Is it time to rethink the patent drawing requirements?

The function of patent drawings is to aid understanding of an invention, but are they fit for purpose?  Embodiments of a mechanical invention may be easier to explain and understand as a drawing compared to a lengthy description. The European Patent Office (EPO) considers good quality drawings as very important for the correct disclosure of an invention (Guide for applicants, Drawings). Scientific data necessary to support biotech and pharmaceutical inventions are also provided as “drawings”. However, these data do not serve the same purpose as mechanical drawings and do not naturally conform to the formal drawing requirements for technical illustrations of mechanical objects. However, this difference is not reflected in the formal drawing requirements of the EPC or PCT. This Kat asks therefore, whether the formal drawings requirements deserve a re-think. 

Slinky patent drawing, US2415012
The formal requirements for the form in which patent drawings of patent applications are to be presented are provided by Rule 11 PCT  and Rule 46 EPC. At a functional level, the drawings, like all other parts of the application, must be "presented as to admit of direct reproduction by photography, electrostatic processes, photo offset, and microfilming, in any number of copies" (Rule 11(a) PCT). The special requirements relating to drawings are provided by Rule 11.3 (a)-(n)PCT and Rule 46 EPC.

Are data “drawings”?

From a quick perusal of the special requirements relating to drawings, it rapidly becomes apparent that these provisions are drafted with mechanical inventions in mind. In fact, the very phrase "drawings" seems inappropriate for the types of graphical illustration provided in support of other types of invention, particularly those in the software, biotechnology and pharmaceutical fields. The EPC (but not PCT) addresses this problem somewhat by stipulating that “flow sheets and diagrams shall be deemed to be drawings” (Rule 46 (3) EPC).

However, the problem goes beyond the inappropriateness of the term “drawing” for scientific data. Take for example the first provision of Rule 11 PCT and Rule 46 EPC "(a)  Drawings shall be executed in durable, black, sufficiently dense and dark, uniformly thick and well-defined, lines and strokes without colorings". This seems to be a sensible requirement for drawings taking the form of technical illustrations of a mechanical object. However, the types of "drawings" required to support the claims of a biotechnology or pharmaceutical generally take the form of data. If you have, for example, a claim in the second medical use form: "Drug X for the treatment of disease Y", the applicant is required to provide sufficient data demonstrating the plausibility of the treatment effect. This may be presented, for example, as a bar chart showing a treatment effect in various patient groups over time. 
Bar chart using cross-hatching
Scientific data are not suited for representation with black lines only. Different bars on a bar chart may be distinguished from each other by colour or colour intensity (e.g. different shades of grey). However, colours and shading are not permitted under Rule 11 (a) PCT. In order to satisfy the formal drawing requirements, it seems therefore that the shading must therefore be replaced by ever increasingly complicated types of cross-hatching. It in fact appears from Rule 11 PCT that graphs in general are not looked on favourably, given that Rule 11 (f) PCT states that a scale (even a graphical one) should only be drawn in "exceptional" cases.

The EPO by contrast, has attempted to address the issue of the unsuitability of representing scientific data with black lines only. Whilst Rule 46 EPC stipulates that only black lines may be used, the EPO Guidelines for Examination indicate that “the use of shading in figures is allowed provided this assists in their understanding and is not so extensive to impede legibility” (A-IX 7.2).

What about photographs?

Immuno-florescence data
Scientific data may also take the form of photographs. Western blots and immuno-fluorescence are standard techniques for detecting proteins, and both type of data are often presented as photographs. In the field of genetic modification, it is also usual to provide photos of the resulting modified organism so as to show the effect of a genetic modification on a physical trait. Does it make sense to execute these data "in durable, black, sufficiently dense and dark, uniformly thick and well-defined, lines and strokes without colorings"?

The PCT applicant's guide indicates that photographs may be submitted: "[t]he PCT makes no provision for photographs. Nevertheless, they are allowed where it is impossible to present in a drawing what is to be shown (for instance, crystalline structures). Where, exceptionally, photographs are submitted, they must be black and white...Color photographs are not accepted, nor are color drawings" (PCT applicant's guide, 5.159).

Modified tomatoes
The EPO Guidelines for Examination similarly indicates that photographs may be permitted “where it is impossible to present in a drawing what is to be shown…Colour photographs are accepted, but will be scanned, printed and made available via file inspection only in black and white” (A IX 1.2). 

The current PCT and EPO guidelines thus seem out of step with a normal interpretation of the PCT and EPC formal drawing requirements (e.g. that drawings must be executed in durable black lines).

Where does this all leave the applicant?
Western blot data

If the EPO find that the drawings provided in an application do not satisfy the requirements of Rule 46 EPC, they issue an invitation to the applicant to remedy the deficiencies within 2 months of notification (Rule 48 EPC). If the defect noted by the EPO is not remedied on time or properly, the application will be refused (Article 90 (5) EPC). To avoid refusal of the application, the applicant is therefore simply required to remedy any deficiencies found in the drawings. So what is the problem?

Whilst the EPO guidelines do indicate that graphs and photos may be allowed, the lack of a specific provision in the EPC means that the extent to which scientific data will be expected to conform to the Rule 46 EPC requirements can be open to the whim of the EPO Receiving Section. Replacing data with drawings satisfying the requirements of Rule 46 EPC can also represents a significant burden (in terms of time and expense) for the applicant. Furthermore, the resulting black and white, cross-hatched and text-free figures are often worse at communicating the data than the original figures.   

All of this raises the question of how necessary the requirements of Rule 46 EPC really are? If the purpose of data is to demonstrate the plausibility of a claimed effect, surely what matters is whether a skilled person would be able to read and understand the data? Given that data generally cannot be considered “drawings”, and often do not serve the same purpose as technical drawings of mechanical inventions, perhaps data should be submitted under a different category, akin to the supplementary data of a scientific article?

The issue of the lack of applicability of the formal drawing requirements to scientific figures may not be the most pressing issue with the International and European patent system. Perhaps this Kat has just spent one too many times trying to squeeze the square peg of scientific data into the round hole of the formal drawing requirements for patent applications. Nonetheless, with the number of biotech and pharmaceutical applications rising every year (up 1.5 and 8.1% respectively in 2017), and the increasing importance given to the data required to support these applications, perhaps both applicants and the public would benefit from a rethink of the requirements.  Do other EPO patent practitioners have any thoughts?
Is it time to rethink the patent drawing requirements? Is it time to rethink the patent drawing requirements? Reviewed by Rose Hughes on Friday, January 25, 2019 Rating: 5


Paul Kemp said...

YES, apart from the weighty points raised above in relation mainly to non-mechanical inventions, many if not most mechanical "drawings" are now produced at first instance as 3D models. These commonly represent much greater detail than can be presented as 2D views, and in many cases are capable of animation. 3D PDF formats enable such views to be presented without specialist software (CAD). In preparing specifications I am commonly presented with the 3D model and have to select 2D views which illustrate what I am trying to communicate. Nearly all mechanical inventions move, often in complex ways. This either requires a lot of description, which is not easy to understand (and I have seen more than a few descriptions which are simply wrong) or multiple cartoon animation views.
Even 2D PDF views accepted by the current filing software are of limited resolution, which removes a lot of detail from large scale drawings. Not a few of my engineering clients regard this as quaint at best (the at worst comments are not reproducible). This goes nowhere to enhance the credibility of the patent system generally.

Anonymous said...

Sorry to say, but I have never had a problem with the drawing requirements in relation to life science inventions. Chemical compounds, manufacturing processes, tables of data, and more, may be included in the description. Second medical use patents do not require drawings, bar charts, or 3D manipulatable CAD designs in 64-bit colour to render them sufficient. The wonderful thing about patents is the requirement to describe an invention using words, drawings being a mere aid to interpretation.

Where a technology is not best-served by words and drawings, patent laws provide for things such as biological deposits. However, when something ain't broke, there is no need for anyone to create a problem to be fixed in order to have something to write about.

As for the mass-inclusion of drawings in life science patents, I feel many are unnecessary, even if they had been provided in a legible form. Photographs, for example, of stained cells and the like, show nothing, mean nothing, and add nothing.

Ex-examiner said...

The Korean Patent Office accepts colour photographs. These could present problems in getting legible drawings for EP filings. In one case where the draftsmen we used had great difficulties, I got much better results using a basic image processing program that came with my ancient Windows 98 PC that could render continuous tone images as contours of different patterns.

Cell Stainer said...

Microscopy data in particular, often with multiple different dye stains, can be very important to support an invention while being impossible to hammer into the existing rules. Please don't attach too much weight to the anonymous comment of 26 January (I can understand why it was anonymous).
If the invention is in influencing cell morphology, or subcellular targeting, or whatever, should we NOT show the data? Is the alternative of using text, an alternative that is indeed available, indeed preferable? Imagine this: "When the invention was used, it looked really good. When the comparison from the prior art was used, it looked really bad. Trust us. We have the pictures at home." Yeah, I'd rather be able to file the microscopy images.
Sometimes you can choose to file both the colour drawings and the black/white ones (for example: zip them together). The b/w file will get used, but at least the colours will have been filed and will be available.

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