Israel Patent Application No. 220476 to Mapi Pharma titled “Long Acting Depot System Comprising a Pharmaceutical Acceptable Salt of Glatiramer” was allowed and published for opposition purposes. Teva filed an opposition under Section 34 of the Law.
The application relates to a dosing regime of Glatiramer and salts thereof. The drug is an immunomodulator medication used to treat multiple sclerosis.
The application is a national stage of a PCT filed on 19 August 2010 which claims priority from an American patent application of 4 January 2010.
The patent was examined and published for opposition purposes on 31 March 2016. On 28 June 2016, Teva filed an opposition. After the parties submied their statements of case, Teva withdrew their opposition for commercial reasons.
Under Section 34 of the Patent Law 1967, the Commissioner has to decide whether the suspended opposition provides a sufficient basis for the patent to be granted.
In their Statement of Case Teva raised various issues regarding the patentability of the claimed invention. Since no evidence was submitted the Deputy Commissioner concerntrated on the allegation that the publication of WO2005/041933 from 12 May 2005 anticipates the invention and negates novelty.
Claim 1 states:
“A long acting parenteral pharmaceutical composition comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer, the composition being in a sustained release depot form which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.”
Paragraph 20 of the Statement of Case which from paragraph 58 of their counter statement, it appears the patentee accepts, construes claim 1 as follows:
- A long acting pharmaceutical composition
- For parenteral dosing
- comprising a therapeutically effective amount of a pharmaceutically acceptable salt of glatiramer,
- the composition being in a sustained release depot form
- which releases a therapeutically effective amount of the pharmaceutically acceptable salt of glatiramer over a period of about one week to about 6 months.
Posted by Dr Michael Factor 
Ro.R. Sheli ltd own Israel Trademark No. 233836 for “wok and walk noodle bar” shown alongside.
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 his stage is not in accordance with the civil procedure. Deputy Commissioner Ms Jacqueline Bracha concurs with Wok to Walk Franchise.
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 entirety.
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.
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 mislead into believing that they are purchasing Baladi’s product.
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 behaviour for which the case should be thrown out.
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 claims that their product package is completely different to 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.
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 expensive than their own label, which is against their policy.
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 no 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 he 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.
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.
Alkermes Pharma Ireland LTD has an exclusive license from Novartis to manufacture a drug in accordance with IL 142896 and its divisional patent no. IL 179379 entitled “Multiparticulate Modified Release Composition”. The active ingredient is Methylphenidate and is commonly known as Retalin. It is used for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
Medice Arneimittel GmbH filed a request to cancel the relevant patents and the claim scope was narrowed in a preliminary action by Alkermes, but the cancellation actions were unsuccessful. Now Alkerermes has requested costs of $1,029,561.95 which comes to 3,626,118.18 Shekels costs.
Both sides filed their statement of case, and then, at the evidence stage, Vacotec applied to reference two additional pieces of prior art. The Opposer justified the need to add these citations by arguing that the Applicant had taken an unexpected position in their Statement of Case and had post-dated the filing date due to amendments during the prosecution. This resulted in them doing a further search and discovering the two additional references.
