may be overcome by emphasizing the active ingredient in the mixture. prior art teaches away from the combination of the unpredictability of the art and arguing Alternatively, as for combinations and struc- compounds A and B, for example by teaching an that a skilled artisan would not have had a turally similar compounds, the non-obviousness undesirable property associated with one or reasonable expectation of success in generat- of a purified compound may be established by both of the individual compounds. Finally, ing the claimed compound from the numerous showing its unexpected potency or unexpected where the prior art discloses A and B among a possibilities presented. Such an argument is properties as compared to the prior art. Finally, large number of compounds but provides no likely to be particularly effective where the an obviousness rejection or challenge to a puri- guidance as to which should be combined for applicant encountered unexpected challenges fied compound may be overcome by demon- further investigation, the combination may not during the synthesis or purification of the strating that the compound’s purification from have been obvious – particularly where combin- claimed compound. Similarly effective in the prior art mixture presented unexpected ing compounds A and B proved uniquely chal- rebutting a non-obviousness assertion based challenges or required the development of a lenging or difficult. on structural similarity is a demonstration new protocol or technique. invention, have had a reasonable expec- tation of success in achieving the claimed In the areas of biotechnology and pharmaceuticals invention. In the predictable arts, substantial unpredictability of the art may be used to the challenges exist to demonstrating the patentee’s advantage non-obviousness of inventions based on combinations of known elements. In the areas of biotechnology and pharmaceuti- drug were obvious under KSR because of the “finite number cals, however, unpredictability of the art may be used to the of identified, predictable solutions” to the market’s need for patentee’s advantage. This is particularly true where an ordi- a new antidiabetic drug – that is, that topiramate was obvi- narily skilled artisan would not have had a reasonable expecta- ous to try. In reaching the contrary conclusion, however, the tion of success in achieving the invention through mere combi- Federal Circuit noted the multiple steps at which a person of nation of elements known in the art. Thus, it is most effective ordinary skill would have had to make one of multiple choic- to argue the non-obviousness of a biotechnology or pharma- es in order to produce topiramate and recognize its utility as ceutical invention by demonstrating its unpredictability an anticonvulsant; such steps included choice of enzymatic through surprising results. target, choice of starting material, choice of synthesis route, A well-drafted patent application documents the unexpect- and the decision to test a reaction intermediate for properties ed results observed for a claimed invention – typically through unrelated to the purpose of the drug development undertak- working examples that include data demonstrating the sur- en. Consequently, the path to topiramate’s discovery did not prising activity. While presenting and supporting unexpected constitute “the easily traversed, small and finite number of results through declarations may be effective in some circum- alternatives that KSR suggested might support an inference stances, it is preferred practice to thoroughly document unex- of obviousness”. This case thus demonstrates that “a flexible pected results within the patent specification itself. This per- TSM test remains the primary guarantor against a non-statu- mits the practitioner to cite support from the specification in tory hindsight analysis such as” that proposed by Mylan. rebutting an obviousness rejection, and avoids the risks asso- ciated with scrutiny of a declaration during litigation. New strategies The included examples (see box) address commonly The KSR decision mandated a shift away from rigid applica- encountered circumstances in which an obviousness rejection tion of the TSM test in assertions of non-obviousness. Thus, or challenge may be raised to a biotechnology or pharmaceu- while an express teaching, suggestion, or motivation in the art tical invention. may strongly support the obviousness of a claim, a practition- er can no longer rely on their absence to establish non-obvi- ousness – either in rebutting an examiner’s prima facie case of obviousness or in overcoming an obviousness assertion during litigation. Instead, a non-obviousness argument must now Ewa M Davison Gary M Myles focus on the predictability of the relevant art and on whether © Ewa M Davison and Gary M Myles 2008. The authors are associates the person of ordinary skill in the art would, at the time of at Darby & Darby PC in Seattle www.managingip.com 82 July/August 2008