Ignorance as a Defense

July 10, 2018

thomas jefferson

Ignorantia juris non excusat – “ignorance of the law excuses not” and ignorantia legis neminem excusat – “ignorance of law excuses no one”.

This legal principle holds that a person who is unaware of a law may not escape liability for violating that law merely because one was unaware of it.

pizzaA commercial Broadcasting Authority sued ‘Pizza Slice’ for broadcasting the 2016 European football matches without obtaining a license for public showing.

The owner of the pizza shop claimed the defense of ignorance under Section 58 of the Israel Copyright Law. Somewhat surprisingly, the court accepted that he wasn’t to know that there were rights in the broadcast that prohibited public exhibition.

 


Opposition to IL 201320 to Pfizer & limits to amending the Statement of Case

July 2, 2018

Patent Application IL 201320 to Pfizer is titled “CRYSTALLINE FORMS OF 6-[2- (METHYLCARBAMOYL) PHENYLSULFANYL]-3- E -[2- (PYRIDIN2- YL] ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS”.

On allowance, it published for Opposition purposes, and Unipharm submitted an Opposition.

Prior to publication following allowance, Applicants have very wide discretionary powers to amend claims or submit new claims, provided the claimed mater is supported from the specification. After publication, in response to Oppositions, or even after grant, the Applicant/Patentee is only allowed to correct obvious typographical errors or to narrow the scope of protection by cancelling claims or by amendments that clearly narrow the scope of protection. Nothing that protects matter previously not within the ambit of the claims can be allowed.

In this instance, during the Opposition proceeding, Pfizer requested a narrowing amendment to the specification to clearly define the term ‘substantially pure’ that appears in claim 2. Commissioner Alon allowed the amendment in a ruling of 5 March 2018, and gave the parties a window to amend their Statements of Case to take the amendment into account.

Unipharm, who had already submitted their evidence, decided not to amend the statement of claims, but Pfizer submitted an amended Statement of Claims that was wide ranging.  This included background to the development of the invention and eleven appendices.

Unipharm then requested that Pfizer’s amendment be struck from the record, arguing that amendments to the claims following amendments to the specification should be based on those amendments to the specification. Pfizer disagrees. They note that the Law does NOT require that amendments to the counter-statement of claims be related to the earlier amendments to the statement of claims at the start of the Opposition proceedings, or that they be based on the amendments to the specification. Furthermore, the interim ruling allowing amendments to the statement of case did not include such limitations.

The Applicant drew a parallel to civil court proceedings, however the Commissioner does not accept this since in civil court proceedings, when the plaintiff amends his Statement of Case, he can expect the defendant to be allowed to amend their Statement of Case, whether in direct response, or to broaden their position, and this is the risk taken when amending the Statement of Case once the proceeding is underway.

In contrast, in Patent Opposition proceedings, it is the Applicant that has a right to amend the specification, not the Opposer. In this instance, it is the Applicant that causes the Statement of Case to need to be amended, and he can therefore expect that the Opposer will also amend his Statement of Case , and will not restrict himself to amendments resulting from the Applicant’s amendment. If the Opposer does amend their Statement of Claims, the Applicant can make their amendments.

So what is the appropriate Law if the Opposer does NOT amend their Statement of Case? The Commissioner reasons that the Applicant can certainly correct their Statement of Case with respect to anything that needs correcting. Whenever the specification is amended, the main points of disagreement often shift. The Opposer deciding not to amend the Statement of Claims does not prevent the Applicant from relating to new issues raised by the amendment to the Specification, and to redirect his allegations to these issues. This serves the procedure and focuses the Statement of Case on the real issues. The Commissioner considers that the term “issues arising from the amendment” should be interpreted broadly, in light of the relevant case-law.

Nevertheless, where the amendment to the Statement of Case is totally disconnected to the amendment to the specification, it becomes a regular amendment to the Statement of Case which should be subject to the regular criteria. The submission should be accompanied with a statement justifying the amendments and explaining why they could not have been included originally, and why they should be allowable. This is necessary to prevent the amendment to the Specification becoming a technical tool for allowing unlimited amendments to the Statement of Case whenever the Specification is amended.

In this instance, the amendment to the Statement of Case was the addition of background relating to the development of the XLI formulation. From Examination of the amended Statement of Claims, the Applicant did not indicate any connection, even minimal, between the amendments to the specification and the amendments to the Statement of Case. Furthermore, the Applicant did not justify why the amendment was required now, and was not part of the original Statement of Case, or why the Statement of Case was not amended earlier.

In these circumstances, the Commissioner considers that the Opposer is correct, and the amendments as submitted should not be allowed. The Applicant is given 15 days to refile an amended Statement of Case whose claims are related to the amendment to the Specification, or to state that they do not wish to file an amended Statement of Case. Alternatively, the Applicant may submit a request to amend the Statement of Claims justifying the amendments submitted.

The deadlines for submitting evidence that were given in the interim ruling of 5 March 2018 are canceled. New deadlines will be given once the Applicant files his Statement of Case.

Costs for this will be considered when ruling costs for the main ruling.

Interim ruling by Commissioner Ophir Alon Concerning Unipharm’s Opposition to IL 201320 to Pfizer


TEVA slammed with 13,000,000 Euro Pretrial Damage Estimate for At Risk Launch of generic Exforge.

July 1, 2018

Exforge is a blockbuster drug sold by Novartis for lowering blood pressure that combiexforgenes two medications in a film-coated tablet It contains amlodipine, a dihydropyridine-type calcium channel blocker, and valsartan, an angiotensin II receptor antagonist (ARB or A2RA); typically formulated as the benzenesulfonate salt.

The drug, whose patent protectiton expires on  July 9, 2019, had a world turnover in 2016 of $926 million dollars.

TEVA successfully opposed Novartis’ patent application no. IL 140665 “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION” in Israel. However, they failed in their opposition to the corresponding patent in Europe.

On  June 7, 2018, the Paris Court of  First Instance (Judge Marie Courboulay) issued a preliminary injunction against Teva’s generic version of the drug on the basis of Novartis’ European Patent EP 2 322 174. The dispute was subject to parallel proceedings in several EU countries. In fact, an injunction was issued in Gewrmany on 14 December 2017, but injunctions were refused by the courts in Spain and Switzerland. After these earlier rulings, TEVA decided not to proceed with the planned commercialization of the generic version in Austria and Finland.

0n October 16, 2017, Novartis discovered that Teva was commercializing generic versions of the pharmaceutical in France. By February 2018, Teva had cornered 42% of the market.

Novartis sued for infringement of claims 1 and 2 of EP 2 322 174, while Teva counterclaimed alleging the invalidity of the patent based on double patenting, insufficiency, extension and obviousness. In a 42-page ruling, the Court reviewed and individually rejected all of Teva’s invalidity arguments which had also been rejected in the Opposition proceedings.

One central issue related to the sufficiency of disclosure. Teva claimed lack of sufficiency since the dosages used in the clinical trials on rats were not sufficiently specified and the exact dosages to be administered to humans were unclear. The Court clarified that the patent in question does not protect a second medical indication of a known substance, but rather the combination of two known substances with known medical indication. The inventive character of the specific patent lies with the clinical superiority of the combination itself. The Court found that clinical trials on rats were sufficiently documented and that it is well-known to persons skilled in the art that the dosages administered to humans are not the same as those administered to rats.

In its ruling,  the Court ordered Teva to pay €5,846,628 to Novartis Pharma AG, the Swiss company which owns the patent, and €7,308,285 to Novartis Pharma SAS, the French licensee) as an advance on damages, prohibited further production of the generic medicines and required that Teva provide Novartis with the names and addresses of those involved in the production of the generics, information on the quantities produced, as well as to submit all relevant documentation related to the acts of infringement.


Panama Jack Cancellation Proceeding – Proving Something Did not Happen

July 1, 2018

Panama JackOn 30 November 2016 Panama Jack International Inc  filed a request to cancel Israel TM No. 79829 for Panama Jack in class 25. The registered trademark, then owned by Grupp Internacional S.A.,  is shown alongside.

Back in March 2017, the Adjudicator of Intellectual Property Ms Yaara Shoshani Caspi issued an interim ruling  that since Grupp Internacional S.A., though represented by an Israel Law firm, did not file a response to the cancellation proceedings instituted by Panama Jack International Inc., Panama Jack can supply their evidence and she would rule on the cancellation proceeding if the arguments were persuasive.

On 2 April 2017, Panama Jack International submitted an Affidavit from Mr Erez Drucker, director of Access (Xes? Axes? Excess?) Private Investigators, to support their allegation that the mark was not in use by Grupp. Again Grupp failed to respond, despite having legal representation back then.

On 21 August 2017, Panama Jack International requested a decision despite the lack of response.  On 28 March 2018 they requested to add a further Affidavit, this time from Mr Ronen Menashe, director of “”Information Services of Israel”.  Again, the owner failed to respond.

(On 2 October 2017, Grupp’s attorneys requested to cease representing their client for various reasons that Ms Shoshani Caspi considers justified. On 10 October 2017 they submitted an affidavit to the effect that the client’s local attorney in Spain knew about the hearing. On 23 October 2017, Ms Shoshani Caspi assented to the request).

Now, on 23 May 2018, a hearing was held before Ms Shoshani Caspi, which Grupp and their representatives did not bother attending, despite knowing about the date thereof. Panama Jack International requested to withdraw the Affidavit by Mr Erez Drucker and to replace it with that of Mr Ronen Menashe who was available for questioning at the hearing. This request was granted. During the hearing, a recording of conversations between Mr Menashe and the Spanish office that was referred to in the Affidavit was also listened to.

Discussion and Ruling

The question in this instance is whether there is justification to cancel the issued mark. Section 41(a) of the Trademark Ordinance states:

  1. [a] Without prejudice to the generality of the provision of indicate sections 38 to 40, application for the cancellation of the Registration Madrid of a trade mark regarding some or all of the goods or classes of amendments goods in respect of which a trade mark is registered (hereinafter – goods regarding which the cancellation is requested) may be made by any person interested on the ground that there was no bona fide intention to use the trade mark in connection with the goods for which it is registered in connection with the goods regarding which there is a request to cancel the registration and that there has in fact been no bona fide use of the trade mark in connection with those goods in connection with the goods regarding which there is a request to cancel the registration, or that there had not been any such use during the three years preceding the application for cancellation. [b] The provisions of subsection (a) shall not apply where it is proved

Thus the relevant period regarding usage of the mark by Grupp is from 30 November 2013 to 30 November 2016 when the cancellation request was submitted.

In this instance, as stated above, the mark owner failed to respond to the cancellation request, and did not even request extensions. Panama Jack International, did however, submit their evidence.

During the hearing, Mr Menashe’s integrity was examined and from his evidence and responses, Ms Shoshani Caspi was assured that he was trustworthy. Mr Menashe’s opinion included a survey and investigation of the relevant markets in Israel (i.e. clothing and footwear) in an attempt to find stores that sold goods bearing the Panana Jack man in the relevant time-period. In addition, his office searched the Internet for evidence that goods bearing  the mark were available in Israel at the relevant time. He determined who owned the mark and the identities of the leading employees of the company to contact them directly to determine usage of the mark in Israel. Within the framework of Mr Menashe’s investigation, neither he nor his investigators found any indication of sale of goods under the Panama Jack trademark in the relevant time period.

It is established case-law that a registered trademark is a property right for all intents and purposes, that cannot be whittled away without cause. The burden of proof that a mark was not used lies with the challenger of the mark. See for example, Bagatz 476/82 Orlogd ltd vs. the Commissioner of Patents p.d. 39 (2) 148. During a proceeding, the burden of proof passes back and forth. Thus the requester for cancellation of a mark has to bring evidence that a mark is not in use. If this is proven, the burden of proof then falls on the mark owner to attack the challenger’s evidence and to establish that the mark is indeed in use.

The challenger has more than met the initial level of proof required to establish a prima facie case that the mark is not in use, and the mark owner failed to even attempt to rebut this position, and thus the apparent lack of use remains unchallenged.   The Adjudicator considers the evidence that the mark has not been in use for three years prior to filing the cancellation submission and thus it is fitting to cancel the mark.

In light of the above and in like of claims made at the hearing, it is clear that the mark owner has intentionally ignored the challenge to the mark and the cancellation proceedings submitted to the Israel Patent and Trademark Office.  In addition to concluding a lack of usage, one can only conclude that the mark owner is simply holding the mark for no purpose. One would expect the mark owner to acknowledge and respond to the cancellation proceedings by abandoning the mark, thereby rendering this proceeding unnecessary.

The mark is therefore cancelled. Using her authority under Section 69 of the Ordinance, Ms Shoshani Caspi has also issued relevant costs in the proceeding, based on the work done by the challenger, and rules 9000 Shekels costs, which the mark owner is informed of via the address in the register.


The Admissibility of Late Submitted Evidence

July 1, 2018

Competing Marks Proceeding – DMI Dental Supplies vs. DMI Innovative Medic al Technologies ltd.

Where there are two competing pending trademark applications in Israel, unless the parties can agree to co-exist under conditions acceptable to the Israel Patent and Trademark Office (i.e. not confusing to the public), a special proceeding occurs under Section 29 of the Trademark  Ordinance 1972, to determine which application should be examined first, usually barring the other application from registration. The first to file is considered less important than the usage of the mark and the investment in promoting it. As always, inequitable behaviour trumps other considerations, and where proven, the mark of the guilty party is generally cancelled.

This interim ruling focuses on admissibility of late submitted evidence.

On 15 April 2018 there was proceeding under Section 29a of the Trademark Ordinance 1972 during which DMI Dental Supplies was ordered to produce an audited financial statement for 2017 showing sales of the company in Israel.

On 15 May 2018, DMI Dental Supplies submitted the document together with additional documentation not requested, including a balance sheet, profit and loss account and explanations.

The same day, DMI Dental Supplies submitted an urgent request to add further evidence. The evidence in question was a short statement from Mr Zaza Debershvilli that attempted to establish that the name was registered since 2012. This was appended to the Affidavit of Mr Alon, a witness for DMI Dental Supplies whose Affidavit was already on file. The affidavit itself was appended to the request to allow its submission.

On 21 May 2018, DMI Innovative Medic al Technologies ltd requested that this additional submission be removed from the file, or they be allowed to submit their balance sheet. Prior to obtaining permission, DMI Innovative Medic al Technologies ltd simply submitted their balance sheet.  DMI Innovative Medic al Technologies ltd opposed the additional submissions from DMI Dental Supplies claiming that they were attempting to strengthen their position and this was not allowable at that stage of the proceeding. Simultaneously they claimed that the additional evidence did not add anything new, and that its submission was acceptable if given negligible evidentiary weight as an affidavit that is not cross-examined, and that costs be awarded to them.

On 28 May 2018, DMI Dental Supplies responded to DMI Innovative Medic al Technologies ltd, objecting to the awarding of costs for the additional submission. Furthermore, they argued that since DMI Innovative Medical Technologies ltd’s balance sheet was not audited, it could not be considered as evidence, particularly as it related to foreign entity that was not a party to the proceeding.

Section 41 of the Trademark Ordinance 1940 states:

No party may submit additional evidence in any hearing before the Commissioner, however the Commissioner may, at any time permit the Applicant or Opposer to submit any evidence under conditions that he considers appropriate, regarding costs or other matters.

In general, parties should submit all their evidence in one go, and not in a trickle (Appeal 579/90 Rozin vs. Bin Nun, p/d/ 46(3) 738, 742 (1992), and Zusman, Civil procedures 509-510, 7th edition, 1995. Whilst it is true that the court can accept additional evidence during the proceeding and even during summations, (Appeal Shenzer vs. Rivlin, p.d. 45(2) 89, 95 (1991) and even during Appeal (Shenzer 95. Regulation 457 of the Civil Court Procedure Regulations, 1984).

Together with this, the court has to be very wary and careful when exercising this discretion “and in general should be careful to follow civil procedures, including the submission of evidence at the appropriate time” (Shenzer, page 95). The rationale for this principle is general efficiency of the handling of the case and of the court system in general.

There are four criteria to allow the submission of evidence at a different stage than that specified in the Civil Court Procedures:

  1. The most important is the importance of the evidence to ensure that justice is dispensed. This requires consideration of the new evidence in deciding the case, and the weight given to it, since it was not timely submitted.
  2. The amount of damage (evidentiary and with regard to the hearing) that would be caused to the opposing party if the evidence is accepted, which would alter the balance between the parties.
  3. The reasons why the evidence was not timely submitted and the responsibility of the submitting party for the lateness of the submission and whether they can be considered as acting inequitably by withholding the evidence until its late submission. (see Appeal Shasha Securities ltd vs. Adanim Mortgages and Loans ltd. p.d. 42(1) 14, 18)
  4. The damage to the effective management of the proceeding (re Rozin, page 743).

Applying these principles to the present case leads to the decision not to allow either party to submit additional evidence regarding the extent of their sales, since she does not consider that the evidence helps determine making a correct ruling or uncovering the truth. The deadline for the timely submission of evidence has passed, and neither party provided justification for their late submissions.  The evidence has been heard and the parties should be making their summations.

Ms Shoshani Caspi is less than enamoured with the behaviour of the parties, who chose to submit their additional evidence without waiting for authorization to do so. It is well-known that one should only submit late evidence after receiving authorization. Submitting the evidence together with the request does not accord with the Supreme Court ruling in Appeal 6658/09 Multilock ltd. vs Rav Bareakh ltd, 12 January 20110 on page 11 paragraph 12:

Until there is a judicial ruling allowing submission of additional evidence, a party to a proceeding is not allowed to relate to that evidence in his claims. Under the guidance 1/92 published by the Chief Justice, a request to submit additional evidence should “describe the purpose of the evidence without attaching it (section 1 of the guidance). This guideline attempts to strike a balance between the requirement not to expose the court to the additional evidence prior to being authorized to do so, and the need for the court to have an understanding of the nature of the evidence in order to consider whether it is relevant and significant.

As to the additional affidavit that DMI Dental Supplies wished to submit, Ms Shoshani Caspi considers that it should be allowed, despite it being submitted prior to receiving authorization. This is since DMI Innovative Medic al Technologies clearly stated that they do not object to its submission. However, DMI Innovative Medic al Technologies are correct that it should be given little weight since they cannot cross-examine the witness. However, she does not agree that DMI Innovative Medic al Technologies should be allowed to continue to cross-examine, as the new evidence does not add anything new. Since DMI Innovative Medic al Technologies did have to relate to the new evidence, they are indeed entitled to costs.

In conclusion, DMI Dental Supplies cannot submit the new material. DMI Innovative Medical Technologies are not allowed to submit their balance sheet.  DMI Dental Supplies can submit their Affidavit and costs of 350 Shekels (just under $100) are ruled to DMI Innovative Medic al Technologies.

The period for submitting summations starts today, 29th May 2018.

Interim ruling by Ms Shoshani Caspi re DMI competing marks proceeding, 29 May 2018.


Protecting Extrusion Profiles by Design Registration has Gotten Tougher

June 29, 2018

Building products sold by length, such as aluminum profiles used for window frames creates a problem. Leading manufacturers in this competitive market want to mark their products to discourage customers purchasing cheaper alternatives. Quite apart from the fact that end users do not generally want makers’ marks conspicuously showing on their window frames, such marks have to be stamped on which is time consuming. 

In the past, Adv. Adi Levit, then of Seligsohn et Gavrieli representing Klil, a leading aluminum profile manufacturer, created a new solution; registering profiles as design applications.

Strictly speaking, this could have been viewed as manipulating the system since most of the elements of the profile are strictly functional. Elements that are not viewable in the finished product when installed are not really design elements, and extruded scratch marks are more correctly trademarks, but often lack the inherent user recognition to be registered as such.

Strictly speaking, this could have been viewed as manipulating the system since most of the elements of the profile are strictly functional. Elements that are not viewable in the finished product when installed are not really design elements, and extruded scratch marks are more correctly trademarks, but often lack the inherent user recognition to be registered as such.

The Deputy Commissioner Jacqueline Bracha has now revisited this somewhat specialist issue. The name of applicant, representative and details of the design application number have been withheld so this case can be referenced as Ruling re Design XXX to Applicant YYY represented by ZZZ, by Jacqueline Bracha, 27 May 2018. The pictures used to illustrate this write-up are just that, pictures. They may or may not represent the product ruled on here.

Prosecution History

This ruling concerns a couple of design applications submitted on 1 Feb 2016 and 17 March 2016 respectively, both for profiles. The first Application was examined on 20 April 2016, and the Examiner considered them lacking in novelty in light of earlier registered designs of the same Applicant and thus registration was prohibited by Section 30(1) of the Patent and Design Ordinance 1924. The second application was examined on 14 June 2016 and a similar Objection was raised.

window frame 2

On 7 June 2016, representatives of the Applicant met the Examiner and the Head of the Trademark Department with the intent to persuade them otherwise, based on the differences between the application and the registered design as viewed. The Applicant argued that the differences were more than the similarities, and were not purely functional. The Applicant showed examples of window frames made from both the registered and the new profiles to emphasize the difference between them. At the end of the meeting, the Applicant was invited to submit their claims regarding each application in writing, emphasizing the differences.

On 21 July 2016, the Applicant responded to the Office Actions and emphasized the differences, referring to the drawings.

There were several further rounds of correspondence between the Applicant and the Examiner, during which the Applicant was requested to provide images of the finished product [presumably the window frame – MF]. The main difference that the Applicant noted, was that the new Applications show a ‘clean’ window frame, whereas the previously registered ones have a ‘rustic’ look, since the slot running along the front surface of the profile was removed.

On 20 April 2017, the Applications were rejected. Hence the appeal before the Deputy Commissioner.

It is emphasized that Design Application No. WWW had successfully been registered, despite the similarities to other registered profiles since the Examiner was persuaded that the differences were significant. It is noted that also in this case, the differences are on the front of the profile, which creates a new impression due to the lack of the slot.

The Applicant submits that the Examiner should have registered the design applications since other designs in the same series have been registered. Furthermore, all the designs in the series could be registered as a system.

The Deputy Commissioner notes that to the extent that other designs were erroneously registered, this does not oblige the Patent, Design and Trademark Office to repeat that mistake. See for example Appeal 66183/06/11 Shmuelovich  vs. State of Israel, 26 October 2014.

The Authority can change its ruling from a decision given in error and is not obliged to repeat that error.

It will be noted that the Registrar of Designs is NOT authorized to cancel a registration unless a third party requests cancellation based on a prior art publication –Appeal 733/95 Arpel Aluminium ltd vs. Klil Industries ltd, 51(3) 577. Thus even if Ms Bracha decides that the current designs should not be registered, and if this implies that previously registered designs were allowed in error, that does not authorize her to rule that such previously registered designs  should be cancelled. In light of this, Ms Bracha refrained from opining on how this decision affects previously registered designs.

The Applicant’s Claims

extrusion profiles

Miscellaneous extrusion profiles

The Applicant claims that there is room to allow the registration of the series of designs as a system application, since the profiles will be purchased together to assemble a finished article, such as a window. The Applicant submits that this assertion conforms to previous patent office rulings.

As to the registration of the designs, the Applicant submits that there are significant differences in form between the previously registered designs and that of the current application.  These include both elements on the visible surfaces of the installed frame, and indentations and slots that are not visible in the finished window, and that the new designs presents a clean modern line, whereas the registered designs present a more rustic appearance. The slot [could be indentation. some sort of depressed feature is indented –MF] along the front face has been cancelled, and this creates a purposefully different appearance. Furthermore, this results in additional differences in other parts of the profile.

The Applicant further claims that in light of the similarities between the inner lines of the design, they are registerable with a declaration of novelty regarding the front surface. Furthermore, the relevant ‘eye’ is that of the end user and the architect, and thus it is the visible surface of the installed window frame that matters.

RULING

Section 30(1) of the Patent and Trademark Ordinance 1924 sets out the conditions for design registration as follows:

(1) The registrar may on the application made in the prescribed form and manner of any person claiming to be the proprietor of any new or original design not previously published in Israel register the design under this Part.

The main question in this instance, is whether, under the Ordinance, the applied-for designs are new with respect to the registered designs. In other words, are the changes that the Applicant proposes sufficient to establish novelty or not?

There is established case-law that requires that when making the comparison between products, or a design Application and the prior art, the design should be considered in its entirety, but with an emphasis on the features that draw the eye,  However, functional elements should not be considered . Thus the similarity in the functional elements does not hinder registration, but the differences do not help either (see Russell-Clarke and Howe on Industrial Designs, 8th Ed., p. 146 (2010). See also the ruling regarding design applications 50200, 50202, 50519, 50902 and 60909 to Victualic Company, 12 February 2012.

These considerations are the result of the intention that design registration protects new forms of desirable objects that attract the eye of the consumer, as ruled in Appeal 7125/98 Mipromal Industries Jerusalem vs. Klil Industries p. d. 57(3) 702, , 8 May 2003, on pages 710-711 of Judge Rivlin’s ruling:

The design registration is intended to provide protection for novel forms of products. The protection is intended to protect the individual’s interest, but also that of the public by encouraging the development of new or original aesthetic designs. The protection is given for the unique form of the product, as the eye discerns it…the form should draw the eye of the relevant consumer in a manner that influences his choice of a specific product. Together with this, in addition to the positive requirement of drawing the eye, protection is not available – due to the end of the clause – for articles that are fully functional, i.e. having purely functional forms.

….

Given this general rule, one has to consider whether the differences are sufficient and, in this regard, it is not the number of differences that matters, but the effect of them taken together.

However, minor differences need to be significant and not merely minor differences that are known in the relevant industry.

As a rule, the design should have a form or decoration that is substantially different from that known previously, and minor differences as generally accepted in industry are not sufficient to render a design novel or original under the ordinance. See Seligsohn, The foundations of Copyright, Trademarks and Designs, page 196.

Application of these general rules to this instance leads the Deputy Commissioner to conclude that the present applications cannot be registered. The differences that the Applicant points to boil down to the removal of a slot on the front face of the assembled frame. The other differences are simply the result of the cancelling of this slot.

window frame

The Applicant’s claim that the relevant eye is that of the customer or the architect does not help since, if this was the case, there would be no point registering the hidden surfaces [typically the section through the profile – MF] but only the form of the finished window. However, the Applicant has registered hundreds of profiles that include internal cavities and inner surfaces that are not visible in the assembled and installed frame, and many of them claim novelty for the inner parts.

Windows-frames

Even if she were to accept the Applicant’s position that the current applications be considered, unlike in the past, only with regard to the visible surface of the assembled and installed window frame, the Deputy Commissioner ruled that a smooth frame without any extruded protrusions or indentations is not new. Although the cited frames did not have a clean front surface, such a front surface is known in other extrusion profiles for frames.

In other words, when considering the profile as a whole, it is insufficient to refer to differences that exist in the concealed parts of the product and on the front face. These differences are trivial and do not impart novelty to the design. As to the front surface alone, the appearance is regular and accepted in the industry. It is noted that if the Applicant desires to be examined on the front face alone, the remaining sections should have been disclaimed with dashed lines. By not doing so, the Applicant has indicated that the concealed parts are integral to the design and the extrusion should be considered in view of its cross-section under Section 2 of the Ordinance.

Not only the Applicant considers that the profile is the complete article, but the Supreme Court in re Klil held this and accepted the finding of the District Court and ruled that:

In this instance, the District Court held that the correct comparison between the products has to be by comparing the profiles as sold – as six meter long extrusions, piled up on shelves such that the customer can see the section – and not as they appear when joined with other elements and installed. In consequence, it is insufficient to consider only the external appearance of the profile, as they appear to the final customer, rather one has to consider the similarities prior to assembly, from all angles, including the section.

Similar to the Court of First Instance, I also hold that the differences indicated are insufficient to rule out infringement, since the general impact of the appearance of the section and the visible surfaces leads one to conclude that the new profile is a blatant copy of the registered design. When applying the appearance test it is insufficient to go into the minor aspects of the design and there is no need to examine the product with a magnifying glass to determine the differences. As the District Court found, the profiles have the same slots, protrusions and indentations, and similar dimensions. The differences noted are insufficient to be memorable and so the District Court seems to be correct that the relevant consumer is likely to confuse the profiles, particularly where he comes across them separately. It is noted that the District Court determined as a matter of fact that shelf fillers do not necessarily pile up these profiles in adjacent piles.

Since the Israel Supreme Court has ruled on how profiles are to be considered under the Patent and Design Ordinance, the Deputy Commissioner did not see herself as having the freedom to dissent from their determination. However, she noted that it is possible that with the entry into force of the Design Law 2017, it may be appropriate to reconsider the appropriateness of this case-law with respect to registered designs.

The Design Law draws inspiration from the European legislation COUNCIL REGULATION (EC) No 6/2002 of 12 December 2001 on Community designs and the basic definitions of the design and product in the (new) Law are taken from it – see the words of explanation of the new law from 6 July 2015).

The term product (מוצר) [perhaps literally object of manufacture] replaces the [archaic] term חפץ [desirable in the sense of a product, chattel?] that appears in Section 2 of the Ordinance, and is similar to the term that appears in the European legislation. The definition reflects, inter alia, the changes in technology since the Ordinance was legislated.

The term ‘design’ replaces the term ‘example’ that appears in the Ordinance. The term is not intended to widen or narrow the scope of protection that the law provides. The new term implies, inter alia, the technological changes that have occurred since the ordinance was legislated. The definition is the same as that found in the European Law, and emphasizes that the design is the general appearance of the object or a part of it, that consists of its visual elements.

It is noteworthy that in 2014, the European Office for Trademarks and Designs (then the OHIM and now the EUIPO) by which the majority of the elements of a profile are not registerable as a design, appear from the front face and marks thereon:

“As far as understood from the submission of the Holder technology driven features and mechanical fittings form up to 95% of the design of the profile, and the only features in which the competing products may differ, are those indicated in its submission, i.e. curving of the walls and the marker. In other words, all essential features, 95% of the appearance of the profile, fall in the exclusion pursuant to Articles 8(1) and (2) CDR. Should it be the case, the design has to be excluded from the protection as it does not fulfill the requirements of protection of a Community design. (ALUPROF S.A. v. ALU SYSTEM PLUS JJM KUCHARSCY [2013] OHIM)

The European Trademark and Design Office recently affirmed this ruling in re INDECO INDECO S.A v. BONARI Sp. z o.o. [2017] p.5 EUIPO (published by Darts IP).

The Deputy Commissioner considers that this sheds light on the question raised by the Applicant as to whether the profiles can be registered as systems of manufacturables under regulation 5 of the Design Regulations 1926, which will be replaced by Section 1 of the Law when it comes into effect.

The condition for registering manufacturables as a system under the Law, is that “the visual differences are trivial.” If we consider the appearance of an extrusion profile from all sides, including internal elements, and relate to the differences between the projections, protrusions, slots, as significant and important differences, then any differences in such protrusions and slots, even those required for coupling the different elements together,  would be sufficient to prevent them from being registered together. However, if the profile is examined ONLY from the outer face visible to someone looking at a window or door frame, all the profiles that link together to create the door frame could be registered as a system since they would then have identical appearances, or only insignificant differences.

That said, since there was no request to register the profiles as such a system in this case, and since she had determined that the designs are not new, the Deputy Commissioner did not see herself required to address this question under the current law.

In conclusion, the application for registration is rejected.

Ruling re Design XXX to Applicant YYY represented by ZZZ, by Jacqueline Bracha, 27 May 2018.

COMMENT

We note, without enthusiasm, that the Deputy Commissioner has asserted the existence of flat front faces of extrusions in the prior art. We think that that this is unworthy without referencing at least one example – not necessarily from the register and not necessarily manufactured by the Applicant whose name was withheld from the ruling.

Without images available, it is very difficult to truly appreciate the differences between the profiles, but the lack of a slot running along the visible surface does create a smooth frame lacking all distinguishing features so it seems reasonable to conclude that this is not new and cannot be registered. I tried to argue a case for registering a gabled beverage carton lacking the standard screw topped spout but featuring a score line along the roof and ridge for easier formation of a spout for pouring. I was unsuccessful, and it is comforting to see that other Attorneys are having similar difficulty registering variants of previous designs. However, Israel does not have a petty patent system. Arguably there is a need to prevent objects of manufacture being immediately copied by competitors such that customers cannot tell where their product originates.

There has recently been a sea change in the registerability of designs in Israel. The Ordinance is archaic and only requires absolute local novelty. Examination was more based on formalities and less on substance. However, what the Israel Design Examiners are now doing is to look for some sort of design step and not merely for absolute novelty.  In my opinion this places the bar for registerability too high. It should be possible to register unique items of manufacture that may be near variants of previously existing designs, combining different features known from different competing products. In many jurisdictions registration is just that; there is no substantive examination for novelty, but merely a comparison of the various views for internal consistency. That said, the current decision is in line with other recent rulings, both published ones and rejections I’ve had from Examiners based on the differences between the application and the prior art being insufficient to provide novelty and originality.

I have a few local clients that register designs in 10 or 12 jurisdictions and in my experience the leading jurisdictions generally do not seem to conduct substantive examination but rather a formalities based one for internal consistency, appropriate classification and so on. However, the standards are not consistent across jurisdictions. Dashed lines are treated differently, disclaiming is possible in some countries but not in others. Where an object folds, the folded and unfolded configurations are sometimes considered one design and sometimes two. In Israel, there is a circular that states that products having open and closed configurations should be shown closed and in one open position. I can see the value in standardization of registration, but some products cannot reasonably be described in only two configurations, or it is impossible to understand how it morphs from one form to another without intermediate views. I’ve found that the Israel Design Examiners slavishly follow such circulars whereas I think they should provide guidelines that can be ignored where the essence of the product requires more than two configurations to be shown.

Anyway, this ruling is significant, and correctly does away with profile protection by design, by showing cross-sections that include internal features that are not visible on the installed product, and features that are concealed when the extruded section is installed. Such design registration was well-established but was somewhat dodgy. It’s become more difficult.

By way of comparison, this link relates to a decision for window seals that illustrates the former practice of the Patent Office. Clearly, things have changed.


New Patent Commissioner overturns Patent Term Extension decision by Predecessor

June 28, 2018

Manufacturers_Association_of_Israel.pngThe Manufacturers Association of Israel opposed an ex-partes decision to allow a patent term extension for Dexlansoprazole, and New Commissioner Ofer Alon has disallowed the extension accepted by his predecessor.

Background

Dexlansoprazole.pngDexlansoprazole is used for treating gastro-reflux and for treating or preventing digestive ulcers.

IL 145996 to Takeda is a patent for Dexlansoprazole that claims various crystalline forms of the salt, a pharmaceutical preparation including the forms, and methods of treatment or prevention of digestive ulcers.

After Takeda successfully obtained regulatory approval for Dexilant™. (Dexlansoprazole) which is the R enantiomer of Lansoprazole, they applied for a patent term extension, which was refused by the Deputy Chief Examiner on 30 June 2016 on the grounds that the registration of Dexlansoprazole is not the first approved medical usage of the active ingredient in Israel, as the racemic mixture of the same active ingredient (Lansoprazole) is already registered.

Left and right antiomers in a lattice arrangement.jpg

Racemic Lattice for Shoes

In a response filed on 28 August 2016, the Applicant acknowledged that the racemic mixture Lansoprazole includes the R-enantiomer Dexlansoprazole, but the R-enantiomer cannot be separated from the racemic mixture since the crystals themselves contain both the right and the left enantiomers within the same lattice, creating a new complex that is different from the separate enantiomers.

The Applicant submitted that previously registered Lansoprazole is thus not a racemic mixture but rather a racemic compound and consequently the Dexlansoprazole crystals are substantially different from those of Lansoprazole and should, therefore, be registerable.

The Applicant distinguishes between racemic mixtures and racemic compounds with reference to Mitchell AG, Racemic drugs: Racemic Mixture, Racemic Compound, or Pseudoracemate? J. Pharm Pharmaceut Sci 1(1):8-12, 1998).

Dexasportshoe Lattice Arrangement

Dexasportshoe Crystalline Structure

On 27 October 2016, the Deputy Chief Examiner understood the argument as stressing that the enantiomer is more efficacious than the racemic mixture and rejected the request for the patent term extension citing former Commissioner Meir Noam’s ruling concerning Unipharm’s opposition to IL 90465 to A/S Lundbeck (3 February 2009), which ruled that the higher efficacy of enantiomer with respect to the racemic mixture was patent worthy, but did not provide a new material in the sense required for a basic patent that is eligible for patent term extensions.

On 24 November 2016, the Applicant appealed this decision to the Commissioner of Patents, reiterating the arguments that were rejected. Then Commissioner Asa Kling accepted that the enantiomer was not found in the racemic compound and agreed to a patent term extension of 959 days until 30 January 2023 (see ruling re IL 145996 to Takeda from 12 Feb 2017:

In paragraphs 24 to 26 of his decision, then Commissioner Kling stated:

I have been convinced that Lansoprazole is a compound of the enantiomers and it is not possible to isolate Dexlansoprazole from the racemic compound, in contradistinction to the state of affairs in Unipharm vs. Lundbeck where the racemic mixture could be separated into the enantiomers.

Where the relative efficacy is different, Applicants assertion that Lansoprazole is NOT a racemic mixture but rather that the enantiomers share the crystalline structure, one cannot isolate the R enantiomer.

Opposer’s Argument

On 25 May 2017, the Association of Israeli Industrialists opposed the ex-partes decision to issue a patent term extension, based on Section 64g(a) of the Israel Patent Law 1967 for the following reasons:

  • the registration in the register of medical formulations which was the basis for the patent term extension was not the first registration for the active ingredient, contrary to Section 6d(3) of the Law.
  • The Applicant concealed significant relevant facts from the Patent Office. So the Application for a Patent Term Extension is contaminated with inequitable behaviour and is contrary to Section 64b(1) of the Law.

These claims were supported by an expert opinion from Professor Menachem Kaftori dated 24 May 2017.

The Opposer relies on the Lundbeck ruling (Appeal 223/09 Lundbeck vs. Unipharm ltd from 25 May 2009 which asserted that the various terms for material in Section 64a include enantiomers, and wherever the material is an active ingredient or form of the active ingredient that is found in a prior medical formulation that is listed in the register, it cannot be considered as being a first registration under Section 64d(3) of the Law.

The Opposer further alleged that the applicant had already acknowledged that the active ingredient Dexlanoprazole is included in the racemic Lansoprazole in the pharmacology report for Kapidex in a request to market a formulation including Dexlansoprazole in the US (NDA 22,287) which was appended to the ex-partes submission.

Based on Professor Kaftori’s opinion, the Opposer further alleged that coupling between the different molecules in the crystal were inter-molecular bonds and not intra-molecular bonds, so that on dissolution into water a racemic mixture of the enantiomers results.

DexilantThe active ingredient of Dexilant™ is Dexlanoprazole and not the crystal, and the morphological structure of the crystal has no relevance to the issue of patent term extensions. The racemic compound is no different to a racemic mixture as has as the difference between its components, apart from the crystal structure of the raceme. The inclusivity of the re Lundbeck decision does not relate to the isolation of the material by separating the basic cell of the crystalline structure whilst in a solid state, but to the possibility of any separation.

The Opposer further argues that the efficacy of the enantiomers when considered separately or as part of the racemic mixture is not relevant to the question of whether the application in question relates to the first formulation that allows the material to be used for medical purposes in Israel.

LansopropazoleThe Opposer further claims that the Applicant concealed the fact that the material was previously registered in the Lansoprazole registration, and the experimental evidence used to justify the registration were those using Lansoprazole which the Applicant had asked to be relied upon. Similarly, the Applicant had concealed the fact that Lansoprazole had been defined by themselves as being a racemic mixture and not, as they now claimed, a racemic compound, for example, before the Canadian Federal Court of Appeal.

Applicant’s Argument

Takeda reiterated the arguments submitted in the ex-partes hearing by former Commissioner Kling, his ruling of 12 February 2017, and an Opinion of Professor Avi Bino of 19 September 2017.

Furthermore, Takeda rejected the allegation of inequitable behaviour noting that the racemic material Lansoprazole was disclosed and related to in their submission for a patent term extension, and reiterated that it was a different material.

optically active.jpegFurthermore, in their response of 28 August 2016, they clarified that Lansoprazole is racemic compound that is optically active in a different manner to that of the enantiomer. The XRay diffraction pattern of Dexlansoprazole is different, and it is a different chemical entity. The Applicant further claims that the request for a Patent Term Extension is based on a registered product and not on a material after subsequently undergoing any type of process within the human body [apparently dissolution is intended – MF].

The Applicant alleged that the Opposer did not provide support for the contradiction in Mitchell’s paper, and did not provide scientific textual support, experimental evidence or research to challenge the validity of the evidence submitted by themselves in the ex-partes proceeding.

In the pharmacology submission for Kapidex which includes Dexlansoprazole there was experimental evidence relating to pregnant women which included one test conducted with Dexlansoprazole and one test conducted with Lansoprazole. Thus contrary to Opposer’s assertion Dexlansoprazole was examined, and the testing of Lansoprazole was additional data.

Although the therapeutic results themselves are insufficient to prove that a patent term extension is justified, they do teach that there is a difference between the materials that allows a patent term extension.

raceme.jpgTakeda referred to the definitions of racemic mixture, raceme and racemic compound in the IUPAC gold book which is the definitions used by the International Union of Pure and Applied Chemistry and which they claim accords with Mitchell’s paper.

Finally, Takeda submits that the Commissioner is not able to sit in judgment and rule on a ‘kind of appeal’ of his own decision, or that of his predecessor.

Discussion and Ruling

For sake of clarity, the Commissioner notes that the term raceme relates to racemic mixtures of S and R molecules in equal amounts, or to racemic compounds where there is a repeating arrangement of the two enantiomers in different proportions within a crystal,

The legal authority of the Commissioner to rule on the Opposition

legalCommissioner Alon dismisses the allegation that he cannot hear this case. Section 64f of the Law allows anybody to oppose patent term extensions or their duration. Under section 64g, ANY reason that the Commissioner should not grant a patent term extension is a valid reason for opposing the extension. The right of the Opposer is independent of whether the extension was the result of an ex-partes ruling or otherwise.

The logic is clear. In the ex-partes hearing, one side presents THEIR arguments, evidence and documentation supporting the issuance of the PTE. The opposition is an adversarial proceeding whose purpose is to allow third parties to challenge the granting of the PTE, Once an Opposition is filed, the Commissioner is obliged to consider the issues raised and to reconsider the determination that a PTE is justified in light of the claims and evidence of the parties.

Registration of Lansoprazole allowed usage of Dexlansoprazole

Section 64d of the Law sets out the conditions for obtaining a Patent Term Extension. Inter alia, it states that one can only obtain an extension for a material listed in the pharmaceutical register, and only if that registration is the first registration of the material for medical use.

It does not appear that there is any dispute between the parties regarding the following facts:

  • The crystal of the Lansoprazole raceme is a racemic compound, which is difference from the enantiomer of Dexlansoprazole (Cross-examination of Professor Kaftori page 12 lines 12-18).
  • When the raceme Lansoprazole is in a crystalline form, one cannot separate the enantiomers into Dexlansoprazole and Levolansoprazole.
  • One can separate a solution of Lansoprazole into its enantiomers by known and established procedures for separating enantiomers. (Opinion of Professor Bino, paragraphs 13-14).
  • When Lansoprazole is separated into its enantiomers one obtains the R-enantiomer Dexlansoprazole and the S enantiomer Levolansoprazole.

As to the possibility of separating the enantiomers. Under cross-examination, Opposer’s expert Professor Bino agreed:

Attorney Tal Band:  Take, let’s repeat this, take a crystal of Lansoprazole, dissolve it in water and what do you get? I suppose you will allow me…

Professor Avi Bino: With pleasure

Adv. Band: You will obtain a solution that includes the R-enantiomer

Prof Bino: the R-enantiomer and the S enantiomer

Adv. Band: and the S enantiomer, which is the active ingredient if we now know that the active ingredient is the R enantiomer? It is the R enantiomer, right?  

Prof Bino: the R-enantiomer in solution

Adv. Band: the R enantiomer I solution is the active ingredient?

Prof Bino: Correct.

Protocol of 9 January 2018, page 53 lines 17-26.

In a different stage of the cross-examination, 9 January 2018, page 46 line 6:

Attorney Tal Band:  It can, that means to say, it can dissolve into the solution…

Professor Avi Bino: Yes

Adv. Band: And this change from crystalline to solution is not a chemical change but a physical one, correct?

Prof Bino: True.

Adv. Band: Good. So in the two states the chemical compound maintains its identity, correct?

Prof Bino: Correct.

See also paragraph 60 of the Applicant’s claims from 19 September 2017 and paragraphs 9-15 of Professor Bino’s Opinion.

right hand.pngThus there is no argument that the R-enantiomer included in Dexilant™ is the same R-enantiomer included in Lansoprazole.

In the Lundbeck ruling, the District Court ruled that registration of a raceme would be considered the first registration for the enantiomers.

The Applicant considers that the Lundbeck case is different since there one could separate the enantiomers as the patent covered a racemic mixture. However, in the present instance, one cannot separate the enantiomers whilst solid, but have to dissolve them in water first, and only then can the enantiomers be separated.

To clarify the point, the Applicant submitted the following schematic illustration on 28 August 2016 to the Deputy Chief Examiner:

Lansopropazole imageThe Applicant claims that the law relates to the active ingredient of the medical formulation, which is crystalline and so should be considered in this form.

lefty.jpgIn re Lundbeck, a mixture was considered, and the unit cell of r-enantiomer structure is found in the mixture (right side) and in the enantiomer (center top), whereas in the present case, (illustrated on the left), there is no r-enantiomer unit cell so one has to dissolve the crystal and then separate and recrystallize to obtain the separate enantiomers in crystalline form.

Applicant claims that the Law relates to the active ingredient of the medical formulation. The medical formulation includes the crystalline structure, and so it should be [examined for patent term extension purposes] in this manner.

The Examiner considers that the fact that one cannot separate the R and L enantiomers whilst crystalline is irrelevant. In paragraph 17 of the District Court ruling in re Lundbeck the court differentiates between inter- molecule bonds and intra-molecular bonds.

Even if we were to accept the Applicant’s claim that the Lansoprazole is a racemic molecule, there are no intra-molecular bonds, but only bonds connecting the molecules to each other, and each enantiomer molecule maintains its identity within the crystal. The attractive forces between the S and R molecules creates the crystal by inter molecular bonds (see paragraph 18 of Professor Kaftori’s opinion and Professor Bino’s remarks on page 48 lines 6-12 of the protocol. As Commissioner Alon clarifies below, it is incorrect to consider the material at the crystalline layer, and so the R-enantiomer is NOT to be considered a new material as far as Patent Term Extensions are concerned.

If one were to consider the crystalline form of the pharmaceutical formulation as being a new material as far as Patent Term Extensions are concerned, the consequence would be that one could dissolve Lansoprazole and consider the solution as being a pharmaceutical formulation, the solution contains both enantiomers in solution would be considered as a different formulation and thus subject to a Patent Term Extension, and it is difficult to accept this result.

Furthermore, the definition of material in Section 64a of the Law is:

“Material” – the active ingredient of the medical formulation or its salt, ester, hydrate or other crystalline structures of the same component.

Commissioner Alon considers that one should read Section 64a as all the forms of the active ingredient being considered the same material. This definition implies that the identity of the material is NOT considered in terms of its form in the formulation. The case-law has ruled that the fact that different enantiomers and crystalline structures have different physical properties does not make them considered as being different materials as far as patent term extensions (PTEs) are concerned – see District Court ruling in re Lundbeck, section 20.

This interpretation sits well with the rationale of the Law as stated in the Patent Term Extension ruling concerning IL 124123 to Bayer Healthcare LLC, 16 April 2018:

With regards to active chemical ingredients, one can claim that the legislator defined enantiomers that, although not structurally identical, can be considered as being the same active ingredient, since the experiments on the active ingredient will shorten the way or help develop drugs based on the same active ingredient. So different salts of the same active ingredient are defined as being the same active ingredient with respect to Section 64D(3) of the Law (it is noted that in other jurisdictions, a different conclusion was reached).

Additionally, there is an explicit connection between the breadth of patent protection under Section 64h(d) of the Law and the interpretation of the term ‘material’. Section 64h(d) states:

  1. d) If the Registrar granted an extension order, then the holder of the basic patent may – during the period in which the extension order is in effect – prevent any person from marketing or from producing in order to market without his permission the medical equipment or the medical preparation that incorporates the material, as far as the material, the process of its production, its use or the medical preparation or the process for its production were claimed in the claims for the basic patent.

Recognizing all forms of the active ingredient as being a new material as far as Patent Term Extensions are concerned would result in Patent Term Extensions being granted, not for all forms but only for the form of the active ingredient in the medical formulation. Commissioner Alon considers that proper policy is to provide wide protection for the party developing a new drug, and recognizing the physical form of the material as being different would result in narrowing the breadth of the patent term extension.

The Applicant argues that from the ruling of former Commissioner Noam regarding the Patent Term Extension for IL 97219 Novartis AG (26 December 2005) one can conclude that two active ingredients acting together could be considered as being a new material that is different from the two ingredients considered separately.

Commissioner Kling does not agree. In re Novartis, Commissioner Noam considered the eligibility for a Patent Term Extension for a formulation including two active ingredients that were previously separately recorded in the pharmaceutical register, and concluded that even were there to be a synergetic effect and not merely an additive effect (aggregation), this is only relevant for the question of patentability but not for the question of eligibility of Patent Term Extension, nothing further is stated.

It appears that Commissioner Kling’s ruling of 12 February 2017 was largely based on the conclusion that one cannot separate the enantiomers of the racemic compound. As shown in the Opposition by the statements of case and evidence, is that the compound can be separated into its enantiomers, and that the form is not significant. In other words, the factual basis for Commissioner Kling’s ruling has been eroded and we can thus change the decision.

In light of above, Commissioner Alon rules that the R enantiomer is found in Lansoprazole and the registration of Lansoprazole is the first registration of the R-enantiomer Dexlansoprazole which is the active ingredient of Dexilant™.

The Allegation of Inequitable Behaviour

The Opposer’s allegation that Takeda’s behavior was inequitable, contrary to Section 64b(1) of the Law, is supported by two props. One is the statement appended to the request for a patent term extension that was written by Miyuki Hora which states that Dexlansoprazole is the first registration that allows the use of the product for medical purposes in Israel, without going into details, which comes later.

In addition, the Oppose claims that the Applicant concealed the fact that the examination of the request for registration in the pharmaceutical formulation register relied on tests performed on Lansoprazole, and that the Applicant itself relates to Lansoprazole as being the racemic mixture in a proceeding before the Federal Court of Appeal in Canada, and regarding the date of the claim that Lansoprazole is a racemic compound.

The Applicant’s response to these claims was that the experiments were clearly indicated in the pharmacology report mentioned above, and Commissioner Kling even related to it in his ruling of 12 February 2017. As to the Canada decision, the Applicant acknowledges that they were inaccurate in their terminology regarding mixtures and compounds, but this was due to the fact that case related to a different issue and not to something relevant to the issue of whether the Lansoprazole raceme is a compound or mixture. The same inaccuracy is found in the FDA regulatory approval in the US.

When considering Miyuki Hora’s affidavit, it is true that it relates to the Lansoprazole raceme:

“… Although racemic Lansoprazole was previously approved for medical use, enantiomerically pure Dexlansoprazole has never been approved …”.

Additionally, it seems that the Applicant themselves muddled up the terms in the definition of the raceme, and sometimes referred to it as a mixture and sometimes as a compound, however the Commissioner does not consider that this is indicative of inequitable behaviour. Furthermore, in light of the above ruling, it is irrelevant whether we refer to the raceme as a mixture or a compound, since the question of whether the molecule were previously registered exists in the raceme, which we have established to be the case.

Conclusion

In light of the above, the Commissioner accepts the Opposition and cancels the patent term extension. The Applicant will pay 15000 Shekels costs and 100,000 Shekels legal fees to the Manufacturers Association of Israel.

Opposition by the Manufacturers Association of Israel  to Patent Term Extension for IL 145996 to Takeda, ruling by Commissioner Ofir Alon, 24 May 2018  

COMMENT

I think this decision is completely correct and is also well written and whilst comprehensively addressing the issues raised, is relatively concise.

Since the racemic compound dissolves into the free molecules, the discovery that the R-enantiomer is active may be inventive, but the clam that this is a new material that warrants a patent term extension is ludicrous in light of the previous cases related to by the Commissioner and linked to above.