Amendment from Swiss Style Claim to Second Medical Use Claim Constitutes Added Matter
In the recently published decision T 1673-11 Genzyme Corporation v ZyStor Therapeutics Inc the EPO Board of Appeal held that amending a Swiss-style claim into a second medical use claim constituted added matter.
The patent was granted with the following Swiss-style claim 1:
The use of human acid alpha glucosidase in the manufacture of a medicament for the treatment of infantile Pompe's disease, wherein the human acid alpha glucosidase is in the 100 to 110 kD form, wherein the medicament is to be administered intravenously, and wherein the treatment is to be continued for at least 4 weeks.
However, post-grant opposition proceedings culminated in the Opposition Division allowing claim 1 to be amended into second medical use form as follows so as to avoid a novelty objection:
Human acid alpha glucosidase in the 100 to 110 kD form, for use in the treatment of infantile Pompe's disease, wherein the human acid alpha glucosidase is to be administered intravenously, and wherein the treatment is to be continued for at least 4 weeks.
ZyStor appealed the change of claim form on the basis that it added matter and so invalidly extended the scope of protection. In particular, ZyStor pointed to the principles in the previously reported Enlarged Board of Appeal case T 1780/12. Namely:
- a Swiss-style claim is a purpose-limited process claim;
- a second medical use claim is a purpose-limited product claim;
- a process claim and a product claim are in different categories and so they cannot have identical scope;
- in general a purpose-limited process claim confers less protection than a purpose-limited product claim.
Genzyme argued that there was no added matter on the basis that Article 64(2) of the EPC extends the protection conferred by a claim to a process to the products directly obtained by that process. According to Genzyme, if the manufacturing process in a Swiss-style claim is not limited by any technical feature, then the manufacture could not be limiting on the product obtained by it. The medical use as limiting feature was the same whether the claim was drafted in the format of a Swiss-style claim or as a purpose-limited product claim. Consequently, Genzyme argued, the protection conferred by both types of claims is the same.
However, the Board ruled that even if Article 64(2) EPC were to be taken into account, the two claims still conferred differing amounts of protection. It found that the product directly obtained would be the particularised manufactured medicament packaged and/or provided with instructions for use in the treatment of infantile Pompe’s disease. Contrary to Genzyme’s assertion, the Board held that the functional characterisation of the medicament’s therapeutic application implies limitations to that product.
The Board also held that the second medical use claim is not limited to a manufactured medicament, packaged and/or with instructions for use in the treatment of infantile Pompe's disease, and as such is broader than any product obtained via the process of the Swiss-style claim.
The Board further held that where the medicament is packaged and provided with instructions for use in the treatment of a different condition, but which is nonetheless used in the treatment of infantile Pompe’s disease, then such use would fall within the scope of the second medical use claim. However, the Swiss-style claim would not encompass such use, and as such the proposed amendment would result in added matter.
Consultation on Patent Extension of Term Regulations
A consultation document on draft regulations for the (re-)introduction of extension of term provisions in the Patents Act has been released, with feedback being required by 8th August 2016. In order to be TPP compliant the Patents Act will be amended to include extension of term provisions where there has been:
- unreasonable delays in patent grant; and
- unreasonable curtailment of the effective term of a patent covering a pharmaceutical substance or a biologic as a result of the Medsafe’s marketing approval process.
Requests for extension of patent term will need to be made during the patent term and the Commissioner will not be able to extend the patent term if the patent is subject to any proceedings in which the validity of the patent or any claim therein is in dispute. Where the request is made for unreasonable delays in grant it is proposed that the patent owner will not be required to provide additional material as the register will contain the relevant information. However, in the case of extension of term requests under the unreasonable curtailment provision will require the following additional material:
A statement specifying:
- the pharmaceutical substance per se or biologic in respect of which the extension of term is requested; and
- the claims of the patent that include within their scope the pharmaceutical substance per se or biologic.
A statement that the marketing approval to which the certificate from Medsafe relates is the first marketing approval of a product containing the pharmaceutical substance or biologic in respect of which the term extension is requested. The statement could be provided either:
- by the applicant for extension; or
- in the certificate provided under proposed s111D(2)(c).
Regarding when an extension of term request should be made in respect of unreasonable delays in grant, it is considered that there are 3 broad options:
Option 1: the request for extension may be made any time up to the normal expiry date of the patent.
Option 2: the request for extension may be made any time up to a period of years prior to the expiry date of the patent.
Option 3: The request for extension must be made shortly after patent grant.
Option 2 is stated as the preferred option since it both gives the patent owner ample time to decide whether to apply for such an extension of term and also gives third parties advance notice of the maximum term of the patent. It is proposed that no extension of time would be allowed for making any such extension of term application. It is also proposed that the regulations should specify a non-exhaustive list of time periods that are to be disregarded in the calculation of any such extension of term.
For extension of term requests under the unreasonable curtailment provision, which are only available where marketing approval is obtained after grant, it is considered that there are 3 broad options:
Option 1: the request for extension may be made at any time up to the normal expiry date of the patent;
Option 2: the request for extension of term must be made at any time up to several years prior to patent expiry.
Option 3: the request for extension of term must be made at any time up to a short period after grant of the first marketing approval.
Option 3 is stated as the preferred option, largely due to pharmaceutical patents being more likely than non-pharmaceutical patents to run their full term. Consequently, option 3 gives third parties advance notice of the maximum term of the patent without burdening too many patent owners with requesting an extension of term for a patent that may not run its full term. It is proposed that extensions of time for making any such extension of term application would only be allowed in exceptional cases, such as where the patent owner has disputed the content of the certificate that Medsafe proposes to provide. No regulations are proposed for specifying time periods that are to be disregarded for any such extension of term request. Rather, it would be left for Medsafe to develop practice guidelines over time.
It is noted without preference that the regulations for oppositions to extension of term applications could be modelled either on:
- the (more detailed) procedures set out for oppositions under sections 87 and 92 of the Patents Act 2013; or
- the (less detailed) procedures set out for oppositions under sections 120 and 127 of the Patents Act 2013.
Feedback is sought on which of the options is preferred and what the time period should be after publication of the grant of an extension of term within which an opposition must be filed and whether any extension of time should be allowed for such.
Kuwait and Djibouti Joining the PCT
From 9th September 2016 Kuwait (KW) will be bound by the PCT. Hence, international applications filed on or after 9th September 2016 will automatically designate Kuwait.
From 23rd September 2016 Djibouti (DJ) will be bound by the PCT. Hence, international applications filed on or after 23rd September 2016 will automatically designate Djibouti. (PCT Newsletter; 2016/7)
De Minimis Infringement of Patent Claims Considered
In Napp Pharmaceutical Holdings Ltd v Dr Reddy’s Laboratories (UK) Ltd the Patents Court considered the issue of de minimis infringement in the context of manufacturing variations bringing a third parties product within the scope of a patent’s claims.
Napp initiated the proceedings after Dr Reddy’s and another generic manufacturer (Sandoz) threatened to infringe Napp’s patent by marketing branded generic 7 day buprenorphine transdermal patches. Claim 1 of Napp’s patent is as follows:
A buprenorphine transdermal delivery device comprising a polymer matrix layer containing buprenorphine or a pharmaceutically acceptable salt thereof, for use in treating pain in humans for a dosing interval of at least 7 days, wherein the transdermal delivery device comprises 10 %-wt buprenorphine base, 10 to 15 %-wt levulinic acid, about 10 %-wt oleyloleate, 55 to 70 %-wt polyacrylate, and 0 to 10 %-wt polyvinylpyrrolidone.
A preliminary point of construction was whether the composition figures refer to the ingredients in the recipe for the matrix (i.e. the inputs into the manufacturing process) or the composition of the finished product (i.e. the outputs from the manufacturing process). The Judge held that the composition figures refer to the composition of the finished product for several reasons, including:
- While a product can be described by reference to its ingredients and method of manufacture, that is not how the claim is written.
- The use of the word “about” shows that precision with respect to the absolute quantity of buprenorphine is not necessary to achieve the delivery rates specified.
- Such products are only routinely referred to by reference to their ingredients when there were no losses during manufacture, but in this case the skilled person would appreciate that there could be losses during manufacture.
- There is no evidence that reproducing the patch described in the patent, or carrying out assays, would be difficult. On the contrary, the evidence is that this is routine laboratory work.
The Judge’s review of authorities on the construction of patent claims with numerical ranges centred on the Court of Appeal decision Smith & Nephew plc v ConvaTec Technologies Inc. In that decision it was held that the precision with which a numerical range is to be construed depends upon the precision that the skilled person would attribute to the patentee’s chosen expression taking into account the common general knowledge and the specification as a whole. In particular, the scope need not be limited to the exact values if the skilled addressee would not understand the patentee as intending the limits to be read in that way.
For this case the defendants argued that the numerical limits would be understood to be expressed in whole numbers with rounding allowances of 0.5 either side. In contrast, Napp argued that the numerical limits should be understood as being expressed to the nearest 5%, effectively giving a rounding allowance of 2.5 either side. The Judge favoured the defendants construction as being in accord with that of the skilled reader and giving a reasonable degree of certainty to third parties while not denying the patentee fair protection for the claim it chose to draft.
Napp accepted that on such a construction the defendant’s products would not infringe. However, the Judge then proceeded to hypothetically consider whether the defendants would have infringed if Napp’s construction applied. Even then Napp accepted that the products already made would fall outside the claim, but argued that when manufacturing variations where taken into account an appreciable quantity of products could infringe. This led the Judge to consider the relevance of the de minimis principle, which was referred to as a well-established principle of statutory construction. Namely:
“Unless the contrary intention appears, an enactment by implication imports the principle of legal policy expressed in the maxim de minimis non curat …; so if an enactment is expressed to apply to matters of a certain description it will not apply where the description is satisfied only to a very small extent.”
In applying the principle the Judge accepted that it should not be given a quantitative limit. Instead, the de minimis threshold should be drawn as a matter of practical reality. In this case, the Judge noted that Napp had the burden of establishing infringement on a balance of probabilities basis and that injunctive remedies for patent infringement must not be disproportionate and be applied in a way that avoids the creation of barriers to legitimate trade. Considering the scenario of manufacturing variations resulting in very small, but more than de minimis, infringement, the Judge considered that an injunction would be disproportionate given the minimal harm and would be a barrier to legitimate trade by requiring a third party to operate further outside the boundaries of the claim. Using the available data and assuming a normal distribution of variations the Judge held that the risk of infringement would be de minimis, irrespective of whether the confidence interval was 50% (1 in 69 million patches) or 95% (1 in 25,600 patches).
Clarification on Law of Nature Exception to Patent Eligibility
The recent Federal Circuit decision Rapid Litigation Management Ltd v CellzDirect Inc has clarified what constitutes a claim to a law of nature.
The patent at issue was directed to an improved method of cryopreserving certain liver cells following the discovery that hepatocytes had a high survival rate from multiple freeze-thaw cycles. Claim 1 of the patent reads as follows:
A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes, being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:
(A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable hepatocytes,
(B) recovering the separated viable hepatocytes, and
(C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.
Following recent Supreme Court decisions a two-step test was formulated for determining patent eligible subject matter. This requires determination of
(1) whether the claims are directed to one of the judicial exceptions, such as a law of nature and if so
(2) whether the claim as a whole recites something significantly different to the judicial exception.
In earlier proceedings a District Court found the patent invalid for in effect claiming the law of nature that hepatocytes can survive multiple freeze-thaw cycles. However, the Federal Circuit vacated and remanded the District Court decision, holding that it misapplied the test at the first step. In particular, the Federal Circuit drew a distinction between claims that are directed to a law of nature and claims that involve a law of nature. The Federal Circuit found that the claims are directed to a new and useful laboratory technique for preserving hepatocytes for later use, which, while involving a law of nature, should not be construed as being directed to a law of nature. The Federal Circuit noted that without this distinction many other patents would be invalidated. While a method claim can describe the natural ability of the subject matter to undergo a process, this does not make such a claim ‘directed to’ that natural ability. One of the hypothetical examples used to make this point was treating headaches with asprin, which would otherwise be considered patent ineligible for being directed to the human body’s natural response to asprin.
Given that the Federal Circuit found the claim to be directed to patent eligible matter it was not necessary to consider the second step. Nonetheless, the Federal Circuit held that even if the subject had been found patent ineligible at the first step, as a whole the claim involved sequenced steps that transform the process into an inventive application.
2. Trade Marks
Quia Timet Interim Injunction Granted, Mandatory Interim Injunction Refused
In Yellow Holdings Ltd v Eurobelt Ltd a High Court Judge granted an interim injunction against use of a domain name that was registered back in 1998.
Yellow Holdings, through its subsidiary NZ Directories IP Ltd, owns many trade mark registrations for or including the word and/or colour YELLOW in relation to a broad range of goods and services primarily relating to print and online directories. They also own several domain names including www.yellow.co.nz. Yellow Holdings sought to obtain the domain name www.yellow.nz, but this was blocked by the Domain Name Commission who considered it too close to Eurobelt’s domain name www.yellow.net.nz, which it obtained in 1998 but have never used. In its 2015 decision the Domain Name Commission refused Yellow Holdings request for www.yellow.net.nz to be transferred to it, largely on the basis that Yellow Holdings had not established rights in the word YELLOW on its own.
In addition to filing substantive proceedings Yellow Holdings sought an interim injunction restraining Eurobelt from using the domain name or any confusingly similar YELLOW trade marks.
The Judge held that Eurobelt’s registration of the domain name did not amount to passing off, since Yellow Holdings had not established sufficient goodwill in YELLOW in 1998. However, given Yellow Holdings subsequent establishment of reputation in YELLOW and Eurobelt’s intention to sell the domain name, the Judge held that the real prospect of future use of the domain name established a serious question to be tried in respect of passing off (and breach of the Fair Trading Act). The Judge held that the balance of convenience and overall justice favoured the granting of a quia timet interim injunction restraining future use or sale of the domain name or any confusingly similar YELLOW trade marks pending the outcome of the substantive proceedings. In contrast, the Judge refused to grant a mandatory interim injunction, since the balance of convenience in that regard lay with Eurobelt. One of the questions for determination at the substantive hearing will be whether Yellow Holdings should have known of the domain name from its due diligence when it purchased the directories business in 2007.