Not Losing the Forest for the Trees: Newman Concurs in Ariad

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Coming as no surprise, a majority of the en banc Federal Circuit just ruled in Ariad Pharmaceuticals v. Eli Lilly &Co. that there is a separate and distinct “written description” requirement in the first paragraph of 35 U.S.C. § 112.  See Some Heretical Thoughts on the Ariad Case: What Does “Any Person Skilled in the Art” Mean and Should It Apply to the “Written Description” Requirement? Also not surprisingly, there were multiple concurring (and dissenting) opinions discussing this separate and distinct “written description” requirement.  Judge Lourie (also not surprisingly writing the majority opinion) has now won the on-going debate that has raged between him and Judge Rader (who has strenuously argued there is no “written description” requirement separate and distinct from the “enablement” requirement) since the 1997 case of Regents of the University of California v. Eli Lilly & Co.

What might have gotten lost in the trees during this mind-numbing walk through 72 pages of majority, concurring, and dissenting opinions is what, exactly, does this separate and distinct “written description” requirement mean?  Fortunately, Judge Newman’s concurring opinion doesn’t lose sight of the forest by concisely capturing the essence (and not simply the form) of the “written description” requirement, and why the patent in Ariad felt short of that requirement.

At stake in Ariad was U.S. Pat. No. 6,410,516 (the ‘516 patent) on regulating gene expression by the transcription factor NF-κB.  Specifically, the ’516 patent identified this transcription factor and uncovered the mechanism by which NF-κB activated gene expression underlying the body’s immune responses to infection.  In fact, the inventors for the ‘516 patent recognized that artificially interfering with NF-κB activity could reduce the harmful symptoms of certain diseases.  With this recognition, the ‘516 patent claiming methods for regulating cellular responses to external stimuli by reducing NF-κB activity in a cell.

A major problem that became apparent when Ariad brought suit against Eli Lilly was that the ‘516 patent was “very long on theory’ but potentially lacking in exemplification of actual molecules that were known to regulate and reduce NF-κB activity in a cell.  In fact, Judge Lourie’s opinion is tinged with language suggesting the “theoretical nature” of the method claimed in the ‘516 patent.  For example, Judge Lourie’s opinion refers to the patent specification as reciting “the desired goal of reducing NF-κB activity and binding to NF-κB recognition sites in cells in response to such external influences” (emphasis added).  This patent specification was also characterized as “hypothesiz[ing] three types of molecules with the potential to reduce NF-κB activity in cells: decoy, dominantly interfering, and specific inhibitor molecules.”

The parallel between the ‘516 patent on reducing NF-κB activity and U.S. Pat. No. 6,048,850 (the Young patent) that was asserted against Pfizer, the maker of Celebrex, for treating pain and inflammation by inhibiting the “pain causing” COX-2 enzyme, in the 2004 case of University of Rochester v. G.D. Searle & Co. is strikingly similar.  Like the ‘516 patent, the Young patent described in detail the mechanism by which pain and inflammation relief could be achieved without undesired side effects, as well as a screening assay for identifying potential drugs.  But, in ruling the Young patent failed to satisfy the “written description” requirement, the district court found that the Young patent did “not identify any particular drugs that the assay will identify as suitable for” pain and inflammation relief.  In fact, only one specific compound was identified by the patent that might be suitable in the claimed method.  (Indeed, without running prospective compounds through the drug screen described in the Young patent, there was no way to predict which of these compounds would satisfy the COX-2 enzyme mechanism.)  On appeal, the Federal Circuit affirmed the district court ruling:  “We agree with Pfizer that our precedent recognizes a written description requirement and that the [Young] patent does not satisfy that requirement.”

On Eli Lilly’s appeal in the Ariad case, the original 3 judge Federal Circuit panel ruled that the asserted claims of the ‘516 patent were invalid under the “written description” requirement.  In the en banc opinion, Judge Lourie’s walk through the thicket of “written description” requirement jurisprudence began with parsing the language of the first paragraph of 35 U.S.C. § 112, or as some might call it “how many angels can stand on the head of a pin.”  Judge Lourie’s lengthy dissertation agreed with Eli Lilly’s position that this first paragraph contained two separate description requirements:  (1) a “written description” of the invention; and (2) “written description” of the manner and process of making and using the invention.  While acknowledging that Ariad agreed with this interpretation of the first paragraph, Judge Lourie disagreed with their position that the adequacy of the first requirement (“written description of the invention”) must be judged “by whether that description identifies the invention so as to enable one of skill in the art to make and use it.”

Judge Lourie’s tome on “statutory language parsing” included a review of prior statutes going as far back as the 1793 Patent Act, Supreme Court precedent as early as the 1822 case of Evans v. Eaton and as recent as the 2002 case of Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. (“[T]he patent application must describe, enable, and set forth the best mode of carrying out the invention.”), as well as Federal Circuit jurisprudence starting with the 1967 CCPA case of In re Ruschig.  Surprisingly Judge Lourie’s opinion makes no mention to the 1996 case of In re Alton which is the clearest statement by the Federal Circuit that the “written description” requirement is ”distinct from the enablement and best mode requirements.”

After concluding the “statutory language parsing” exercise (including confirming that this separate and distinct “written description” requirement applies to both amended and original claims), Judge Lourie’s opinion meanders next amongst the timbers for about 17 pages to describe, explain, and exemplify what this separate and distinct “written description” is and why the ‘516 patent failed to comply with this requirement.  Particularly significant is Judge Lourie’s reliance on the Regents of the University of California case that, with regard to broad generic claims, “an adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.”  In fact, to adequately describe this genus “requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.”  That includes “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials.”  Indeed, Judge Lourie specifically characterized the ‘516 patent as “similarly illustrat[ing] the problem of generic claims.”

In addition to the Regents of the University of California case, Judge Lourie was quite cognizant of the parallel between the Young patent in the University of Rochester case (an opinion he also wrote) and the ‘516 patent in Ariad:

In the [University of] Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme.  We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification’s function description, the specification did not provide an adequate written description of the claimed invention.  Such claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in [Regents of the University of California] and Ariad’s claims, cover any compound later actually invented and determined to fall within the claim’s functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.

Ariad complained that this view of the “written description” requirement would “disadvantage[e] universities to the extent that basic research cannot be patented.”  But Judge Lourie’s reply was unsympathetic:

Much university research relates to basic research, including research into scientific principles and mechanisms of action [citing the University of Rochester case], and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered.  That is no failure of the law’s interpretation, but its intention. Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.

So much for the “theory” of what the “written description” means in Ariad.  As applied to the claimed method for reducing NF-κB activity in a cell, Judge Lourie’s opinion found the “written description” in the ‘516 patent lacking.  In particular, the three “hypothesized” classes of molecules potentially capable of reducing NF-κB activity (specific inhibitors, dominantly interfering molecules, and decoy molecules) described in the ‘516 patent was not enough for Judge Lourie, again drawing parallels to the University of Rochester case, as well as the Regents of the University of California case and the 1993 interference case of Fiers v. Revel, each involving claims which “explicitly included the non-described compositions.”  Regarding “specific inhibitors,” only one example (I-κB) was given in the ‘516 patent.  No examples of “dominantly interfering molecules” were mentioned in the ‘516 patent.  The ‘516 patent did propose example structures of “decoy molecules.”  But in Judge Lourie’s view, that wasn’t enough as “there is no descriptive link between the table of decoy molecules and reducing NF-KB activity,” especially in view of “the vast scope of these generic claims.”

And so the ‘516 patent tree fell before Judge Lourie’s “written description” axe.  But it was Judge Newman’s concurring opinion that does some astute pruning to put the holding in Ariad in appropriate context:  “In my view, the overriding policy of patent systems requires both written description and enablement, and it is less critical to decide which statutory clause applies in a particular case, than to assure that both requirements are met.”

Judge Newman’s concurrence also eloquently (and concisely) addresses Ariad’s complaint about the impact of the “written description” requirement on basic research at universities (with reference to the 1853 case of O’Reilly v Morse where Samuel Morse’s claims to the telegraph were upheld, but not those for use of an electric current “however developed”):

Basic scientific principles are not the subject matter of patents, while their application is the focus of this law of commercial incentive.  The role of the patent system is to encourage and enable the practical applications of scientific advances, through investment and commerce.

The practical utility on which commercial value is based is the realm of the patent grant; and in securing this exclusionary right, the patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right.  This is not a question of grammatical nuance of the placement of commas in Section 112; it is a question of the principle and policy of patent systems.  The court’s opinion implements these precepts.

The university community may “howl” at the “written description” burden imposed by the holding in Ariad on basic academic research.  But Judge Newman’s concurrence correctly explains why that burden is appropriate, as well as making sense of the written description “forest” that lurks within the “trees” of Judge Lourie’s opinion.  As Judge Newsman’s concurring opinion astutely observes, the “patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right.”  Simply describing the “basic scientific principles” behind a biological mechanism doesn’t necessarily tell you enough about what the “trees” are in that expansive generic “forest.”

© 2010 Eric W. Guttag

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10 comments so far.

  • [Avatar for EG]
    EG
    March 29, 2010 02:22 pm

    BD,

    Thanks fo the link to Dr Salzberg’s article. Salzberg, like the ACLU and others pursuing the misguided suit against Myriad, needs to get a dose of reality, as well as accurately portray what was patented. Contrary to what Salzberg implies, Ariad didn’t patent human genes, but instead a method for controlling the regulatory pathway of the gene. In fact, and Salzberg completely misses this point, as Ariad’s patent didn’t go down on lack of patent eligibility grounds under 35 USC 101, but for failure to satisfy “written description” under the first paragraph of 35 USC 112. There’s a big difference.

    I sorry if I come off as “arrogant” on this point, but I grow weary of those who act like they know what they’re talking about but don’t when it comes to the patent area. Salzberg may be expert in his biotech field, but he’s a “babe in the woods” when it comes to talking about what can or should be patentable in the biotech field. The danger of foks like Salzberg is their “science credentials” carry wait with others who are equally ignorant of what patents can (and cannot) cover. This ignorance is also too blindly accepted by those on high, including our “friends” on SCOTUS.

  • [Avatar for Blind Dogma]
    Blind Dogma
    March 29, 2010 01:23 pm

    And now for something completely different:
    http://blogs.forbes.com/sciencebiz/2010/03/a-patent-purely-about-greed/

    Those greedy gene patenters are at it again.

  • [Avatar for Blind Dogma]
    Blind Dogma
    March 24, 2010 09:16 pm

    optionally – as the description – that may not be clear above.

  • [Avatar for Blind Dogma]
    Blind Dogma
    March 24, 2010 09:15 pm

    I like to think that I’m not just a front – I sometimes will poke Gene with a software/patentability question so we can see some massive raving over here (just to keep Gene’s blood pumping at a healthy pressure, of course).

    I found the 112 paragraph 1 question interesting because the decision is so forceful yet its affect on the design patent side of the fence probably was not considered at all, but still – design patents must meet that section. I recognize that the picture is the desciption as well as the claim (optionally), but enablement simply isn’t something that is typically even considered.

    I’m not into design patents all that much, so I would be interested in actual knowledge (something not available in appreciable amounts over at the other blog)

  • [Avatar for EG]
    EG
    March 24, 2010 04:20 pm

    “Does Perry post here?”

    BD,

    I don’t know the answer to that, but Perry is certainly welcome to opine all he wants on this issue.

    So you’re just a “front” for someone else’s comment? That’s OK, as I sometimes “front” for my patent attorney brother.

  • [Avatar for Blind Dogma]
    Blind Dogma
    March 24, 2010 03:38 pm

    Thanks for the compliment, but the astuteness belongs to another. I am merely provoking a conversation as is my want.

    Does Perry post here?

  • [Avatar for EG]
    EG
    March 24, 2010 01:19 pm

    “What about Design patent applications (which are required to satisfy 112 paragraph 1) and the requirement to provide “(2) “written description” of the manner and process of making and using the invention.”?”

    BD,

    You astutely point out the paradox of applying the provisions on utility patents to design patents. In fact, trying to apply the first paragraph (or even second paragraph) of 35 USC 112 strictly to design patents is an exercise in futility as the design drawings (and how they’re prepared) generally dictate the scope of coverage for design patents. I would be interesting to get Perry Saidman’s views on this subject as he’s the true “design expert” (it’s certainly not me). Thanks for the comment..

  • [Avatar for EG]
    EG
    March 24, 2010 11:48 am

    SB,

    Thanks for the comment. I’m not truly a “biotech” person but I am a chemist and the “supporting the scope of the genus” problem is longstanding issue with us. I’ll also agree that Judge Lourie is not the clearest on what satisfies the “written description” requirement (and his opinion in Prometheus on when a drug dosage calibration method satisifes Bilski is a model of obfuscation of the point). My problem with Lourie’s opinion is that it spends an inordinate amount of time on the “separate and distinct” aspect of the “written description” requirement which I characterize in my article as equivalent to “how many angels can stand on the head of a pin.” As far as I was concerned, this question was settled by the Federal Circuit at least as far back as the 1996 case of In re Alton, and even earlier by the Supreme Court.

    I also wouldn’t go as far as you suggest that Ariad sets an unreallistic and unreachable standard for obtaining claims having broad generic. Probably the most significant statement by Lourie to consider in this regard is at page 21 is where Lourie says (referring to Univ. of California v. Eli Lilly) “an adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.” I call this the “black box” analogy because you may define the boundaries of a “black box” without ever defining what its contents are. What Lourie is looking for (and which makes sense to me) is some definition of what’s in the “black box,” or in patent claim lingo, what’s in the broad genus, functionally, structurally, etc. What the ‘516 patent did (as the Young patent in the Rochester case also unfortunately did) was simply define the boundaries of the generic “black box” but didn’t give you sufficient explanation as to how define and identify what molecules (in sufficient quantity) that would fit within that ratther large generic “black box.”

    Why I applauded Newman’s concurrence is that it astutely and concisely observes what the “essence” of the first paragraph of 35 USC 112 is, “the patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right.” That’s the key: if you want broad generic coverage, you must adequately describe and enable that scope in the patent spec. As I noted in my article, that’s been true since 1853 O’Reilly v. Morse case (cited directly by Newman and unfortunately only addressed in a footnote by Lourie) which has regretably been miscited (repeatedly) as a 35 USC 101 case, but is really a first paragraph 35 USC 112 case.

    My additional 2 cents for what it’s worth. Does that help you?

  • [Avatar for Blind Dogma]
    Blind Dogma
    March 24, 2010 11:41 am

    This may be a different forest full of different trees, but a thought provoking notion has appeared on another blog concerning the bifurcation of 112 paragraph 1 into separate description and enablement requirements.

    What about Design patent applications (which are required to satisfy 112 paragraph 1) and the requirement to provide “(2) “written description” of the manner and process of making and using the invention.”?

  • [Avatar for step back]
    step back
    March 24, 2010 10:52 am

    The Ariad opinion was a disappointing one. The court could have, and should have, gone much further in explaining to the lay public what the implications of the written description are.

    My take away from Ariad (and I’m not a biotech person) is that the specification must go to the point of providing proof positive that the inventor was in full conceptual possession of every major included species of a genus claim. If there is reasonable doubt as to whether: (1) the inventor was merely providing prophetic invitation for others to explore new areas or (2) the inventor was in full conceptual possession of every major included species of the genus claim (and in Ariad, if I read it correctly as a non-bio person there were 3 such species) , then the presence of such reasonable doubt must tip its weight against the inventor. He should have provided more proof; like a best mode for each of the major species in the forest. The fact that there was no mode indicates that this was more likely than not, a mere invitation to future exploration and not actual conceptual possession of every major included species.