In re Kubin: Federal Circuit Expands Obvious-to-Try Jurisprudence

In re Kubin (Fed. Cir. 2009), 08-1184.pdf (Opinion by Judge Rader)

In a much anticipated biotech case, the Federal Circuit has affirmed a BPAI obviousness decision and in the process expanded the court’s obvious to try jurisprudence. The Kubin opinion found that the Supreme Court’s KSR decision overturned In re Deuel and its admonition against an “obvious to try” test for obviousness.

To be clear, Kubin does not hold that an invention that was “obvious to try” was necessarily obvious under Section 103(a). Going forward, however, the question in this long-running debate will be “when is an invention that was obvious to try nevertheless nonobvious?” (quoting In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988).

Kubin revives the O’Farrell analysis of obvious to try and carves-out two factual situations where obvious-to-try analysis should not apply.

(1) Throwing darts versus a finite number of Identified, predictable known options:

In such circumstances, where a defendant merely throws metaphorical darts at a board filled with combinatorial prior art possibilities, courts should not succumb to hindsight claims of obviousness. The inverse of this proposition is succinctly encapsulated by the Supreme Court’s statement in KSR that where a skilled artisan merely pursues “known options” from a “finite number of identified, predictable solutions,” obviousness under § 103 arises. 550 U.S. at 421.

(2) Exploring new technology versus improving known and predictable technology:

[An] impermissible “obvious to try” situations occurs where ‘what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.’ (Quoting O’Farrell).

Again, KSR affirmed the logical inverse of this statement by stating that § 103 bars patentability unless “the improvement is more than the predictable use of prior art elements according to their established functions.”

Application: In this case, the court finds that neither of the O’Farrell exceptions apply. The invention is old-school biotech: isolating and sequencing a human gene that encodes for a protein. People do this in high school now, and the application explicitly states that the DNA and Protein sequence may be obtained through “conventional methodologies known to one of skill in the art.” Likewise, the protein in question had already been identified and the prior art suggested that the protein plays an role in human immune response.

KSR moves to Non-Predictable Arts: Biotech has traditionally been thought of as unpredictable. Here, Judge Rader may have dismantled the art-level distinction in holding that KSR applies to the unpredictable arts. The issue rather is if the particular invention in question was predictable.

Therefore this court cannot deem irrelevant the ease and predictability of cloning the gene that codes for that protein. This court cannot, in the face of KSR, cling to formalistic rules for obviousness, customize its legal tests for specific scientific fields in ways that deem entire classes of prior art teachings irrelevant, or discount the significant abilities of artisans of ordinary skill in an advanced area of art.

Affirmed.

Notes:

  • Kevin Noonan provides an important critique of the case – focusing primarily on the court’s mishandling of the factual issues. [Link].
  • I should note here that the PTO is well ahead of the Federal Circuit. MPEP 2141 indicates that being “obvious to try” is a proper rationale to “to support a conclusion of obviousness.” The big book does hint that such an application would only be proper if the “trying” means “choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.”
  • This case makes clear that the level of enablement of the prior art is very important to any obviousness conclusion. That result is in contrast to the recent Gleave case that found anticipation absent known utility.

66 thoughts on “In re Kubin: Federal Circuit Expands Obvious-to-Try Jurisprudence

  1. If I remember right, Luke, the English first instance found invalid a claim to the enantiomer (per se) reached via the inventive process, and then the appeal instance reversed, finding that claim to the enantiomer per se to be valid as well. The English court of appeal rarely interferes with the judgements of the English patents judges at first instance. When they do, you know it’s a real 50:50 legal point. The Dutch court had the benefit of further evidence from the former professor of chemistry, adduced after the English court had finished its work. But the extent to which the two chemistry professors, Baldwin and Davies, were cross-examined at the Dutch trial is something I don’t know. Mainland Europe doesn’t “do” cross-examination, does it?

  2. John Nagle wrote:

    ‘Clearly, if the mixture of both isomers has some effect of interest, it’s “obvious to try” the two isomers indvidually. Does that constitute “obviousness” for patent purposes’.

    Well, it may be “obvious to try” now, but it wasn’t always the case – there are plenty of patents whose terms are such that they were conceived when it was assuredly not so obvious to try. And even if it is now “obvious to try” separating out the enantiomers, that doesn’t equate to “obvious” – it may be for practical reasons a very difficult process – quite conceivably a patentably inventive process in of itself, rather than a mere matter of routine.

    Nonetheless, as the state of the art advances, in the enatiomer-separation field, the more routine it is becoming to separate out isomers, and the more “obvious to try” is equating to “obvious” per se.

    Take the escitalopram patent litigation on-going in Europe. IIRC, in 2007, the UK High court found the resolution method not obvious (no matter clearly desirable it was to try) because the resolution required an inventive step. However just last week a Dutch District Court found the opposite, distinguishing the British case, after a duel in court between the two expert witnesses, one the former Oxford Organic chemistry HOD, and the incumbent Oxford Organic chemistry HOD, went the former’s way. The Dutch court held the resolution was obvious.

    Cheers, Luke

  3. What’s current thinking in this area with regard to stereo-isomers of drugs? Asymmetric molecules come in “dextro” and “levo” forms, which are mirror images. Simple chemical processes produce a mixture of both forms, but they can be separated. The drug effects of the two isomers may be different.

    Clearly, if the mixture of both isomers has some effect of interest, it’s “obvious to try” the two isomers indvidually. Does that constitute “obviousness” for patent purposes.

    As an example, Clarinex, the allergy drug, is one isomer of Claritin. The patent on Claritin has expired. The patent on Clarinex is still in force. That gimmick alone was worth billions.

  4. Since 6 has graciously asked me to provide the “facts” behind my argument, I’ll reproduce what we put up on the Patent Docs blog:

    Sorry, 6, I got sidetracked by our discussion on Dennis’s blog.

    Here’s the deal. The patent explains in Example 1 that the library was made from NK cells that had been stimulated with a specific cocktail of activator molecules (IL-2, IL-12, IL-15, IFN-gamma and anti-CD-16 antibody); this treatment, and the necessity of this treatment is not found in Valiante, Sambrook or Matthew.

    Score: 1 for me

    In their Appeal Brief to the Board, Kubin argued that there was no guidance on how to “prepare” human NK cells so that they would produce sufficient NAIL mRNA to be detectable in a cDNA library.

    Score: 2 for me

    In their brief to the CAFC, Kubin argued that the prior art did not teach stimulating human NK cells with “certain activators.”

    Score: 3 for me

    Further in their brief, Kubin argued that the evidence of record showed that Applicants did not use conventional methods to clone NAIL.

    Score: 4 for me

    Finally, at oral argument Kubin’s counsel said: It does not tell one with skill in the art how to produce a NK cell library, and if you look at the methodology that’s recited in the specification, what they [Kubin] used was a specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators. That’s not disclosed in Sambrook. That’s not disclosed in Valiante. That’s not disclosed anywhere[.]

    Score: 5 for me

    Not directly related to the point I have been making, but relevant to the point in general, Kubin argued that Matthew did not teach that 2B4 was conserved between mouse and human (and indeed it was not, sharing only 69% sequence homology) AND that Matthew reported that 2B4 expression could NOT be detected in human NK cells.

    Score: 6 for me

    6, I understand that, from reading the decision is sounds logical and correct. Upthread [at Patent Docs] I invoked Kevin Kline in “A Fish Called Wanda.” Everything he said sounded logical and correct, too. It is unreasonable to think that Judge Rader would write an opinion that sounded any other way. But when the fundamental facts are missed or ignored, you get these types of errors.

    I don’t think it’s too much to ask that a decision having the consequences we can expect this one to have (the sky is not falling but it isn’t trivial, either) should be based on the facts. My point.

    Thanks for the discussion.

  5. Dear db:

    The answer would depend on many things, but this one in particular: was the “gene” in the genome cataloged (as in In re Hall) so that the skilled worker could identify it?

    I say that because you might have noticed that Kubin, and most gene patents, are all about cDNA. That’s because the cDNA is prepared from messenger RNA (mRNA) which, pretty much, just includes the coding sequence of the gene that produces the protein. (This is an over-simplification, but bear with me.)

    In genomic DNA from humans (and most higher organisms), the coding sequences of genes are frequently separated by intervening sequences or introns; genes have the structure:

    beginning of protein code – intron – continuing protein code – intron -etc – end of protein code.

    There are good evolutionary reasons for this, but the consequence is that it isn’t always so clear when you have a “gene” in genomic DNA (again, over-simplified but generally true). All you can usually say is that there is an open reading frame in this portion of the genome.

    So the question is, did the prior art disclose the cDNA? Answer is probably not, unless someone did the work to say “Gee, looking at this genomic DNA you could produce an mRNA encoding the following protein.” Next, would it be obvious? Well, by your hypothetical, filtered through the Kubin decision, probably not, since it would be an unknown protein with an unknown source of mRNA. I’m sure some would disagree, but I think this eliminates at least 2 of the factual bases of the Kubin decision, so I think it would be non-obvious.

    The problem is that you would also need to find out what the protein did, its activity, in order to satisfy the utility requirements of Sec. 101. So it isn’t as easy as looking up open reading frames in a database and filing a patent application.

  6. “I would accept your argument if it made sense to me.”

    And I think most legal minds would immediately realize that their arguments were fatally flawed if they made sense to 6.

  7. “Based on this analysis, the Second Circuit’s decision could be seen as a license to steal. … It would be as if a soft drink company could steal the formula for Coke, without fear of being enjoined…”

    It was a preliminary injunction, and the defendant was in possession of the trade secrets by virtue of a previous license. It’s a bit of a stretch to suggest that this will empower Pepsi to go after Coke’s formula with impunity, isn’t it?

    But I guess the hysterical approach will get more readers?

  8. Realizing this is off-topic and may invite a firestorm, the following information caught my eye. Granted this involves IP of a different nature than patents, there may be interest to regular participants of this blog.

    Seyfarth Shaw LLP
    Michael Levinson

    USA
    March 31 2009

    “Following up on our recent post about Faiveley Transport Malmo AB v. Wabtec Corporation, No. 08-5126 (2d Cir. March 9, 2009), the Second Circuit’s reversal of the preliminary injunction in that case effectively granted a compulsory license to Wabtec, the likely trade secret misappropriator. The evidence showed that Wabtec was using the Faiveley air brake secrets to sell its own air brakes. The court reasoned that there was no evidence that Wabtec had or was threatening to disseminate Faiveley’s secrets any further. Indeed, Wabtec itself gained a competitive advantage by not further disclosing the secrets. The “only possible injury that [the] plaintiff may suffer is loss of sales to a competing product . . . [which] should be fully compensable by money damages.” As a result, according to the Second Circuit, Faiveley did not face irreparable injury sufficient to justify equitable relief.

    Based on this analysis, the Second Circuit’s decision could be seen as a license to steal. It means that a trade secret misappropriator who “only” uses a purloined secret for its own benefit may not be enjoined. It would be as if a soft drink company could steal the formula for Coke, without fear of being enjoined, so long as it “merely” used the formula itself to compete with Coke and thus Coke could obtain money damages. This flies in the face of the well-accepted presumptions that trade secrets are unique and that their loss might not be able to be measured in money damages. This result could also empower misappropriators to steal their competitor’s secrets, confident that they can compel a license and that the worst that might happen if they get caught is that they would have to disgorge some amount of profits.”

  9. “Since you all raise a good question about “the beef” behind the factual argument, I’ll track it down for ya. But before I do that, let me know whether you are willing to accept this argument if I do:

    I think ultimately we are talking predictability – if it was not predictable that following the prior art would produce the NAIL cDNA, then the result should be that the Kubin’s invention was non-obvious. ”

    I think it is worth your while to find the beef anyway considering you just wrote up a HUGE post about it on your site and have spent a lot of time talking about “facts” and factual evidence etc that does not exist.

    I would accept your argument if it made sense to me. From what I can understand, NAIL is p38, they state that at the very beginning of the oral arguments and the applicant can’t be bothered to deny it, so I’m taking it as a given, just like Rader likely did. Since this is a structural claim, I don’t see how you can argue that if it wasn’t predictable that a prior art method would make NAIL then the structural claim is nonobvious since p38 was blatantly created somehow.

    In any event, if you can find an attorney on these boards to agree with your statement then I will go along with it. In the mean time though, there’s been substantial hubbub about these “facts” let’s see em.

  10. Hi Max,

    It isn’t a “Constitutional hang-up.”

    35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.
    (a) 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 subject 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. Patentability shall not be negatived by the manner in which the invention was made.

    Re: “Let the mind float, this Easter week-end.”

    Excellent advice: A floating mind promotes idle curiosity which leads to invention, “the Progress of Science and useful Arts.”

  11. Hey Just. The first step in any journey is the hardest. But you’re now on a path that leads to that sub-set of TSM which is the 100% objective, hindsight-free EPO-PSA. If you really try, you can get over this “manner it was made” Constitutional hang-up you have. It is illusory. Let the mind float, this Easter week-end.

  12. Dear step back,

    May I add to your most thoughtful comment?*

    I’ve been thinking about a test for obvious for a long time.

    The daunting challenge in constructing such a test is to remove subjectiveness, which, I submit, is impossible without requiring something tangible to test for obvious.

    The Federal Circuit should be applauded for establishing the need for some form of evidence of a Teaching, Suggestion or Motivation, TSM, to combine two or more published documents before tanking a patent under 103(a).

    Until – if ever – someone figures out something better that TSM, I’ll continue to believe TSM is the only way to remove subjectiveness from a test for obviousness.

    * Malcolm,
    It may be a rhetorical question, but KSR answered nothing, and it did much worse than nothing – KSR set up the “perfect storm” for any Examiner or Judge to tank a perfectly good patent if s/he got up on the wrong side of the bed – even if that Examiner or Judge takes her/his Oath of Office to heart!

    That’s only human nature 101.

    KSR is an abomination, whimsically screwing things up.

  13. Noonan: “if it was not predictable that following the prior art would produce the NAIL cDNA, then the result should be that the Kubin’s invention was non-obvious.”

    The issue is what does “following the prior art” mean? Does it mean doing exactly what one reference says, or can the skilled artisan use his/her “common sense” (e.g., by resorting to myriad other general teaching in the art) to modify a protocol?

    Bearing in mind, of course, that this is a composition claim.

    It’s rhetorical question. KSR answered it already.

  14. Broje, a few years of handling opposition proceedings at the EPO would help you to get a good feeling for the right obviousness standard. Over here we have as many clients who are desperate to keep their patents as we do clients who oppose, because they are desperately impeded by issued claims on obvious subject matter. The 3-member EPO Examining Divisions also spend much of their time hearing opposition cases, then writing their reasoned decisions “patent maintained” or “patent revoked”. I think all this experience of inter Partes dispute handling makes them better Examiners in ex Parte work, prior to issue. What would you think?

  15. The men and woman (not sp error) who sit as judges on the US Supreme Court are extremely intelligent people as is evident from the wide areas of law in which they must render decisions concerning questions that are often quite complex.

    But with that said, it would be wholly unAmerican to not permit rigorous criticism of their decisions, particularly in patent law where they get it wrong time and again. KSR was an example of bad fact patterns leading to the making of bad law. KSR was also an example of smooth talking lawyers persuading a group of people wholly inexperienced with patent practice that phrases like “common sense” and “ordinary creativity” and “predictable results” make sense. They don’t. There is no time like the present to point out that the Emperor wears no clothes (where said clothes include patent weathered shoes :-).

  16. The “obvious to try” standard bothers me in that, it seems to me, many of the great inventions of yesteryear would not have been patentable under it.

    For example, consider the light bulb. Many people were experimenting with different kinds of filaments trying to find one that would both blow brightly and last a long time. Edison found it first. He got the patent.

    Also, consider the airplane. People were driving all sorts of winged cycles with pedal powered propellers off of piers in contests to fly the farthest. The internal combustion engine (ICE) was already being used as a means for propulsion. The Wright brothers put an ICE on one of the winged contraptions and Voila! Patent on an airplane.

    I just think the stance on obviousness has become too strict, and the lifting on the band of the obvious to try standard is a step in the wrong direction.

  17. “Also it must be understood that the judges on the US Supreme Court are not scientists.”
    The scotus author of KSR does in fact have a science degree — no joke. it’s in political science, not that there’s anything wrong with that.

  18. Thanks Step. Any thoughts on Binding Precedent being analogous to Intelligent Design, while the EPO’s thousands of Decisions from 24 Technical Boards of Appeal, none Binding on any other, is more like “Survival of the Fittest” legal line of logic. BTW, the members of the Technical Boards of Appeal are mostly engineers and scientists.

  19. Max,

    You are quite right. The word predictable (capable of being predicted)is absolute nonsense. Essentially everything (whether it happens or not) is capable of being “predicted” by some soothsayer or another. See Nassim Taleb’s book –Fooled by the Randomness.

    I think KSR v. Teleflex has to be limited to its very specific fact pattern. Also it must be understood that the judges on the US Supreme Court are not scientists. Sometimes they will say things that make absolutely no scientific sense. KSR’s predictability line is one of those occasions.

  20. Hey Boss, you screwed up again.

    No 6, don’t do this:
    (ii) then cut and paste into the comment box and
    Do this instead:
    (ii) then COPY and paste into the comment box and

    Re: “OMFG my POAST DIDN”T POAST …
    OH AND D FIX YOUR SITE ALREADY SO IT STOPS EATING POSTS.”

    I have a suggestion you may find useful:
    (i) Write you POAST in MS Word;
    (ii) then COPY and paste into the comment box and
    (iii) then hit enter.

    Then, if your POAST gets eaten, you will be able to repeat steps (i) to (iii).
    Don’t forget to then hit enter (or else “preview” and “post” won’t be activated).

  21. Mr Noonan, and others, please forgive the intrusion of a non-biotech person, who hasn’t followed this thread up to now with any serious attention, but who just can’t help jumping in on “predictability” as a touchstone of “obviousness”. One worries.

    With hindsight, most everything in ME/EE is “predictable” but much in Chem/Bio is not. I imagine skilled researchers in Chem/Bio often proceed on the basis of a “hunch”. They have a reason to expect “success” but maybe can’t articulate that reason. Success is in some way being “predicted” by the utterance of that “hunch”. in other words, if somebody “predicted” it then it wasn’t “unpredictable”.

    JAOI is keen on the Statutory “invention shall not be negatived by the manner” etc. Is “predictability” far enough away from the statutory prohibition. Isn’t a better litmus paper test needed, than “predictability”?

    Or am I interpreting “predictable” too widely?

  22. Kevin, Would this be correct?
    Even if the entire genome is out there for the world to see, can one simply find a particular gene that is not transcribed or expressed as a protein and develop some way to induce transcription and then get a patent on the cDNA sequence (and not the method)?

  23. Dear No. 6,

    Re: “OMFG my POAST DIDN”T POAST …
    OH AND D FIX YOUR SITE ALREADY SO IT STOPS EATING POSTS.”

    I have a suggestion you may find useful:
    (i) Write you POAST in MS Word;
    (ii) then cut and paste into the comment box and
    (iii) then hit “enter.”

    Now, if your POAST gets eaten, repeat steps (i) to (iii). Good Luck.
    Don’t forget to hit “enter.”

  24. Sorry, guys, I was sleeping.

    Since you all raise a good question about “the beef” behind the factual argument, I’ll track it down for ya. But before I do that, let me know whether you are willing to accept this argument if I do:

    I think ultimately we are talking predictability – if it was not predictable that following the prior art would produce the NAIL cDNA, then the result should be that the Kubin’s invention was non-obvious.

    Because if you don’t agree with that, then we’re just going to have to agree to disagree.

  25. “For this to be a 102 case, the cDNA would have to be in the prior art. No one has argued that the cDNA was in the prior art, just that obtaining it was obvious. Which it is only because Judge Rader and friends says it is.”

    Noonan, following on 6’s inherency argument, do you remember Schering from 2003 – no recognition required to establish some feature as inherent? The facts aren’t exactly fresh in my mind right now, but I do remember that the “facts” used to establish inherency in that case came AFTER the critical date – i.e. they were *not* in the “prior” art.

  26. Let’s see, kev’s site doesn’t eat poasts. Hawks site has stopped eating posts as long as you say the magic word. And JPE and 271 do not eat posts. Why is it that the best eats posts?

  27. OMFG my POAST DIDN”T POAST.

    Long story short Kev, I just detailed all of Kubin’s arguments. NAIL = p38 (tacitly admitted at oral argument) and the cd 48 binding site or whatever was inherent. It being hard to find is irrelevant. The last remaining thing, finding the library, was your lab assistants work. And Mathew was showing a mouse DNA (if I understand them correctly), at worst for Rader’s case it was just inapplicable.

    Rudolph’s profile:

    link to martindale.com

    Oh, look there, I knew there was something between those two. She used to work for Rader. No wonder someone got shown the pimp hand.

    And he’s been keeping that hand strong with the likes of Bilski.

    “Find me where in the prior art it was disclosed that these cells express NAIL and while you’re at it, show me that the expression level was high enough that the cDNA could be found in a library made from those cells, and you may have an argument.”

    I think you’re referring to the part that is lab assistant work correct?

    OH AND D FIX YOUR SITE ALREADY SO IT STOPS EATING POSTS.

  28. I knew there seemed to be something between these two, Rader and Rudolph, it is obvious Kubin needed a guy, and a guy that didn’t work for Rader 13 yrs ago.

  29. Great to have you with us Kev.

    “Find me where in the prior art it was disclosed that these cells express NAIL and while you’re at it, ”

    Inherency is not only established by the prior art recognizing that NAIL was expressed… or so I’ve heard. Correct me if I’m mistaken here. Inherent feature is inherent. Bad/worthless argument is bad/worthless.

    “show me that the expression level was high enough that the cDNA could be found in a library made from those cells, and you may have an argument.”

    The only thing that I’ve seen that came close to Kubin arguing what you’re arguing here is:

    “It does not tell one with skill in the art how to produce a NK cell library, and if you look at the methodology that’s recited in the specification, what they [Kubin] used was a specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators. That’s not disclosed in Sambrook. That’s not disclosed in Valiante. That’s not disclosed anywhere[.]”

    Which simply says that Kubin did something different to acquire the libraries rather than performing the Sambrook method. That doesn’t mean that Rudolph (Kubin) is arguing that one performing the Sambrook method would not have gotten the same libraries.

    Where is the evidence? Where is even the assertion by the applicant?

    “This statement misses, or simply ignores, the evidence that performing the methods of the prior art would not have resulted in production of the claimed genus of polynucleotides.”

    You make the above statement on your blog. Where is the evidence? Somewhere in the brief buried? Somewhere in the oral arguments that you haven’t quoted? Show it to us because it surely isn’t in the small quote you showed us.

    You reply to me on your blog:

    “Back to biotechnology, in order to obtain the NAIL cDNA Kubin had to treat the human NK cells in ways that were not taught in the art. So the factual predicate of the decision was that the Valiante reference provided an antibody and a scheme for cloning the gene encoding the p38, Sambrook provided the routine methods for cloning, and Matthew showed that by following the art you reliably (predictably) obtained a cDNA (for 2B4, of course, the mouse protein). And this was wrong.”

    Oh really? How do you know this? Where is the evidence? How do you know Kubin HAD to use those methods? The only “evidence” shows that Kubin DID use those methods.

    “Once again, the specific factual distinction is that you cannot obtain Kubin’s cDNA by practicing the combination of the prior art relied upon by the examiner, the Board and the court.”

    Once again, where is the basis for this factual distinction? Nonexistant. There is no evidence on the record showing that you CANNOT obtain Kubin’s cDNA by practicing Sambrook on Valiante. There is only evidence (aka assertion) that Kubin DID NOT obtain Kubin’s cDNA by practicing Sambrook on Valiante, and that’s his choice.

    Kev, you do a great job on your blog, but come on man, I just got through jabbing at you on your blog about going on and on about nothing without giving us the beef. WHERE’S THE BEEF?

    I think that when you find the beef you’ll find the answer to why Rader wins and you lose. Because Kubin didn’t have to use his process, he just chose to.

    I’m going to go listen to the oral arguments one more time and I’d better hear something that is pure win for your Kev or I’m going to be sorely disappointed.

  30. Dear anon:

    We were talking facts, not KSR. If the facts supported Judge Rader’s conclusions you wouldn’t be hearing these arguments from me.

    And, having read KSR, the Court’s “obvious to try” portion is just a recapitulation of O’Farrell, as Judge Rader pointed out.

  31. “No one has argued that the cDNA was in the prior art, just that obtaining it was obvious. Which it is only because Judge Rader and friends says it is.”

    I think you need to re-read KSR and come to terms with it. The “cookie-cutter” days of rigidly applying TSM obviousness analysis are long gone, sorry.

  32. Dear Anon:

    No, because it is possible that the prior art could have taught (from probing with the p38 antibody) that all these cells made p38 (but it did not). For this to be a 102 case, the cDNA would have to be in the prior art. No one has argued that the cDNA was in the prior art, just that obtaining it was obvious. Which it is only because Judge Rader and friends says it is.

  33. Let’s see: innovation creates profit; everyone wants to create profit; therefore its obvious to innovate and so every innovation is obvious. Yep, makes perfect sense. Close up the PTO, everything that’s non-obvious has been invented.

  34. “Your comment illustrates nicely the problem with hindsight – we know NOW that these cells express the gene. It’s always pretty obvious once you know the answer. Find me where in the prior art it was disclosed that these cells express NAIL and while you’re at it, show me that the expression level was high enough that the cDNA could be found in a library made from those cells, and you may have an argument.”

    Ok Dr. Noonan, but if all that was spelled out so nicely in the prior art we’d be talking about 102 (anticipation) which isn’t the issue here.

  35. Dear critique:

    Your comment illustrates nicely the problem with hindsight – we know NOW that these cells express the gene. It’s always pretty obvious once you know the answer. Find me where in the prior art it was disclosed that these cells express NAIL and while you’re at it, show me that the expression level was high enough that the cDNA could be found in a library made from those cells, and you may have an argument.

    But we all agree the sky is not falling. Per the first sentence of my post.

  36. Greetings No. 6,

    No offense, but you should be grateful you can find your way home.

  37. “for reasons Kevin Noonan brought out ”

    I just got through reading that and I cannot for the life of me find where he brought them out.

  38. MM,

    You so miss my fundamental concern that you are, truly, clueless. The correctness of the findings of fact do matter in reaching the correct legal conclusion. And the factual support for the decision in Kubin is fundamentally flawed for reasons Kevin Noonan brought out which you’re obviously unwilling to accept. So let’s just “agree to disagree” and move on. And like Harry Callaghan would say “you still don’t know your limitations.”

  39. Kevin,

    You state that to obtain NAIL from the NK cells, a very particular set of conditions had to apply. But when I go to the NCBI site with GEO information (the Gene Expression Omnibus), I find that NAIL (also called CD244), is identified as expressed in 625 different human gene expression profiles. Looking at the first 10 hits, I see evidence of expression in a glioblastoma cell line, skeletal muscle, breast cancer, whole blood, CD34+ stem cells, T lymphocytes, amniotic fluid, and lamina cribrosa cells (whatever they are).

    Given the wide expression pattern of this gene, I rather doubt that library screening would have been all that difficult at the time of filing. I also think your statement that “you cannot make human NAIL cDNA by following the prior art” is almost certainly wrong. I think if you took a few of the human cDNA expression libraries that were present in your lab, the ordinary college intern or grad student would have been able to isolate the NAIL cDNA in a few weeks at most (probably much quicker if there is any sequence homology with the mouse NAIL cDNA).

    I do agree with Mooney that the sky is not falling. Evidence of unexpected results (with an appropriately reasonable claim), might have caused either the Examiner to allow or the Board to reverse. (I don’t think Fed. Cir. predictions are as easy).

  40. A few comments in response to EG.

    First, the claims at issue were d.o.a., regardless of Rader’s obviousness decision. So I can’t get too worked up by an alleged “fundamental flaw” in the reasoning. Kubin wasn’t going to get those claims, ever.

    Second, assuming the facts are as Rader presented them, the reasoning does not seem flawed. The reasoning is … reasonable. Very reasonable. We all knew that Deuell was headed for the grave eventually.

    And finally, I think both you and Kevin tend to overestimate the impact of every case that finds a biotech invention ivalid. Or maybe it’s more accurate to say that you have a tendency to spin these decisions into nightmare scenarios where innovation in a field ceases or slows to a rate where the public is harmed because patent protection is not as easy to obtain.

    Nobody is going to stop cloning genes because of this decision. And the rate at which sequence date is disclosed to the public can certainly be measured. Let’s put a reminder in our calenders to check in 18 months and see if we can detect a remarkable drop-off in the rate of sequence disclosures — worldwide, in all available publications — starting in March of 2009. Bets on what we’ll find?

  41. “Also, I think Noonan’s and EG’s obsession with the panel’s “understanding of the technology” is naive.”

    MM,

    Only if you accept that a legal conclusion need not be based on “substantial evidence”, and the Kubin case is rife with problems in this regard. As for your comment about “patent law” isn’t a “science fair” I do recall that SCOTUS said in eBay that patent law is governed by the same equitable standards for injunction grants as other areas of the law. I don’t believe that excludes from the patent law that the PTO must have “substantial evidence” to support its legal conclusion in Kubin that the claimed invention was obvious (remember Zurko?). And if PTO’s legal conclusion is based on “evidence” that is fundamentally flawed in understanding what the art says, and what the distinctions are between the claimed invention and that art, pray tell why isn’t that relevant to patent law? Once again showing your cluelessness MM. And you might even “make” Harry Callaghan’s “day” with such drivel.

  42. “This is patent law, not a science fair.”

    Nicely said. I’m not qualified to speak to the specifics of the Kubin decision, but the broader points of your post are right on.

  43. Ultimately, I think Rader’s decision is more helpful to biotech applicants than not. In particular, the affirmation of the passages from O’Farrell and the guidance as to when “obvious to try” arguments are impermissible is far more helpful than the particular finding (whether right or wrong) that Kubin’s crappy claims were obvious.

    Also, I think Noonan’s and EG’s obsession with the panel’s “understanding of the technology” is naive. This is patent law, not a science fair. Kubin failed to persuade and, in large part, I think it’s because Kubin’s strategy was weak and also poorly excecuted. Like these commenters, Kubin, too, seemed to believe that “all they needed to do” was “educate” the Federal Circuit about some “basic facts” and then *poof* their broad compositions claims would suddenly become non-obvious. Wrong.

    It reminds me of the griping by the armchair physicists that signal claims would be allowable if only the Supreme Court could be made to appreciate that information and matter were the same! Right. If only.

    “The benefits of sequencing (and its widespread adoption as a way to satisfy 112 for nucleic acids) is that all the sequence information (which is by itself not patentable) because publicly available much sooner than it otherwise might have. This result “promotes the progress” by encouraging disclosure, the real benefit of the patent system.”

    Three cheers for the patent system. I’m old enough to remember when medical progress in this country was well-promoted by public funds, such as grants to university researchers and their graduate students, and every intellectual contribution wasn’t treated like a lottery ticket to a “start-up” or whatever. I’m sure there are those who will never tire of trying to turn back the clock to the “good old days” when “everyone” was getting rich overnight by leveraging their marvelous IP.

    Of course, the reality is that only a tiny tiny fraction of gifted and talented people got rich at that party. Everyone else will be cleaning up the mess for decades.

  44. “All pharmaceutical formulations are basically combinations of well known components; so, how does this case, along with KSR, impact the patentability of pharmaceutical formulations? ”

    They’re all invalid now. Go back to your nest, Chicken Little. Mommy is waiting.

  45. The twin decisions by Judge Lourie – Deuel and Eli Lilly – placed gene patenting in a fruitful equipoise: claims to specific genes would not be deemed obvious just because there were generic methods for obtaining them (and for those who never actually did this work, it ain’t necessarily so that the results were so predictable, particularly prior to 1990), BUT to be an inventor you actually had to obtain the nucleic acid (not just say you knew how to do it). This restricted inventors of DNA claims to those who had actually obtained the gene; this is pretty sound policy since it rewards those who satisfied the quid pro quo of patent disclosure.

    Both of Judge Lourie’s opinions were based on principles of chemical obviousness – as Judge Rader said at oral argument, they are based on “structure, structure, structure.” There is certainly a point (and maybe we have arrived at it) where the art becomes sufficiently predictable that a claim to a nucleic acid is obvious if the protein is known, absent other considerations. But we should recognize that this is cannot be a bright line rule, since every gene will have features (like whether there is a known cell or tissue that expresses it) which will impact just how “obvious” it is.

    And, with regard to inventions like antibodies, these are typically supported by deposits which satisfy written description/enablement concerns. Indeed, prior to readily-available sequencing, deposits were also sufficient for nucleic acids; look at Schering v. Amgen for an example. The benefits of sequencing (and its widespread adoption as a way to satisfy 112 for nucleic acids) is that all the sequence information (which is by itself not patentable) because publicly available much sooner than it otherwise might have. This result “promotes the progress” by encouraging disclosure, the real benefit of the patent system.

    As for rationality in the court’s written description jurisprudence, the presence of Judge Linn on the Kubin panel, coupled with his spirited “concurrence” in the Ariad case, suggests rationality may not be coming any time soon.

  46. The decision by the Federal Circuit in In re Kubin does an end-around of the main principle established in In re Deuel. In Deuel (51 F.3d 1552 (Fed. Cir. 1995)) the Federal Circuit reversed a Board of Patent Appeals Interferences decision holding a claim to a specific cDNA sequence obvious over the sequence of the protein encoded by the cDNA and known methods of cloning cDNA molecules using the sequence of the encoded protein. The decision in Deuel was clearly based on the priciple that the cDNA claimed was a chemical compound with a specific structure. The Federal Circuit reasoned that because the cited prior art taught a method of obtaining a cDNA but (according to the court) did not provide any suggestion of the structure of the claimed cDNA, the claimed cDNA could not be obvious. The court in Deuel clearly focused on the lack of teaching in the prior art of any structure of the claimed cDNA. Although the court also mentioned that the prior art method of obtaining the cDNA was “obvious to try” and that “obvious to try” art was insufficient to render a claim obvious, this was not the basis of the decision in Deuel, nor was it the legal principle thereafter applied from Deuel. The lasting legal principle from Deuel was that the structure of a claimed chemical compound could not be described by a mere method of obtaining that chemical (in the absence of a teaching suggesting the structure of the compound).

    With amnesiatic sleight of hand, the Federal Circuit in In re Kubin recasts In re Deuel as a case about the “obvious to try” principle in obviousness analysis. In Kubin the court affirms a Board of Patent Appeals and Interferences decision holding a claim to a polynucleotide encoding a protein structurally and functionally related to a cell surface receptor obvious over prior art teaching the same receptor protein and a general method of obtaining the gene encoding the receptor protein.

    The court first highlights how obvious the art made it to isolate the gene encoding the receptor protein based on the protein and emphasizing that it was undisputed that the prior art method would almost surely result in obtaining the gene. Thus, the court agreed that there would have been a reasonable expectation of success in obtaining the gene using the method. The court then recognized that affirming the Board decision in Kubin would require the court to address that contrary decision of In re Deuel. To do so, the court notes that the KSR Supreme Court decision has changed the landscape for obviousness determinations. In particular, the court spends some effort highlighting how KSR weakened the status of the “obvious to try” principle in assessing obviousness. The court even suggests that the Supreme Court in KSR was repudiating the obvious to try principle of In re Deuel (“Insofar as Deuel implies the obviousness inquiry cannot consider that the combination of the claim’s constituent elements was “obvious to try,” the Supreme Court in KSR unambiguously discredited that holding.”). The court also noted that the Supreme Court cited In re Deuel as supporting the “obvious to try” principle. However, as noted above, the holding in Deuel does not depend on the “obvious to try” principle. In any case, this repudiation of the holding in Deuel (now apparently based on application of the “obvious to try” principle) allowed the court to hold that the prior art method of obtaining the gene for the receptor protein made the claim to the gene itself obvious, noting that the proper application of the “obvious to try” principle supported a conclusion of obviousness.

    In a sense, the decision in In re Kubin brings obviousness of biotechnology inventions back to more rational ground. Even in 1995 (and in the 1980s, the era of the invention in Deuel), biotechnologists considered cloning of a gene based on a protein sequence to be routine, with success given a high probability. Thus, the decision in In re Deuel was greeted with some disbelief by those knowledgeable in biotechnology. The Deuel decision was pro-inventor, but the true basis of the holding in Deuel was soon applied to reach a significantly anti-inventor decision that followed directly from the true principle of the Deuel holding.

    In Regents of the University of California v. Eli Lilly (119 F.3d 1559 (Fed. Cir. 1997)), the Federal Circuit addressed the question of whether a method of obtaining a gene provided a sufficient written description of the gene to satisfy the requirements of 35 U.S.C. § 112, first paragraph. A specific human cDNA was claimed in patents at issue in Eli Lilly but the patent specification provided only the sequence of the rat version of the cDNA and a method of using the rat cDNA sequence to obtain the human cDNA sequence. It was agreed by the court and the parties that the method of obtaining the human cDNA was enabling and would (and did) result in the human cDNA when it was performed. However, neither the rat cDNA nor the method suggested the structure of the human cDNA. Citing the reasoning in Deuel, the court held that an enabled method of obtaining a gene did not provide an adequate written description of the gene because it did not provide sufficient information about the structure of the gene. There was no doubt that the method/structure aspect of Deuel was the basis for the holding in Eli Lilly.

    “We had previously held that a claim to a specific DNA is not made obvious by mere knowledge of a desired protein sequence and methods for generating the DNA that encodes that protein. See, e.g., In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1215 (1995) (“A prior art disclosure of the amino acid sequence of a protein does not necessarily render particular DNA molecules encoding the protein obvious because the redundancy of the genetic code permits one to hypothesize an enormous number of DNA sequences coding for the protein.”); In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed.Cir.1993). Thus, a fortiori, a description that does not render a claimed invention obvious does not sufficiently describe that invention for purposes of § 112, ¶ 1. Because the ‘525 specification provides only a general method of producing human insulin cDNA and a description of the human insulin A and B chain amino acid sequences that cDNA encodes, it does not provide a written description of human insulin cDNA. Accordingly, the district court did not err in concluding that claim 5 is invalid for failure to provide an adequate written description.

    * * *

    “A written description of an invention involving a chemical genus, like a description of a chemical species, “requires a precise definition, such as by structure, formula, [or] chemical name,” of the claimed subject matter sufficient to distinguish it from other materials.”

    Eli Lilly, 119 F.3d at 1567-68 (emphasis in original).

    Thus, the court in Eli Lilly applied the scientifically questionable principle from Deuel—that an enabled and predictable biotechnology method of obtaining a biological molecule does not provide an adequate description of the biological molecule because the structure of the biological molecule cannot be determined a priori—to establish what is and is not an adequate written description of such biological molecules. The problem with this reasoning is that, in biotechnology and molecular biology, most biological molecules can be discovered and used without any need to know their structure (antibodies are an example). This view of the error of Eli Lilly (and of In re Deuel) has not gotten much traction in the last decade. However, the view of the biotechnological arts by the court in In re Kubin is now more in line with the scientific and practical realities of biotechnology and molecular biology. It is to be hoped that the this same rationality will now filter into written description decisions involving biotechnological inventions. However, the fact that the Federal Circuit did not mention or deal with the true principle of In re Deuel makes it more likely that this issue will be lost in the shuffle.

  47. Question

    All pharmaceutical formulations are basically combinations of well known components; so, how does this case, along with KSR, impact the patentability of pharmaceutical formulations?

  48. In view of these cases, how can the Patent Office continue to allow anything in the mechanical arts?

  49. The problem with this approach is that examiners use non-document evidence that came into existance after the filing date of the patent application. In the above case, the court talks about [An] impermissible “obvious to try” situations … where the prior art gave only general guidance. Does that mean that we’re back to requiring the examiners use only prior art documents to support their conclusions? (If I see one more “examiner opinion” rejection such as “since it was obvious to try something obvious to improve the prior art device to make it better, the claimed invention is 103 obvious,” I’m gonna bust.)

  50. It seems that the real invention here was the determination of the conditions necessary to isolate the known cDNA. Kubin simply did not claim this method and instead claimed the cDNA itself. If this were some small pharmaceutical and you found an ingenious way to manipulate difficult or expensive reactions, I would not make a claim to the molecule but rather the method.

  51. Andrew,

    I’d be very interested to read your article, but it isn’t “linked above” as you suggested.

  52. Critique/MM

    I’m in Kevin Noonan’s camp on Kubin, a case which desperately needs en banc review by the entire Federal Circuit. In the Kubin case, even Judge Rader is now running scared from SCOTUS. His treatment of the continuing validity of Deuel is puzzling as SCOTUS said in KSR (as was quoted in the opinion) that “the fact a combination was obvious to try might show that it was obvious under [section] 103.” SCOTUS didn’t say “would show it was obvious” but you would never believe that after this Kubin decision. If ever there was a case for an en banc hearing, this is one as this panel has, in essence, negated the previously Deuel precedent. I can just see Judge Newman going ballistic over this one (she’s the only judge on the Federal Circuit not running scared from SCOTUS).

    But what really bothers me in Kubin is this panel’s astounding ignorance of important underlying biotech facts necessary to render this decision. (That this panel chose to basically overrule standing precedent, such as Deuel, when not compelled to do so by SCOTUS’s KSR opinion is also very bothersome.) Dealing with a technologically-challenged SCOTUS is bad enough. But having the Federal Circuit be almost clueless about certain aspects of the technology involved in a given case is very discomforting. This suggests that the Federal Circuit needs at least a judge or with the appropriate technical backgrounds for the newer technologies like biotech and computer science. What we’re seeing now from the Federal Circuit regarding their understanding of the technology involved is starting to get embarrassing.

  53. Deuel was doctrinally unstable and long overdue for reversal.

    See my article Artful Prior Art and the Quality of DNA Patents, 57 Ala. L. Rev. 975 (2006), linked above.

  54. Dear Malcolm:

    To answer your second question first, I think the context of the admission was that Judge Rader had missed the point: it wasn’t that the cloning methods were not conventional, it was that the source (or at least how to treat the source) was not in the art. Also (and I would have to check). I don’t know that the Matthew reference was prior art (i.e., published prior to Kubin’s filing date). I think the Matthew sequence would fall within the scope of the 80% sequence identity recited in the claim, so if the sequence was in the prior art this would have been a 102 case, not 103. So even though the examiner, the board and the CAFC used Matthew’s success in cloning the mouse ortholog to show how “obvious” Kubin’s cDNA was, I think the board, at least, understood that the reference was illustrative.

    Kubin’s counsel brought this up (I quoted it in an earlier post about the oral argument), and I assume it’s in their briefs, but the court didn’t consider it.

  55. That Kubin’s explanation of how to make sequences could be called an “admission” of obviousness of their invention is the gem of Rader’s work.

  56. Kevin, two questions (and not to pester, just to ask because it seems like you have thought about this):

    (1) what is the degree of sequence identity between mouse 2B4 and p38?

    (2) what do you make of Kubin’s alleged admissions regarding the “standard” methods used to clone the gene?

  57. Dear Critique:

    It isn’t surprising that you fail to notice the problem with the court’s analysis because they didn’t even mention it. I’ll spell it out: you cannot make human NAIL cDNA by following the prior art. What may surprise you is that mouse NK cells and human NK cells differ, and one of the ways they differ is that mouse NK cells produce sufficient NAIL-encoding cDNA “at rest”, i.e., without any manipulation, for Mattew to be able to “follow the prior art” and produce a cDNA encoding mouse 2B4 cDNA (this is the name Mattew gave the protein, because the art did not identify 2B4 to be the mouse ortholog of p38). As Kubin’s counsel pointed out, Kubin had to treat human NK cells with a unique combination of cytokines and stimulatory molecules to be able to isolate the cDNA. Neither the requirement for special treatment or the cocktail of stimulants were disclosed in the art.

    Biotechnology has become much more “predictable” than in the past; the price of success, I suppose. But I don’t think it unreasonable for the court to address this issue, except for policy-driven hindsight.

    They would have done patent law a big favor to have decided the written description issue (where there jurisprudence is a real mess) and left the obviousness question alone.

  58. “35 USC 103 “…Patentability shall not be negatived by the manner in which the invention was made.” Just wondering?”

    It’s intended to prevent courts from fashioning per se rules, e.g., that an invention is per se obvious if it was “discovered” while the inventor was drunk, regardless of any other considerations.

    But it doesn’t mean that courts can’t consider the level of skill in the art when evaluating obviousness. On the contrary, the Supreme Court has **required** fact finders to consider such facts for many many years.

  59. Reviewing my own comment, perhaps I was wrong about the “tight sandwich.” Maybe it’s more like an open-faced sandwich where the second piece of bread has been blown off by the howling winds and nobody knows where it’s going to land, except that it will be butter side down.

  60. 35 USC 103 “…Patentability shall not be negatived by the manner in which the invention was made.” Just wondering?

  61. Kubin/O’Farrell: “An] impermissible “obvious to try” situations occurs where ‘what was “obvious to try” was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.'”

    Well, let’s just say that between this case and Gleave, the PTO and CAFC have put the field of recombinant biotechnology patents (and any field whose technological advancements are based mainly in selection and/or testing of identified or readily identifiable compositions) in a tight sandwich, at least as far as composition claims are concerned.

    On one hand, Gleave seems to suggest there are sub-fields (including, certainly, the most basic antisense compositions) where thousands of compositions are *anticipated* by the disclosure by a reference of a gene (or entire chromosome sequence?) along with a generic suggestion to “make an antisense molecule” to the sequence.

    On the other hand, Kubin/O’Farrel seems to suggest that in the context of a “general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it” then it’s “impermissible” to suggest that it was even obvious to try making the composition!

    It seems to me that in both Kubin and Gleave, the worst facts for both parties were not that they were practicing in the wrong fields, although at some point we have to expect that the simplest patentable compositions (and broadest claims) are going to dry up. The worst facts for Kubin in Gleave were the claimed inventions themselves (broad and/or not particularly thrilling from a therapeutic standpoint) and the prior art (laying out the research plan for discovering the claimed inventions as specifically as possible, including identification of the source material).

    Onward, comrades!!!

  62. Dennis: “This case makes clear that the level of enablement of the prior art is very important to any obviousness conclusion. That result is in contrast to the recent Gleave case that found anticipation absent known utility.”

    First, a nitpick: it’s not the case that Gleave found anticipation “absent known utility”. The sequences disclosed by the prior art in Gleave certainly had utility. At a minimum, they could be used as probes to recognize the presence of complementary sequences. Such a utility is deemed trivial, however, and doesn’t meet the utility bar for patentability purposes. More importantly, the court in Gleave emphasized that a prior art composition is enabled for anticipation purposes MERELY by showing that one of skill could readily make it.

    In re Kubin does, however, illustrate the importance of getting one’s claims out of Gleave territory: if you are presented with an obviousness rejection, you get a chance, at least, to play around in the secondary factors sandbox. One of the problems for Kubin was that Kubin was claiming, in some of the claims at issue, a multitude of DNA sequences encoding related proteins that Kubin had not synthesized or studied. Obtaining the sequence of the gene did not appear to present unforseen difficulties, nor did the claims recite a sequence with unexpectedly wonderful properties (instead, the sequence merely encodes the protein, in exactly the same way that any other sequence encodes the protein). Similarly, Kubin’s claimed sequences weren’t demonstrated by Kubin to possess any marvelous therapeutic properties.

    Compare the result in Kubin with that reached in last year’s Sanofi case, where non-obviousness hinged on an allegedly costly and bafflingly archaic purification scheme which yielded a product with truly glorious properties that humanity will stand in awe of for centuries (according to Judge Newman, anyway). Another distinction between Kubin and Sanofi: the claims in Sanofi somehow made it past the PTO. Ka-ching!

  63. Kevin Noonan’s critique is interesting, but ultimately unpersuasive. Since the NAIL protein was known (from the prior art) to be derived from the NK cell library, any reasonable molecular biologist would have been able to generate an NK library which would have contained a version of the human NAIL cDNA and/or genomic DNA. Any human NAIL cDNA or genomic DNA isolated from a human NK library would have more than reasonably been expected to share at least 80% homology (the claim requirement) with the claimed protein, satisfying and rendering obvious the claim.

    Obtaining this nucleic acid from the easily generated library is selection from a finite number of predictable solutions.

    Noonan also seems upset that biotechnology has gotten predictable, stating that

    “it would take an attitude studiously ignorant of history not to consider that the promise of biotechnology and its fulfillment was precisely in providing genes that made it possible to produce useful quantities of erythropoietin, tissue plasminogen activator, human insulin, interferon, blood clotting factor VIII, and several other otherwise unavailable proteins. But today, in this panel’s perspective, this is but “some minor advance in the art.””

    An electronic accelerator pedal was a big advance when first invented and I’m sure the very first children’s game was a really big deal too, perhaps more important to human culture than any advance in biotechnology. (see link to 1911encyclopedia.org).

    It has been an amazing run, but some aspects of biotechnology are now routine and predictable (and are harder to patent without secondary considerations). That is something to celebrate, not bemoan. We should be happy that the technology has advanced to the present point, where performing high school science will not obtain a patent.

    Unlike Noonan, I think this decision shows Rader’s excellent instincts. The Deuel doctrine no longer made sense, and O’Farrell is a better case for the ages.

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