In Novartis AG & Others v Johnson & Johnson Medical Limited & Others ([2009] EWHC 2029) the English Patents Court found that Johnson & Johnson’s product infringed the Patent, but that the Patent was invalid due to insufficiency.

Background

Novartis AG (“Novartis”) is the exclusive licensee of EP 0 819 258 (the “Patent”) for contact lenses which may be left in the eye overnight or for several days. It brought a patent infringement action against Johnson & Johnson (“J&J”) which manufactures and sells its product Acuvue Oasys in the UK. J&J contested the infringement action and counterclaimed for invalidity.

A peculiar feature of the Patent is that its claims cover not only the materials from which the contact lenses may be manufactured, but the characteristics that they should display, such as ophthalmic compatibility, corneal health, wearer comfort, and their physical properties, such as oxygen transmissibility and ion permeability.

The common general knowledge at the priority date was that the ideal long-wear contact lens would have the correct balance of properties: transmission of oxygen through the lens to the eye, hydrophillicity to allow the lens to move across the eye and wettability so that a smooth, stable and continuous tear film is formed both behind and on the front of the lens when it is worn (to allow corneal health, good vision and comfort.)

The Patent seeks to describe a lens which will have the correct balance of all the required characteristics. However, J&J claimed that the Patent failed to explain how to manufacture a product with these characteristics.

Priority

J&J first contested the priority date of the Patent. If the earliest priority date was disallowed, they had two extra pieces of prior art which could invalidate the patent for lack of novelty.

The Patent claimed priority from three earlier applications. The first and second priority documents disclosed materials claimed in the Patent to make contact lenses. However they did not disclose the additional characteristics required by the Patent. An earlier document can found a claim to priority where it discloses the “same invention”. This means that “the skilled person can derive the subjectmatter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole” (Article 87(1) EPC.) J&J argued that these documents could not be used to claim priority as they did not disclose the same invention. Novartis argued that the integers of the claims of the Patent could have multiple priority dates.

The possibility of partial and multiple priorities is addressed in Article 88(2) EPC: “Multiple priorities may be claimed in respect of a European patent application. […] Where multiple priorities are claimed, time limits which run from the date of priority shall run from the earliest date.” This provision has been interpreted in decision G02/98 by the Enlarged Board to mean that, where the claims are for integers A and B, multiple priorities are not allowed, whereas they are possible for an A or B claim.

The judge was therefore required to decide whether the claims could be divided into a limited number of clearly defined alternative subject-matters, some of which are disclosed and enabled by the first and second priority documents. He found that the features of the lenses listed in the claims could not be considered separate from each other. The additional characteristics are essential features of the invention and are not disclosed in the first and second priority documents. The Patent was therefore only entitled to priority from the date of the third priority document. This meant that the extra prior art asserted by J&J could be considered as it was disclosed before the newly established priority date of the Patent.

Novelty

J&J therefore claimed that the Patent lacked novelty under s 2(3) of the Patents Act 1977, on the basis of five of prior disclosures (Hopken, Domschke, Chang, Lai and Koegh). The test that must be applied in considering an allegation of anticipation was explained by the House of Lords in Synthon v SmithKine Beecham [2005] UKHL 59; [2006] RPC 10. The prior art must both constitute a prior disclosure and be enabling.

To constitute a prior disclosure the prior art must contain a clear description of, or clear instructions to make, something that would necessarily infringe the patentee’s claim if carried out after the grant of the patentee’s patent. In respect of the disclosure, both parties agreed that there is insufficient information to determine whether the lenses in the prior art do or do not satisfy the requirements of the claim, without specific tests being carried out. The judge was therefore unable to conclusively decide that a prior disclosure had been made, so the lack of novelty attack was unsuccessful.

The issue of enablement was considered later in terms of sufficiency of the Patent.

Obviousness

The judge found that the patent was not obvious over the common general knowledge, as asserted by the defendants: “I am satisfied it was not obvious how to make a silicon hydrogel lens which was opthalmically compatible over a period of extended wear in the light of the common general knowledge at the priority date.”

He also found that the patent was not obvious over the other prior art. J&J’s claim for invalidity due to obviousness therefore also failed.

Insufficiency

J&J claimed, under section 72 of the Patents Act 1977, that the teaching of the Patent did not provide sufficient information for the person skilled in the art to make lenses falling within the claims without undue experimentation. The Patent should therefore be invalid for insufficiency as it does not provide a solution to the known problem of identifying a suitable material from which to make a lens which will meet the functional requirement of ophthalmic compatibility over a period of extended wear.

The judge agreed with J&J’s argument that the description provides little or no practical assistance to the skilled person faced with this problem. He noted that there is no teaching in the Patent of a principle of manufacture and that the claimants themselves had acknowledged that it would only be possible to ascertain whether a product falls within the scope of the claims by carrying out a trial over a test period.

Infringement

The judge held that had the patent been valid the Acuvue Oasys lens would have fallen within the scope of claims 1 and 24, but not claims 8 or 11.

In claim 1, J&J only argued that their product did not infringe one of the elements of the claim: the oxygen permeability levels. The judge found that Novartis had shown that the Oasys lens infringed this part of the claim. Claim 24 required the product to have a hydrophilic surface, and the judge found that this was the case for the Oasys lens.

Claim 8 and 11 cover a polymeric material comprised of a plurality of co-continuous phases, at least one being an oxyperm phase (permeable to oxygen) and at least one other being an ionoperm phase (permeable to ions and water). The judge found that Novartis had not conclusively shown that the Oasys product fell within these claims.