Williams Powell

British and European Patent and Trade Mark Attorneys

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Patents

Category contains 4 blog entries contributed to teamblogs

Supreme Court decides that plausible use of a gene sequence meets UK patent law crietria.

The Court delivered its judgement in Eli Lilly v. Human Genome Sciences on gene sequence patenting on 2 November 2011 and has reversed the decisions of the lower courts regarding industrial applicability of a gene sequence.  The decision appears to have been essentially a political one, with a submission by the BioIndustry Association having been influential.

The disputed patent relates to a novel protein, neutrokine-α, identified through the generation of human genome sequence data.  Putative functions for neutrokine-α were ascribed on the basis of its similarity to members of the tumour necrosis factor family of proteins.  However, the members of this family have diverse functions, although they are all involved in the immune system.  The original patent application therefore could not assign a specific function to the protein, and much work was required after filing to determine its precise role.

It was decided that a plausible claimed use, later confirmed by evidence, was enough for industial applicability to be acknowledged in this case.  The decision of the Supreme Court is therefore in line with the earlier findings of the Boards of Appeal at the European Patent Office.  The case is likely now to return to the Court of Appeal for consideration of obviousness and insufficiency.

 
Tagged in: biotech

The UKIPO has launched an online document inspection service for its recent patent files.

The service, called Ipsum, allows anyone to view documents sent by the UKIPO (such as search reports and examination reports), as well as documents received by the UKIPO (such as the responses filed to examination reports).

Some documents are not available online, although they can still be cheaply obtained via an official file inspection request. The database gives some status and bibliographic information, although it is not as comprehensive as the online register which is still the best source of status information.

 

A disclaimer is an exclusion, in negative terms, of subject matter from the scope of a claim.  Disclaimers are generally used to carve out from the claim scope something that is co-incidentally covered by prior art but which is not relevant to overall novelty/inventive step of an invention. In its decision of G2/10, the Enlarged Board of Appeal at the European Patent Office has considered whether and when it is allowable to amend a claim to disclaim subject matter which was disclosed as an embodiment of the invention in the original application.

In G1/03, the Enlarged Board laid out strict rules governing when it is allowable to use a disclaimer which was not disclosed in the application as filed.  Subsequent case law at the EPO generally adopted the approach that even if the subject matter excluded by the disclaimer was disclosed in the application as filed, the disclaimer would count as an undisclosed disclaimer if the subject matter had been originally disclosed as part of the invention.  The reasoning behind this was that to avoid the rules of G1/03, the disclaimer itself needed to be disclosed, not just the subject matter excluded by the disclaimer.  However, in G2/10, the Enlarged Board found this approach to be incorrect.  It found that the rules laid out in G1/03 only apply to situations where neither a disclaimer nor the subject matter excluded by the disclaimer was disclosed in the application as filed. 

In the present decision, the present Enlarged Board decided that the criteria of G1/03 only applies to disclaimers where both the negative limitation and the excluded subject-matter were not disclosed in the application as filed. In contrast, the Enlarged Board decided that disclaimers which exclude subject-matter disclosed as part of the invention in the original application do not necessarily add subject-matter. Whether such a disclaimer would be allowable is dependent on normal added subject-matter tests (whether it is directly and unambiguously disclosed in the application as filed).

In reaching its decision, the Enlarged Board of Appeal also rejected the argument that the disclosure of a generic claim and a specific embodiment necessarily discloses all of the other embodiments of the generic claim as the logical complement of the specific disclosed embodiments and such a disclaimer cannot therefore add subject matter.

The Enlarged Board found that the question to be asked was whether there is basis in the application as filed for the subject matter remaining in the claim, and that determining whether or not that is the case “requires a technical assessment of the overall technical circumstances of the individual case under consideration, taking into account the nature and extent of the disclosure in the application as filed, the nature and extent of the disclaimed subject matter and its relationship with the subject matter remaining in the claim after the amendment”. 

In particular, the Enlarged Board suggested that where, in the application as filed, “an invention has been disclosed and claimed in general terms and different specific embodiments or groups thereof have also been disclosed, and one of these later excluded from the requested protection by the disclaimer, the remaining subject matter, i.e. the remaining general teaching, will normally not be modified by the disclaimer”.  However, the Enlarged Board contrasted this with the situation in which “the disclaimer would have the effect of confining the subject matter remaining the claim to a sub-group of the originally claimed subject matter, which sub-group could not be regarded as disclosed in the application as filed”.  It considered that such a disclaimer would impermissibly add subject-matter and would therefore not be allowable.

Tagged in: disclaimers EPO patents