Copaxone patents invalidated by the US Patent Trial and Appeal Board (PTAB)

August 27, 2016
copaxone 2

Following an inter-partes review brought by Mylan against two patents protecting Teva Pharmaceutical Industries’ Copaxone, a drug for treating multiple sclerosis, the US Patent Trial and Appeal Board (PTAB) has invalidated all claims of the ‘250 and ‘413 patents for double-dose 40 mg Copaxone (glatiramer acetate injection) multiple sclerosis treatment. However, on 24 August 2016, TEVA announced that it plans to appeal to the US Court of Appeals for the Federal Circuit.

Erez Vigodman, president and CEO of Teva, said: “We remain confident in the strength of our intellectual property surrounding Copaxone.”

“We are prepared to defend the full suite of our intellectual property through the PTAB and US courts regardless of the time required.”

copaxone 3“We believe patients, physicians and payers will continue to value the efficacy, safety and tolerability of Copaxone and that it will remain a proprietary, global market-leading product for the reduction of relapses in RRMS patients.”

Teva have also announced that the PTAB had declined a request for a post-grant review on an additional Copaxone patent.

Copaxone represents 20% of TEVA’s income and the invalidation sent shares plummeting by 3%.


The Third Annual PCTea Party!

August 26, 2016

AIPPI Milan

the mad hatter's tea party

For the last couple of years, around the Jewish New Year which falls in the autumn, at least in the Northern Hemisphere, IP Factor has held very popular PCTea Parties. The first one was held in 2014 in Cinema City, Glilot, and the second was held last year in Cinema City Jerusalem.

In the past, we were honoured to be able to present the one and only Professor Jeremy Phillips. However, unfortunately for the profession, Jeremy has now well and truly retired. This year we’ve decided to turn the AIPPI Bi-Annual International Conference in Milan into a giant PCTea Party. All participants will receive a freshly blended box of PCTea-bags that are carefully formulated to take away the stress of last53b4219b-e7ef-4e92-acba-79f861ed7394 minute PCTea filings. The unique formulation is also good for design and trademark stress and we’ve recently successfully tested it on copyright litigation. We believe that its mix of natural organic ingredients provides a healthy dose of anti-oxidants that will help regulate the blood pressure of all IP practitioners.

20160823_131027The tea may be drank hot or as iced tea during summer days.

We are shipping 2000 boxes to Milan so all participants in the International AIPPI Conference will be able to take back a box.

 

Please note that 2000 boxes, each containing 25 teabags is a mere 50,000 bags. Using a fresh bag each day, this will take me  135 years to drink my way through. Thus all participants are urged to take a box and try out in their offices.

Anyone wishing to discuss Israel related IP issues are welcome to contact us to set up a meeting.


Coexistence Agreement Rejected and Attorney Accused of Conflict of Interest

August 17, 2016

Kennedy Electricity and Assets Ltd filed Israel Trademark Application Number 246560 for “Belissima”.

Belissima

The application was filed on 15 May 2012 in class 8 for “hair straighteners, hair removers and hair curlers, electrical tongs, shavers et al.” and for hair dryers in class 11. The original application was for a somewhat wider range of goods, but this was narrowed in response to an office action on 31 July 2014.

Bellisima ImetecBefore this mark was registered, the Tenacta Group S.p.A. filed Israel Trademark Application Number 251952 for “Belissima Imetec”. The application was filed on 26 July 2012 under International Application Number 1140345 claiming priority from European trademark number 011073319, and was submitted for “Electric and electronic apparatus and instruments for curling, cutting, waving, straightening, styling, trimming hair; electric epilators; electric pulsed light epilators; electric razors; electric and non-electric apparatus for cutting nails; manicure sets, pedicure sets; electric apparatus for removing, softening nails, corns, bunions ; in class 10 for Ultrasound electric apparatus for medical purposes for cleaning the face and reducing wrinkles; electric radio-frequency apparatus for medical purposes for reducing wrinkles and toning the skin; electric apparatus for the care of skin and acne; electric apparatus for medical purposes which vibrates or rotates for the cleaning of the face, body and for massaging the body; electric apparatus for medical purposes for microdermabrasion and electrostimulators for toning the body”; in class 11 for “hair drying apparatus, electric; heated or LED apparatus for reducing blemishes or imperfections on the skin; electric apparatus for drying nail polish or for decorating the nails; steam facial apparatus (saunas)” and in class 21 for “Electric and non-electric apparatus for removing make-up; brushes and sponges for body care; combs”.

On 7 September 2015 the Trademark Department at the Israel Patent Office informed the applicants that in view of their not reaching agreement, a competing marks procedure would ensue under section 29 of the Trademark Ordinance 1972. On 21 September 2015 the parties submitted a joint statement to the effect that they did not consider the marks confusingly similar and would cooperate to prevent confusion and mistakes by the public. On the basis of this agreement the parties requested that the Section 29 objection be removed.

On 22 October 2015, the Examiner refused to retract the competing marks assessment and to allow coexistence, resulting in the case being transferred to the Commissioner for judicial review.

edward scissorhands

On 9 November 2015 the parties submitted their coexistence agreement to the Commissioner of Patents and Trademarks. The parties agreed between themselves that the marks could be registered in parallel. The Tenacta Group undertook to only use the term Belissima in conjunction with either Imetec or Italia to differentiate between the marks. The parties stated that the term Imetec is a trademark that is associated with  the Tenacta Group. Furthermore, the parties undertook to clarify any confusion, should it occur.

In her decision of 18 November 2015, the Deputy Commissioner Ms Jacqueline Bracha rejected the coexistence agreement. In that decision she ruled that:

From the agreement it transpires that not only is there no difference in the goods sold under the two marks, but that the first applicant (Kennedy Electricity and Assets ltd.) would be the distributor of the Tenacta Group’s products.

So the parties were invited to state their claims.

sweeneytoddOn 2 March 2016 the parties submitted a joint notice that the first applicant (Kennedy) will remove all goods in classes 8 and 11 from their application, and the Patent Office was asked to reconsider its ruling in light of this development.

In her ruling of 3 March 2016, Ms Bracha stated:

“After reviewing the details of the goods covered by the two marks it is possible to accept the coexistence agreement on condition that ‘combs’ are removed from the list of goods in class 21 for the 251952 mark and that the 246560 mark be combined with Kennedy’s logo and only used therewith. These conditions are intended to protect the public from confusion since the relevant public and the distribution channels are identical.”

Following this decision, the parties submitted additional notices. On 10 March 2015, the Tenacta group announced that its application was only for the stylized mark shown above that includes the term INTETEC and that its mark was for registration in classes 10 and 21 only, and that Kennedy was not attempting to register its mark for goods in those classes. Consequently there was no reason not to allow coexistence. However, Kennedy claimed in a notice of 13 March 2016 that it was not prepared to limit its application to goods carrying the Kennedy logo together with the stylized Belissima mark since it was not marketing the Belissima brand under the Kennedy logo, and they requested reinstatement of the competing marks procedure.

Following Kennedy’s submission, Ms Bracha gave the parties two months to submit their evidence. Some days later, the Tenacta Group again requested coexistence of the marks. On 18 April 2016 Ms Bracha again requested that the parties submit their evidence. On 19 April 2016, the Tenacta Group restated that the parties had reached agreement and that the marks could coexist. On 20 April 2016 Ms Bracha ordered the Tenacta Group to clarify how their notice fulfilled her request. In the same decision it was clarified that this clarification did not extend the deadline for submission of evidence. On 2 May 2016, the Tenacta Group detailed why coexistence was in order. Read the rest of this entry »


Heinz Tomato Dip May Now Call Itself Ketchup

August 17, 2016

ketchup

Last year we reported  that Osem, Israel’s largest local food manufacturer, had won an injunction against Heinz that prevented them from referring to their tomato sauce as ketchup since it did not include the percentage of tomatoes required by the Israeli regulations.

In a weird and wonderful development, The Israel Minister of the Economy Moshe Kachlon, and the Israel Minister of Health, Yaakov Litzman have now ruled that Heinz Tomato Ketchup may be sold as Ketchup in Israel.

To be honest, Heinz contains only 21% tomato paste. It is mostly added sugar, but they split the added sugar into two types so that the tomato content comes up as the main ingredient. Those worried about genetically modified products may like to know that the vinegar and the syrup used are both derived from genetically modified corn. Personally, I don’t have an issue with this. Nevertheless, it is interesting to reflect that Osem’s ketchup contains more tomatoes (it is made with 37%, tomatoes) and seems to be a higher quality product.

Ketchup does not imply tomatoes at all. Since Heinz’ product is low in tomato content, it should perhaps be called Ketchup without the word tomato appended. Alternatively, it could be labeled Almost Tomato Free Ketchup. That said, I suspect that Heinz Ketchup has so much sugar content that bacteria simply dehydrates due to osmosis, whereas Osem’s Ketchup, which is free of preservatives, can serve as a breeding groGene.jpgund for microbes and must be kept refrigerated after opening.

As both are made from real tomatoes, consumers should beware that they each contain millions of genes.

Ketchup is often used to simulate blood and gore in violent movies. Here is a link  to the iconic Goodies episode: Bunfight at the O.K. Tea Room.

 

 


Is Evidence Submitted in Response to Evidence Inadmissible?

August 16, 2016

 

inadmissible evidenceThis ruling relates to an interim skirmish regarding the admissibility or otherwise of certain evidence. Specifically, the Opposer is entitled to the last word consisting of a rebuttal of the evidence presented by the Applicant. At that stage the Opposer is not supposed to raise new issues. The grounds for opposition in the evidence should not exceed those in the statement of case. During the period of Opposition, the allowed but opposed patent is unenforceable. The regulations attempt to referee the opposition proceedings so that it moves forwards at a reasonable pace and there are deadlines for each stage. However, the deadlines have some flexibility…

The timeline

IL 169358 is the National Phase Entry of PCT/JP2003/016724 to Otsuka Pharmaceutical Co. Ltd. On 20 April 2013 the Application was allowed and published for opposition purposes. On 29 July 2013 Teva Pharmaceutical Industries Ltd. opposed the patent, submitting their statement of case on 1 December 2013. The Applicant responded on 26 March 2014 and the parties then submitted their evidence.

On 22 December 2014 the Opposer (TEVA) submitted an Opinion by Professor Paul Harrison. On 29 June 2015, OTSUKA submitted an Opinion by Professor Michael Thase. and one by Professor Abraham Weizmann. A counter-response for the Opposer (TEVA) comprising a second Opinion by Professor Paul Harrison was submitted on 13 December 2015.

After the round of submissions as defined in the Patent Regulations 1968 was over, the mutually acceptable dates of 8-10 November 2016 were set aside for a hearing in consultation with the parties and the various expert witnesses.

On 14 January 2016, Applicant (OTSUKA) filed for deletion of paragraphs 78-84  and 86, and appendices 22-26 of Professor Harrison’s opinion as submitted in the second opinion in the response of 13 December 2015. As an alternative submission, OTSUKA requested permission to respond to the issues raised.

On 15 February 2016, the Opposer (TEVA) submitted their response to the deletion request arguing that it was to be rejected. As an alternative, they requested permission to correct their statement of case to relate to the issues in the evidence in dispute. On 7 March 2016, the Applicant counter-responded to the response.

The case

The Application describes pharmaceutical formulations for treating moodiness. MoodinessParticularly depression. The applications includes 9 examples, of which examples 3 and 9 describe clinical trials on mice with serotonin reabsorption inhibitors and with Aripiprezol to test anti-depression effects.

 

During the Examination of the patent, the Applicant submitted a letter of 6 April 2011 with examples detailing the additional combinations of serotonin reabsorption inhibitors and aripiprezol in order to overcome prior art rejections by the Examiner and to show, as they put it, “…that the combination as presently claimed in the Application, has an excellent therapeutic effect for treating mood disturbances”.

Mouse in wonderlandIn Example 3 of the Application and supplementary experimental evidence, use was made of the so-called Forced Swimming Test (FST). In Example 9, use was made of the so-called Tail Suspension Test (TST).

In Section H of the second opinion submitted in response to the Applicant’s evidence, Professor Harrison responded to Professor Weizmann’s claims that what was allegedly surprisingly found in combining aripipre or dihydro-aripiprezol with serotonin reabsorption inhibitors resulting in an enhanced symbiotic effect was fairly obvious.

The Applicant does not deny that Professor Weizmann said this. They claim that the synergistic effect appeared in the statement of claims and that the Opposer could have related to it as they saw fit in their first evidence filing rather than by way of response.

In response to the synergy claim, Professor Harrison raised three points in his second expert opinion as filed in response:

  1. The claims of the patent application are not restricted to formulations having a synergistic effect and the clinical trials described in the application do not demonstrate any synergetic effect between ariprezol / hydro-aripiprezol and the serotonin reabsorption inhibitors. In this regard, Professor Harrison went on to state his finding that examples 5-8 of the application, which related to the combinations, do not provide evidence to any synergy.
  2. The examples described in the clinical trials do not include any relevant control groups that  can enable deriving the conclusion that there is a synergistic effect. In his second opinion, Professor Harrison refers to the first opinion and explains that there is no evidence that any improvement in patients being treated by the combination can be attributed to a synergetic effect of the combination.
  3. The examples allegedly showing a synergistic effect do not necessarily show this. One cannot determine a synergetic effect from the Tail Suspension Test.

Appendices 22-26 are references that are cited by Professor Harrison to demonstrate and to provide a basis for that claimed in paragraphs 78-86 of his second opinion. From the above, one can regard the challenged evidence as evidence submitted in response to the synergistic effect raised by Professor Weizmann in his submission of evidence.

The Applicant does not see this as evidence submitted in response. In the Statement of Case, paragraph 46 relates to the tests performed in examples 3 and 9 and stresses that there is no evidence of a surprising synergy:

The tests described in the Application relate to the combination of ariprezol / hydro-aripiprezol and serotonin reabsorption inhibitors selected from a specific group of chemicals for treating depression and major depression. There is nothing in these tests that demonstrates, even implicitly that the combination has an advantageous or surprising effect over that previously known which describes combining neurolifts with SRI. Specifically, these tests do not prove an advantage in the claimed combination over any combination of ariprezol with SRI.

Section 46 relates to the combinatory effect or synergy between two materials. The things were stated with respect to the examples described in the Application and not specifically with respect to the additional examples.

In light of the above, Commissioner Kling could not conclude that there is no argument with respect to the synergistic effect itself. Furthermore, since the Applicant himself referred to the examples and a claimed synergetic effect, it seems that this point requires clarification and analysis in the framework of the hearing. Thus one cannot conclude that the issue is moot in light of the exchange of statements of case.

The question remains if reference to the supplementary examples is not by way of response. As the Applicant emphasized, these materials were included in the prosecution file and therefore were presumably before the Opposer when the Statement of Case and the evidence submissions were written.

That said, examination of the Applicant’s statement of case does not testify as to which specific examples were considered, and if they limited themselves to examples specified in the application or if they widened their case to include the examples within the prosecution file that were before the Examiner.

To the extent that the alleged synergy effect relates to the supplementary examples, the Opposer reasoned that the Applicant cannot give these much weight in the framework of their evidence. With respect to the supplementary examples, the Opposer stresses that the results were submitted in the evidence stage only, and reference to these in the statement of case itself was merely in a general manner. The Opposer explains that since it was not clear if the supplementary examples, that are not within the application itself, but were only submitted during the examination, would be referred to in the opposition proceedings, they did not relate to them prior to the Applicant introducing them in Professor Weizmann’s Opinion. Consequently, the Opposer claims that relating to these examples in the evidence stage is essentially by way of response.

The nature of evidence submitted in response is defined in Regulation 62:

The opposer is allowed, within three months from when evidence is submitted on behalf of the Applicant, as per regulation 59(b) or regulation 61, to submit counter-evidence that relates to the facts specifically denied by the Applicant in his evidence or to issues first raised in that evidence.

The criterion relevant to our case is the question of facts first raised in the Applicant’s submission of evidence.

The Opposer cannot grab the rope from both ends. The Opposition is a continuation of and a part of the Examination process. See Civil Appeal Shechter vs. Abmatz ltd, p.d. 44(2) 846 and Appeal 665/84 Sanofi vs. Unipharm p.d. 41(4) 729. The material within the prosecution file is available to the parties. Nevertheless, during the opposition procedure, by virtue of the issues raised during the proceedings, the parties are required to identify the material to be discussed in the hearing. Since even from the Opposer’s perspective, the supplementary examples were available in the file wrapper, one cannot relate to this evidence as facts first brought up in the Applicant’s submission of evidence. Since these are supplementary examples, one cannot consider them as evidence suddenly presented for the first time in the Applicant’s submission of evidence.

Nevertheless, in light of the discussion of the synergistic effect in examples 3 and 9, and in view of the not insignificant reference to the supplementary examples by Professor Weizmann in his expert opinion, one cannot consider the supplementary examples irrelevant. The synergetic effect as discussed by Professor Harrison is not a widening of the statement of case.

In several instances the case-law has concluded that the rules of submitting evidence before the Commissioner of Patents are more flexible than the rules governing the submission of evidence to the court. See for examples Appeal 5041/13 Einat Gabai vs. Aminach Furniture and Mattress Industries Ltd, 21 January 2014, where the court discussed the period for submitting evidence and concluded that in legal proceedings before the Patent Office, the test for accepting evidence are more flexible (see paragraph 4 of Judge Hendel’s ruling). The District Court recently reached a similar conclusion in 34039-01-14 Mifalei P.M.S. Migun Ltd cs DSM IP Assets B.V. (12 August 2014) where the court allowed new evidence to be filed during the Appeal as the desire to reach the truth and fair justice was considered over-riding the procedural issues. in that instance, the Court concluded that patents, as opposed to civil law, the rules for allowing new evidence to be submitted were even more flexible. See also 5307-10-14 Orbotech Ltd vs. Camtek Ltd, 8 December 2015.

It appears that in this instance, where the material is anyway in the prosecution file, there is room to be flexible and to allow the parties to contribute to the public interests of the register being correct (i.e. allowing or disallowing patents on the basis of the evidence, not on procedural reasons preventing relevant evidence from being submitted) and further in the interest of efficiency (see Appeal 217/86 Schechter vs. Ambatz ltd. p.d. 44(2) 846, 857) by allowing the additional examples to be considered.

in light of the above, Professor Harrison’s second opinion as submitted in response to the Applicant’s evidence is allowed to remain in the opposition proceeding file as it was originally submitted, and the Applicant is given 30 days to submit short evidence relating to the supplementary examples as discussed in the paragraphs whose deletion was sought – paragraphs 78-84 and 86 of the opinion.

Costs for this interim ruling will be awarded as part of the main ruling.

Asa Kling: intermediate ruling re submission of evidence in Opposition to IL 169358 to Otsuka, 10 July 2016.


Co-op Shop Again

August 15, 2016

Back in February we reported on the Co-op Shop Decision. Essentially, in light of an early registrations for Co-Op and Super Co-Op trademarks, both owned by Mega Retailers who had bought out Blue Square, the Co-op Israel Supermarket Chain LTD were unable to register their logo, TM co-opshop.

The Deputy Commissioner Ms Jacqueline Bracha accepted that the registered marks may not be in use and gave Applicants 30 days to file a cancellation proceedings, offering to suspend her final ruling, pending a decision of non-use should it be filed.

coop   super-coop

The marks were indeed challenged in a cancellation proceeding filed on 12 April 2016, and this ruling relates to the cancellation of TM 83846 and TM 98697 for Co-Op and Super Co-op which were registered in June and November 1996 respectively, both in class 35.

In the cancellation request, Co-op Israel alleged that the marks were not in use and had not been since 2003. Furthermore, there were no extraordinary circumstances justifying the non-use. Therefore the marks should be cancelled. However, Coop Israel did not provide any evidence supporting its allegations.Section 41a of the Trademark Ordinance 1972 states:

“...Any interested person may request that a trademark be cancelled on the grounds of lack of bona fide use and lack of bona fide intent to use the mark over the previous three years.”

It is a matter of case-law that trademarks are property rights in all respects, and these may not be simply nibbled away. There is a burden of proof that the mark owner did not use the mark that rests on the shoulders of the party requesting that mark’s cancellation. See Bagatz Orlogad Ltd vs. Commissioner of Patents, p.d. 39 (2) 148. 

The burden of proof shuffles back and forth: the party requesting cancellation of the mark has to bring initial evidence of non-use of the registered mark. If it is accepted as sufficient to make a case, the burden of proof shifts to the mark holder to refute the challenger’s evidence and to show that the mark is in use.Failure to show lack of use works in the interest of the mark owner. See Bagatz 296/89 Moorgate Tobacco Co. Ltd. vs. Philip Morris Inc. p.d. 41 (1) 485 page 493.

With respect to the order of the proceedings in a challenge to a trademark registration on grounds of lack of use, regulation 70 of the 1940 Trademark regulations states:

A request to correct the Register or to delete a trademark from the register should detail in duplicate, the applicant, the facts on which the request for cancellation are based and the desired correction. A copy of the request should be sent to the mark owner.

There is no indication that the request for cancellation was sent to the marks owner who is not represented in this instance.

According to regulation 71 one should act as follows:

With the filing of the request and sending a copy to the registered owner, the commissioner should inform the Applicant and the Applicant should submit his evidence within two months of the notification.

In light of that said previously, and in view of the absence of a statement of case by the mark owners, I give the requester of cancellation two months to submit their evidence.. similarly, and in the same time-frame, they are to provide proof of delivery of the application to the marks owner.

The Court secretariat will ensure that this decision is delivered to the non-represented marks owner.

Interim ruling re cancellation of TM 83846 and TM 98697 for Co-Op and Super Co-op, Ms Shoshani-Caspi, 26 July 2016.

COMMENT

red kingThis reminds me
of the Red King in Alice Through the Looking Glass noting how good Alice’s eyesight was for being able to see nobody on the road at a distance where he would have trouble seeing anybody. In other words, it is difficult to show that something is not happening. How can prove that a mark is not in use???

 

 

 


Reconsideration of a Patent Extension Term

August 10, 2016

last minute shopping

In an odd development, but not one that without precedent – see here and here – Dr Shlomo Cohen Law Offices has asked the Israel Patent Office to reconsider a judicial ruling.

In this instance, the original ruling relates to the Patent Term Extension (PTE) of IL 169693 to “Bristol Myers Squibb” and Pfizer that issued under section 64(v)5 of the Israel Patent Law. The original ruling issued in September 2015, and granted a patent term extension of 974 days until 18 May 2025. That ruling followed a challenge by the patentees to Examiner’s decision of 5 March 2015.

The way that Patent Term Extensions (PTEs) are calculated in Israel is detailed in Read the rest of this entry »


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