A ray of hope for embryonic stem cell patents in Europe; and the 4 things you need to know

Guest Post by Thomas Leonard of Kilburn & Strode LLP, London

The Advocate General of the Court of Justice of the European Union (CJEU) has issued his opinion in C-364/131, and in doing so has provided hope for the patentability of embryonic stem cells in Europe.

The Background

International Stem Cell Corporation (ISCC) is the applicant for two UK patent applications (GB0621068.6 and GB0621069.4) relating to stem cells derived from unfertilised human ova that have been parthenogenetically activated to stimulate cell division (“parthenotes”). The UK Intellectual Property Office (UK IPO) refused the applications on the basis that, given the CJEU’s earlier judgment in Brüstle2, the claimed subject matter related to the use of human embryos for industrial or commercial purposes and was therefore not patentable.

The Court in Brüstle was concerned with the definition of the term “human embryo” within the meaning of Article 6(2)(c) of Directive 98/44/EC (the “Biotech Directive”), which states that inventions shall be considered unpatentable where they relate to uses of human embryos for industrial or commercial purposes. The Court in Brüstle ruled that the term “human embryo” included unfertilised human ova whose division and further development have been stimulated by parthenogenesis (i.e. parthenotes).

Following the UK IPO’s decision to refuse the applications, the matter was appealed to the High Court. At request of the parties, a question was referred to the CJEU seeking clarification on whether parthenotes can correctly be considered “human embryos” considering they die at the blastoma stage, unable to undergo further division and development, and are thus not capable of developing into a human being. The question referred in this case was exactly the same as one asked in Brüstle but for the additional specification that parthenotes “in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings”.

The Advocate General Opinion in C-364/13

The new Opinion includes a detailed analysis of the relevant law and background, as well as the submissions of the parties (not only those of the applicant and the UK, but also written observations by France, Poland, Portugal, Sweden and the European Commission).

Among the submissions included evidence suggesting it is possible to produce live-born parthenogenetic mice that have been genetically manipulated to surmount the “genetic imprinting” that usually prevents a parthenote from continuing development past the blastoma stage. ISCC had already amended their claims before the UK IPO to exclude the possibility of extensive genetic manipulation beyond parthenogenesis (by including the word “pluripotent” before “human stem cell line” and referring to a lack of “paternal imprinting”).

The Advocate General in principle agrees with ISCC and has come to the conclusion that unfertilised human ova whose division and further development have been stimulated by parthenogenesis are not included in the term ‘human embryos’ as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity.

The 4 things you need to know

1.    This is good news for applicants in the stem cell field. Any judgments that limit the impact of Brüstle will be a welcome development.

2.    The Opinion is not legally binding – yet. For the most part, subsequent CJEU judgments do come to the same result as the preceding Opinion (although perhaps for different reasons), but we need to wait for the final judgment of the CJEU before this will become law.

3.    The ray of hope only applies to stem cells derived from parthenotes that are explicitly not able to continue the developmental process to form a human being. When drafting applications in this field, practitioners should include language that supports an amendment to exclude the possibility of further genetic manipulation, bearing in mind of course the EPO’s strict rules with respect to amendments.

4.    Remember, in contrast to the US following the judgment in Myriad, it is enshrined in European law that elements isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element (Article 5(2) of the Biotech Directive).

Kilburn & Strode partner Nick Bassil is part of the team handling the UK patent applications on behalf of ISCC before the UK IPO. ISCC was represented before the UK High Court and CJEU by Piers Acland, QC on instructions from DLA Piper LLP.

= = = = =

1 Opinion of Advocate General Cruz Villalón in International Stem Cell Corporation, delivered on 17 July 2014, C-364/13, ECLI:EU:C:2014:2104 (here)

2 Judgment in Brüstle v Greenpeace eV, C-34/10, EU:C:2011:669 (here)

38 thoughts on “A ray of hope for embryonic stem cell patents in Europe; and the 4 things you need to know

  1. Question, if someone came up with a way of removing genetic diseases from embryos, would this be patentable either in Europe or in the US?

    1. It would depend on the how. If an inventor can force the mutation by some process that hasn’t yet been invented, I would assume the inventor would patent that method of making mutations…

      1. I suppose a general way of manipulating DNA to edit out specific sequences would be entirely patentable.

        So, would applying that to an embryo be illegal?

        It certain would not to an adult because of informed consent. Neither to a child because of their parent’s consent.

        I think the same would be true of a parent’s embryo.

        I really don’t seem to understand why there is a ban if the parents of the embryo consent. Where does the state think it has the authority to override the wishes and jurisdiction of the parent?

  2. link to cbsnews.com

    This article must just be nonsense. I guess Elon hasn’t heard that the shadow director Lee has asserted that AI is really just the abstract concept of making machines intelligent. None of these machines are real. They are just abstractions that people are talking about without real machines. Must be if shadow Director Lee is correct.

    1. He said we are still way too far behind in our understanding of how the brain works

      Now we know that isn’t true. Tarantula recently held that simulating the mental steps was per se ineligible so we must know all about the human brain and it must be trivial to build intelligent machines and simulate the human brain.

    2. …maybe there is some deeper “policy” reason why machines (directly mentioned as a patent eligible category under 101) should not be patent eligible, while human tinkering apparently lacks any obvious policy overtones…

      ;-)

    3. The article is nonsense, but mainly because artificial intelligence technology is nowhere near the level of sophistication required for a Terminator or Matrix scenario, and nobody’s dumb enough to allow a Wargames scenario to happen.

      Besides, if the technological singularity happens, patents will be irrelevant, because our Giant Computer Overlords will be inventing everything, and we’ll all be scheduled for the Processing Vats.

        1. I don’t know how there could be any law on that topic. Still, it gets back to the tried-and-true sci-fi trope of putting an AI on trial to determine whether it counts as a person and has rights as a person would.

          Barring any sort of legislative developments granting personhood rights to an AI, the likeliest outcome would be that an AI would be viewed as a tool for producing an invention at the behest of its creator or controller, and that person might be considered the inventor.

          Most heuristic-search-based algorithms for design (e.g., genetic algorithms) would likely not be considered truly intelligent, but they can produce designs for software or hardware that functions in a manner that the human researcher might lack the capacity to understand. There was a research project in the late 1990s where a GA was allowed to randomly program the gates of an FPGA, and it came up with a circuit that solved the problem at hand, but used the analog properties of the transistors (and possibly even magnetically induced currents) to operate the FPGA (normally operated as a digital device, not analog) in a manner that a human designer would likely never have considered.

          So in that sense, the GA likely invented something, even though it isn’t intelligent – it’s just an algorithm for searching an extremely large search space. Would the person controlling the GA be considered the inventor for purposes of patenting? I don’t see why not, and the same argument could be extended to situations where the designing algorithm *was* considered to be intelligent.

  3. The advocate general’s position just seems weird. Plain language would seem to indicate a human embryo is just an embryo from a human etc. Not limited only to embryos that will turn into a human. I don’t care which way the outcome goes but that part of the whole shebang just seems weird. Even if that effectively becomes “law” that could attract political animosity sufficient to provoke backlash.

    1. Plain language would seem to indicate a human embryo is just an embryo from a human etc

      On the other hand, “plain language” would not seem to indicate that an unfertilized egg that can’t develop into a human is a “human embryo.”

      1. B-b-b-but you are ignoring the policy behind the existence of the law in the first place: stay away from messing with the “stuff” of humanity.

        You – of all people – should be aware of the policy drivers, n’est-se pa?

        Or is this just another of those turn a blind eye things that you like to do, using “plain language” when it suits you and ignoring it in other areas (i.e. 35 USC 101) when it likewise suits you?

        1. the policy behind the existence of the law in the first place: stay away from messing with the “stuff” of humanity.

          Where did you find this statement of “the policy behind the existence of the law”? Or are you just making it up?

          1. LOL – nice dust-kicking Malcolm.

            Let’s start then with what you think is the policy behind the law. Is it really only as narrow as one wold naturally take from your post at 2.2?

            Please, do tell.

              1. Here’s what you wrote Billy:

                the policy behind the existence of the law in the first place: stay away from messing with the “stuff” of humanity

                Here’s my question: Where did you find this statement of “the policy behind the existence of the law”? Or are you just making it up?

                C’mon, Mr. “Intellectual Honesty” (trying not to laugh as I type that). You made an assertion. Now back it up, or admit that you made it up. And then grow up.

                Good luck.

              2. I also wrote this: Let’s start then with what you think is the policy behind the law

                (you kind of missed that)

                The ball’s in your court Malcolm – maybe an answer from you for a change….

    2. The opinion gets the a lot of the science right. However, it doesn’t focus on the reason for [i]Brustle[/i] enough… protecting human dignity. Could this patent be used to eventually cover things that belong to the natural world?

      It’s Europe’s own “101 problem.”

      1. The opinion gets the a lot of the science right. However, it doesn’t focus on the reason for [i]Brustle[/i] enough… protecting human dignity

        I can’t speak for everyone but I think the “dignity” of most people isn’t adversely affected much by the engineering of a cell that will never evolve into a human. On the contrary, the “dignity” of many people might be greatly improved if that engineered cell enables them to live the sort of life that most humans take for granted (i.e., not connected to a machine, capable of feeding and/or fending for yourself, etc).

        Could this patent be used to eventually cover things that belong to the natural world?

        From what I understand of the claims, that seems doubtful.

    1. With minor changes for pertinent aspects of patent law writing:

      “The Royal Nine’s pattern of waiving, amending, and suspending our laws violates the Constitution and is devastating to political accountability in our Republic. If the Royal Nine are allowed to change laws by themselves, thye and future Courts can be expected to change more and more laws that impact the rights and obligations of all Americans. As Americans’ elected representatives in Congress, we have taken a solemn oath to uphold and defend the Constitution. Today, the House has kept this promise to the American people by authorizing litigation to restore political accountability and enforce the rule of law. The stakes of inaction are high and we must do all we can to preserve the separation of powers enshrined in our Constitution.”

      the only problem of course, is that the action would end up right in front of those transgressing the separation of powers….

      1. You’re wrong, Anon. It will never make it to the Supreme Court. It will be rejected, and upheld in every appeal, because the lawsuit is squarely in the “political question” realm.

        There is only one recourse for Congress when the President (or Judge or Justice) refuse to implement the rule of law: impeachment and removal. But of course, the House doesn’t want to do that because it will lose the political battle… which is the whole point of the lawsuit anyways.

        1. J,

          You are correct in the traditional mode of what the recourse has been. But you overlook what Congress is trying to do: ADD another recourse (for the attack on the executive breach of separation of powers).

          You also seem to miss the point of my post in that this added mode would do little for the patent particular problem of separation of powers when it is a different branch that violates the separation of powers doctrine.

          Sorry, but once again, I find your contribution to be, well, not adding anything of note to the conversation.

          Do you have a suggestion for a mechanism to maintain the separation of powers doctrine when it is the judicial branch that is violating the separation of powers doctrine? The traditional mode that we have in place: congressional override (Prof. Hricik has a couple of posts on this topic) seem far too cumbersome in the way they work (or, more to the point, in circumstances where they do not work).

          1. “Do you have a suggestion for a mechanism to maintain the separation of powers doctrine when it is the judicial branch that is violating the separation of powers doctrine?”

            Don’t you guys just love how to the OCPDer the abstract “doctrine” has become a “real thing”? It’s amusing to see examples every time they pop up.

            In order to maintain that doctrine I would suggest using a book. Or a computer. Really any recording device will do.

          2. you overlook what Congress is trying to do:

            Pretty sure it’s you who is “overlooking what Congress is trying to do”, Billy.

            J, on the other hand, seems to have nailed it.

            congressional override seem far too cumbersome in the way they work

            Pretty sure that is by design. The problem is the large contingency of m0 r0ns in this country who elect people not to govern but to undermine the government and hand the controls over to private interests.

            Do you have a suggestion for a mechanism to maintain the separation of powers doctrine when it is the judicial branch that is violating the separation of powers doctrine?

            He already gave you the suggestion: impeachment and removal. But let’s imagine for a moment that you are not waaaaaaaaaaaay out in left field screaming at the sky and you manage to convince more than 0.0001% of the population that, e.g., the Prometheus decision was some egregious violation of the Constitution. What happens next, Billy?

            Tell everyone what happens next.

          3. off-topic…

            Um, you want to intrude into a discussion and offer that?

            From the guy who by far hijacks more threads than anyone?

            Pretty funny AOOTWMD…

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