Adding matter by cherry-picking from separate embodiments: Philip Morris v BAT ([2023] EWHC 2616 (Pat))
In the recent UK case of Philip Morris v BAT [2023] EWHC 2616 (Pat), His Honour Justice Hacon (Hacon HHJ) considered the standard for invalidity due to added matter. Invalidity in view of added matter is a common patent pitfall in Europe (IPKat). The EPO takes a hard-line against amendments that cherry pick non-generalisable features from separate embodiments. The High Court decision in Philip Morris v BAT confirms that the UK courts may apply a similarly strict approach. The case thus reaffirms the need for careful drafting of international patent applications in order to circumvent, as much as possible, the potential for invalidity due to the strict added matter standard in Europe and the UK.
Case Background: "Heat not burn"
Philip Morris (PM) and BAT both market so-called "heat-not-burn" devices as alternatives to conventional cigarettes. In these electronic devices, cartridges of tobacco are heated ("not burned"). Philip Morris' heat-not-burn devices, such as the IQOS, are a linchpin of PM's global "smoke free world" marketing campaign and represent a tobacco-containing alternative to electronic cigarettes (e-cigs), that are purportedly safer than conventional cigarettes.
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| "Smoke Free World..." |
The case in Philip Morris v BAT related to the validity of BAT's patent EP (UK) 3367830 B1 for a heat-not-burn device. PM sought revocation of the patent, and BAT counterclaimed infringement of the patent by PM's heat-not-burn IQOS ILUMA device. During proceedings, BAT submitted an amendment to the claims in an attempt to overcome invalidity for inventive step. PM argued that the amendment added matter.
Added Matter in the UK and Europe
The EPO has a famously strict approach to added matter under Article 123(2) EPC. Any amendment made to an application as filed must have clear and unambiguous basis in the original application. The EPO particularly takes a hard-line against what it may perceive as the cherry picking of features from separate embodiments disclosed in the application in order to arrive at a previously undisclosed combination (EPO Guidelines for Examination, H-IV, 2.1).
The UK courts are generally considered to take a slightly less severe approach to added matter than the EPO. However, the legal principles relating to added matter at the EPO and in the UK are the same. As summarised by the the judge in the present case, in the UK it is necessary for the court to compare the explicit and implicit disclosure of the application as filed and the granted patent, and decide whether matter is "clearly and unambiguously disclosed in the application as filed" (Conversant Wireless Licensing Sarl v Huawei Technologies Co., Limited [2020] EWCA Civ 1292, AP Racing Ltd v Alcon Components Ltd [2014] EWCA Civ 40).
In the present case, the granted claims related to a heat-not burn device into which a cartridge of smoking material could be inserted. A patent claim to the device itself is potentially of greater use to the patentee than a claim to the device including a cartridge, given that the cartridges will generally be sold separately. BAT submitted an amendment to the claims of the disputed patent specifying that the heater of the device "extends to opposite longitudinal ends of the mass of smokable material". The feature itself had explicit basis in the application as filed, but only in the context of a single embodiment of the invention. In this embodiment, the heater was described as forming part of the cartridge ("article") inserted into the device, and not part of the device itself.
The judge was not convinced by BAT's arguments that a skilled person would understand this feature to be generalizable to other embodiments, including the claimed embodiment in which the heater was specified as forming part of the device itself, and not the cartridge. Hacon HHJ therefore concluded that the amendment added matter.
The patent was also found to invalid for lack of inventive step and to be not infringed (either under a normal construction, or under the doctrine of equivalents).
Final thoughts: Added matter versus patent profanity?
The judge's conclusion on added matter in Philip Morris v BAT demonstrates that the UK courts may be just as willing as the EPO to enforce a hard-line against added matter in patents. Careful drafting of patent applications is needed in order to avoid added matter attacks against prosecution or post-grant amendments derived from individualised embodiments in the description. This approach to drafting is sometimes characterised as being in conflict with a US style approach, in which reference to "the invention" or broad references to "preferable" features are considered "patent profanities" that should be avoided in order to prevent unhelpful claim construction during US litigation. However, US patent profanity may still be avoided whilst also guarding against EPO added matter traps by making reference to "optional" (as opposed to preferred) features that the "disclosure" may comprise. A successful international patent strategy requires a cross-jurisdictional approach to patent drafting.
Further reading
- Nothing to see here, Lilly wins in kicking out Genentech's Talz progeny patent (for now) (Feb 2020)
- Another case of catastrophic comma loss (T 1473/19): Interpreting the claims in view of the description (Jan 2023)
- Adding matter by amending the description to exclude embodiments (Ensygnia v Shell [2023] EWHC 1495 (Pat)) (Aug 2023)
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As Rose has mentioned the USA, I should welcome a BTL discussion here about the differences and similarities between the EPO and the USPTO on our "added matter" versus US lack of written desciption (WD).
ReplyDeleteHistorically, the US has been liberal on the WD issue but seems now to be tightening up (although not yet as far as the EPO "Gold Standard" of "clear and unambiguously derivable" (let's call it cud). Me, I think it inevitable for all FtF jurisdictions assymptotically to approach the EPO's cud standard, if only because the courts are ever-increasingly called upon to do justice between rival Applicants fighting high value priority contests. The monumentally costly priority contest in CRISPR-cas9 technology might be a case in point.
It is my feeling, that not just the courts in England but also patent practitioners in the USA are increasingly accustoming themselves to, and ruefully accepting, a strict cud standard imposed on all their post-filing prosecution amendments, but that it takes at least one full patent term for such sea-changes to become part of the consciousness of patent litigators.
The stance taken by the EBA an'd the BA has one big advantage: was is lost under added-matter is gained on novelty. N and added matter are the two sides of the same coin!
ReplyDeleteThis is the more so, since in case of a selection in a range of values, the criterion of purposive selection has now be transferred to IS.
Be careful, if everything is optional, nothing is optional!
If you have preferred, more preferred and most preferred embodiments you can combine embodiments at the same level of preference, but you cannot, in the absence of a pointer, mix levels of preference.
... where levels of preference appear in the EPC
Delete@ Please remind me
DeletePrima facie you appear to be right as levels of preference do not appear in the EPC.
There are indeed lots of things which do not appear in the EPC, but there is case law, and the merit of case law is exactly to interpret the EPC. Some people do agree with certain pieces of case law, other do not agree with the same pieces of case law.
Levels of preference can be equated with different lists whereby the same level of preference for different parameters constitute a list. Preferred features constitute a first list, more preferred features constitute a second list and most preferred features constitute a third list. Any mixing between the levels of preference without a pointer results in added matter. In T 2273/10, the board held that the selection carried out is with respect to preferred or non-preferred features, and not just preferred features as argued by the proprietor.
There is case law on selection from lists, as lists do not appear as such in the EPC. See for example T 2368/16 (selection allowable) which goes itself back to T 1621/16. In T 3050/19 the proprietors/appellants generally criticised a strict application of the concept of selection from several lists, and cited in this respect T 783/09 and the judgment of the British Patents Court in Novartis Pharmaceuticals UK Limited v Dr Reddy's Laboratories (UK) Limited [2019] EWHC 92 (Pat). The board did not agree.
What has been said about levels of preference also applies to combinations of ranges. There again, ranges do not appear in the EPC, but there is case law about ranges. See for instance T 356/16 in which the selection of various lists was not disclosed as being preferred which is equivalent to a pointer. In T 1095/18 novelty was given as the opponent cherry-picked features from the disclosure of prior art D1 to come to a lack of novelty. In T 858/17, the board held that already in claim 3 as filed, the selection of a less preferred range out of two ranges has been made.