Exforge Patent Successfully Opposed in Israel, despite surviving an Opposition based on similar citations in Europe

November 7, 2016

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.

Israel Patent Application No. IL 140665 titled “USE OF COMBINATION COMPOSITIONS COMPRISING VALSARTAN AND AMLODIPINE IN THE PREPARATION OF MEDICAMENTS FOR THE TREATMENT AND PREVENTION OF DIABETES ASSOCIATED WITH HYPERTENSION” relates to the drug.

In an Opposition to the Patent Application issuing, the Deputy Commissioner, Ms Jacqueline Bracha, has ruled that the combination of two active ingredients, each individually known for treating high blood pressure, into one pill for ease of dosage is not inherently inventive where the separate efficacy of the active ingredients is known, as are other two component pills for treating hypertension. Though claimed by applicants, there is no evidence of a synergy between the active ingredients.  The Patent Application is therefore ruled not patentable in Israel and significant costs were awarded to Teva and Unipharm. We expect that the decision will be appealed. This decision may have a knock on effect regarding patents for the same drug abroad and may encourage Teva to proceed with at-risk launches of generic competitors in other jurisdictions.

A translation of the ruling follows:

Read the rest of this entry »


IL 221116 – Extending the Period for Reconsideration of a Refused Patent

November 2, 2016

mouth-cleanerIsrael Patent Application No. IL 22116 titled “Mouth Cleaner” was applied for by Yaakov Dichtenberg and Danny Unger who is also a patent attorney.

The Application was rejected. Under Section 21a and 164a of the Israel Patent Law 1967,  within 12 months of a final rejection, the Applicant may request reconsideration by the Commissioner. After that time it is possible to have a closed application reopened, but it is difficult and it is generally necessary to show extreme circumstances resulted in the application becoming abandoned.

weve-movedThis Application was filed on 25 July 2012 and, in accordance with Section 16a of the Law, a Notice of Imminent Publication was sent to the Applicants on 5 January 2014. This notice was sent to the address given on the application form which was the address of the first Applicant, Mr Danny Unger, a patent attorney who represented himself and the his c0-applicant. The Application published on 30 January 2014.

On 2 February 2014 the Applicants received a Notice of Imminent Examination in accordance with Section 18 of the Law and regulation 36 of the patent regulations 1968. Since the Applicants did not respond to this Notice within the period ordained in regulation 36, a reminder was sent on 5 November 2014 to the effect that in absence of a response within 30 days, the Application would be deemed abandoned. Subsequently, on 21 December 2014 a Notice of Rejection issued that also informed the Applicants that they could request reinstatement within 12 months.

On 21 December 2015 a request for reinstatement was received together with a response to the Notice Prior to Examination. The Notice of Reinstatement did not include a signed affidavit as required by Commissioner Circular  026/2014, however the Applicants alleged that they never received the correspondence due to a change of address.

On 15 March 2016 the Deputy Commissioner Ms Jacqueline Bracha requested that the Applicants provide a detailed signed statement of the events leading to the Application becoming abandoned and set a date of 20 April 2016 for a hearing.

On 19 April 2016, one day before the hearing, the Applicants requested a postponement for personal reasons. Despite the lateness of the request and the lack of a doctor’s letter, Ms Bracha agreed to the postponement. Nevertheless, the detailed statement was not submitted.

Applicant and Patent Attorney Unger arrived very late to the rescheduled hearing and claimed that he thought that updating the Ministry of the Interior regarding his change of address was sufficient to automatically update the patent office records. The Applicant was informed that Regulation 16a makes it clear that he should have proactively informed the Israel Patent Office of his change of address and that he still needed to provide an affidavit.

On 25 May 2016 an Affidavit was received in which the Applicant informed the Israel Patent Office that he neglected to inform them of his change of address and consequently never received the correspondence from 2014 to 2016 which was sent to his previous address. He went on to affirm that he never intended to abandon the Application and wanted to continue prosecuting the Application in parallel with the US application.

RULING

Section 21a sets the timetable for requesting reconsideration of a rejected Application as follows:

21A. If the Registrar refused to accept an application under section 21, then he may— on the applicant’s application—reconsider the refusal, on condition that the application be submitted within 12 months after the day on which the Registrar refused to accept it as aforesaid.

Section 164a of the Law enables the Commissioner to extend Section 21a due to reasonable causes:

Where the 12 month period stated in Section 21 has passed, the Commissioner may, nevertheless, reinstate a patent application in exceptional circumstances under Section 164a which states:

164.—(a) The Registrar may, if he sees reasonable cause for doing so, extend any time prescribed by this Law or by regulations under it for the performance of anything at the Office or before the Registrar, except for the times prescribed in sections 30, 56, 57, 61, 64F, 64M…

As the Deputy Commissioner, Ms Bracha sees it, Section 21a gives the timeline for an Applicant to restore an Application. Section 164a gives the Commissioner sweeping powers to reinstate but has to be applied with consideration of the fine balance between the Applicant’s interest and that of the public; see 2806/04 Commissioner of Patents vs. Recodati Ireland LTD:

The policy regarding different requests to extend deadlines will vary depending on context and the type of proceeding that the extension is requested for.

If the Commissioner agrees to an extension, he is entitled to make the decision dependent on appropriate conditions in the circumstances as detailed in Section 164b:

The Commissioner may make the extension dependent on any conditions as seen fit.

As ruled in the decision concerning IL 157563 ICOS Corporation from 21 October 2013:

Citing Opposition IL 110548 Shmuel Sadovski vs. Hogla Kimberly Marketing LTD. regarding Revivals, the relevant considerations are the time passed and the underlying reasons for the delay. In this regard, the time passed not only provides an indication of the reasonableness of the Applicant’s behaviour, but also affects the likelihood of third parties relying on the case being abandoned, since it is evident that the longer an application remains abandoned, the greater the likelihood that third-parties will have relied upon the invention not having been patented.

In this instance, the period beyond the 12 months automatically  granted by Section 21a of the Law is minimal. The Applicant filed a request on the last day but did not file it properly since no Affidavit was included. The Affidavit was only submitted after the hearing.

However, the behaviour of the Applicant does not conform to that expected of a Patent Attorney, who, in this case, represents not just himself, but also a second Applicant. A Patent Attorney is expected to know that he should provide an address to the Israel Patent Office and that this address will be the one that post is sent to. The Patent Office cannot change the address of record without instruction to do so in a formal request to change the address of record. No such request was submitted. Furthermore, the Applicant found it difficult to conform with the revival instructions after being instructed to provide an affidavit explaining the circumstances leading to the application going abandoned. Nevertheless, it does seem that the Applicant followed the case or he would not have known that he should request revival of the Application.

elephant-and-post-boxIn the circumstances, the Deputy Commissioner ruled that the case should be returned to the Examiner as per Section 21a. However, because of the public interest, the Deputy Commissioner makes revival conditional on anyone relying on the patent lapsing from when it lapsed until when it was reinstated being allowed to continue using the invention, even if a patent should eventually issue.

Notice is given to the Applicant that his address has still not been updated.

Decision by Ms Jacqueline Bracha regarding reinstatement of IL 221116 “”Mouth Cleaner” to Yaakov Dichtenberg and Danny Unger”,  7 September 2016

COMMENT

Apart from being rather surprised that a registered Patent Attorney could forget to update the patent office about his change of address and assume that the Ministry of the Interior would do it automatically, I am at a loss as to why he didn’t bother checking up the progress of the application for his own invention on-line.

Since the request for revival was filed within the 12 month time period, at least, since all yearly and monthly deadlines are to the same calendar day, I think the decision is correct.

chewing-gumI couldn’t resist reviewing the Application as claimed, and note that the first few claims attempt to monopolize apples and chewing gum. Go figure.


Are methods of calculating rediculous alleged legal costs trade-secrets?

November 1, 2016

novartis    teva

Teva successfully opposed IL 184027 to Novartis titled “COMPOUND TRISODIUM [3-((1S,3R)-1- BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1- BUTYLCARBAMOYL)PROPIONATE-(S)- 3¶METHYL-2¶PENTANOYL{2¶¶ TETRAZOL-5-YLATE)BIPHENYL- 4¶YLMETHYL}AMINO)BUTYRATE] HEMIPENTAHYDRATE, ITS PHARMACEUTICAL COMPOSITIONS, METHOD FOR ITS PREPARATION AND USE THEREOF IN THE PREPARATION OF MEDICAMENTS.”

The application was filed on 18 June 2007 as the national phase entry of PCT/US2006/043710. A divisional application was filed as IL 219782. The application published for opposition purposes on 30 November 2014, and on 25 February 2015 Teva Pharmaceuticals LTD filed an opposition. One day later Unipharm also filed an Opposition. Subsequently, since there was a pending divisional application and because the opposer had not filed their statement of case, the Opposers filed for suspension of the Opposition proceeding for 18 months as per Commissioner Circular 020/2012 “Opposition to a divisional patent or to a patent that is divided” from 18 November 2012. The Applicant opposed the request to stay the opposition. However, on 9 August 2014, the Commissioner agreed to stay the opposition proceeding.

On 7 September 2015, the applicant abandoned the divisional application and requested that the Opposition against the parent application be renewed and that the Opposer file their statement of case. The commissioner accepted this, and on 9 September 2015 gave the Opposers 60 days to file their statement of cases.

On 8 November 2015 Teva announced that they were withdrawing their opposition for “pure business reasons”. On 30 November 2016, the Commissioner ruled that the Teva opposition be closed and that the Unipharm opposition continue.

detailed-costsOn 11 January 2016, Novartis requested costs from TEVA. The costs request was supported by a statement from Liad Whatstein, Novartis’ counsel, but with many details thereof blacked out as they are allegedly business secrets and some are pertinent to the ongoing Opposition by Unipharm. They also requested a confidentiality order with respect to the blacked out data.

The Commissioner decided that Novartis had failed to make a case that the data should remain confidential, and issued a ruling on 4 February 2016 rejecting the confidentiality clause. Novartis’ counsel chose not to provide a time-sheet detailing the work done, considering this also as being a trade-secret.

Novartis’ Claims

The Applicant considers that TEVA’s withdrawing from their opposition puts them into the category of a party that loses their case. They do not think that the ongoing opposition by Unipharm should release TEVA from having to bear costs in a proceeding that they initiated. Thus Novartis alleges that TEVA should have to pay half the actual costs incurred by Novartis from when the opposition was filed until when it was abandoned, which comes to $17,136.72.

The Applicant claimed that due to the tight deadlines and the complicated scientific data they had to prepare for the opposition prior to the statement of case being filed. The complications are evidenced by Unipharm’s opposition and by the corresponding opposition filed in Europe. Furthermore, the Applicant claims that TEVA’s behavior and the time passed from when the opposition was filed until when it was withdrawn after the continuation was abandoned, created a state of affairs wherein TEVA could reasonably expect that Novartis would work on the opposition and incur costs thereby.

Novartis also claimed that TEVA had abused the opposition process by filing a baseless opposition simply to delay the patent issuing and to cause the divisional application to he withdrawn. Consequently Novartis considered that TEVA should pay costs.

 TEVA’s Claims

TEVA considers that Novartis is NOT entitled to costs at all and the cost request should be denied and Novartis should be charged for Teva having to respond to their costs claim. Alternatively, each side should bear their own costs.   Since the Opposition was terminated early it is by no means clear that were it to have continued, Novartis would have prevailed and would be entitled to costs for the preliminary part where Teva was involved. Teva alleges that if the Novartis application is refused, not only would Teva not have to compensate them, but conceivably Novartis would have to pay the costs  that Teva incurred in filing the statement of case.

Additionally, Teva considers that the Applicants actions and the costs incurred thereby in preparation of an anticipated opposition were needlessly incurred. Teva considers that from studying other statements of opposition, there is nothing to justify the preliminary and anticipatory actions that Novartis took, and certainly one cannot hold Teva responsible for such actions. Furthermore, the actions taken by the Applicant preceded the time when Teva had to submit their statement of case – which, in the event, were never submitted.

Teva went on to allege that the claimed expenses were unreasonable when considering the stage that the opposition procedure had reached. Furthermore, these so-called expenses were, in the main, not supported by an affidavit.

The Ruling

True, Teva filed an Opposition which was then abandoned early on. The Application is, however, still being opposed by Unipharm and has not issued as a patent. In this specific case, following review of the claims and counter-claims of the parties, Commissioner Kling concluded that the request for costs to be awarded to Teva should be deferred until the Unipharm opposition runs its course, depending on the outcome thereof.

The Commissioner has the authority to delay cost ruling under section 162b of the Law:

162b The commissioner is authorized to rule reasonable costs, to determine which partner should pay costs and how they should be paid.

Generally, the Commissioner rules costs in favour of the winning party. As a general rule, the side that abandons their case for whatever reason, and consequently a patent issues, is considered as having lost the proceeding and is to bear costs of the opposing party. (See 133957 cost ruling Pfizer Products Ltd vs. Teva Pharamaceuticals 14 February 2008). Nevertheless, the awarding of costs is left to the commissioner’s discretion and this is certainly the case where the abandoning of an Opposition does not necessarily lead to a patent issuing.

In this instance, despite Teva abandoning the Opposition the proceedings are ongoing. Unipharm’s opposition is still being fought and one cannot consider Novartis as being one who has won their battle. It is thus not the time for Novartis to claim costs. Consequently, at this stage the Commissioner is refraining from determining what costs the Applicant is entitled to, and what costs the Opposer is or may be entitled to. These will be determined once the fate of IL 184027 us known.

As an afterward and without final determination of the costs themselves, the Commissioner noted that it is rather difficult to rule on costs in the manner that they were submitted, with certain facts blacked out and no support for other contentions. This makes the reasonableness, necessity of and proportionality of the alleged expenses difficult to substantiate and makes it difficult to award real costs (see Supreme Court Ruling 891/05 Tnuva Cooperative for Marketing Israeli Produce vs. The Authority for Granting export Licences of the Department of Trade and Industry p.d 60(1) 600 (30 June 2005). This is particularly the case when considering the enormous costs claimed and the early stage at which the Opposition was abandoned by Teva, prior to submission of any substantive arguments.  See the ruling of the Then Deputy.  Commissioner re IL 113433 Smithkline Beecham Corporation (SKB) vs. Teva Pharmaceuticals (30 May 2005).

Interim Ruling re Costs in Il 184027 Teva vs. Novartis Oppostion Asa Kling 19 September 2016.

COMMENT

Whilst filing an opposition and then suspending until a divisional application issues or is abandoned could be considered as a delaying tactic, often filing such divisional applications is simply a means to keep an applications pending through parallel opposition proceedings, enabling a new claim approach not conceived at the time of filing to be considered. Since Unipharm is rather good at successfully opposing patents, it is a reasonable tactic for Teva to leave it to them to challenge the validity of the allowed claims. One suspects that Teva will have made relevant prior art and arguments available to Unipharm.

The successful opposer is entitled to claim costs from the applicant. Nevertheless, I am flabbergasted that Whatstein could make a claim for over $17,000 for costs incurred by having an opposition filed against his client prior to even having a statement of case requiring analysis being submitted. There were no patents or other prior art or other evidence that needed to be analyzed and no claims that needed consideration. Apart from informing Novartis that an Opposition had been filed, it is difficult to see what work was necessarily incurred.  Submitting a blacked out statement simply flags the fact that this is unreasonable. In desperation, I went to his website and discovered that as part of patent litigation “The firm orchestrated and designed complex experiments in patent infringement and opposition proceedings and uses a network of internationally acclaimed experts and external laboratories. In addition, the firm is involved in a large number of multi-jurisdictional patent proceedings.” This certainly goes some way to explain how $17,000 worth of costs could be accumulated, but one wonders if it was proportionate, reasonable and neccessary in response to an opposition being filed prior to relevant prior art and arguments being made of record.


Wet-wipes, The Issue of Inventorship and the Responsibilities of the Patent Attorney

September 22, 2016

wetnap-were-ready-for-any-messThis ruling concerns a product that resulting from the contributions of two people who were formerly friends. A patent application was filed that named both people as both inventors and applicants. Later, after powers-of-attorney signed by each of the named inventor – applicants had been filed, there was an attempt to ‘correct an office error’, to list one of them as an inventor only. The corresponding PCT application and the national phase entry applications, including two issued patents in the United States only bore the name of one inventor and applicant. In an Opposition ruling the Israel Patent Office has now accepted that the second named inventor is indeed an inventor and also an owner.

Apart from emphasizing the need to determine who is the inventor and who is the owner of an invention when the patent is filed, the need to put everything into writing, and the dangers of working with friends, the case raises interesting questions regarding what contribution to reducing a patent to practice entitles someone to recognition as an inventor and whether this standard is the same in all jurisdictions. It also raises interesting questions regarding the duties and responsibilities of the patent attorney to ascertain the facts, or at least to avoid signing on contradictory statements regarding ownership and invention in different jurisdictions.

BACKGROUND

IL 152867 titled “Tissue Container With Auxiliary Compartment”is a patent application for a package of wet-wipes
rc-chairswith an adjacent container for nappy cream. The Application was filed back in November 2002 and listed Boaz Krystal and Liat De-Vries as inventors and owners. The patent application was allowed at the end of June 2010.

Subsequently, an Opposition was filed by WET-NAPS LTD and Liat De-Vries on 4 October 2010 under Section 31(3) of the Israel Patent Law 1967 on the grounds that Boaz Krystal was not in fact an owner, and that the patent was exclusively owned by Ms Liat De-Vries.
affidavitsMr Boaz Krystal and his wife Mrs Dorit Krystal each submitted affidavits. Mrs Liat De-Vries submitted a primary affidavit and a supplementary one in response to Mr Boaz Krystal’s affidavit. Wet-Naps Ltd. is owned by Mr Ilan De-Vries, who is Mrs Liat De-Vries’ husband. He also submitted an affidavit on behalf of the company.  Mr David De-Vries, a patent attorney at Reinhold Cohn & Partners who drafted and filed the application and is a cousin of Mr Ilan De-Vries, Ms Ronit Tal who is an acquaintance of Liat De-Vries and Mr Yoram Hadar who is an industrial designer, also submitted affidavits. A hearing was held and the parties submitted their summaries.

wetnapWet-Nap Ltd manufactures, exports and markets wet-wipes. The company had a business relationship with Packtop Ltd., a company directed by Mr Boaz Krystal that distributes wet-wipes amongst other things.   At the time of filing, both the Krystals and the De-Vries couple were good friends.

roobarbs-shedThere is no argument that Mr Boaz Krystal and Mrs Liat De-Vries met at the Wet-Nap Ltd factory, where Mr Boaz Krystal heard the idea of including baby ointment together with a package of wet-wipes from Mrs Liat De-Vries. There is also no argument that Mr Boaz Krystal and Mrs Liat De-Vries had some kind of collaboration, to develop and improve this invention and to file a patent application for it. Eventually a joint application was filed in both Mr Boaz Krystal and Mrs Liat De-Vries names. However, the parties disagree regarding Mr Krystal’s contribution to the development of the invention and consequently disagree regarding whether he is to be considered an inventor and owner of the patent.

The Main Documents in the Prosecution File Wrapper

roobard-and-custard-friendsThe Application was filed in November 2002 by Reinhold Cohn Patent Attorneys. The Application form lists both Mr Boaz Krystal and Mrs Liat De-Vries as joint owners due to them being inventions. Both parties filed Powers of Attorney, and the Filing Certificate gives both names.

On 10 December 2002, Adv. David De-Vries of Reinhold Cohn Patent Attorneys submitted a notice stating:

office-error“Due to an office error, the name of the inventor, Mr Boaz Krystal was inserted as an Applicant. With our apologies for this, we are submitting a new cover sheet and application form in duplicate, listing Mr Boaz Krystal and Mrs Liat De-Vries as joint inventors, but Mrs Liat De-Vries as the sole owner.”

On 10 December 2002, Adv. Edna Haruti, now Mr Krystal’s representative, submitted a letter in which it was stated that Mr Krystal was a joint owner together with Mrs Liat De-Vries as he had invented the tissue container with auxiliary compartment together with her.  Adv. Edna Haruti also noted that registration of the patent in the name of Mrs Liat De-Vries only was contrary to the agreement between the parties.

shimon-shalitOn 2 February 2003 Patent Attorney Shimon Shalit, then Senior Examiner in charge of formalities at the Israel Patent Office, responded to both Reinhold Cohn and to Mr Krystal that Mr Krystal could not be removed as an owner in the application as filed, since there was no indication that he had assigned his invention to Mrs Liat De-Vries prior to the application being filed. In absence of such proof, since Mr Krystal was not an employee of Mrs De-Vries, by virtue of being a co-inventor, he was also a co-owner.

(As an aside – On 12 March 2006 Mrs De-Vries submitted a divisional application of IL 152867 for certain applications of the invention. This divisional application (IL 174309) was examined, allowed and issued as a patent. On 1 December 2010 IL 174309 lapsed due to failure to pay the renewal fees. That patent is not directly relevant to this Opposition, but Wet-Naps Ltd and Liat De-Vries related to it in their claims).

procrastinateIn the protocol of a hearing held on 5 February 2007 before then Deputy Commissioner Noah Smulevezh it was decided to defer the issue of ownership until the examination of the application was completed. It was further ruled that Reinhold Cohn would be address of record, but would update Mr Krystal or his representative regarding actions taken to get his input before responding to office actions. The patent application was eventually allowed and published for opposition purposes, resulting in this opposition proceeding.

The Opposers’ (Wet-Naps Ltd and Mrs Liat De-Vries) Main Claims
wetnap

Mrs De-Vries and Wet-Naps Ltd claimed to have thought of the idea and developed the invention whereas Mr Krystal had merely provided technical drawings and a business plan for commercializing the product. They alleged that during the period in question, Mr Krystal provided technical and consultancy services to the company as almost an in-house service provider and as such, was exposed to the invention. They further claimed that Mr Yoram Hadar (industrial designer) and Patent Attorney David De-Vries provided sketches for the product that eventually evolved into the patent application. They further alleged that Mr Krystal had suggested a specific implementation (embodiment?) – storing the cream in a blister pack or sachets, which developed into  Read the rest of this entry »


Revival of IL 132540 Opposed

September 18, 2016

chequeBack in June 2015 we reported that an attempt by the patentee Yehuda Tsabari to revive Israel Patent Number IL 132540 titled “A method and System for Direct Transfer of Funds via Magnetic Cards” and covers using credit / debit cards to gift money into the account of celebrants. It is designed for use by guests at weddings and Bar Mitzvas, and is a variation of what a refer to as a hardy perennial – it is the sort of invention that seems to be reinvented every few months, and I have provided consultations to several would be entrepreneurs, and have even drafted and successfully prosecuted patent applications for variations of the invention in the past.

paymentTsabari’s patent was abandoned due to failure to pay the fourth renewal for years 14 to 18. The Patent Office agreed to allow the revival subject to their decision publishing for opposition purposes. On publication, Going Dutch Ltd opposed the revival claiming that the patent was knowingly and intentionally abandoned, and the present decision is a substantial ruling on their opposition.

Tsabari’s application was filed on 24 October 1999 and the patent was allowed on 13 April 2004. The fourth renewal was due on 24 October 2013 but was not paid, and six months later, the patent lapsed as per Sections 56 and 57 of the Israel Patent Law 1967.

reinstatementOn 7 July 2014, Mr Tsabari filed a request for reinstatement together with an affidavit, arguing that the reminder was sent to the wrong address as the Israel Patent Office has failed to update its records with his new address, despite his updating them. According to the Affidavit, in 2005, on receiving the patent, Mr Tsabari requested that a change of address from the address of the Attorney-of-Record to his own address be entered into the Patent Office records. Despite his request, the Israel Patent Office sent a reminder for the renewals to the offices of Dr Mark Friedman, the Agent of Record. According to Tsabari, it was this mistake by the Patent Office that caused the patent to become abandoned. In support of his contention, Mr Tsabari produced a receipt for 272 Shekels which was the fee for updating the patent office register. Tsabari further claimed to have wanted the patent to remain in effect and had attempted to enforce it both in the District Court and in the Patent Office. Furthermore, he’d taken immediate action for reinstatement as soon as he’d learned that the patent had become abandoned.

reinstatement2In light of the circumstances described in the request for reinstatement, Deputy Commissioner Jacqueline Bracha was convinced that conditions for reinstatement under Section 60 of the Israel Patent Law 1967 were met, and, in her ruling of 24 July 2014, she ordered the notice of intent to reinstate published in the patent office journal for opposition purposes.

On 23 November 2014, Going Dutch Ltd opposed the reinstatement. Going Dutch Ltd brands itself Easy2give and was active in an initiative to provide a credit card based gift service at functions and events.

oppositionIn their Opposition, Going Dutch Ltd claimed that the reinstatement was contrary to Section 60 and should not have published. As a fall-back position, they argued that if the revival be upheld, they should be considered as having relied on the patent lapsing and should be indemnified from being sued for infringement, and could continue to utilize the patent under Section 63 of the Law.

In their counter statement of case, the Applicant contended that they did NOT want the patent to lapse. In support of this contention, the Applicant described attempts to commercialize the invention, and included a few appendices to support the claims. However, the Applicant requested that the appendices remain confidential, claiming that they were trade-secrets under the 1999 trade-secret act, and, in her decision of 7 May 2015, The Deputy Commissioner agreed to these remaining confidential.

The patentee also described attempts to enforce the patent against Check-Out Ltd in the District Court, and Check-Out Ltd.’s attempts to have the patent cancelled in a proceeding before the Israel Patent Office. Also, attempts at collaboration with Check-Out Ltd. that were aborted for financial reasons were described.

The Opposer’s Claims and Evidence

The Opposer, Going Dutch Ltd claimed that the reinstatement was contrary to Section 60. They contended that no reasonable excuse was given for the renewal not being timely paid and they argued that the request for reinstatement was inequitable. The 272 Shekels receipt shown by Tsabari was not for a change of address at all. Rather, it was the second renewal paid in 2005 and so the Applicant did not show evidence that the patent lapsed unintentionally. It was evident that the payment in 2005 had nothing to do with the patent lapsing since five years later, in 2010, despite the change of address, one of the owners managed to renew the patent.

The Opposer alleged that Tsabari wanted the patent to lapse. The Opposer learned this from Tsabari’s lack of activity in this area from when the patent was filed until the date of the Opposer’s submission, which indicates that the business had failed and the applicant had lost interest. The business failure of Check Out Ltd. which was a potential partner, further supports the allegation that Tsabari had abandoned the patent.

In cross-examination in February 2013, it transpired that Tsabari was aware of the Opposer’s activities back in 2013, and this supports the opposer’s contention that reinstatement was not sought immediately on learning that the patent had been abandoned.

As supporting evidence to their claims, the Opposer, Going Dutch Ltd, submitted an affidavit of Mr Guy Giyor, who was a founder and former CEO of the Opposer. Mt Giyor testified that the Opposer was established as a company offering various event related services including credit based presents at events. Mr Giyor testified that the Opposer had relied on Tsabari’s patent lapsing and Tsabari’s lack of  business activity  in developing their own initiative. Furthermore, Mr Giyor testified that Going Dutch Ltd started marketing in June 2014, after the patent had lapsed.

 Applicant’s Claims and Evidence

The Applicant detailed his attempts to monetize the patent, and repeated his claims from the application to revive, that the patent had lapsed due to a technical error of the Israel Patent Office, which continued to send reminders to the wrong address, despite a request to change the address of record submitted in 2005.

The Applicant also claimed that the Opposer was acting inequitably and in bad faith since the opposer had started commercializing their invention before the patent had lapsed, and had, in fact, infringed the patent. The Applicant for revival substantiated his claim by submitting newspaper articles that showed that Mt Guy Giyor had taken actions in 2012 and had set up a company in 2012 with the intention as stated in its constitution, of enabling wedding presents to be made at events via credit cards. The Applicant backed his claims with an affidavit.

On 3 February 2016 a discussion was held before the Deputy Commissioner, Ms Jacqueline Bracha, during which both the Applicant and the CEO of the opposer were cross-examined on their affidavits.

Discussion

The legal basis for opposing reinstatement of a lapsed patent is Section 61 of the Law, as follows:

Anyone may oppose a request to reinstate a patent within three months of the decision to allow reinstatement publishing, based on a claim that the Commissioner should not have authorized reinstatement.

The Commissioner’s authority to publicize the decision to reinstate a patent is based on Section 60 of the Law, which defines three conditions for reinstatement that are all required to be fulfilled:

  1. The renewal fee was not paid for reasonable reasons
  2. The patentee did not intend to abandon the patent
  3. The request for reinstatement was filed soon after realizing that the patent had lapsed.

When ruling on an Opposition to reinstatement, the Commissioner has to reconsider whether the conditions are fulfilled in light of the evidence brought during the opposition.

There is a difference in evidentiary requirements for authorizing reinstatement subject to publication of the decisions for opposition purposes as per Section 60 of the Law, and the evidentiary requirements to affirm that decision under Section 61 of the Law. During an opposition, the Opposer challenges the Commissioner’s determination that there are grounds for reinstatement and has to provide a strong case that the Commissioner erred in the assessment.  For more details, see the discussion on reinstatement of IL 15211 which lapsed due to failure to pay the fee; Gershon Eckstein et al. vs. Mezer Peles, Limited Paretnership of Kibbutz Mezer, published 1 April 1984.

After consideration of the claims and evidence of the parties, the Deputy Commissioner concluded that the non-payment of the renewal fee was not actually due to reasonable circumstances.

In the request for reinstatement, the Applicant claimed that the non-payment was due to a mistake of the Israel Patent Office, which, despite his request to the contrary, did not change the address of record. consequently, reminders sent  from the Patent Office did not reach their destination. As evidence of the request to change the address of record, the Applicant produced a receipt for payment of a Patent Office fee of 272 Shekels.

Here it is noted that in the past, as ruled in the Gershon decision, lack of payment of Renewal fees due to the Patentee forgetting has been recognized as a scenario where reinstatement is possible under Section 60 of the Law. See the Eckstein ruling and also the Opposition to reinstate IL 14548 Reuven Margulies vs. Exra Darrel et al. , 12 January 1972. However nowadays, in a slew of decisions on this matter, it has been ruled that failure of the Israel Patent Office to send reminders does NOT constitute reasonable grounds for revival, since tracking these deadlines is the responsibility of the patentee. See, for example, the decision re IL 185526 Chaled A’quad et al. from 24 October 2012, since we are now in an age where the patentee can easily track renewal dates, the onus is on him to show that a patent lapse wasn’t due to negligence or abandonment.

In the decision to allow reinstatement, the Deputy Commissioner had noted applicant’s attempt to update their address and their apparent relying on the Israel Patent Office to remind them of the renewal and the Patent Office’s apparent failure to do so. However, in the hearing on the Opposition to that decision it transpired that back in 2005, a payment was made to renew the patent and not to request updating of the patentee’s address. In a more rigorous examination of the patent office records it transpires that there is no evidence of any request to update the patent office record as to the address of the patentee and no evidence that any fee for this was paid. Back then, the fee for renewals was 272 Shekels and for amending the register was 204 Shekels, so it clear that the payment receipt was for the renewal and not for amending the register.

On presentation of the evidence that the fee paid was for the renewal, the Applicant for Reinstatement (Patentee) was unable to provide further evidence for requesting a change of address and, since he’d kept a copy of the renewal fee, one assumes that he would have kept a copy of the fee for change of address had it been paid. The Applicant neither provided evidence for the alleged request to change address nor any other reasons or evidence justifying the renewal not being timely paid.

The patentee who was not represented, requested to understand why he was being cross-examined, and this was explained to him as follows:

The relevant questions as far as this hearing is concerned are whether you wanted to abandon the patent, and, if you did not intend abandoning the patent, was the failure to pay the renewal fee due to a reasonable reason, and so the question as to whether you were informed of the renewal and whether you are still in contact with Dr Friedman (the agent of record) or not, are the the most relevant questions to this discussion. (Protocol Page 26 line 12).

In addition, the Deputy Commissioner was somewhat surprised that the patentee did not call Dr Mark Friedman to testify that he had not sent a reminder regarding the fourth renewal. Dr  Friedman’s testimony would have shed light on whether actions were taken after issuance to keep the patent alive and what instructions were given to Dr Friedman regarding renewal of the Patent.

The failure to provide testimony from Dr Friedman has negative evidentiary weight. Without a reasonable explanation, one can assume that Dr Friedman’s testimony would not have helped the patentee – See Civil Appeal 548/78 Ms. Anonymous vs. Mr Anonymous, p.d. 35(1)736, 760 (1980):

The Courts have always considered that a party to a decision will not fail to provide evidence that is in his favour. Failure to bring such evidence without clear explanation indicates that such evidence would act against his interests. This assumption is well rooted in both civil and criminal rulings, and the more important the evidence, the more clearly is it not being brought indicative that were it to be brought, it would act against the party bringing it. See Civil Appeal Naftali Schwartz vs. Raminoff Company for Trading and Building Equipment LTD. (Nevo 27 July 2008).

The lack of a connection between the change of address of the patentee and the non-payment of the renewal is evidenced by the fact that eight years later, in 2013, the patentee did pay the third renewal. This was clarified after the hearing when the Patent Office checked their records. This fact was reported to both sides in the 22 February decision, but the patentee did not relate to this in his summation.

The above is sufficient for the opposition to reinstatement to be successful.

Although not necessary to do so, the Deputy Commissioner added that the evidence shows that the patentee was tardy in monetizing his intellectual property. The Applicant showed that four years passed between the patent issuing and the first draft of an agreement with a credit company, and that agreement was never signed. Nearly 5 years passed from the patent issuing until the patentee had a detailed specification for a system based on the invention. The various cases between the patentee’s company Shai For You (Shai means gift) and Checkpoint seemed to have lapsed with Checkpoint going bankrupt in 2014 (see 8870-10-09 Shai For You vs. Check Out LTD 7 January 2014) and Checkpoint’s challenge of the validity of this patent was also abandoned in November 2012.

It is noted that patentee alleged that Check Point abandoned their case due to them collaborating with the patentee. However, since Check Point had requested an extension of time, doubt is cast on the patentee’s version of events.

The Applicant testified that he’d known about the Opposer’s actions back in 2013, which he alleged, infringed the patent.However, the Applicant failed to take any action, and did not even send a Cease and Desist Letter. This also indicates that the Applicant had lost interest in the patent.

CONCLUSION

Instead of justifying his request for reinstatement, the Applicant chose to attach the Opposer, accusing him of tardiness and inequitable behaviour and of attempting to commercialize the patent before it was abandoned.

Mr Giyor even testified that he knew about the patent and undertook various examinations via a private detective t ensure that the sole licensee, Shai Four You LTD> was no longer active. This indicates that he thought that Shai Four All’s patents could be enforced against him. Since Giyor’s company was established in 2012, it does not seem that Giyor had relied on the patent lapsing, and had launched his competing service in May 2013, as is clear from one of his publicity films on the Internet.

Anyone can oppose the reinstatement of a patent. The incentives for so doing are usually economical, typically the desire to utilize the patented invention. In this instance it appears that the Opposer started using the patent prior to it lapsing and waited for the patent to lapse rather than cooperating with the patentee.

equitableIt will be appreciated that the Duty of Equitable Behaviour applies to all fields of law (see Sections 39 and 61 of the Law of Contracts 1973), and the rights to a hearing are not exceptions to this rule see Bagatz 566/81 Eliyahu Amrani vs. The Supreme Rabbinical Court p.d. 37(2) 1 (7 August 1982).  Although this cannot be taken into account in the Opposition itself,  and the Opposer has proven that the patentee had not shown that the abandonment was unintentional as required by Section 60 of the Law, this can be taken into account when ruling on costs. Consequently, due to the Opposer utilizing the patent knowingly prior to it lapsing, no costs are awarded.

Opposition to IL 132450 to Yehuda Tsabari (Shai Four You) by Going Dutch Ltd, ruling by Ms Jacqueline Bracha, 31 August 2016.

 


Extending the Deadline to File Complaint

September 13, 2016

genentechIL 146954 to Genentech is titled “HUMANIZED ANTI-ErbB2 ANTIBODIES AND TREATMENT WITH ANTI-ErbB2 ANTIBODIES”. It is the national phase of PCT/US2000/07366. The active ingredient is Pertezumab.

Pertuzumab received US FDA approval for the treatment of HER2-positive metastatic breast cancer on June 8, 2012.[3] Pertuzumab was developed at Genentech and is now owned by Roche which acquired Genentech in 2009. The drug received regulatory approval in Israel on 8 July 2012, and on 21 February 2013 a patent term extension was requested and this was granted until 11 May 2021.

patent-extensionThe patentee requested an extension of time for responding to an Examiner’s action under Section 161 of the Israel Patent Law 1967. As explained below, the intended response relates to the intention to publish the grant of a patent term extension until the date awarded. However, the intention published in the July 2016 journal.

On 19 February 2013 the patentee requested a patent term extension for IL 146954. The conditions set out in Section 64e(5) of the Law were in place, but at that stage there was no extension to the basic patent in the US as required by 64d(5).  In the January 2015 journal there was an announcement of the intention to grant an extension under Section 64e(5) 1 of the Law.

Afterwards, when the Section 64d(5) requirement was met, the patentee gave evidence of the patent term extension of the basic patent in the US. In that notice the patentee noted that they expected that the Examination would be completed and a corresponding extension of the patent would be granted.

Consequently, the Deputy Senior Examiner completed her Examination and, on 4 July 2016, informed the patentee that the patent was entitled to a 353 day extension until 10 June 2021, which is the length of the extension in the US, and is the shortest of all the extensions granted by an extension granting state, as per Section 64i(1) of the Law.  The Patentee had until 18 July 2016 to respond to this notification.

calculating-sec-154-patent-term-adjustments-1-728-1On 18 July 2016, the patentee responded to this notification. From the wording of the response it is clear that the patentee does not have any problem with the mathematics used in  calculating the patent term extension. However, the patentee noted their position that the Examiner should take into consideration not just the Patent Term Extension period in the US (PTE), but also the Patent Term Adjustment (PTA) in the US.

Without substantive reference to the relevancy or otherwise of the Patent Term Adjustment, it is noted that until the patentee requested that the extension NOT be published, Genentech (Roche) had not raised Patent Term Adjustment (PTA) related issues and even now, did not provide details of the Patent Term Adjustment granted by the USPTO. So the Examiner was under no obligation to relate to this additional time period.

Once the period for responding had passed, and on receipt of the Patentee’s response, the Examiner informed the Patentee on 18 July 2016 that she intended extending the patent protection period in  Israel by the Patent Term Extension (PTE) awarded in the US as per Section 65(e)(5)(3) and that this decision would publish for opposition purposes in the July Journal, and this happened. The request to extend the period for filing a critique was submitted on 11 August 2016, after the publication of the extension order. The contents of the critique, which has not been submitted, is unknown.

The reason put forwards by the patentee for the patent extension is based on the allegation that the current law damages their property rights and they are considering the possibility of changing the current legislation. Thus it follows that the patentee does not contend that the Examiner’s actions were in accordance with current legislation. The requested Extension is until the basic patent lapses, which is until 23 June 2020, or a further year if the Patent Term Extension is also considered.

Thus the patentee does not argue that the Examiner was acting in contravention of the law and admits that the Examiner’s actions were in accordance with current legislation. The Commissioner, Asa Kling, does not believe that a patentee’s intention to try to change the legislation is sufficient reason for the Israel Patent Office to delay publishing its actions; particularly when the action has already happened and happened in accordance with the Law.

So the Commissioner does not see fit to extend the period prior to publication.

In a footnote, the Commissioner does not think that his refusal in any way adversely affects the patentee, since he can always submit a detailed request for recalculation under Section 164(c) of the Law.

COMMENT

In a recent decision the Supreme Court weighed in on a challenge to the patent term extension rules as being unconstitutional, and found that the legislative body can write the rules as it sees fit, to find  a balance between the competing need of the drug developers to be able to profit from their investment and have an incentive to conduct research and development and to file applications, with the public good provided by competition, non-monopolistic markets with generic competition.

The specific issue of the differences in Patent Perm Extensions and Patent Term Adjustments was discussed in a February decision.

I can understand the drug manufacturers considering the current law unfair, but, in light of the amendment to the amendment, it does seem to reflect what the Knesset wants and has been upheld by the courts. I don’t think that Genentech – Roche will be able to  have the Law changed.


Applicant Successfully Has Allowance of Patent Application Cancelled, Following Initiation of Opposition Proceedings

September 12, 2016

reexaminationUsually an Opposition results in an allowed patent being either cancelled, upheld or having its claim-set narrowed. Apparently, not always!

Israel Patent Application No. 240684 titled “GLYCOPYRROLATE SALTS” was filed by Dermira Inc on 19 August 2015. It is the national phase entry of PCT/US2014/19552 and so the effective filing date is 28 February 2014. It claims priority from two provisional applications and from two regular US applications, but the earliest priority claimed was 28 February 2013.

On 18 October 2015, the Applicants petitioned to make special under Section 19(a)(a)(2) of the Patent Law 1967 and requested allowance under Section 17c based on US 9,004,462.

After the application was allowed and published for Opposition purposes, S0l-gel Technologies ltd. opposed the patent issuing. They noted that the case had been allowed under Section 17c, but this was incorrect since the two regular US applications from which priority was claimed were continuations-in-part of US 13/781,390 which published on 15 August 2013.

In the US, the earlier patent application to which material is added in a Continuation-in-Part cannot be cited against the Continuation-in-Part. It is a little like a Patent-of-Addition in Israel.

Since priority is NOT claimed from US 13/781,390 which published 15 August 2013, it is prior art to IL 240684 since its publication precedes the filing of PCT/US2014/19552 on 28 February 2014. Consequently, as far as Israel is concerned, US 13/781,390 could be cited as prior art against IL 240684 and so allowance under Section 17c was wrong, as there is presumption of validity since US 13/781,390 (now US 8,558,008) was not prior art in the US, but is prior art against the Israel application.

Here’s the odd thing. US 13/781,390 was itself filed on 28 February 2013, so the PCT could have claimed priority from it!

In their statement fo case, the Opposer requested that the allowance be cancelled and the case returned to the Examiner for examination on its merits in light of the prior art (including US 13/781,390). The Applicant (represented by Pearl Cohen) agreed with this suggestion.

In his ruling, the Commissioner, Asa Kling, noted that only rarely can an allowed patent be returned to the Examiner. Patent prosecution is a one way street, and after allowance, the Examiner is no longer part of the process. Generally, opposed patents are either invalidated as lacking novelty and inventiveness, or the scope of their claims is narrowed, or, the opposition is overcome or withdrawn and the patent as allowed, is granted.

In this instance, both sides agree to the allowance being withdrawn and to the claims being (re)considered on their merits by the examiner in light of the prior art, including  US 13/781,390, thereby avoiding costly opposition proceedings.

The commissioner noted that agreement of the parties is not generally enough for odd solutions, due to their being a public interest. Generally one does not return an allowed patent application to the Examiners since the public is always third-party to such proceedings. See the ruling on request to cancel allowance of IL 219586 Fritz Collischan GMBH vs. Data Detection Technologies Inc., 9 March 2015, paragraphs 9 and 10 of the ruling.

However, it is clear that the Section 17c assumptions detailed in the Albermarle ruling do not apply here as inventiveness over US 13/781,390 was not considered by the US Examiner as it was not an issue in the States, and so the IPO cannot rely on the US Examiner’s ability, professionalism and integrity in this instance. In the circumstances, for the sake of efficiency, it was deemed appropriate to reexamine rather than to conduct an opposition. The Commissioner allowed the Section 17c allowance to be withdrawn and the case to be returned to the examiners for substantive examination on the merits.

The cancellation of the allowance now publishes for opposition purposes. Costs of 2500 Shekels are awarded to the Opposers; the low sum reflecting the early stage reached.

COMMENT

In this instance, the PCT application could and should have claimed priority from US 13/781,390. The  Opposers could have claimed both invalidity over US 13/781,390 and / or inequitable behaviour in requesting allowance under Section 17c from a continuation in part. There is a public interest in technologies remaining in the public domain. Thus I think this decision could be challenged in an opposition. Still, doing so takes resources and would incur costs. For the same reason that S0l-gel Technologies ltd seem happy with reexamination, I suspect that noone else will file an opposition to this ruling.