Colon cleaning solutions for colonoscopy – is ‘obvious to try’ no longer the standard of inventiveness for Israel pharma patents?

NorgineIL 227582 to Norgine BV was finally refused by the Examiner despite the corresponding patent issuing in Europe and allowance being requested under Section 17c. The Applicant appealed the Examiner’s refusal to the Commissioner of Patents, and following a hearing by the new Adjudicator of Intellectual Property, Dr Roya Israeli, the claim set was allowed subject to various amendments in accordance with the Examiner’s objections.The allowed application will now publish for Opposition purposes.

Israel Patent Application no. 227582 to Norgine BV is titled “Colonoscopy Preparation”. It was submitted on 21 July 2013 as the National Stage of PCT/GB2012/050526 which was submitted on 9 March 2012 and published as WO2012123720.

The Application claims priority from three applications filed between 11 March 2011 and 23 August 2011.

Plenvu dosageThe application relates to a method for cleaning the bowels for colonoscopy examinations and various medical procedures using various cleaning solutions, mixtures that are included in the cleaning solutions, and a kit including such solutions.  During the prosecution of the application, various claims were raised against the registerability thereof.

  • Back in April 2016, the Examiner alleged a lack of unity contrary to Section 8 of the Patent Law which the applicant overcame by claim amendments.
  • The Examiner alleged a lack of inventive step contrary to Section 5 of the Patent Law in light of prior references WO2004037292 and GB 2471954 which were both assigned to the Applicant and which describe methods and solutions for cleaning the bowels. The Applicant claims that these earlier publications also describe bowel cleaning solutions. However the Applicant considers that these describe much more dilute solutions which are used in a different manner.
  • The Examiner found the terminology confusing and resulting in a widening of the protection claimed. The Applicant amended the claims to overcome this objection.

On 13 November 2017, after several rounds of substantive examination that related to the issues described above, the Applicant requested allowance on the basis of the corresponding European Patent No. EP 26833375 under Section 17c of the Law.

Under section 17c, the Applicant conforms the claims pending in Israel to be identical to those allowed in an examining jurisdiction recognized by the Israel Patent Office, and the application is typically allowed, unless it relates to what is considered non-patentable subject matter in Israel, such as business methods per se, methods of therapeutical treatment and the like.

The Applicant considered that the request for allowance under Section 17c renders void the allegation of lack of inventive step since the European Patent was allowed despite consideration of the two references cited in Israel. The Applicant further alleged that the clarification issues were similarly void, although he did not elaborate. The Adjudicator assumes that the Applicant meant that the European Patent Office had decided to accept the claim set, and had no issue with regards to their clarity.

It appears that the Applicant considered that once he’d invoked Section 17c, the Examiner no longer had any judgment and should allow the patent by relying on the overseas Examiner, who in this case was the European examiner. The new adjudicator, MS Roya Israeli accepts that the purpose of Examination under Section 17c is to speed up examination, but considers that Section 17d allows the Commissioner, the Chief Examiner or his deputy to refuse to allow an Application based on material that is in their possession or was brought to their attention during examination, or because of a another specific reason: see IL 136482 Albermarle Coroporation vs. Bromium Compounds Itd., 20 August 2007, paragraph 42 of the ruling, which relates to the interpretation of Section 17d of the Law.

The Examiner noted the Applicant’s wish to have the patent allowed under Section 17c but maintained the objection of 20 September 2018 that the invention was obvious in light of the prior art cited, and refused to allow it.

On 24 November 2018 the Applicant responded and amended the claims once again (version 5) and responded to the Examiner’s objections. This response was unsuccessful and the Applicant requested a meeting with the Examiner and one was held on 220 January 2019. The summary of the meeting shows that during the meeting the Applicant was unsuccessful in convincing the Examiner. The Examiner did, however, suggest that the preparation by defined in a narrow manner that restricts it to specific ingredients, concentration and volume and that this could be considered as a patent of addition to IL 217296 (the second citation).

In a response of 29 May 2019, the Applicant rejected this proposal and asked for a hearing under Regulation 46. On 19 June 2019 the Applicant received a final rejection and on 18 July 2019 requested a hearing.

On 19 November 2019, a hearing was held before the new adjudicator, Ms Roya Israeli. Prior to this, the Applicant submitted a summary f their arguments and a claim set amended for the sixth time. The hearing concerned the summary and this version of the claims.

Discussion and Ruling

colonoscopyAs stated above, the application relates to a method for cleaning the bowels using a cleaning solution, appropriate mixtures and a kit. Actually we are dealing with a general protocol for cleaning the bowel that includes two preparations that the patient takes prior to a colonoscopy and specifically claims the solutions and a kit thereof.

There is no doubt that fluids for colonic cleaning were known by the priority date. The Applicant claims that their invention is a sufficiently concentrated solution that a mere 500 ml of the second Dose can effectively clean the bowel.

This solution, since it is used in a smaller quantity than previous solutions, results in the patients following the instructions more accurately and is thus preferable than the prior art solutions. The taste was also improved. The Applicant claimed that the second solution, i.e. that of dose II was new.

As the Patent Office warned during the hearing, the final version of the claims (version 6) provides wider protection to that taught and does not reflect the invention. Furthermore, some of the claims are unclear. So the adjudicator invited the Applicant to narrow and clarify the claim set. Then the adjudicator would rule on their allowability. Following the hearing, the Applicant amended the claims a seventh time, and the following discussion relates to this version.

Claims 1-12 claim a colon cleansing solution, and relates to the formulation of the dose II solution. Following the hearing, a previously missing definition of the volume of the solution was added to the claims. Prior to the amendment the claims did not relate to volume, such that the claims effectively included unlimited possible volumes, some of which will not achieve the claimed advantage of a small volume that the patient can be expected to ingest as per instructions. Following this further amendment, claims 1-12 were allowed.

CLaims 13-22 of the application claim a composition that is intended to be diluted with water. Following the hearing, the Applicant added the volume of water that the patient should add to the mixture to obtain the solution of dose II. Without the amendment, the claimed invention is for a concentrate that could be diluted with different amounts of water to obtain different concentrations for cleaning the bowels, and this is not inventive as most of these do not achieve the desired result of patient compliance.

During the hearing, the Applicant noted that the claims for the composition deal with a mixture of dry ingredients and the claims relate to these as ‘for mixing with water’, which might be taken as implying that the mixture is dry, however the composition need not be dry, and thus claims 13 to 22 are rejected. However, should the applicant replace the term composition in these claims with the term ‘dry composition’ or ‘dry powder’, these claims will be allowed as well.

Claims 23 and 24 claim use of the composition and solutions, and were amended as required and so are allowable.

Claims 25-34 of the applicant claim various kits that include the formulations in the earlier claims. Claim 25 relates to a kit comprising inter alia, a first colon cleansing solution, whose contents remains unclear, and is only clarified in claim 26, so claims 25 and 26 should be merged into a single claim.

Similarly, claim 27 claims a first component, the contents of which are unclear in claim 27, but are clarified in claim 28 so these claims should be combined as well.

Claims 29-33 should similarly be amended to reflect these changes.

New claims 35-37 relate to a first colon cleaning solution. This solution is not inventive and so cannot be allowed and should be canceled.

Claim 38 deals with use of the first and second solutions for cleaning the bowels and recite ‘an effective amount’. This phrase is unclear and should be deleted and replaced with the amount by joining claim 39 to claim 38.

Claim 40 depends on claims 38 and 39 and narrows their scope by requiring the patient to drink clear fluids as well. This claim should be amended to reflect the requested changes to claims 38 and 39.

Claim 41-43 deal with the volume of the first and second cleansing formulations ends on claims 38 and 29, and should be renumbered to reflect the changes above.

The adjudicator considers that the claim set after the amendments relates to a new invention under Section 4, in that the prior art teaches dry mixtures for mixing with water to obtain 1 litre at an sorbate concentration of 3-20 g per litre, which is 17-113 milli-mol, whereas the patent application claims low volumes of 300-800 ml of a much stronger concentration of 400-700 milli-mol. This change in composition and volume provides an invention that is technically simple but nevertheless advantageous over the prior art and which answer a need that the earlier publications were aware of, i.e. to ensure more effective cooperation of paqtients following the cleaning regime.

PlenvuThe formulation in question (in dry form for adding to water) is part of the cleaning regime accepted by the FDA and marketed as Plenvu. The fact that there are now products based on the invention indicates the contribution that the invention makes in this field.

Dr. Roya Israeli considers that the advantages of the invention embody a modest inventive step and notes that the case-law states that “there is no need for the inventive step to be significant and a small step can be an improvement, as long as it represents  a scintilla of inventiveness.  See Civil Ruling 47/87 Hassam Defence and Reliability Systems ltd. vs. Abraham Bachri 45(5) 194 (1991) paragraph 4. As stated, the inventive step is small as is the scope of the claims that define it. The width of the protection reflects the amount of inventiveness and the contribution to the field.  (See 407/89 Zuck Ohr ltd. vs. Car Security ltd. 48(5) 661 (1994) Section 7 of the ruling, which deals with the scope of protection provided by a patent being determined by the scope of the claims.

In light of this, the Applicant has until 23 January 2020 to amend the claims as instructed hereinabove and then the claim-set will be allowed and will publish for opposition purposes. Failure to make the amendments will result in the patent application publishing with only the already amended claims that have been allowed.

Appeal for patentability of IL 227582 Ruling by Dr Roya Israeli, 23 December 2019.

OUR COMMENTS

A previous Israel Commissioner of Patents, Dr Meir Noam, himself a chemist, ruled that the standard of patentability for pharmaceutical patents was ‘obvious to try’. In line with that standard, a wide range of patent applications for various dosages and the like were considered obvious and were not allowed. It seems that the new adjudicator Dr Roya Israeli may not accept this standard unless the very realization that a smaller quantity of stronger concentration fluids is more likely to be drunk by the patient is considered inventive. It is, however noted that the European Patent Office has allowed the corresponding patent.

It is too early to tell with this case implies a new standard of patentability and that henceforth pharma patents will be easier to obtain. Furthermore, this is only the second published ruling of Dr Israeli. Nevertheless it is interesting to speculate if this ruling indicates a change of policy having ramifications beyond the specific field of colon washing solutions.



Categories: claims, Intellectual Property, inventive step, inventiveness, Israel Patent, Israel Patent Office Rulings, החלטת רשות הפטנטים, התקדמות אמצאתית, קניין רוחני, קנין רוחני

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