Patent Applicant’s Perseverance Pays Off
In Taiho Pharmaceutical Co Ltd  NZIPOPAT 1 multiple grounds for rejection maintained by the examiner were found to either have no basis or were upheld with the applicant being given the opportunity to make suitable amendments.
The application in question is a divisional of a PCT national phase entry that claims priority from a Japanese application, with a priority filing date of 27th March 2013. The New Zealand claims are in Swiss-style format, whereas the national or regional phase entries in other jurisdictions that have subsequently been granted use different claim formats. The New Zealand application in question has 8 claims, with claim 1, as follows, being the only independent claim:
1. Use of trifluridine and tipiracil hydrochloride in a molar ratio of 1:0.5 in the preparation of an antitumor medicament for the treatment of solid cancers,
- wherein the antitumor medicament is adapted to administer trifluridine and tipiracil hydrochloride at a dose in the range of 35 to 70 mg/m2/day, and
- wherein the antitumor medicament is adapted to administer trifluridine and tipiracil hydrochloride in combination with irinotecan hydrochloride hydrate at a dose in the range of 45 to 130 mg/m2/day.
There were several outstanding objections by the examiner. Namely:
Section 40/Regulation 58/Section 33(5) – whether support for amendment in priority document
Section 39(2)(b) — whether claims are clear
Section 14(b)(i) – whether invention claimed lacks novelty
Section 14(b)(ii) – whether invention claimed involves an inventive step
Section 14(a) – whether double patenting
The Assistant Commissioner rejected the examiner’s lack of support objection to claim 1 after finding that the upper range value of 130 mg/m2/day was a slight rounding up of dosages disclosed in the priority specification.
The examiner’s clarity objection to claim 1 concerned the absence from the claim preamble of one of the active ingredients – namely irinotecan hydrochloride hydrate. While the inventors discovered that the use of the three named active ingredients in the manufacture of a medicament is beneficial for the treatment of solid cancers, only two of those active ingredients are mentioned in the claim preamble. The Assistant Commissioner upheld that objection finding that the claim does not comply with the acceptable format of a Swiss-style claim, and ordered that the claim be amended so as to be in an acceptable claim format.
The examiner also made a clarity objection to claim 7 on account of it being dependent upon claim 6 while containing the phrase “the administration schedule” which only has antecedence in claim 5. Claim 7 is as follows:
7. The use according to claim 6 wherein the patient has received irinotecan hydrochloride hydrate within one cycle of the administration schedule.
While claim 6 can be dependent upon claim 5 it can also be dependent upon any one of claims 1-4. Consequently, when claim 6 is dependent upon one of claims 1-4 while not also being dependent upon claim 5, then claim 7 has no antecedence for the phrase “the administration schedule”. The Assistant Commissioner also upheld this clarity objection and allowed the applicant the opportunity to amend the claims either such that claim 7 is dependent on claim 6 when dependent on claim 5, or making claim 6 only dependent on claim 5.
The Assistant Commissioner rejected the examiner’s novelty objections, finding that neither of the prior art documents ‘planted the flag’ as they did not disclose the use of irinotecan hydrochloride hydrate with the other two active ingredients and one of the documents disclosed a different chemical structure for tipiracil hydrochloride.
In addition to the above differences the lack of inventive step objection also took into account further differences. The first document (Temmink) gave the best chance of establishing obviousness, yet used higher dosages of trifluridine and tipiracil hydrochloride and even taught away from using a lower dosage. While the higher dosage ranges in Temmink would be within the common general knowledge of a person skilled in the art, the Assistant Commissioner found that it would not be obvious to a person skilled in the art to use the dosage range given for those active ingredients in claim 1.
While Temmink did not disclose the use of irinotecan hydrochloride hydrate with the other active ingredients mentioned therein, it did indicate that combining irinotecan hydrochloride hydrate with the disclosed active ingredients could be worth trying. The examiner considered that to provide a realistic expectation of success for the combination of the three active ingredients claimed in Taiho’s application. However, the Assistant Commissioner rejected that contention, holding that Temmink did no more than speculate on the combination as it contained no studies of the effect of using the combination. At best it provided a motivation to try the combination, but even then the Assistant Commissioner considered that establishing the dosages would require some degree of inventiveness, especially in light of dosages being used that are lower than what would be common general knowledge for the person skilled in the art. Consequently the obviousness ground was rejected.
The examiner had raised a double patenting objection in relation to a granted patent also in the name of Taiho having the same priority and international filing dates and having very similar claims. Despite the similarities the Assistant Commissioner noted that the regulation 82 prohibition on double patenting does not apply as the patents are not linked in the parent – divisional relationship required by regulation 82. Nonetheless, the Assistant Commissioner noted from the precedential UK case Dreyfus’ Applications (1927) 44 RPC 291 that where an applicant has two applications having the same priority date directed towards the same invention only one of the applications will be allowed to proceed to grant. However, after comparing the claims, the Assistant Commissioner concluded that there is no double patenting as neither the patent nor the application claims matter falling wholly within the scope of the other. In particular, claim 1 of the granted patent includes an administration schedule and has a higher dosage range for irinotecan hydrochloride hydrate that does not fully contain the range for that active ingredient in the application.
Iraq Joining PCT
From 30th April 2022 Iraq (IQ) will be bound by the PCT. Hence, international applications filed on or after 30th April 2022 will automatically designate Iraq.
China Joining Hague Agreement
From 5th May 2022 China (CN) will be bound by the Hague Agreement. Hence, international applications filed on or after 5th May 2022 will allow China to be designated. Designation of China does not also designate Hong Kong or Macao, as design protection needs to be applied for directly for those special administrative regions.
China will bring the number of countries that can be designated via a Hague Agreement application to 94. While Australia and New Zealand are not currently members of the Hague Agreement, their respective Free Trade Agreement negotiations with the EU and the UK could soon result in them joining. Australia earlier indicated that it would be more likely to join the Hague Agreement once China had.
3. Trade Marks
Recent Decision Evidences Benefit of Registering Trade Marks
In Korea Ginseng Corp v Calvin Klein Trademark Trust  NZIPOTM 1 the opponent successfully opposed an application that mainly covered services that are dissimilar to the goods that the opponent licences third parties to use its trade marks on.
In late 2018 Korea Ginseng applied for the mark CKJ in class 35 for retailing or wholesaling services relating to a wide range of goods that would fall within classes 3, 5, 29, 30, 32 and 33. This was opposed by Calvin Klein under the grounds of: likely to deceive or cause confusion (s 17(1)(a)); conflict with earlier similar registrations (s 25(1)(b)); conflict with well-known mark (s 25(1)(c)); and not the owner (s 32(1)). Calvin Klein has registrations in a wide variety of goods and services classes for the device mark shown as well as a range of other device marks with a dominant CK element in classes 3 and 25. Calvin Klein also claimed use (by way of licensing) and reputation in marks including CK, CKJ and CALVIN KLEIN JEANS particularly in relation to apparel, sunglasses, cosmetics and fragrances.
The Assistant Commissioner found much of Calvin Klein’s evidence of use or reputation to be irrelevant on account of not relating specifically to the New Zealand market and in the absence of evidence linking overseas reputation to New Zealand declined to find that spill-over reputation had been established. Nonetheless, there was sufficient evidence for establishing reputation in the CK device marks in relation to apparel, sunglasses and fragrances. Further, two stores traded under the name CALVIN KLEIN JEANS and CKJ was used in product codes for jeans and sunglasses. However, while the Assistant Commissioner held that there was sufficient reputation for these marks in relation to the products they were used on to satisfy the initial onus on the opponent under section 17(1)(a), it was held that there was insufficient reputation for section 25(1)(c) purposes.
Likelihood of Confusion:
The Assistant Commissioner found that a likelihood of confusion under the section 17(1)(a) ground was only established in relation to the retailing or wholesaling of toiletries or cosmetics as the other services were in relation to goods that were too far removed from the Calvin Klein’s goods in which reputation had been established. While Calvin Klein had not established use of CKJ in relation to its class 3 goods, its positive finding under section 17(1)(a) in relation to those goods was assisted by it being perceived as having a family of CK marks for those goods.
Conflict with Earlier Similar Registrations:
The Assistant Commissioner noted that reputation is not relevant under section 25(1)(b) as the opponent’s registrations are assumed to be used in a normal and fair manner (and that is also the case for the applicant’s mark). It was also noted from precedent that in comparing goods and services, the following factors are relevant and that there is no fundamental reason why goods cannot be similar to services, and vice versa.
- The respective uses of the respective goods or services;
- The respective users of the respective goods or services;
- The physical nature of the goods or acts of service;
- The respective trade channels through which the goods or services reach the market;
- In the case of self-serve consumer items, where in practice they are respectively found or likely to be found.
The Assistant Commissioner found the most relevant Calvin Klein registrations in relation to the services covered by Korea Ginseng’s application to be the CK device marks for retail store and related services and for dried flowers and other device marks with a dominant CK element in class 3. Of these registrations the CK device marks were found to have a moderate level of similarity to CKJ, while the other device marks were found to have low or very low similarity. Given the unchallenged scope of Calvin Klein’s CK device mark for retail store and related services, it covers all the retail services of Korea Ginseng’s application and is similar to their wholesale services. That and the moderate level of similarity to the CKJ application led the Assistant Commissioner to conclude that Korea Ginseng had not discharged its onus of showing that there would not be a reasonable likelihood of deception or confusion among a substantial number of persons if CKJ was used in a normal and fair manner.
Korea Ginseng sought to evade the consequences of the finding under section 25(1)(b) by arguing honest concurrent use. Its strongest case for this was that in the 1940’s it adopted marks with the English transliteration “Cheong-Kwan-Jang”, and claimed that the abbreviation CKJ is recognised internationally as a trade mark of theirs. However, there was no evidence from prior to their application date to support the claim that the abbreviation CKJ has trade mark status and so the concurrent use argument was rejected.
This finding was also relevant to the ‘not the owner’ ground as the earliest date that Korea Ginseng could provide basis for ownership in the CKJ mark was the application date. In 1999 Calvin Klein applied for and obtained registrations for various marks consisting of or prominently containing CKJ in classes 25, 35 and 42 on a proposed to be used basis. However, these registrations were all allowed to expire in 2006. Given the proposed to be used basis of those applications and the absence of any evidence of use the Assistant Commissioner found that Calvin Klein’s rights in those marks did not survive the expiry of the registrations.
Consequently, given the identical or substantially identical mark criterion for claiming ownership, Calvin Klein’s best claim to ownership of the CKJ mark was from the use of that mark by its licensees through online retailing in relation to jeans, tee-shirts and eyewear. There was no evidence as to whether Calvin Klein had supplied those licensees through wholesaling of those goods. Yet, even if there had been such evidence those goods or a reasonable generalisation thereof are unrelated to any of the services covered by the opposed application and so the ground of not the owner was rejected.
The opponent only had limited success on the likelihood of confusion ground and none on the not the owner ground (which has stricter criteria), but its registrations proved to be beneficial as the applicant was found to have not discharged the onus that the registrations placed on them.
Damages from Unsuccessful Copyright Claim Thwartable by Patent Assertion
In Orion Marine Ltd v Sealegs International Ltd 2021 NZHC 3207 the Judge found no unjustifiable prejudice or abuse of process in Sealegs patent infringement defence to the damages action brought against them after they lost their copyright infringement case.
As previously reported, Sealegs was unsuccessful before the Court of Appeal in their copyright action against various parties, where they alleged that the activities of those parties infringed their copyright in various aspects of their amphibious boat designs. Along with finding the works Sealegs claimed copyright in have negligible originality, the Court of Appeal held that the trial Judge wrongly strayed into the realm of patent law by extending copyright protection to functional equivalents when discounting the effect of the differences. The Supreme Court subsequently declined leave to appeal the Court of Appeal’s decision.
Prior to the trial Judge’s substantive decision Sealegs obtained interim injunctions over various parties which, as is standard, included Sealegs giving undertakings as to damages to those parties in the event no copyright infringement or threatened infringement was found. Following the Supreme Court bringing an end to the substantive proceedings the injuncted parties sought damages of over $6.8 million as well as interest and costs from Sealegs. In its defence and counterclaim Sealegs argued that any production, display or sale by Orion or the other parties would have infringed Sealegs’ patent and so no amount is owed on the undertaking. In response those parties sought to strike out Sealegs patent infringement defence for being an abuse of process as the patent infringement proceedings should have been brought with the copyright infringement proceedings. It was also asserted that Sealegs substantively abandoned its patent claim and that bringing it now would cause unjustifiable prejudice.
The Judge proceeded by considering whether Sealegs could have brought the patent action with the copyright proceedings and if so whether they should have done so, as well as whether strike out would be a justifiable limit on Sealegs ability to defend itself. After reviewing various UK and New Zealand cases, the Judge surmised that there is no hard and fast rule for abuse of process determinations, as all circumstances need to be taken into account, and that the determination of the ‘could have’ aspect does not necessitate the ‘should have’ aspect.
The evidence showed that in October 2016 Sealegs declared its intention to bring a patent infringement action. However, in December 2016 a September 2017 fixture date was set for the copyright action and Sealegs decided it was impractical to initiate and join a patent action as the other parties did not want further delay for the substantive proceedings. Further, in March 2017 Sealegs applied to amend its patent which on account of legislative and procedural considerations also would have made it impractical for a patent action to join the September 2017 fixture. The Judge considered both of Sealegs reasons for not commencing a patent action as more relevant to the ‘should have’ aspect and concluded that technically Sealegs could have commenced the patent action at the same time as the copyright action. Regarding the ‘should have’ aspect it was further noted that Sealegs declined the opportunity to include a patent infringement action in its 30th June 2017 amended statement of claim. However, the Judge held that this only meant that Sealegs should be declined leave to bring the patent action with the copyright action, not that it should be also declined leave to bring a patent action on a stand-alone basis. Consequently, it was found that Sealegs had not abandoned its patent claim. The Judge agreed that amendment of the patent made it impractical to join a patent action to the copyright action, while also noting that Sealegs amendment of its patent evidenced possible future reliance on it.
The Judge rejected the contention that on the facts of this case copyright and patent actions have considerable overlap. While the copyright infringement proceedings indirectly involved analysis of numerous integers of Sealegs’ patent, there was only some overlap rather than close resemblance. There are clear differences in copyright and patent monopolies with copyright protecting the expression, not the idea and a patent protecting the idea, not the expression. Further, findings of fact for copyright originality are not determinative of patent inventiveness and there can be different implications such as functionality detracting from copyright while being central for patents.
The Judge went on to hold that there was no absence of good faith on account of the delay in asserting the patent, and that strike out is not a justified limit on Sealegs’ right either to bring a counterclaim or to plead defences and so rejected the strike out application.