The EPC Requirement for “Industrial Application” – Has Britain’s Supreme Court Advocated a Different (Lower?) Utility Threshold When Considering a Patent For Biological Material?

Published December 2nd, 2011

Background – For the first time, Britain’s highest court recently considered the utility requirement for a biotechnology patent[1].  The UK Supreme Court (“UKSC”) overturned two lower court decisions and found that European Patent No. 0 939 804 B1, a biotechnology patent, met the requirements of Article 57 of the European Patent Convention (“EPC”).  Article 57 establishes a “threshold” promise (to use the language of Canadian cases on utility).  A patented invention must be susceptible of industrial application – meaning “it can be made or used in any kind of industry, including agriculture”.  Human Genome Sciences (“HGS”) applied for a patent 15 years ago for a protein (Neutrokine α) and its various associated encoding genetic sequences.

The European Patent Board (“Board”) referred to the specification as “boiler-plate” [para. 6].  The patent provided the structure of the protein and the encoding sequences, and stated that (based on similar structure) it is a member of a particular “superfamily” of proteins that are involved in immune responses.  The patent also stated that the genetic sequences exist in certain tissues and the protein has “T-cell” activity (T-cells are known to be involved in the immune system) [para. 7, 19, 23, 108, 155].  The key problems with the patent (as far as the lower courts were concerned) were “extravagant” assertions as to applications of the invention, and descriptions of the invention as “potentially useful” for a wide variety of immune disorders and other conditions [para. 6, 8].  At the same time, there is no “data or any suggestion of in vitro or in vivo studies”.   The lower court characterized the patent as having been filed much too early:  the protein’s functions “were, at best, a matter of expectation and then at far too high a level of generality to constitute a sound or concrete basis for anything except a research project”. [para. 104]  Although the UKSC referred to the fact that later HGS studies confirmed use of the protein for immune response/tumour control [para. 108], there is no discussion in the case as to what HGS had done secretly as of 1996 – because the requirements of industrial application require the court to consider only (1) the patent disclosure and (2) the common general knowledge.

After reviewing the patent, the UKSC listed out the common general knowledge regarding the particular superfamily [para. 24].  The most significant aspects relate to the fact that all protein members were expressed in T-cells and played a role in T-cell mediated immune responses.

 Supreme Court Findings – The UKSC described the “central issue” as whether “in the light of the common general knowledge at October 1996, by disclosing the facts [in the patent] (namely the existence and structure of Neutrokine-α, the sequence of its encoding DNA, its tissue distribution, its expression, and its membership of the TNF ligand superfamily)” the patent had industrial application permitting HGS to “claim the encoding gene for Neutrokine-α.” [para. 27]  After noting there was no relevant jurisprudence in the UK, and noting the “obvious risks” in relying on US case law, the UKSC relied on the jurisprudence of the European Patent Office (“EPO”) regarding the application of Article 57 to “patents for proteins and their encoding genes” [para. 43]. 

The UKSC provided a summary list of guiding principles specifically limited to the industrial application requirements of only “biological material” [para. 107].  Overall, the standards set out appear to be rather low.  Although in general the UKSC endorsed the requirement that a patent must disclose a practical application of the substance, and not merely a speculative use, it appears rather easy to avoid a speculative use objection with a protein/gene patent, and in particular where the protein is part of a known superfamily.  In the latter case, it is acceptable if the use is “plausible”/ “reasonably credible”/ an “educated guess”/ a mere “possibility of exploitation” (at even the biochemical, cellular and not necessarily biological level) [para. 162].  The threshold is particularly low once it is established that the protein is part of a superfamily having a known common cellular role, and that most of the known members have common activities.  The only way to challenge these rather low requirements is if there is evidence which questions the family membership, or questions whether known members have different activities.  This approach appears to give the benefit of the doubt to the patentee, and places an onus on challengers to bring in evidence akin to inutility.

Subsequent to listing out the general principles, the UKSC easily reached its decision that Article 57 had been satisfied [para. 109-111].  Once it was known that the protein was part of a known superfamily (based on its structure and tissue distribution [para. 78, 153]), the protein was expected to have a similar function to that shared by all known members (T-cell proliferation) [para. 111].  In a concurring decision by another judge, the UKSC explained that the lower courts were using an incorrect legal test for Article 57 –  requiring identification of a particular biological role/disease to treat [para. 163] while the proper test  required  only consideration of whether there was a reasonable expectation that the protein would be usable for further research (this being an immediate concrete benefit, and further research being industrial activity) [paras. 154, 155, 161, 165]. 

HGS’s patent application has still not issued – outstanding validity issues are now to be decided by the Court of Appeal.

Notable Points to Consider for Drafting/Litigating Canadian Patents – It is interesting to note that the lower court decisions in this case were cited by Vaver as an example of a patent failing the industrial application requirement where only “bioinformatics” was relied on, as opposed to actual “wet-lab” analysis (Vaver, D. Intellectual Property Law, 2nd ed. (Toronto: Irwin Law Inc., 2011) at p. 340).  In fact, bioinformatics is referenced only in passing by the UKSC to describe improved methods available to identify genes/proteins “by comparing their sequences with previously identified and characterised genes” [para. 17].  However, this new technique provides an underlying (though not discussed) basis for the UKSC’s concern to provide a consistent, principled, fact- based analysis. It would be expected that this type of methodology can generate any number of proteins with any number of guesses as to therapeutic application. 

The BioIndustry Association intervener accepted that it would not be desirable to permit patenting where there is only “a vague indication of possible objectives that might or might not be achievable by carrying out further research”.  Two competing issues are at play.  On the one hand, there is a need to permit patent filing early enough in development to protect further research and attract critical funding.  At the same time, “the purpose of the patents system is not ’to reserve an unexplored field of research for the applicant nor to give the patentee unjustified control over others who are actively investigating in that area and who might eventually find ways actually to exploit it.’” [para. 102]

The decision does not address the potential problems that flow from permitting a patent  to issue where there is merely an educated guess as to use, because it was enough for an industrial application to have isolated another new member of an important superfamily having at least one common cellular function.  For example, a later company (like Eli Lilly) may be actively researching this same protein, and determine for development purposes one of the many uses listed in HGS’s patent.  Eli Lilly would not be able to make, use and/or sell the protein for any use.  Should Eli Lilly try to obtain a patent for their newly determined use, they would need to address the prior “paper disclosure” of this use in HGS’ patent by arguing that, based on HGS’ “guess” in its patent, the “new” use was not obvious to try (certainly a difficult task).  This may be another example of how, in certain circumstances, the “old” established patent law may be ill-fitting when applied to new technologies. 

Does it really make common sense that a patentee who lists out many guesses as to uses for its new protein (that it located and isolated using computer generated techniques), can effectively preclude others from seeking patent protection once they in fact have a sound basis for  saying a new protein is useful for a certain use/therapy?

The UKSC repeatedly refers to its findings as being very specific to “biologic” or protein/gene patents.  “The drafting of a patent is a ticklish business, no doubt particularly in some types of cases, of which biological patents may well be an example, not least because it is a fast developing field, with substantial commercial and scientific pressures.” [para. 117]  There is a clear recognition that this type of patent – initially based on mere guesses and plausible possibilities – will become more prevalent in the future. The UKSC initially expressed its concern for consistency in this “fast-developing field” [para. 2] and concludes that Article 57 has been complied with after setting out specific principles. However, the UKSC leaves the reader somewhat confused by concluding that there is “good sense” in both the approaches of the lower courts (that found no industrial application) and the Board (that found an industrial application). [para. 129]  There are many grey areas here that may preclude the sought after certainty and clarity.

Applying this case to the Canadian situation, where one is considering a patent to proteins/genes – that is, susceptible to an “early filing issue” and where out of necessity one will be filing a patent application before the research project is done – patentees do not need to worry about a statutory set bar of “industrial application” as the promise of the patent.  Instead, the patentee is its  own lexicographer and can set the promise as high, or as low, as it chooses. For example, contrast the recent decisions of the Federal Court of Appeal (“FCA”) in latanoprost[2], wherein the promise for the compound was set high and determined not to be met and the Federal Court (“FC”) in anastrazole[3], where the promise for the compound was set low and was determined to be met[4]. 

However, unlike the  forgiving approach taken by the UKSC with the new protein patent, Canadian courts require much more than a “guess” to fulfill the patentee’s promise. The FCA recently accepted that for sound prediction an inventor cannot merely cover off a possibility that a compound might later on turn out to have surprising activity[5]. 

There are some commonalities  between the general approach taken by the UKSC to evaluate Article 57 compliance and the approach to sound prediction in Canada – both involve an evaluation of (1) the patent disclosure; and (2) the common general knowledge.  Admittedly, the Canadian three-part test from the AZT Supreme Court of Canada (“SCC”) case[6] also involves an evaluation of the inventors’ secret work.  However, ultimately there must be disclosure of the basis for the prediction.  The UKSC recognized that its approach was “necessarily one of prediction” because it was understood that no tests had been done,  although the UKSC appears to equate prediction with “plausible” which means “there must be some real reason for supposing that the statement is true” [para. 149, 160].  Arguably, the tests of “plausible” and “sound prediction” may not appear to be very different on their face, and may be a matter of degree.  Although Canadian courts have now adopted the four- part UK based obviousness test (under direction from the SCC in Sanofi[7]), it is not expected that they  will adopt the benevolent approach in HGS and start lowering the requirements for sound prediction to accept an “educated guess” as sufficient.  Such an approach would run contrary to the quid pro quo requirement that underlies the patent system. 

The SCC will have an opportunity in 2012 to address utility issues in the Teva v. Pfizer case dealing with the Viagra™ patent[8].

EP 0 939 804 B1 may be obtained online at:

[1] Human Genome Sciences Inc. v. Eli Lilly and Company [2011] UKSC 51

[2] Apotex Inc. v. Pfizer Canada Inc. 2011 FCA 236 (appeal to the SCC has been filed)

[3] AstraZeneca v. Mylan Pharmaceuticals 2011 FC 1023 (under appeal)

[4] Although it is clear that utility is not required to be recited in a compound only claim (Janssen v. Novopharm, 2006 FC 1234), there is some disagreement in Canada as to the threshold utility required for a compound only claim.  The approach of going to the disclosure to determine the threshold promise (even for a compound only claim) is arguably a very technical and sometimes arbitrary approach.

[5] Sanofi-Aventis v. Apotex 2011 FCA 300 at para. 9.  A claim to 8 compounds, one of which was ramipril, was invalid.  Although ramipril’s utility was soundly predictable by the inventors, the utility of the other 7 stereoisomers was not soundly predictable. (There was no data in the ramipril patent.)

[6]Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77

[7] Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61

[8] SCC Court File No. 33951, scheduled to be heard by the SCC on February 8, 2012.  This is an appeal of Novopharm v. Teva 2010 FCA 242

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