Reading between the lines when assessing novelty of patent claims

Reading between the lines when assessing novelty of patent claims

Reading between the lines when assessing novelty of patent claims

Regardless of the jurisdiction, novelty is a fundamental requirement for the patentability and validity of a claimed invention and is assessed relative to a single piece of prior art information. However, a recent decision by the New Zealand Patent Office (IPONZ) in Lonza Ltd [2020] NZIPOPAT 1 (Lonza) raises a question as to what, if any, information can be read into a single prior art document for the purpose of assessing novelty in New Zealand.

The relevant claims

The application at issue in Lonza was NZ 712239, which contains Swiss-style claims directed to:

Use of a composition comprising arabinogalactan and polyphenols extracted/isolated from larch trees in the manufacture of a medicament [or nutritional product] for use in the treatment or prevention of an upper respiratory tract infection,

wherein the composition comprises 1 weight-% to 4 weight-% polyphenols relative to a total amount of arabinogalactan and polyphenols in the composition, and

wherein the medicament is formulated for administration to a subject in a daily dose of 0.5 g to 15 g, or in a daily dose of 1.0 g to 7 g.

The recited daily-dosing regimen was purported to be the novelty-conferring feature.

Cited prior art

During examination, the Examiner alleged that the claims lacked novelty in light of a prior art document designated D10, which discloses information relating to a clinical trial of the product ResistAidTM – which contains arabinogalactan and polyphenols in the amount claimed – for reducing the incidence of upper respiratory tract infections.

While D10 teaches that a total of 4.5 g ResistAidTM was administered over 12 weeks (corresponding to approx. 5.3 mg daily), other documents relating to the same clinical trial – designated D11 and D12 – disclose that the dosage regimen used in the trial was 4.5 g daily. Accordingly, the Examiner treated D10–D12 as a single piece of prior art information to deprive the claims of novelty. However, the Applicant argued that the Examiner had impermissibly “mosaicked” D10–D12 and requested a hearing to resolve the novelty objection.

Assessing novelty

Under New Zealand law, the prior art base for assessing novelty includes all matter (e.g., a product, a process, information about a product or process, or anything else) that has at any time before the priority date of the relevant claim been made available to the public by written or oral description, by use, or in any other way. In contrast, the prior art base for assessing novelty under Australian law includes information made available to the public before the relevant priority date in a single document or act, or in two or more related documents or acts if the relationship between those documents or acts is such that a person skilled in the art would treat them as a single source of information.

Both New Zealand and Australia also have “whole of contents” novelty, where a patent specification having an earlier priority date but later publication date than the claims in question may be cited against those claims for novelty (but not inventive step).

Mosaicking of multiple documents is not permissible for the assessment of novelty in either jurisdiction. Further, while a prior art document should be read in light of the common general knowledge (CGK) of a person skilled in the art such that words and phrases used in a document are to be given the meaning a skilled person would ordinarily ascribe to them, CGK cannot be “added” to a document to establish a lack of novelty. These approaches belong solely to realm of inventive step assessment.

Single source of information

The circumstances under which two or more documents can be treated as a single source of information were identified by the Full Federal Court of Australia in Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40; (1990) 16 IPR 545 (Nicaro Holdings) at [21]:

The invention must appear in a single disclosure, so it is not permissible to make a pattern or mosaic of or to read together various pieces of prior art in different patents. It is, however, permissible, to refer not only to the patent relied on as the source of disclosure but to another patent or other patents incorporated by reference provided that it is plain that the incorporation by reference unequivocally and plainly demonstrates that the draftsman has adopted the cross referencing system solely as a shorthand means of incorporating a writing disclosing the invention…

However, for the purposes of anticipating a combination patent, all elements of the combination must be disclosed together in a single document (Nicaro Holdings at [22]).

While there is no provision relating specifically to the treatment of multiple documents as a single source under New Zealand law, it is likely that IPONZ would permit the treatment of documents as a single source in the circumstances set out in Nicaro Holdings, in line with both Australian and UK law.

Clear and unambiguous errors

While the Hearing Officer in Lonza did not comment on the propriety of the Examiner’s objection in relation to D10–D12 representing a single source of information, D10 is not a patent specification that incorporates D11 or D12 by cross-reference. As such, D10–D12 do not represent a single source of information in the sense contemplated by Nicaro Holdings.

Instead, the Hearing Officer relied on the UK High Court decision in Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly and Co Ltd [2008] EWHC 2345 (Pat), [2009] FSR 5 to read the term “daily” into the dosing regimen of D10. In that case, the Court found that if a skilled person recognises an error in a piece of prior art and the actual meaning is clear and unambiguous (as distinct from a mere probability), that disclosure may be used to anticipate the claims.

The Lonza decision

The Hearing Officer considered that a skilled person would recognise a clear and unambiguous error with respect to the dosing frequency of ResistAidTM in D10 because an effective dose of 4.5 g daily would be well known from various earlier publications, including D11 and D12. Further, it would “make sense” to the skilled person reading D10 that the dosing regimen is daily because a literal reading (i.e., a total of 4.5 g administered over 12 weeks) would not provide an effective daily treatment amount.

Both lines of argument rely on the disclosures of various prior publications to correct an error in D10. However, in order to do so, it must be established that the relevant disclosures of these publications form part of the CGK. Further, such CGK cannot merely be added to D10 to establish a lack of novelty unless there is a clear and unambiguous error. Therefore, the relevant questions in assessing novelty in view of D10 were:

(i)  can it be established that a 4.5 g daily dose of ResistAidTM forms part of the CGK?

(ii) would a skilled person recognise that D10 contains an error in relation to the dosing frequency of ResistAidTM?

(iii) is it clear and unambiguous (as opposed to merely probable) that D10 is referring to a 4.5 g daily dose?

The affirmative answers by the Hearing Officer to each of these questions were undisputed by the applicant in Lonza. However, such questions of fact are typically best addressed using expert evidence, which, if it were to establish that only one of these questions could been answered in the negative, would likely be sufficient to show that the claims are novel.

Alternative outcomes

Ultimately, a finding of novelty in Lonza would have been unlikely to change the outcome since the claims were nonetheless found to lack an inventive step (where mosaicking is permitted). However, this decision highlights that IPONZ is prepared to read deep between the lines when assessing novelty and expert evidence could play an important role in refuting assertions of fact. This may be particularly advantageous in the case of whole of contents novelty citations, where inventive step cannot be raised as a fallback ground of invalidity.

Notably, a similar issue does not arise in relation to the corresponding Australian or U.S. application because Lonza’s complete PCT application was filed within 12 months of the publication date of D10 and therefore D10 does not form part of the prior art base for the assessment of novelty and inventive step under the respective “grace period” provisions. New Zealand also has grace period provisions, but these are only effective for disclosures made after 30 December 2018 (i.e., after D10 was published).

Key takeaways

In relation to novelty in New Zealand:

  • Novelty may be assessed on the basis of two or more pieces of prior art information where a person skilled in the relevant art would treat them as a single source of information.
  • A patent specification and a document incorporated therein by cross-reference may be regarded as a single source of information where the cross-referencing has been used solely as a shorthand for incorporating a writing disclosing the invention, but mosaicking is not permitted.
  • CGK is relevant to the interpretation of prior art documents but cannot be “added” to include an element that is not otherwise disclosed.
  • A mistake in a prior art document may be read as corrected where a skilled person would recognise that there is a clear and unambiguous error.
  • Expert evidence may be valuable tool in refuting allegations as to lack of novelty based on a clear and unambiguous error in a prior art document.

Please contact Claire Gregg (CGregg@davies.com.au), Michael Caine (MCaine@davies.com.au) or your regular DCC contact if you would like any more information about patents in New Zealand or Australia.

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