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Australian Patent Law

Introduction to Regeneron Pharmaceuticals Inc v Kymab Ltd Analysis

The case revolves around the essential principle called the patent bargain. It is that when the patentee needs to give his invention in detail in return of time-limited monopoly. One of the ways to have this patent bargain along with sufficiency, novelty, inventive step and industrial application, is to ensure that at the right moment the claim must be proportionate to the contribution made by the person in the technical art made by the person is seeking the patent. The Lords and Lady of the Supreme Court were of this view that their judgment is not doing to affect the current and existing legal principles of the sufficiency as prevails in the countries like the UK and of the Technical Board of Appeal of the European Patent Office. This case however is going to define the importance of and the complexity that occurs in ascertaining patent’s technical contribution and the further consequences that shall precede it. The Hon’ble Supreme Court had made his judgement in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27 wherein they allowed the Kymab’s appeal and held Regeneron’s patent to be invalid due to insufficiency my a judgement ration of 4:1.[1]

Facts of The Case

The claimant, Regeneron had a patent of a technique via which they were able to produce human anti-bodies with transgenic mice. Being the one and only company to have invented a crossbreed of the genetic structure of both mouse and humans, this structure could be implanted into the mice to generate the anti-bodies that would not defy it when used in humans, as it was formed with the genes of both. Mice that have been used for generation of antibodies to protect the human from their diseases, has been the nucleus of their patent since 2001. It was called a hybrid (chimeric) anti-body gene structure. The only issue with such genetically produced mice for curing the human anti-bodies which means that causing a cure of the disease of humans without themselves showing any progress of immunity. They were immunologically sick. The proportion of the anti-bodies produced were with more of the human element and less of mouse element which came to be known as ‘Reverse Chimeric Locus.’ While the patent was being granted to Regeneron, the only thing which had them avail it is that they were able to show that the hybrid structure is formed with the elements of both mouse and humans. No emphasis was given on the part of how much of the proportion did that structure contained both of them. Till date, it was used very in curbing the human disease very amicably and many anti-bodies were developed and approved too. It could also be possible that these anti-bodies could have been used for treating coronavirus as well.

Issue

The issue arose when Kymab Ltd also a hybrid structure with the same of mice and humans. The only difference was that in their composition, the human element was much of the quantity compared to Regeneron’s structure. They called it as Kymice. They had asserted that the human genes in this structure are of vital importance and the whole thing which this structure is about. It is a part of the technical contribution. It held the Regeneron’s product is not of technical importance as the composition of human element used by Regeneron in it structure affects the ability of the mouse to create the right amount of B cells and hence is ineligible to have any effect as an anti-body structure.

Regeneron asserted that the contention of Kymab is baseless as the unique feature of the Reverse Chimeric Locus is the cure the immunological sickness of the mouse and it is not of any importance how much of the human element has been inserted in the murine genome. The results have outcasted all such negative speculation as its structure has been successful in curbing human diseases. In simple words, the technical contribution is the solution to the technical problem which means it prevented the immunological sickness in the mice and hence the protection is simultaneously quite vivid.

As a result, Lord Briggs raised a question of importance in this case. It was that did the product patent, which allows any skilled person to make some, with certain exceptions, does fall under the purview of the type of product under this claim? Does Regeneron’s product pass the sufficiency test meaning that does the product justifies the utility of it, if and when it is made as per the range of products this test entails?

The Decision of Lower Courts

The trial judge had held that the patent of Regeneron, along with the patent knowledge of that time, did not have any recognition of the fact that any structure could possibly be made from the genes of mice. In other words, the patent granted to Regeneron is baseless as none of the genetic structure can possibly exist. The methodology and the series of the experiment that was explained in the Court are not practical and something that is pure imagination and hence the result is not real. However, it also said that it could be possible that with a series of other inventive processes, the final result as 'supposedly' achieved by Regeneron could be possible.[2]

In the Court of Appeal, it was held that as per the sufficiency test, the patent received by Regeneron did meet the sufficiency requirement. This was held so because of the new assertion given by Regeneron. This new assertion was that the team of skilled workers of Regeneron were able to implement the Reverse Chimeric Locus by using ‘minigenes'. This could only be used when a portion of the human variable is used and not the whole of it as interpreted by the patent and said in the claims. However, this was not at all what the claim was. The claim was all about that the patent of Regeneron is different from that of Kyamb as they invented a structure with more of a human element compared to the less composition of Regeneron’s product. Nevertheless, it was held that the sufficiency test was applicable on the invention of Reverse Chimeric Locus which resulted in common application of the usage of the product as the claim was held, regardless of the fact that only a few of the embodiments were applicable at that date then.

The contention of the Court of Appeal on the phrase of 'general application' was that the nature of the invention is such that any transgenic mouse which is applicable on the scope of the claim and so results in the production of hybrid anti-bodies containing the elements of both humans and mouse genes, is able to yield a product which can be of aid to the technical contribution and shall continue to do so regardless of the antigen which was used to contradict the mouse’s genes.

The Decision of The Supreme Court

The leading judgement was given by Lord Briggs. He exclaimed that the issue of the case was majorly based on the part of the product claim which focuses on the mice. The given UK case law is focused on the fact that the patent law is applicable to the whole range of products that are required for the claim. Based on the judgment of the EPO case, which stated that any product claim is applicable on the entire range of products, he said that a ‘substantial’ requirement is required to classify which range of products could be applicable on such claims. He also held that there could be a small or inconsequential number of embodiments on which the claim of the product is not applicable. He insisted on this point rather than focusing on the substantiality of the product claim. He also saw that the reference cases held that for any product claim and managing the scope of it, it is essential to see the applicability of the general principle. This stresses the applicability of the general principle on the scope of the claim of the product. However, Lord Briggs emphasized that it is not practicable for any principle to embody all of the variants. Whenever they shall be available or applicable, it shall be relied on how beneficial and efficient its use is. He tried to draw a distinction between the EPO cases who claim on the basis of a general principle which had justified the claim breath like the Genentech I or Polypeptide expression and that of the others like Exxon and Unilever or Detergents, which have not.[3]

The current case falls on the latter part where the patent granted did not justify how the general technical principle was applicable via which the team of skilled people were able to attain the sought result across the whole variety of the claimed embodiments. It was held that the invention was just about what all of the possible inputs could be applied but the shortcoming of Regeneron to make a Reverse Chimeric Locus which involved a whole or very short part of human variable elements in it. It was a major fallback which at the date of the case made its application quite limited to a very small part as per Claim 1. 

He made his analysis based on the EPO and UK case law based on certain principles-[4]

  1. As per the doctrine of sufficiency which is enlisted under section 83 of EPC, it says that the extent of monopoly power which is given by the patent must be complementary to the contribution which has been made in making that art.
  2. When there is any claim on the product, any contribution to the art of it means that it is the ability of the skilled person to have used in making the product, rather than the invention that has been done.
  3. It is up to the patentees to choose the range of products for which they want or claims protection off. With this, they must emphasise that there is no broader claim as compared to the disclosure they make.
  4. The disclosure which is sought by the patentee equivalent to will. It is seen that whether it is in consonance with the common general knowledge of the patent that is being sought by the patentee, as of that date. Then can the disclosure is adequate enough to enable any skilled person to make all types of embodiments of the products, as what is described in the product. This is what enablement means, in respect of the product.
  5. Any claim that is done to protect the products which are not possible to be formed by any skilled person having disclosure in the patent will, irrespective of the de minimus or wholly irrelevant exceptions, is bound to exceed the contribution made by the patent as per the date on which it is sought.
  6. It clearly does not intend to make the skilled person testify the scope of the claim he had tried, tested and proved to make it enable. Patentees have to focus on the principle of general application if they could prove the range of products within its ambit. If in future it gets challenged, so the general principle shall be proved at a trial to make a significant, relevant part of the claim to be made as and when the date is set.
  7. Nor would an allegation which, in substance, passes the sufficiency test be denied by dividing the commodity assertion into a range denominated by an entirely insignificant element, such as the length of the mouse tail. The obligation to have authorisation for the whole scope of the claim extends only within the applicable range. Generally speaking, the array would be applicable if it is referred to as a variable that greatly influences the benefit or usefulness of the commodity for the reason for which it is to be produced.
  8. Enabling through the range of the product argument is not merely defined by demonstrating that all goods within the applicable range can, if and when they can be made, offer the same general advantage expected to be obtained from the innovation, regardless of how valuable and ground-breaking the innovation can prove to be.

Applying the above principles on the given case, so it could be held that insufficiency in the case. The Reverse Chimeric Locus was an unsuccessful experiment which did not enable transgenic mice for having more than a very small proportion of human element gene locus to be present in it. Hence patentees did not make enable any transgenic mice to be of an important factor that could affect the diversity of the antibodies produced. This range was only relevant for efficiency purposes. Hence it was for this reason that Lord Briggs held that the Regeneron's claim on a monopoly over the wide array of products was not at all in consonance with the out of the product that should we meet at that priority date. Lord Briggs further stated that the Court of Appeal has failed to recognise the contribution of the earth which should be made by disclosure and not by the invention. The blatantly concluded write the invention was adequate for the benefits that were given to the plaintiff over the wide range of products even if all of the embodiments could not be made. It was seen that this decision could be of disadvantage to the plaintiff but it said a groundbreaking role in the IPR industry. In the end, the justice wanted to set this rule that the law of sufficiency of the product claims should be calculated by the range of products which should be presented are the priority date.

Lady Black’s Judgement

Lady Black have a very dissenting opinion when it comes to judging the majority verdict on the loss of efficiency of the patents. she exclaimed that the plaintiff did not content it the minigene enablement at the very first instant of the case because the Court of Appeal from the very first instant had a very different approach in considering the legal issue that whether the claim was enabled across its whole wide range of products or not. CRT mentally explained that this wasn't challenged in the Supreme Court as the court itself adopted the same approach as did the Court of Appeal. As a result of this she does not accept the verdict of Lord Briggs which was then followed by Henry Car J.[5]

She further held that Lord Briggs judgement it was a bit of a disagreement with the Court of Appeal statement on the legal principle if not too much but little. she appreciated the Court of Appeals approach in the demarcating the characterization of the claim by stressing on the principle that any patent could be protected based on the technical contribution of the skilled people related to the art made by the disclosure of the invention. She also admired that the authorities for prudent enough to find out the difference in assessing the sufficiency which depends on the nature of the invention and also differ from facts of the case.

The reason why she said that Lord Briggs judgement was not in consonance with the Court of Appeal judgement is that the justice focused on the quantum of the replaced material as was in Reverse Chimeric Locus. It is for this reason that the Reverse Chimeric Locus was an alternative focus point of the justice that leads to a different conclusion from that of a Court of Appeals. The reason why she said that Lord Briggs judgement was not in consonance with the Court of Appeal judgement is that the justice focused on the quantum of the replaced material as was in Reverse Chimeric Locus. It is for this reason that the Reverse Chimeric Locus was an alternative focus point of the justice that leads to a different conclusion from that of a Court of Appeals. According to her opinion, she and the court should not have intervened in the courts of Appeal's decision as the claim was about the principle of general application and not about the Reverse Chimeric Locus. The clean could have been possible across the entire range of products as the first it was also used in a wide variety of a product not paying enough use text of human genetic materials present in the medicine that could be used to cure the mice immunological sickness.

Conclusion on Regeneron Pharmaceuticals Inc v Kymab Ltd Analysis

In the end, it could be seen that Supreme Court pet focus to the connection between the inventor and the public where the inventor has the Monopoly over the invention as long as a patent is valid and the patentee must give to the public must be given instructions on how how how the products should be used after the patent has expired. To do this Supreme Court held that the nature of the patent should allow the skilled people to make a whole wide range of products on which the patentee can be granted the Monopoly. The Reverse Chimeric locus which was the nucleus of this entire case was granted the monopoly that is the patent overall buy and hybrid antibody genetic structure. This case is all about describing the extent on which a patent could be granted to any suitably skilled member of the public in order for them to make a full range of products on which the patentee can have a Monopoly on which in this case was a variety of hybrid mouse. This was a very established principle in patent now but sometimes it is seen that the early stage of any patent research and seeking the patent for it could be e a problem at a problematic situation for the patentee and the courts as well. The Supreme Court was however successful in establishing ground rules and creating a nuance the patent law. They were able to judge the case on the facts of it and also helped to be referred to as precedents in for the furthermore cases to come. 

References for Regeneron Pharmaceuticals Inc v Kymab Ltd Analysis

Herbert Smith Freehills, UK Supreme Court in Regeneron v Kymab: technical contribution critical to determining sufficiency. (Jun 2020) < https://www.lexology.com/library/detail.aspx?g=3f4676c7-5ecd-45a5-8b48-5e8bbd8435c4>

Amy Couch, Simmons & Simmons, ‘Regeneron Pharmaceuticals Inc (Respondent) v Kymab Ltd (Appellant) [2020] UKSC 27.’ (2020) http://eplaw.org/uk-regeneron-pharmaceuticals-v-kymab-supreme-court/

Nick Sutcliffe, ‘Supreme Court confirms strict line on insufficiency in UK.’ (2020) https://www.mewburn.com/news-insights/supreme-court-confirms-strict-line-on-insufficiency-in-the-uk

Rachel Fetches & Dr Jennifer Bailey, ‘UK Supreme Court invalidates Regeneron’s transgenic mouse patents for lack of sufficiency.’ (2020) http://www.hgf.com/updates/news/2020/06/uk-supreme-court-invalidates-regenerons-transgenic-mouse-patents-for-lack-of-sufficiency/  

Michael Tappin QC, ‘Regeneron v Kymab [2020] UKSC 27.’ (2020) https://8newsquare.co.uk/case/regeneron-pharmaceuticals-inc-respondent-v-kymab-ltd-appellant-2020-uksc-27/

[1] Herbert Smith Freehills, UK Supreme Court in Regeneron v Kymab: technical contribution critical to determining sufficiency. (Jun 2020) < https://www.lexology.com/library/detail.aspx?g=3f4676c7-5ecd-45a5-8b48-5e8bbd8435c4>

[2] Amy Couch, Simmons & Simmons, ‘Regeneron Pharmaceuticals Inc (Respondent) v Kymab Ltd (Appellant) [2020] UKSC 27.’ (2020) http://eplaw.org/uk-regeneron-pharmaceuticals-v-kymab-supreme-court/

[3] Nick Sutcliffe, ‘Supreme Court confirms strict line on insufficiency in UK.’ (2020) https://www.mewburn.com/news-insights/supreme-court-confirms-strict-line-on-insufficiency-in-the-uk

[4] Rachel Fetches & Dr Jennifer Bailey, ‘UK Supreme Court invalidates Regeneron’s transgenic mouse patents for lack of sufficiency.’ (2020) http://www.hgf.com/updates/news/2020/06/uk-supreme-court-invalidates-regenerons-transgenic-mouse-patents-for-lack-of-sufficiency/  

[5] Michael Tappin QC, ‘Regeneron v Kymab [2020] UKSC 27.’ (2020) https://8newsquare.co.uk/case/regeneron-pharmaceuticals-inc-respondent-v-kymab-ltd-appellant-2020-uksc-27/

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