Wednesday, October 19, 2011

Patenting in Life Sciences in the EU

Yesterday, a discussion meeting on patenting in life sciences in the EU was held at Hotel Claridges in New Delhi by Ms.Sunita Sreedharan’s SKS Associates and a Swiss firm, Katzarov SA. 

The discussion, which I took part in, turned out to be extremely lively and fruitful thanks to active participation by members of the discussion group, which included researchers in the field of life sciences, entrepreneurs from the field, patent practitioners and representatives from policy think-tanks.

Several key issues were discussed and doubts were thought aloud for opinions and clarifications from participants. I’ll discuss a few of them in this post which relate to European patent practice.

The representative of the European firm Mr. Andrea Manola informed us that therapeutic methods were excluded from patentability under the EPC. The rationale behind this, according to him, was the “no human contact” thumb rule of the EPO. In other words, if the method of treatment involves human contact, it must be presumed to be “industrially inapplicable”, and is hence out of the ambit of patentability.

However, if the treatment is cosmetic in nature, the active ingredient in the cosmetic would be patentable. To this, my doubt was if there was an incidental therapeutic effect to the cosmetic treatment, would it still be excluded from patentability? The EU agent said this would differ from case to case.

The thumb rule appears to be that if the therapeutic and cosmetic effects are not separable/distinguishable, the method is unpatentable. If they are distinctly identifiable and separable, the cosmetic effect alone can be patented.

The question which I put was, does grant of a patent for cosmetic treatment mean that use of the chemical for therapeutic purposes by a third party in the future does not infringe the patent? The answer to this question appears fairly straight-forward. Since therapeutic methods are not protectable at all in the first place, there is no infringement if the method/ingredient is put to therapeutic use.

On filing of divisional applications under the new rules, he informed us that for a divisional application to be filed before the EPO, the parent application must be pending and the divisional must be filed within 24 months of the first communication from the examining division of the EPO for the parent application.

My doubt was if a second divisional is detected by the EPO itself in the parent application during the pendency of the first divisional, but after the 24-month period, can the EPO direct filing of the second divisional? The European agent answered in the negative.

I asked the same question with respect to another situation- it is possible that a divisional may be detected in the first divisional application. This means, technically speaking, the new divisional is not detected in the parent application, but is carved out of the first divisional application. To this too, the EU agent said the 24 month period would be calculated from the parent application i.e. the earliest of applications.

This translates to additional burden on the inventor and the drafter to clearly understand the inventive step and identify the embodiments sought to be claimed in the parent application.

On filing of clinical/supportive data for pharma patents after the filing of the patent application, we were told that data filed after the priority date cannot receive the benefit of the priority date since the requirement of sufficient disclosure is to be satisfied as of the priority date, and not after that. This rule is not different from the one followed by the Indian Patent Office.

Besides these nitty-gritties, we were told that EPC does not contain provisions on infringement of patents, and that infringement is covered by national laws. To my surprise, I was told that France and Switzerland do not examine for inventive step. Further, if an EP patent is granted and a patent is granted on the same invention by France, the French patent is put in abeyance if the grant of the EP patent is challenged at the EPO.

This means if an infringement proceeding is filed by a French patentee in France, and if the defendant files for revocation of the EP patent on the same invention before the EPO, then until the conclusion of the revocation proceedings before the EPO, the French patent goes into abeyance, which effectively puts pause to the infringement proceedings in the French court.

In all, the discussion meeting was very insightful and a refreshing change from the usual conferences where interactions are exceptions and monologues are the norm.


  1. Indeed a good round up of the day's proceedings. The discussion was quite lively and refreshing. Thanks for posting Sai.

    In fact, the issue of divisional applications at the Indian Patent Office is worth discussing. Section 16 of the Patents Act provides that an applicant may, if he so desires (suo moto) or in view of an objection from the Patent office, file a further application. It does not say anything about a divisional out of divisional. In the draft manual, the Patent Office had specifically pointed that divisional out of divisional would not be allowed. However, surprising, the final manual does not say anything.

    It is worthwhile to note that the Patent office is sitting tight on several such divisional applications after hearing the applicants who have argued for grant. The hesitation in straightaway rejection appears a bit odd. Welcome any comments on this.

  2. Thanks for the comment Deepa. I think the Patent Office would do well to read the explanation to Section 16 carefully. The explanation makes it clear that although the first divisional will be treated as having filed on the date of filing of the parent application, the divisional shall be proceeded with as a "substantive application". In the meeting the other day, I had mentioned that although a divisional may be carved out from a parent application, for all practical purposes the divisional must be treated as a stand-alone application. This means, once a divisional is carved out of the parent, another divisional may still be filed from the first divisional before the grant of patent to the first divisional, even if a patent has been granted for the parent application. The only condition precedent is that the second divisional too must be disclosed in substance in the first divisional, and by corollary in the parent application.

    Stated otherwise, the parsing of divisionals must be contingent on pendency of the application immediately preceding them, and not on the pendency of the first filed parent application.

    I think the Patent Office finds itself in a bind because on one hand common sense could be telling them that it must be permissible to create a divisional out of the divisional, and on the other hand, absence of judicial guidance on this point could be the reason for their cautious status-quo mode.

    May be on issues like these, if practitioners could come out with a reasoned consensus, it could bolster the Office's confidence in taking a firm and reasoned stand, instead of soft-pedalling.

    Let me know your thoughts.

    Warm Regards,

  3. Here's a comment from a regular reader and well-wisher of the blog Ms.Jaya Bhatnagar:

    "I completely agree with Sai and thanks to him for the post. I recall that during my practice years in 1998-2005, further divisional out of already filed divisional was the best practice so as not to jeopardize the rights accruing from the claims made.

    I am not sure, but recall that similar is the practice at EPO where to overcome a final rejection divisional in th eform of Continuation-in-part applications are filed.

    Co-Founder Partner
    ILF-RSJ IPR Partners
    C.R. Park
    New Delhi- 19"