Patent Eligibility in Unsettled Times

Ten years ago if you said that patent eligibility would become one of the most important, hotly debated issues in the patent field most in the industry probably would have thought you simply didn’t know what you were talking about. Five years ago some saw the issues percolating, but still many in the trenches with their day-to-day practice life would likely still have raise a cautious eyebrow and questioned why you thought even the Supreme Court might turn its back on a solid generation of well established patent law. The tone was perhaps cautious, but most couldn’t imagine that the Supreme Court and the Federal Circuit would cease their expansive view of patent eligibility.

Oh how times change!

Today, after several years of substantial turmoil, patent eligibility in a variety of economically significant technologies is extremely uncertain, including software, natural products, medical diagnostics and personalized medicine. It is with great irony that one of the few things we know with any degree of certainty is that business methods are patent eligible. We likewise know that at least some cDNA is patent eligible, except that man-made cDNA that happens to be identical to what occurs in nature. Of course, that raises more questions than it answers.

After Chakrabarty how is anything that is man-made patent ineligible? Would this mean that a perfectly replicated kidney would be patent ineligible because it is identical to a naturally created kidney? What will that do to personalized medicine? Isn’t the whole point to create organs some day that are identical to the receivers originally given organ so as to prevent rejection and the for copious amount of anti-rejection drugs? Of course it is!

But how are companies going to get the funding for this extraordinarily daunting task without the promise of a return on investment? Don’t fool yourself, universities and federal labs are in the business of  scientific theory, not commercialization or applied science. So without substantial private sector investment these and other truly paradigm shifting innovations won’t happen. Who in their right mind would invest hundreds of millions or billions of dollars only to have it stolen by free-riders? Only the most ignorant ideologues would even pretend that exclusive rights are not an absolute prerequisite to the game-changing innovations that are on the horizon.


But let’s not talk in generalities. How about a prosthetic arm? That has to be patent eligible, right? They are electronic, mechanic and part robot, so they are a machine and patent eligible. Dean Kamen, for example, has been working to develop a new prosthetic, robotic arm for soldiers who have lost limbs. The arm created can pick up small objects, even a grape without crushing it. See YouTube videoCertainly this would be patent eligible.  But what if someone were to create a wholly regenerated arm? That task would be one that would be infinitesimally more complicated, yet under the Supreme Court’s reasoning in Myriad it wouldn’t be patent eligible because it is identical to a human arm. How ridiculous!

For decades, and perhaps much longer, anti-patent forces have complained about how the patent system rewards incremental innovations. And now the Supreme Court, and some on the Federal Circuit too, are actually saying that the most ground-breaking innovations imaginable are not patent eligible. Everyone — even the Supreme Court — recognizes that these things are man-made. Is it because they are perfect insofar as we can tell that they are not patent eligible? The pursuit of innovation is becoming so successful and useful that we just can’t patent it? Make up your mind! It is intellectually impossible to on one hand say the patent system is intended to promote ground-breaking innovation and then simultaneously argue that the most sophisticated innovations imaginable are not what the patent system intended to protect. Talk about hypocritical!

Are we afraid of the “god question”? It seems to me we are. Patent law is forcing courts to consider whether it is a patentable innovation to create something wholly man-made, but which is identical to nature. Why couldn’t you just claim: “A man-made human kidney comprising…” That together with sufficient prosecution history statements to disclaim any and all coverage for kidneys that are created by god, or nature if you prefer, would clearly be sufficient to cover the man-made kidney or arm and not the one that occurs naturally.

These are critical questions and the answers matter because we know from history that companies locate where patent protection is available. Once upon a time, for example, the Europe was a dominant player in the biotech industry, but that has changed. The United States, thanks in big part to far more favorable patent laws, took the dominant position. Today the United States is also dominant in software, but with the rather ridiculous decisions from the Federal Circuit that question whether any software can be protected via any claiming technique continued U.S. dominance in the software area is in doubt.

If you haven’t noticed, overwhelming portions of the U.S. economy are tied to the biotechnology and software sectors. Are we about to throw away our economic leadership? There are already some lawyers talking openly with clients about whether they may be able to in some cases actually get broader, more certain protection outside the United States.

At the end of the day, software is and will be patent eligible. The Supreme Court in Bilski explained that business methods are patent eligible at least in part because the Patent Statute mentions business method patents, which means Congress must have known about business method patents and since they were not prohibited at least some must be patent eligible. The Patent Statute makes even more reference to software, including most recently when the patent laws were updated in the America Invents Act (AIA).

Tax strategy patents are still patent eligible subject matter pursuant to Section 101, but for purposes of evaluating an invention under section 102 or 103 of title 35, any strategy for reducing, avoiding, or deferring tax liability, whether known or unknown at the time of the invention or application for patent, is deemed insufficient to differentiate a claimed invention from the prior art.

The deeming of tax strategies, known or unknown, as being within the prior art does not does not apply to that part of an invention that (1) is a method, apparatus, technology, computer program product, or system, that is used solely for preparing a tax or information return or other tax filing, including one that records, transmits, transfers, or organizes data related to such filing; or (2) is a method, apparatus, technology, computer program product, or system used solely for financial management, to the extent that it is severable from any tax strategy or does not limit the use of any tax strategy by any taxpayer or tax advisor. Thus, you can still patent technologies, including software related innovations, that relate to the preparation of tax filings and the like.

Thus, Congress must have intended for computer programs (i.e., software) to be patented. There is simply no other explanation. Still, many judges on the Federal Circuit inexplicably ignore claim language and find every attempt to describe software as leading to a patent ineligible invention. They don’t ever even acknowledge that software is and must be patent eligible, nor do they provide any alternative suggested claiming to make this happen despite the clear articulation that software is patentable in the Patent Statute. So where does this leave us? Ultimately software will be deemed patent eligible just like business methods, and for the same reason. In the meantime we need to continue to use every possible claiming strategy we can muster so that we can nail down rights. This is tricky since we don’t know what the test will ultimately be, and it unnecessarily creates uncertainty, which raises costs. That is bad patent policy and terrible for the economy.

How we got to this point with software is well recognized, but the path forward is anything but clear. Since a failed attempt at en banc reconciliation in the CLS Bank v. Alice Corporation case members of the Court have gone in diametrically opposite and irreconcilable directions, so that a litigant’s outcome depends almost entirely upon the makeup of her CAFC panel.

And, while many think that Myriad lost at the Supreme Court in Association of Molecular Pathology v. Myriad Genetics, the company continues to aggressively assert its patents, in the face of widespread assumption that their claims are clearly invalid. The claims being asserted were not invalidated, but still there is a stench surrounding the case. Myriad is not doing the industry, or themselves, any favors if you ask me. This is why if you have clients who have an interest you absolutely must encourage them to become engaged. You cannot assume that others will fight the battles, because they won’t, and when they do they often times fight it poorly. Sometimes very poorly. For example, the critics made a big deal in the case about Myriad’s test costing $3,000. But did you know that Myriad never denied anyone the test even if they couldn’t pay? I was at a conference where a high level executive made that assertion, but it never found its way into the case or record. Sounds like the winning argument was buried.

While it might be OK for Myriad to lose on their own for whatever reason, the industry lost as well. You must get involved and not let others fight the fight if you have an interest. That means recommending clients, or groups of similarly situated clients come together to fund the filing of amicus briefs. The Supreme Court increasingly relies upon them, for evidence no less. The Federal Circuit says they can be quite helpful to provide context and raise issues not otherwise addressed. In short, they matter! Also consider recommending clients engage in lobbying Congress. If you are going to lobby Congress successfully, however, that means getting involved early. By the time it hits the broader news it is too late. Lobbying requires early attention.

Manus Cooney of American Continental Group is one of the top lobbyists in DC on intellectual property issues. He is a former Chief Counsel to the Senate Judiciary Committee, and a former  Senior Vice President and Policy Counsel for the file-sharing company Napster, Inc. Cooney is well seasoned in the art of legislation and trying to help clients who have interest in the outcome of legislative efforts. Here is what he explained to me after passage of the AIA and why so many found it impossible to jump in and have their concerns taken seriously late in the game:

By the time a bill reaches the floor, most of the significant decisions have already been made.  And most of the significant informed stakeholders have already taken a position one way or the other on that product.  And then it’s just a matter of executing the fight.  Trying to come into o the debate on any bill when  a measure is on the floor or during markup and expecting to be able to affect that product at that given time is really tough. It’s fighting windmills at that point.  You’re a day late and a dollar short.  You need to be engaged much farther in advance.

See A Conversation with Manus Cooney — Patents and Lobbying.

The message is clear. If it matters get involved and do so early. The anti-patent forces are engaged and continue to push their agenda year after year.

If you or your clients don’t have the budget to lobby independently Bob Stoll, former Patent Commissioner who is now with Drinker Biddle, says to seek out groups and coalitions with similar views and join along with their efforts. It can and does make a difference. Stoll says that Members of Congress are particularly interested in issues that affect individuals and companies in their district. If nothing else at least consider having your patent attorney work to draft a letter to your Member of Congress to get your side of the issue out there. If patents are a key to your business success and that can be translated into jobs and economic opportunity Members of Congress will take notice to at least some extent.

Although it may seem a little like shoveling water back into the ocean, if everyone did at least a little it would make a huge difference. An unexpected amicus brief here, a letter or two there, a coalition of like minded clients engaging a lobbyist, joining an already established coalition, it all helps. Even just telling your family and friends why clients need patents and what it means when they can’t get funding because their innovations are not patentable can matter. It won’t feel like it is helping, but that is the power of the crowd. If we aren’t willing to even engage in that low level effort then things are lost and the pendulum has not yet started to swing back toward equilibrium.


Warning & Disclaimer: The pages, articles and comments on do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of Read more.

Join the Discussion

17 comments so far.

  • [Avatar for EG]
    November 11, 2013 10:12 am

    Hey Ron,

    I just read the amicus brief by the IEEE in Alice. Nice job of showing how Diehr and Mayo cannot be reconciled.

    In my opinion, the holding Diehr should prevail, not that in Mayo. Diehr expresses the fundamental principle that the claimed subject matter must be “considered as a whole,” and that includes Section 101. Failure to do so (as blatantly happened in Mayo) causes a complete logical disconnect as the claimed subject matter must be judged the same for purposes of validity (and across all of Sections 101, 102, 103, and 112), as well as infringement. The subject matter to be judged is defined by the claims (that comes from Section 101), and the claimed subject matter has to be judged “as a whole” (that comes from Section 103). In this respect, I’m not “injecting” the requirements of the other validity sections into Section 101, but simply ensuring that the claimed subject matter is judged the same (and consistently) across all of these validity sections.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 10, 2013 11:11 am


    You could get a claim that would cover “a method of making a bio-identical kidney comprising [insert steps].” But apart from the method claim you can also define the resulting product in a device/article claim, which is what I was trying to do by saying “A man-made human kidney comprising…” The later would not be a method claim. I just merely suggested the adding “man-made” in the preamble in order to limit the claim scope so that the resulting described kidney, if identical to a natural kidney, would not capture as infringing a natural kidney.

    Generally speaking the preamble does not limit the claim in any way. It is only limiting if there is something necessary in the preamble to make the body of the claim complete. However, as with any area of prosecution history you can make affirmative representations that limit the scope of the claim. You can do this by defining terms and/or explaining that a certain term or phrase is inserted specifically to carve out from the claim scope something that might be offending. Typically this is done to limit prior art. Here I’m suggesting doing it to get around the patent eligibility issue.

    This does not address how you prove infringement, or know about it. I don’t think that would be as big an issue here. Presumably, when we get to the point where we can grow organs like this for transplantation, the FDA or HHS or some other government entity would regulate the processes and certify the manufacturers much the same way that they do with drugs, for example. So there would likely be a highly regulated process and only a handful of manufacturers, making detecting infringement much easier.


  • [Avatar for Ken]
    November 10, 2013 08:12 am

    I think your suggestion of this distinction is key: ““A man-made human kidney comprising…” That together with sufficient prosecution history statements to disclaim any and all coverage for kidneys that are created by [G]od. . . ”

    Wouldn’t this require a significant change in how non-method claims are construed? I thought device/article claims could only protect structure itself, and not *how* it was created or *how* it is used. (I think the phrase they use is that “how” you will make or use it is not given “patentable weight” for product claims.) In fact, I believe having a claim that appears to “mix” method and product aspects can be held indefinite on those grounds alone. Even product-by-process claims have been held to cover any product that *could* be made by that process, regardless of how it was *actually* made (although there may be conflicting precedent on this point). Have product claims ever been able to have limitations dealing with anything other than their actual structure itself?

    That said, if Congress or the courts would allow patentability to hinge upon the distinction of how something was made – that would indeed seem to be a potential resolution to the whole “product of nature” problem. Of course, the patentee would have the extra burden of showing how they obtained their product, but that probably wouldn’t be too hard in most cases.

  • [Avatar for Anon]
    November 9, 2013 07:27 am

    Kudos again Ron.

  • [Avatar for J]
    November 8, 2013 03:45 pm

    I don’t see an issue with something like a “wholly regenerated arm” being patent ineligible. If a regenerated arm is identical to an arm found in nature then how can one argue that it should be patentable? Of course the methods and perhaps the materials used to regenerate that arm would be patent eligible and thus offer the inventor(s) and investors ample opportunity to block “free-riders” and make gobs of money on the investment.

    The only thing “lost” here is that another inventor could come up with a completely different way to create a “wholly regenerated arm,” and rightfully reap the benefit of his own invention. Seems to me that this is a wholly acceptable situation.

  • [Avatar for Ron Katznelson]
    Ron Katznelson
    November 8, 2013 03:31 pm

    Good article. I hope your positive predictions will come true, although I fear continued confusion on the matter. I see much of that confusion manifested in, and created by, the Supreme Court’s own confusion and conflation of Section 101 and Section 103 as exhibited in its diverging precedents in Diehr and Mayo. We at the IP Committee of IEEE-USA have written about this – see our Amicus brief in support of cert at

  • [Avatar for Pro Se]
    Pro Se
    November 8, 2013 01:25 pm

    I would like to give a bit of warning about these new “cloud” genre patent claims:

    Be aware that simply claiming “cloud”, “in the cloud” and generic forms of this in the spec and claims, and be sure that you teach in spec and claim what cloud you mean:

    Someone someday soon will argue in a markman what “cloud” does the patent mean? Cloud in the sky? How can a cloud in the sky deliver this invention?

    Invalidated over indefiniteness.. be clear what that cloud comprises in the spec and in the best focus of goals within the claims.

  • [Avatar for Mark Annett]
    Mark Annett
    November 8, 2013 07:53 am

    A human being is man and woman made (or at least it used to require the two).

    By your logic, I should I be able to patent the gene sequence of my child, as long as it was within one year of her first ultrasound (potentially first public disclosure) . She would be man-made. She was definitely not a naturally occurring. The longer you are married then you know how less naturally occurring the events are that could potentially produce an off spring.

    What should be patentable (and is) is not the child, or the arm or the lung but the systems and methods for producing the same. Unfortunately, the method used to produce my daughter (a pitcher of margaritas ) is already in the public domain.


  • [Avatar for Gene Quinn]
    Gene Quinn
    November 7, 2013 05:02 pm

    John Smith-

    Not at all. It is an inevitability. Anyone who read Bilski know that. Anyone who understands business and the U.S. Economy knows it. Anyone who can read the Patent Statute know it as well since the Statute is littered with references to software patents. Only a handful of Federal Circuit judges who are ignoring the law refuse to accept this inevitable reality.


  • [Avatar for Anon]
    November 7, 2013 05:01 pm

    John Smith,

    Your comment comes across as unjustifiably smug and pretentious.

    May I suggest that you first understand how dead set against business method patents Justice Stevens was, then read his dissent in the Bilski case, then read the majority opinion in that case.

    When Congress does things that implicate the presence of a patent eligible field, not even the Supreme Court will take such a direct route in re-writing the law so as to remove what Congress has written.

  • [Avatar for John Smith]
    John Smith
    November 7, 2013 04:06 pm

    “Ultimately software will be deemed patent eligible just like business methods, and for the same reason”

    Sounds like you’re trying to convince yourself.

  • [Avatar for Mark Nowotarski]
    Mark Nowotarski
    November 7, 2013 03:56 pm still down as of 16:00 EST

  • [Avatar for Pro Se]
    Pro Se
    November 7, 2013 03:33 pm

    I once read a lawyer say “good patent claims should be no longer than 4 fingers or else it’s too narrow”, well:

    I just won a few patents in the last few months, in which in prosecution my SPE told my Examiner that “nothing is getting allowed unless the independant claim is taller than the palm of my hand”…

    Validity and strong protections still exist, in my opinion all tech patents much now display more intricate details, within the claims, that are on par with pharmaceutical patents.

    Where the AIA and the like try to innovate on changing the rules, practitioners can also innovate to adapt to and find strategic advantages using those rules.

    Another observation: is there some kind of software patent attorneys use that drop boilerplate terms and keywords into specs? I was doing some patent research recently and I find that a few of the big patent firm apps are padded with this generic field of information.

    This may be part of the problem, because as time goes on and these generic wording templates go into patented specs, there’s not much unique about these kinds of discosures, only adding the actual claim language (in pure or alternate form) around the generic “specifically the network can be comprised of computers, database, servers” along with drawings showing only the claims.

    Now in 2013 and moving forward.. the PTO will be slinging 101s to make sure software based tech start showing more substance… “Means for” is dead.

  • [Avatar for patent leather]
    patent leather
    November 7, 2013 02:35 pm

    It better be up soon or I will have to start filing things today via certificate of mailing, something I haven’t done since 2006!

  • [Avatar for EG]
    November 7, 2013 02:22 pm

    Hey Gene,

    Maybe what’s been happening on has “infected” the web site.

  • [Avatar for Gene Quinn]
    Gene Quinn
    November 7, 2013 02:14 pm


    I just received this e-mail from the USPTO, which went out to the media distribution list:

    “The USPTO.GOV website has experienced an outage today, affecting multiple trademark systems. The USPTO is working diligently to address this issue. We apologize for any inconvenience.”


  • [Avatar for Mark Nowotarski]
    Mark Nowotarski
    November 7, 2013 11:22 am

    OT Is down? I can’t get on.