Implications of the Supreme Court's KSR v. Teleflex Decision for Biotechnology

    By Kevin E. Noonan --

The ink is barely dry on the U.S. Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc., perhaps the most anticipated patent law decision of the year, and pundits and practitioners are trying to assess the impact of the decision on patent law and practice.  It is clear from the Supreme Court's language that different technologies will be differentially affected by the application of the Court's obviousness rubrics.  The question (at least for Patent Docs) is how can this decision be expected to impact biotechnology patent claims (both in prosecution and litigation)?

It is important to remember that the Supreme Court did not overturn the Federal Circuit's "teaching-suggestion-motivation" (TSM) test for determining whether an invention was obvious under 35 U.S.C. § 103; rather, the Court disapproved of the manner in which the Federal Circuit applied the test.  Indeed, the Court said that the TSM test represented "a helpful insight," and further, that "[t]here is no necessary inconsistency between the idea underlying the TSM test and the Graham analysis."  These are not words intended to effect a sea change in the law of obviousness.  Instead, the Court provided a corrective for a doctrine it believed had been applied too rigidly and formulaically.

In KSR, the Supreme Court emphasized its own obviousness jurisprudence.  As it has consistently in that jurisprudence (including United States v. Adams; Anderson's-Black Rock, Inc. v. Pavement Salvage Co.; and Sakraida v. AG Pro, Inc.), the Supreme Court was concerned more with preventing patents on inventions that lacked a sufficient amount of "innovation" than in stimulating incremental innovation by the promise of patent protection.  Under the Court's analysis, combinations of previously-known elements are excluded from patentability unless there is some evidence that the desirability or predictability of a successful combination would not be evident to the person of ordinary skill in the art.  The Court opined that the way in which the Federal Circuit had applied its TSM test eliminated the "common sense" appreciation that the skilled worker would have in combining known elements in ways the art would appreciate as being expected to solve a recognized or commercially-significant product.  As a result of the KSR decision, it can be expected to be more difficult to obtain or defend patents based merely on incremental improvements in the art.

These effects can be expected to fall less heavily on biotechnology inventions that in other art areas such as the electrical and mechanical arts.  Importantly in this regard, the Court's analysis included (albeit by implication) the traditional notion that evidence of surprising and unexpected results is evidence of non-obviousness.  These considerations inure to the benefit of patentees and patent applicants of biotechnology inventions, since this is an inherently unpredictable art.

For example, even under KSR, it should be difficult to assert a prima facie case of obviousness against a claim to an antibody against a previously-unknown antigen.  For known antigens for which there are no antibodies known in the prior art, it may be "obvious to try" to obtain an antibody, but it is certainly not predictable either that an antibody can be obtained, or that said antibody will have a particular minimum affinity for its cognate antigen.  Thus, since one characteristic property of any antibody (including both polyclonal antisera and monoclonal antibodies) is its affinity, including in the definition of a claimed antibody an affinity minimum is one way to show non-obviousness.  Whether this is a feature that must be included as a limitation in the patent claims can be expected to depend on other factors; for antigens with known antibodies in the art, it may be one way to demonstrate non-obviousness.

Similarly, it should be difficult to make out a prima facie case of obviousness for a novel gene (at least one for which the entire amino acid sequence is unknown).  However, in view of the extensive gene sequence evidence in the art, and the growing recognition of functionality-related amino acid sequence motifs, a discovery of a new member of a multigene family, without more, would likely face an obviousness challenge.  However, other types of genetic inventions, such as claims to disease-related markers including single nucleotide polymorphisms, should also be non-obvious, since their identities will be unrecognized in the art.

Diagnostic claims may also be in some jeopardy, depending on what is known in the art about the association of a particular disease and any feature or characteristic of the disease, including molecular markers.  Diagnostic methods for diagnosing a disease based on identifying the presence or amount of a disease marker expected to be associated with the disease or the severity thereof may provoke an obviousness challenge that relies on the "common sense" standard identified in the Court's opinion.

These are of course preliminary observations.  However, it is likely that biotechnology claims should be spared the greatest burdensome effects of the KSR decision.  These effects will be most immediately and decidedly felt in applicant's dealings with the Patent Office, where there is already great anticipation for applying the obviousness standard more strictly.  Patent Commissioner Doll has been quoted as welcoming the decision because it will permit patent examiners to utilize their expertise in making patentability determinations.  Regardless of the accuracy of that sentiment, the Office will certainly respond to the KSR decision by developing new examination guidelines, the contours of which are not yet discernable.  However, in view of the fact that at least one biotechnology unit examiner recently bemoaned the Federal Circuit's In re Deuel decision to a Science magazine reporter, biotechnology patent applicants should not expect to be unscathed by KSR.  What can be said is that the recent reversal of the "No Patent and Trademark Office" era is probably over, and the time and expense of obtaining patent protection has just gone up.

For additional information regarding the KSR decision, please see:

• "CLE's on KSR Int'l Co. v. Teleflex Inc."
• "The Patent Office Reacts to KSR: A First Look"
• "KSR Int'l Co. v. Teleflex Inc. (2007)"

APLF Presentation on KSR Int'l Co. v. Teleflex Inc.

Comments

[biotech guy]

"For known antigens for which there are no antibodies known in the prior art, it may be "obvious to try" to obtain an antibody, but it is certainly not predictable either that an antibody can be obtained, or that said antibody will have a particular minimum affinity for its cognate antigen. Thus, since one characteristic property of any antibody (including both polyclonal antisera and monoclonal antibodies) is its affinity, including in the definition of a claimed antibody an affinity minimum is one way to show non-obviousness."

Unless the antigen is especially non-immunogenic or otherwise resistant to the creation or screening of antibodies, especially in the age of phage display, I don't see how such limitations will show nonobviousness. On threshold affinity or avidity limitations, again unless you show that there is something special about your threshold (like it is really difficult to do this unless you had insight to a technical fix). I think this was true before KSR, but the case just underscores this.

I hope you are not saying that one wouldn't be motivated to make an antibody to a known antigen without more, are you? The dicta in KSR goes directly against this, I think.

[Kevin E. Noonan]

It depends on the scope of the claim. A claim to "an antibody produced by the hybridoma identified by ATCC No. X" will be non-obvious because it is limited to the specifically-deposited antibody. If the claim is to be more broad, it would need to have at least a threshold affinity, analogous to the limitations in In re Wands. The fact is that there is no way to know a priori whether something will produce a particular antibody or one having a non-trivial affinity. And the point is the "reasonable expectation of success" prong of the test - which the Court in a backhanded way reaffirmed.

The problem would be if we went back to the old DNA claim calculus, that the protein existed, thus there was a motivation to isolate the gene encoding the protein, and since the Maniatis manual told the skilled worker how to clone genes, a gene for a known protein was obvious. The CAFC said, no because it wasn't obvious that it would be THIS gene (the one you cloned) and this opened up the money for funding the genomics revolution. (And if you think private funding for Celera didn't spur the public HGP efforts to get the thing done quickly, you weren't paying attention.)

Applied to the antibody example, if the position becomes that the existence of a protein, the fact that having an antibody for that protein is good to have, and antibody technology is reliable thus antibodies are obvious, there will be no motivation to invest in antibody drugs. If this is the case, there won't be money for the next Herceptin, and maybe the Supremes are comfortable with that kind of world but I'm not.

Obviousness is all about line-drawing, and factored into where the line is drawn has to be the consequences on the purpose of the patent system - providing a way to protect technology long enough for investment in the technology to make sense. If we go down the "everything is obvious" road again in biotechnology maybe this time we won't be lucky enough to recover.

Thanks for the comment.