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.


Supreme Court Adds Sauce to Temporary Injunction

April 25, 2018

Back in February, we reported regarding a temporary injunction that Barilla obtained in the Tel Aviv District Court against Rami Levy, requiring them to remove packages of pasta that came boxed in blue boxes with cellophane windows and similar packaging to Barilla’s range of pastas.

The image above shows Rami Levy’s packaging under the Olla own-brand on the left, and the Barilla packaging on the right.

Whilst it is true that the Olla packaging does state Rami-Levy – Shivuk HaShikma (Sycamore Packaging), and the name of the pasta is written in Hebrew, it is also true that both brand-names end with the syllable and letters lla, and the fonts are italicized and slope to the right.

Rami Levy appealed the decision to the Supreme Court but Judge Solberg upheld the temporary injunction pending a full trial and ruling, and also widened it to cover pasta sauces, noting that like Barilla, Rami Levy uses glass jars with blue lids for their tomato sauces. Costs of 40,000 Shekels were awarded to Barilla for having to deal with the appeal.

Comment 

We note that Rami Levy has a further own-brand packaging for dried pasta (on the right), where Taaman (whose own packaging is blue) package their pasta for Rami Levy in cellophane bags that seem inspired by Osem’s Perfecto range (on the left) so they can simply pour out the boxes and bag in cellophane, at least until Osem sues them.

steaks

We also note that Rami Levy (on the left) recently jumped into the frying pan with minute steaks, using a packaging scheme not vastly dissimilar from Baladi’s (on the right), and that Judge Avrahami of the Petach Tikveh District Court granted a temporary injunction requiring Rami Levy to adhere a sticker that is not red, white or black to their frozen meat package of minute steaks that should be at least 11 cm by 8.5 cm, that is clearly printed and which states that the product is under Rami Levy’s own label. The sticker must not include the price or the words “Special Offer”, that could dilute the effect of differentiating between the products. The sticker is to be applied to the front of the packaging at the top, under the term “Maadaniyah” (delicatessen).

Appeal 1065/18 and 1521/18 Rami Levy vs. Barilla, 22/4/2018


Wok and Walk

April 20, 2018

wokRo.R. Sheli ltd own Israel Trademark No. 233836 for “wok and walk

The mark owner has tried to have some sections of the request for cancellation struck from the record. Sections 18 -22 claim that the registration was in bad faith and so the trademarks should be cancelled under Section 39(a1) of the ordinance 1972. According to the mark owner, it appears that in an Affidavit by Rami Lev opposing expedited examination and registration of TM Application no. 291833, it is claimed that the franchise started trading in 2004. However the owner of the mark in question registered their mark back in 2000. So the trademark owner claims that there is no grounds to accuse them of acting in bad faith since their use of the mark preceded that of the party requesting cancellation.

wok to walk

Wok to Walk Franchise oppose this request and claims that now is not the time to relate to this claim and to do so at this stage is not in accordance with the civil procedure.  Deputy Commissioner Ms Jacqueline Bracha concurs with Wok to Walk Franchise.

In civil proceedings, the right to cancellation of baseless claims is anchored in regulation 100 of the Civil Procedure Regulations 1984. The Patent Office can rely on this, see cancellation rulings regarding TM Nos. 192398, 193299, 301639, 201641, 201645, 201642, 193947, 193948 HaIr Halvanah LTD. (White City LTD vs. Biyanei HaIr HaLevanah Achzackot LTD10 November 2009.

The case law states that:

The test for whether  or not there is a basis for suing  on these grounds is whether “the plaintiff, on the assumption that the factual basis for the claim is proven, is entitled to receive the requested sanction (Civil Appeal 109//49 Engineering and Industry Company vs. Mizrach Insurance Services, p.d. 5, 1585, 1591 (1951). Cancellations of Statements of Case on the basis of lack of case should be allowed only in cases where were the plaintiff to successfully prove all the significant facts of the case, they would still not be entitled to a ruling since the statement of case does not include a legal basis for the claim that obliges the other party   (Yoel Zusman “Civil Procedure 384-385, 7th Edition, edited by Shlomo Levine, 1995). The purpose of this regulation is to prevent purposeless hearings and expenses in unnecessary human resources considering pointless claims.

In this case, the request for cancellation and the sections to be cancelled are concerned with a bad faith allegation due to the mark owner knowing about the competing mark, and registered it to prevent the franchise going international. The franchise argue that
Read the rest of this entry »


A Balanced Temporary Injunction Against Rami Levy

April 19, 2018

This case concerns ‘minute steaks’ supplied by Rami Levy – a supermarket chain in own-brand packaging that has some similarity to that of Baladi, a brand that had introduced the product to the frozen meat freezers in Israel. Baladi sued Rami Levy for passing off, copyright infringement and unjust enrichment and tried to obtain a temporary injunction against Rami Levy at what is the start of the Israel barbecue season.

steaks

This case concerns ‘minute steaks’ supplied by Rami Levy – a supermarket chain in own-brand packaging that has some similarity to that of Baladi, a brand that had introduced the product to the frozen meat freezers in Israel. Baladi sued Rami Levy for passing off, copyright infringement and unjust enrichment and tried to obtain a temporary injunction against Rami Levy at what is the start of the Israel barbecue season.

baladi minute steak

The claims of passing off and copyright infringement were considered unlikely to prevail and thus not grounds for a temporary injunction. However, Judge Avrahami saw fit to grant a temporary injunction on the grounds of unjust enrichment. Rather than have Rami Levy’s product removed from the shelves and repackaged which could result in the meat being lost, she ruled that a sticker in a contrasting colour should be attached to the packages indicating that Maadaniya was Rami Levy’s own brand. Rami Levy was also advised to work towards introducing a more different package. The parties were invited to try to settle their differences without the court having to hear the case in its

Baladi makes meat products including minute steak which are thinly sliced steak that can be roasted in a frying pan in one minute. Baladi claims to have designed the packaging that they use for minute steaks.

Rami Levi is a public company that runs supermarkets across Israel. The company stocks known brands and also sells popular products packaged for them under their own label.

Rami Levi sells Baladi products. It also sells minute steaks under their only  own label “Rami Levi’s Sycamore Marketing Delicatessen”. Rami Levi’s own label minute steaks are packaged by TBone Veal.

In a preliminary ruling, Baladi claimed that minute steaks were not sold in supermarkets until they launched this product in November 2017 with a massive and expensive sales campaign. From the launch until 19 March 2018, the product sold well due to the marketing campaign. On 19 March 2018, suddenly, without notice, Rami Levi forbade Baladi to replenish supplies and blocked the product, and instead supplied minute steaks under their own label.

baladi logo

Baladi claims that the own-label brand is packaged in a copycat package of that of their product, and that this was a calculated, organized action of Rami Levi in bad faith, to ride on Baladi’s advertising campaign and product launch, benefiting from their investment. Baladi’s campaign has drawn customers to want to purchase their product. The customers go to the meat refrigerators and find the infringing product that is a copy of their package and are misled into believing that they are purchasing Baladi’s product.

Baladi considers that the case is particularly serious since Rami Levi is a retailer that can block their product whilst offering the competing own-label product. This is particularly problematic since Rami Levi’s product launch was just before Pesach and close to Independence Day which is the start of the Israel barbecue season when sales go up significantly.

In light of the above, on 22 March 2018, Baladi sued for passing off, unfair trade practices, copyright infringement in the product package and unjust enrichment. They filed their case in the Tel Aviv and Jaffa District Court. Baladi requested a permanent injunction, compensation and production of sales data. For the purpose of assessing the court fees, Baladi assess the damages at 2,750,000 Shekels.

Baladi also requested a temporary injunction on Rami Levi to prevent them using the product sold under their private label or at least to prevent them selling the product in the packaging used at the time of filing, and to cease from blocking Baladi’s products, and to enable their products to be sold on an equal basis with other frozen meat products. The Request was supported by an affidavit from Ms Irene Feldman, the VCFO of Baladi, and was filed as an ex-partes action for immediate attention since any delay will cause irreparable damage.

El gaucho minute steak

In response, Yossi Sabato, the VCEO of Rami Levy submitted an Affidavit claiming that Baladi was acting in extreme bad faith by not telling the court that they were conducting a parallel action against El Gaucho which is a label of TBone Veal in the Central District Court as 4347-01-18. In that instance, they made similar accusations which were rejected. This action, in a different court, against a different label, was a type of forum shopping that was indicative of bad faith and should be sufficient for the case to be thrown out. This was simply an attempt to corner the market and to prevent competition. The Ex-partes actions in both the El Gaucho case and in the present instance are cynical exploitations of the legal system designed to get free publicity, and the plaintiff was suing for extreme damages without having first contacted the supermarket chain, which is itself inequitable behavior for which the case should be thrown out.

monopoly

With regards to the complaint itself, Rami Levy claims that Baladi is trying to obtain a monopoly on minute steaks, which is a term known in Israel and abroad and which they did not coin. Baladi also tried to obtain a trademark for this generic term. Minute steaks have been advertised in Israel in the past and are available in restaurants and from butchers, and even from supermarkets. Baladi has not been in the market long enough for minute steaks to be identified with them to the extent that they deserve a monopoly on the term (acquired distinctiveness), and a reputation that is protectable, and even Baladi does not claim to have rights to minute steaks but only to the sound of the name.

Rami Levy

Rami Levy claims that their product package is completely different from Baladi’s, including writing and visual elements, and there is no likelihood of confusion. Baladi advertises their product with their trade-name Baladi clearly written thereon and, in the absence of this term, there is no likelihood of confusion. Rami Levy’s private label HaMaadaniya (literally the delicatessen) is well-known to Rami Levy’s customers as a low price brand, and there is no likelihood of confusion.

“Rami Levy” is written clearly on the front and back of the packaging, and is a super brand that does not need to ride on the reputation of Baladi or anyone else. The difference in price also prevents confusion, and all Rami Levy’s own branded products are clearly sold as such in their stores, and there are loads of examples of private labels being sold alongside branded goods and the public are not misled in any way that they are purchasing something other than the own label.

boycott

As to the issue of marketing Baladi’s products in Rami Levy’s stores, Rami Levy contends that they are under no obligation by general law (in rem) or by contract (in personam) with Baladi, to purchase any of Baladi’s products, including their meat products. Baladi’s goods are available in other chains. At present, Rami Levy stores DO stock Baladi’s minute steaks but, in view of the high price that Baladi dictates for their product, Rami Levy is under no obligation to replenish stocks of something much more

In answer to Rami Levy’s response, Baladi reiterated that their issue is NOT the name ‘minute steak’, but the packaging and the product blocking. On 26 March 2018. a long hearing was held. There were many attempts to bring the parties into an understanding, and the affidavits were reviewed and the parties summarized their arguments. After the hearing the parties still refused to come to an understanding, and so there is no alternative but to reach a verdict in this instance.

Relevant Considerations Regarding Temporary Injunctions

Principles-Governing-Issuance-of-Temporary-Injunction

It is known that the party requesting a temporary injunction has to convince the Court, on the basis of apparently convincing evidence, that there is grounds for the complaint and the Court then has to balance the ease of implementing the different actions, i.e. the damage to the complainant if a temporary restriction order is not issued, vs. the damage to defendant if a temporary restriction order is issued but if it later transpires should not have been. The Court has to ascertain whether the temporary injunction was requested in good faith, and if the injunction is just and fitting in the circumstances and does not unduly damage the defendant – See Regulation 363 of the Civil Procedures Regulation 1984.

interests

The main considerations for requesting a temporary injunction are the likelihood of prevailing and the balance of interests of the two parties, but where the Court considers that the likelihood of prevailing is greater, they will be less concerned about the balance of interests, and the opposite is also true.

When deciding on a temporary injunction, the court also has Read the rest of this entry »


Cost Ruling in Moshe Lavi vs. Zach Oz – A failed attempt to get a poorly written patent canceled.

December 20, 2017

Figs for ACMoshe Lavi owns Israel Patent No. 157035 titled “MODULAR SUPPORT BRACKET” which describes  a support bracket for an air-conditioner unit. He’s tried to enforce it in the past against Zach Oz Airconditioners LTD, and the parties came to an out-of-court settlement.

Lavi then sued again, and Zach Oz countered by applying to have the patent cancelled. This attempt was unsuccessful and a ruling upholding the patent issued on 5 March 2017.

Lavi then applied for costs under Circular MN 80. According to Lavi and his attorneys, Pearl Cohen Zedek Latzer Brats, the costs incurred in fighting the Opposition were a fairly massive 526,750.058 Shekels!? We assume that there is a typo here, and the costs requested were just over half a million Shekels and not just over half a billion shekels, as that would be ridiculous even for Pearl Cohen. It seems that they charge in dollars and not Shekels, and are unaware of the need to round up to the nearest 5 agarot.

Lavi claims that he is entitled to the real costs incurred, which are reasonable, necessarily incurred and proportional in the circumstances. He accuses Zach Oz of acting in bad faith by challenging the validity of the patent. His counsel appended a list of legal counsel’s hours, invoices, and an affidavit by Moshe Lavi.

The Respondents Zach Oz, confusingly represented by an Adv. Pearl (not Zeev, even he is aware that fighting both sides of an opposition proceeding is not acceptable) claimed that the costs were unreasonable and some were unnecessary or disproportional. They also claimed that it was Moshe Lavi who acted inequitably. They note that the case-law states that costs are not meant to be a punishment, and the costs in this case were unreasonable and were incurred due to unnecessary wariness by the patentee. Furthermore, the adjudicator is supposed to take into account the public interest and importance in maintaining the integrity of the patent register. Awarding inflated costs in cases that they lose, would discourage people from challenging the validity of patents and would prevent access to legal recourse.

Ruling

The winning party is entitled to costs incurred in legal proceedings. However, the arbitrator is not obliged to rule actual costs, and is required to consider the specifics of the case and judicial policy. See paragraph 19 of Appeal 6793/08 Loar LTD vs Meshulam Levinsten Engineering and Subcontracting Ltd. 28 June 2009.

In the case-law it was ruled that for the Applicant for actual costs to prove that they are reasonable, proportional and necessary in the specific circumstances. See Bagatz 891/05 Tnuva Cooperative for Marketing Agricultural Produce in Israel Ltd. et al. vs. The Authority for granting Import licenses et al. p.d. 70(1) 600, 615 from 30 June 2005. The limitation of costs to being necessary and proportional is:

To prevent a situation wherein the costs awarded are too great, and will discourage parties from seeking justice, will create inequalities and make court proceedings unnecessarily costly, limiting access to the courts. (Appeal 2617/00 Kinneret Quarries ltd. cs. The Nazareth Ilit, Planning and Building Committee, p.d. 70(1) 600, (2005) paragraph 20.

The amount of work invested in preparing submissions, their legal and technical complexity, the stage reached in the proceedings, the behavior of the parties before the court of the patent office and with regard to opposing party, inequitable behavior of the parties, etc. All these are considerations that should be taken into account when considering “the  specifics of the case”.

In this instance, the patentee did win his case and is entitled to recoup costs, and the losing party does not dispute this. However, in this instance, the patentee is not entitled to the requested costs for reasons detailed below.

Firstly, after consideration of the case and the submissions, none of the parties appear to have acted inequitably. It is not irrelevant that neither party has related to the decisions made in this instance, including the main ruling. This is because there is no evidence of inequitable behavior by the parties. Similarly the affidavits are acceptable. In this regard, it is not reasonable to accept the patentee’s allegation that the challenge to their patent was baseless. The file wrapper shows that the challenger made a reasonable and fair attempt to show that the patent was void, based, inter alia, on prior art.

Furthermore, as to the costs requested, the adjudicator, Ms Shoshani Caspi did not think that they were reasonable, essential or proportional, as required by the Tnuva ruling.

The expert opinion of the expert who attended the hearing, costs of 29,685 Shekels including VAT were incurred. This was considered reasonable. It also appears to have been necessarily incurred. However, the Applicants did not need to use lawyers to prepare the expert opinion’s opinion for him, whilst claiming costs for him preparing his opinion as well. This is a double request for costs and should be eradicated.

In his Affidavit, Mr Lavi claimed that the challenge to his patent caused him to spend $137,901.37 including VAT. This is the 499,065.058 Shekels requested by the Applicant, excluding the expert opinion. The Affidavit explains that this sum includes his legal counsel’s work, couriers, printing, etc., however, no evidence of couriers and printing costs were given, and it appears that these incidentals were included in the invoices from his legal representative. To provide evidence for the legal costs incurred, invoices from PCZL were appended which included the hours spent by attorneys working on the case.

One cannot ignore the fact that the list of work done included demanding extensions, attempts to negotiate an out-of-court settlement, interim proceedings that the opposing party won, an appeal of the refusal to throw the case out, https://blog.ipfactor.co.il/2015/03/08/il-157035-if-one-accused-of-infringing-a-patent-does-not-challenge-its-validity-is-the-accused-estoppeled/

and other costs that are not essential and thus not reasonably chargeable to the other side.

double dipThe attempt to roll these unnecessary costs to the losing side and the double charging for the expert witness are inappropriate to use an understatement, and one assumes that these requests were made inadvertently as they were signed by educated attorneys that are well versed in the relevant legal processes.

Furthermore, after a detailed review of the file, Ms Yaara Shashani Caspi concluded that the case was relatively simple and there were neither particularly complicated legal or factual questions. Consequently, it is difficult to accept that the request for costs of 499,065.058 Shekels [sic] including VAT is reasonable, essential or proportional in the circumstances. It will be noted that as ruled in the Tnuva case (paragraph 19). The real costs that the patentee incurred is only the starting point and not the end point of the costs ruling.

It transpires that the time spent in each round was very large. For example, 65 hours was spent on a request to cancel an expert opinion, and 44 hours on the request for costs, etc. The Applicant did not provide an acceptable justification for these figures.

In light of the above, legal costs will be awarded by estimation, and in addition to the 27,685 Shekels (including VAT) to the expert witness, a further 150,000 Shekels (including VAT) are awarded in legal fees.

The deadline for paying the costs is 30 days, then interest will be incurred.

Legal Costs Ruling by Ms Shoshani Caspi in cancellation proceedings of IL 157035 Moshe Lavie vs. Zach Oz, 25 October 2017.

Comment

The whole case was mishandled by Zach Oz, who could and should have won the original infringement case in court, but decided to accept a poorly worded out-of-court settlement. By any reasonable attempt to construe the claims so that the patent was not anticipated by support brackets for shelves, Zach Oz’ supports were not infringing. In other words, they could have used the Gillette defense.

Ms Shoshani Caspi’s criticism of PCZL overcharging and double dipping is appropriate in this instance. The attempt to have the case thrown out on a creative estoppel based on not having challenged the validity of the patent when sued for infringement was ridiculous. Ironically, this patent is not worth the costs spent on litigating it. This is a clear instance of lose-lose by all concerned except the lawyers.


Filing Baseless Patent Infringement Complaints in the US Can be Expensive

August 30, 2017
Octane fitnessIcon Health and Fitness sued Octane Fitness for patent infringement in 2009, claiming that Octane’s high-end elliptical machines infringed US Patent No. 6,019,710, which describes an elliptical machine that allows for adjustments to accommodate individual strides. After two years of litigation, a district court judge found that Octane’s machines didn’t infringe. Octane asked for an award of legal fees, but in 2011, a judge rejected the company’s bid. That decision was upheld on appeal.
It is very rare for US courts to rule costs. This has resulted in the so-called patent troll phenomenon, wherein companies sue for patent infringement on very shaky grounds assuming that they have little to lose.

In this instance, Octane Fitness appealed to the Supreme Court, which heard oral arguments on the case in 2014. In 9-0 vote, the court issued an opinion (PDF) making it much easier to get attorney’s fees. Justice Sonia Sotomayor wrote the opinion, holding that patent laws call for awarding fees in an “exceptional” case, which is “simply one that stands out from others with respect to the substantive strength of a party’s litigating position… or the unreasonable manner in which the case was litigated.”

With that, the case was kicked back down to the lower courts. Under the new standard, the district court judge awarded $1.6 million to Octane over the objections of Icon lawyers.

On Friday, the US Court of Appeals for the Federal Circuit upheld (PDF) that award in its entirety. The district court found that Icon’s claim construction arguments were “wholly at odds with the patent text, prosecution history, and inventor testimony,” The court also found that Icon included Nellie’s Fitness, an equipment distributor, as a defendant for the purpose increasing Octane’s legal costs.

The appeals judges found “no clear error in its analysis” and upheld the district court’s award. The panel dismissed a cross-appeal by Octane asking for a larger award, which would also cover litigation over the fees.

COMMENT

trollThe case is reminiscent of a frivolous law suit brought by Pearl Cohen on behalf of Vagabond Source, where the courts ruled that Source’s counsel (i.e. Pearl Cohen Zedek Latzer pay $187,308.65 in partial attorney’s fees, but that Source not be sanctioned. Pearl Cohen appealed that ruling, and lost again in the Federal Circuit Court of Appeals.

We think that such cost rulings are in order to prevent abuse of the system.

 


Finnegan Sued for Malpractice

July 9, 2017

In today’s world, patents are often owned by corporations or by groups of corporations. Inventors form companies with investors, or assign shares to investors, and these are considered separate legal entities.

Despite the legal niceties of firms of Attorneys representing companies, in practice Attorneys form connections with real persons who are sometimes the inventor, sometimes the head of R&D and sometimes the CEO or CTO. Often the patent attorney is not fully informed of the corporate structure. Structure itself is a misnomer. It implies something with a plan and a logic. Typically with solid foundations.

When receiving instructions from an inventor, receiving payment from a company and having a POA with another company, it is possible for the attorney to act in accordance with instructions from someone who is not the legal owner of an asset, and to find him or herself with a conflict of interest. Sometimes these are legal niceties that are over-looked. Sometimes they blow up.

Michael Kildavaeld conceived of a razor utility knife with a graphite pencil blade.  The “marking blade” invention marks surfaces with far greater precision than a standard carpenter’s pencil.

In October 2012, Kildavaeld met Robert Cumings, who allegedly had extensive experience in the marketing and manufacturing of tools.  That same month, Cumings introduced Kildavaeld to Harry Billado, who allegedly had experience in patent prosecution, licensing of patents, and bringing inventions to market. Together they formed a Delaware company called  “Contractor Trusted LLC”. In March 2013, Contractor Trusted LLC hired Finnegan Henderson to obtain patent protection on the marking blade invention.  Attached to the complaint is an engagement agreement between Finnegan Henderson and “Contractor Trusted, LLC c/o Mr. Michael Kildavaeld.”

The complaint alleges that Contractor Trusted LLC, marketing as Accutrax LLC began marketing its product to Stanley Black and Decker.  According to the complaint, in October 2014, while Stanley was negotiating with “the LLC” for a master purchase agreement, Kildavaeld individually contacted Stanley and tried to negotiate his own exclusive relationship with Stanley that eliminated Accutrax LLC from the picture.

According to the complaint, Stanley decided to back out of the deal rather than get caught in between the two sides who were in the midst of a patent ownership dispute. On December 23, 2014, the USPTO issued Patent No. 8,915,662.  No assignee was identified on the face of the ’662 Patent.

According to the complaint, the “patent for the Marking Blade” was issued “to Kildavaeld.”  Stanley Black and Decker withdrew from negotiations due to a dispute over who owned the patent.

“Contractor Trusted LLC” (Accutrax) has sued Finnegan for what it considers was acting in favour of the inventor and adverse to its interest, alleging claims against Finnegan for legal malpractice (count 1), breach of fiduciary duty (count 2), breach of contract (count 3), and aiding and abetting the commission of torts and breach of fiduciary duty (count 4). Accutrax seeks an unspecified amount of monetary damages.

The case is styled Accutrax LLC v. Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Mass. Suffolk County Civil Superior Court, Case No. 1784CV01617.

For more details see here.