IL 195087 Throwing out an Opposition

June 28, 2014

throw out

Novartis filed a patent application, IL 195087, which was eventually allowed and published for opposition purposes on 31 October 2012. Unipharm filed such an Opposition on 3 January 2013, and claims and counter-claims were exchanged. On 2 October 2013, the director of Unipharm, Zebulun Tomer, filed an affidavit.

In response, and in consequence of the nature and contents of this evidence, on 26 November 2013, Unipharm requested that the opposition be thrown out.

Novartis, represented by Luzzatto et Luzzatto, claimed that Unpiharm was misusing the patent opposition procedure by filing a response to the Counter-Statement of Case in the guise of a submission of evidence. As an alternative position, the Applicant was willing to accept that the Evidence be deleted.

In response, the Patent Office noted that courts allow cases to be thrown out in exceptional circumstances, such as Appeal 693/82 Shemesh vs. The Land Registry P.D. 40(2) 668, 671-672 (1986).  Similarly, the Patent Office is willing to throw a case out only in extreme cases (See then Deputy Commissioner Axelrod in 122161, 122162, 122118. Warner Lambert Co. vs. Unipharm, 14 May 2001 :if in a regular Civil dispute, throwing a case out is an extreme measure, how much more so in patent oppositions”. This is particularly the case with patents, since there is a public interest that the patent register remains clean. Essentially, frivolous law suits without a chance of success may be thrown out in early stages, but once the case has started, the sides deserve their day in court. In Warner Lambert, Unipharm didn’t bother filing an affidavit, and the case wasn’t thrown out, so it seems clear that in the present case, where there was an affidavit, albeit arguably a problematic one, clearly there wasn’t sufficient grounds to throw out the case.

With reference to the specific case, the Affidavit seemed top follow the original Statement of Case and didn’t seem to be a widening of the grounds for opposition. Novartis failed to explain why they considered it unacceptable.

The request to throw out the case was thrown out, and the Novartis and costs of 5000 Shekels were awarded to Unipharm.

COMMENT

Whilst there are some patent oppositions that are filed for economical reasons where sometimes there may be minimal legal justification, Unipharm has a strong track record of successfully opposing patents and voiding issued patents. we watch developments with interest.


Secondary Use Claims – Some Thoughts…

June 27, 2014

second use

Yesterday I attended a meeting of the Association of Israel Patent Attorneys in ZOA  House, Tel Aviv. The invitation and program were blogged here.

The topic under discussion was Secondary Use Claims. Unfortunately, I arrived late and missed the first talk by Adv. Yair Ziv, but caught most of Adv. David Gilat’s presentation, that of Dr Ron Tomer, and that of Ena Pugatsch.

The event was well-organized and well attended. From the remains of the refreshments by the time I arrived, they seemed the usual ZOA fayre. Kudos to the committee headed by Ex-Commissioner Dr Noam, for organizing the event. There were 85 participants in the meeting. This is impressive for a highly specialized topic at an event open to a small organization (noting with approval however, that there were both lawyers and in-house patent coordinators present that are not patent attorneys and thus not members, and also trainees).

Adv. David Gilat posited that drug patents were necessary to compensate the drug developers for their investment, and that secondary uses were also the result of research.  Dr Ron Tomer (confusingly called Dr Yaron Tomer in the original invitation to the event) expertly and clearly countered all of Davidi’s positions, and demonstrated that the pharma industry were creatively filing secondary uses that lacked inventive step and were obvious. He gave various examples. Firstly, he referred to sildenafil citrate, originally developed for treating angina and now used almost exclusively as a treatment for erectile disfunction, as a hard problem. (I thought it was a flaccid problem and a hard solution, but I digress). He went on to argue that an oncological drug for one type of cancer may fairly obviously be tried for another type of cancer since the underlying effects of the drug would treat both mutant cells the same way.  He noted that patents were not awarded for research but for inventions. He claimed that there was nothing new in the drug, despite the new use. He gave convincing examples of ever-greening, and also argued that if it is surprisingly found that a drug treatment for gastro-reflux also kills bacteria in the stomach, then the patient using it takes the same drug for the same purpose that he took it for originally. Since the drug is public domain he could take the generic drug, but to kill the bacteria, he’d have to take the patented drug for a couple of weeks and then move back to the generic. similarly, someone taking a generic statin for cholesterol, on being diagnosed as having genetic cholesterol, would have to switch to the patented version offering protection for this ‘secondary use.’ The talk was intelligent and entertaining, and it was a valuable demonstration of the ubsurd results of secondary use patents.

Ena Pugatsch gave an example of a secondary use claim for a mechanical device that issued in Israel and was upheld by the courts. The device in question was a blackboard that could be used as a screen for showing projected images, where the device and method of manufacture were known but the secondary use wasn’t, and the court upheld the patent. Comparing to European case-law and to US law, she felt that the ruling was ‘problematic’ (a nice way of saying that she considered that the court had got it wrong).

When the floor was opened for questions Mr Zebulun Tomer (Ron’s father and the director of Unipharm) took the opportunity, as he has done on other occasions, to give a little impassioned speech, rather than a question. He made some noises about the results of lobbying and argued that Section 7 prohibits therapeutic treatment of the person and that no-one can convince him that a secondary use is anything other than a method of treatment of the person. Instead of merely pointing out that the issue wasn’t convincing him, but of convincing neutral judge, Adv. David Gilat agreed with him, but said that this was precisely what the Use Claim (Swiss type claims) were for – that is, to allow patents for pharmaceutical methods of treatment despite the prohibition for patents for methods of therapeutic treatment, and this was because of the costs incurred in research and development.

COMMENTS

David Gilat spoke well as would be expected from an experienced litigator. Dr Tomer’s response was also very clear and well constructed. Ena Pugatsch is not an orator, nor is Hebrew her first language (or, I expect, her second language). Nevertheless, her talk, though not the most fluent, was the most thought provoking. All three speakers had far too much content per slide, but none are lecturers. Designing good slides is an art.

David and Ron each presented their opposing positions. As Gilat Bareket represents drug development companies and the Tomer family own Unipharm which manufactures generic drugs, their views were hardly unexpected. I suspect that those in the audience actively involved in prosecuting or litigating pharmaceuticals have equally strong positions based on their source of income. (Richard Luthi, another leading litigator who represents pharma, once told me that under the former Commissioner Dr Noam, the pharmaceutical development industry didn’t have a chance. Whether Dr Naom was biased, whether Unipharm had better arguments, or whether Adi Levit is simply a better litigator, is open to discussion).

The percentage of my income coming from work on pharmaceutical patents is very small. I’ve been involved with both local and foreign clients on both sides of the fence. I tend to find the generic companies’ arguments more persuasive, but can’t tell if this is an inherent bias or whether their arguments are actually better. It is also possible that drugs that are opposed or challenged in cancellation procedures are ones that generally should not have issued, and the both the drug development industries and their litigators have an uphill battle. What is clear, is that Unipharm have had some impressive victories in recent years against Mercke, Smithkline Glaxco, Lunbeck, etc.

Ena’s talk got me thinking. I believe that the original Section 7 law against methods of therapeutic treatment is a historic artefact designed to protect doctors from being sued and represents a moral position that despite obvious utility, novelty and inventive-step, such subject matter would not be patentable. It is a remnant from a period predating the modern pharmaceutical industry. David is correct however. Without effective patent protection, drug development companies would not invest the significant sums required to research and bring a new drug to market. The long approval period also justifies patent term extensions. This development is indeed the result of lobbying, but is, nevertheless, justified. What may not have been justified, is to apply the extensions on cases that were already filed, granting the pharma industry a massive handout that perhaps resulted in them NOT investing in developing new drugs.

Drug developing companies can fairly be accused of ever-greening, and their tactics in filing for secondary uses are commercially driven. However, despite the Special 301 Reports, the generic drug industry are not Robin Hood like outlaws. It is there right to challenge the validity of patents, and some applications are allowed that shouldn’t be. Nevertheless, I suspect that sometimes oppositions are filed for commercial rather than solid legal reasons.

The Swiss Claim (use claim) format is a legal work-around the method of therapeutic treatment clause. Use claims are acceptable in European and Israeli law and are essentially method claims. They do not exist in the US, however in the US one can file methods for therapeutic treatment. What one cannot do, is enforce them against the doctor or surgeon.

After TRIPS, it is clear that one cannot exclude drugs from patent protection. One can still have a principle against patenting methods of treatment. However, countries have to allow patent protection for drugs.

As David Gilat reminded us, patent term extensions were indeed allowed as a package with and justified by a bone thrown to the generic industry – the so-called TEVA amendment, allowing the generic companies to experiment and obtain marketing approval, but not to stock-pile generic patents prior to the patent terminating.  However, one right does not balance the other. Mr Zebulun Tomer is correct that the current balance is the result of lobbying. There were lobbyists on both sides. The ‘one size fits all’ patent law does fail for pharmaceutical patents if such patents have, in the past, been allowed after the 20 year expiry date.

As to second use, the first thing to understand is that use claims are method claims and should be treated as such. The Rav Bareakh crook-lock ruling by the Israel Supreme Court allows contributory infringement and inducement to infringe. However, in Srori vs. Regba, the fact that a sink could be mounted flush with the work surface was insufficient grounds to grant an injunction against the importer, since, As Adi Levit argued effectively, the sinks in question could be mounted under the work-surface, or could be mounted with the lip overlapping the work surface (over-mounted) or could be filled with earth and used as a flower-pot.  Thus, the proper infringers were the kitchen installation companies, and there was no effective bottle neck to sue in the supply chain.  Getting back to secondary uses for drugs, lets assume that using aspirin to dilute blood to prevent thrombosis is indeed novel and inventive. This does not prevent patients buying aspirin over the counter for treating aches and pains and then using it for the new patented use. Manufacturers of aspirin are not infringing the secondary use patent. Similarly, generally speaking, patents for secondary uses are not for the drug itself, but for its use in treating a particular illness. They are method claims. I agree with Dr Ron Tomer that the manufacturer is generally not the infringing party. The physician or patient might be, that the US exception against suing health care officials should apply. There are, of course, some particular dosages that are borderline cases. In such cases, the newly packaged drug is a new product. Whether or not, it is also inventive, is arguable.

Referring back to the blackboard; Ena is correct, it was not a new product, nor was its method of manufacture new. The novelty lay in the method of use, i.e. for projecting an image thereonto. The patent provided grounds for suing schools and teachers for direct infringing – both customers of the patentee and of competitors. This is a patent without teeth. If competing manufacturers note that their blackboards may also serve as a screen, is this inducement to infringe? Maybe it would be better for them to note that although the blackboards may be used as screens, this use is protected by Israel Patent Number IL XXXX, and as long as the patent is valid, is not allowed. This is very different from the crook-lock case where the imported part was designed and manufactured for combining with two common elements to provide the crook-lock, and could only be used for infringing the patent, or for a trivial use such as a paper-weight or land fill.

At the end of the day, it is the job of the patent attorney to draft patentable and enforceable claims. I note that in the US, the pendulum has recently swung away from secondary infringement. See US Supreme Court Ruling 12–786 Limelight Networks v Akamai Technologies Inc et al., June 2, 2014. I believe that often these cases result from poor claim drafting, as do Marksman disagreements. In the past, I drafted and successfully prosecuted a  patent for a kitchen sink AFTER Tsrori vs. Negba. See  US6782593B1.  I’ve also had fun drafting together with Adv. and Patent Attorney Tami Winitz a patent for a new method of using an existing heart valve, where I believe the creative claim-set provides enforceability. See US8408214B2.  Patent attorneys drafting applications try to protect their client’s inventions and stretch the law. Litigators opposing patents do the opposite. We all have our roles to play.

 


Novartis Attempts to Get Unipharm’s Opposition to IL 195087 Thrown Out

June 16, 2014
Opposition

Opposition

Israel Patent Application Number IL 195087 to Novartis titled “ANHYDROUS LACTATE SALTS OF NHYDROXY-3-[4-[[[2-(2-METHYL-1HINDOL-3-YL)ETHYL]AMINO]METHYL] PHENYL]-2E-2-PROPENAMIDE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME” was allowed and published on 31 October 2012 for opposition purposes. On 3 January 2013, Unipharm opposed the patent.

After managing to prevent the submission of new evidence, Novartis (represented by Luzzatto et Luzzatto) applied for the opposition to be thrown out claiming that the the opposition had misused the system by submitting new evidence in the guise of responding to applicant’s response to the original opposition.

In his ruling, Commissioner Kling quoting former Deputy Commissioner Axelrod in Oppositions to IL 122118, 122162, 122161 to Warner Lambert Company (also opposed by Unipharm):

If in civil legislation the courts are very reluctant to throw cases out without a proper hearing, how much more so when dealing with a patent opposition [due to the public interest in preventing patents to wrongfully issue]

He went on to quote opposition 121052 Raytheon vs. EL-OP tot he effect that oppositions should only be thrown out if it is clear that they have no chance of succeeding.

 Finally, the Commissioner went on to state that the applicant had not made a strong case that the behavior was inequitable and the additional material was mentioned in the original Statement of Claims.

The attempt to have the case thrown out was thrown out, and costs of 5000 Shekels were awarded against Novartis.

COMMENTS
The decision is correct. In oppositions, both sides typically sail close to the wind with regard to tactics. Unipharm and their representative, Adv. Adi Levit, have a high success rate in opposing pharmaceutical patents that have been subsequently endorsed by the courts.

It will be interesting to see how this case develops.

 


Jerusalem Post Publishes Write-Up on Teva System for Better Prescribing

June 16, 2014

drug variability

Former Employee and patent attorney Dr Moshe Treitel sent me a link to an article in the Jerusalem Post that describes a technology that Teva has developed for better diagnosing. See here for more details.

Quoting Judy Itzkovich’s article:

“As the average Israeli 65 years and older now takes seven different medications for chronic illness, the danger of drug conflicts and complications is high.
In this country, adverse drug reactions (ADRs) are responsible for 4.1 percent of all hospital admissions, while it is 5.7% in Germany, 6.5% in Britain and a whopping 12% in Australia.”

The system, developed by Dr Ronni Shiloh, attempts to minimize adverse drug-drug interactions and to correct doses for specific patients by providing the doctor with a simple graphic interface or GUI on a smartphone or tablet, that summarizes a wealth of medical information in a simple and easy to comprehend graphical interface.

Drug interactions are a major cause of complications, particularly in the elderly. This product may save unneccessary hospitalization and expensive testing, to the benefit of patients, health funds and the Health Ministry alike.

 גילוי נאות – Full Disclosure

I drafted the patent application for Teva and am prosecuting it in various jurisdictions. They out-sourced to me, since despite being Israel’s largest IP firm (that’s Teva, not IP Factor!),  their extensive in-house patent capability is mostly pharmaceutical and molecular biology, whereas this is a computer based system.


BioLineRx Receives Notice of Allowance for US Patent Covering Novel Treatment for Celiac Disease

June 15, 2014

 

celiac

Israeli company BioLineRx has announced their receiving a Notice of Allowance for a US Patent  covering a novel treatment for celiac disease. See http://online.wsj.com/article/PR-CO-20140611-903862.html for more details.

 

 


New Uses for Old

June 12, 2014

new lamps for old

The Association for Israel Patent Attorneys is hosting a seminar on patenting new uses for old drugs.

Speakers include:

  • Adv. David Gilat (RCIP – Gilat Bareket – represents Pharma so assumed pro drug patent extensions, new uses, etc)
  • Adv. Yair Ziv (Assumed to be the one from Shin Horowitz – Teva’s lawyers, could be for or against, depending on whether the new use is for Copaxone or Seasonique, or someone else’s patented drug)
  • Dr Yaron Tomer (Unipharm – the Tomer dynasty is generally against what they see as ever-greening).

This is followed by a talk on new uses for existing products by Adv. Ena Pugatch (RCIP again)

The event is for members only, so Israel patent attorneys who are not members are invited to join.

The event is to be held on 26 June at 4 PM. As usual for the TelAvivocentric organization, the event is held in ZOA. Worth trying to arrive at 3:30 for refreshments, but more importantly, to arrive before traffic hits. To register: shiri.shinfouks@s-horowitz.co.il  

The more formal invitation is מכתב מפגש שימושים חדשים יוני 2014[1].

COMMENTS

We applaud the organization for organizing this. We applaud them for organizing educational events, noting that in the past there were periods when they didn’t.

We urge members to attend so that the committee will continue to organize events.

It does seem a shame that trainee patent attorneys who could certainly benefit from this in terms of increasing their knowledge and perhaps gaining an insight into passing the exams, are not invited. In general, I think that the already-licensed professionals are less interested in on-going education than perhaps they should be.

If this is going to be a Gilat vs. Tomer debate or boxing match, with Ziv refereeing, it could be fun. I had an idea for a similar event once. What is almost certain, is that all speakers will be biased by their business interests. Nevertheless, with both commercial interests represented, the event as a whole may be balanced and will probably be very informative. 

Some secondary uses, like sildenafil citrate for treating male erectile dysfunction instead of for treating angina in menopausal women are a little more convincing than others.  Is the use of aspirin for lowering blood pressure instead of as a pain-killer a new use? Was willow bark extract used in conjunction with blood-letting, and was it considered a pain-killer or blood pressure reductant?  Is treating one form of insomnia by melatonin different from treating other forms of sleeplessness? Is getting sheep interested in intimate relations a month earlier different from advocating such relations as a means of tiring oneself out and promoting sleep?

Is having two out four speakers from RCIP fair and balanced? As I suspect that half the paid up membership of the organization are RCIP employees, probably.  Not totally disproportionate to their market share either.  Then again, Gilat Bareket and Reinhold Cohn are arguably not the same company, so Ena and Davidi are merely partners in firms having an intimate relationship (that’s the firms having intimate relationships and sharing same premises, NOT the two speakers… ).

Both David and Ena are competent professionals and good speakers, as is Dr Tomer. (I don’t think I’ve heard Yair Ziv but he may well be as well). This promises to be a good event.

 


Teva Announces Favorable European Patent Office Ruling in COPAXONE® Patent Proceeding

May 27, 2014

copaxone loepard spots

In a press release distributed by Business Wire, Teva Pharmaceutical Industries Ltd.  has announced that the European Patent Office issued a decision in favor of Teva in a patent opposition proceeding filed by Synthon BV, Mylan and an unidentified third party. On September 6, 2012, the three opponents commenced an opposition proceeding against European Patent EP 2 177 528, a patent for COPAXONE® (glatiramer acetate injection) that expires September 9, 2025.

In today’s hearing, the European Patent Office specifically determined that claims 1-12 of the ‘528 patent are valid. Therefore infringing follow-on glatiramer products would not be able to launch prior to patent expiry.


Foamix Announces 5 New US Patents

April 22, 2014

foamiz

Foamix is based in Rehovot. Foamix describes itself as a clinical-stage, specialty pharmaceutical company, focused on the development, patenting and commercialization of proprietary topical foams and the first topical minocycline/doxycycline antibiotics to address unmet needs in dermatology.

They have just announced 5 new US patents in the second half of 2013, bringing the total to 25 issued US patents.

The new patents cover:

  • The composition of matter of various kinds of pharmaceutical and cosmeceutical foams;

  • Devices for dispensing them; and

  • A novel platform of the topical foam compositions that stabilize unstable drugs such as minocycline and doxycycline, which would otherwise be unstable with other topical carriers.

For more details, see here

Just before Pesach I spoke to one of their in-house patent attorneys, Tami Winitz-Yehezkel, who I worked with a decade or so ago.  We usually chat a couple of times a year, before Pesach and before Rosh haShana. She siad they’ve been busy. I now know why!

 


Cialis Again – District Court Rules that Only Parties to an Opposition have Standing to Appeal the Decision

February 10, 2014

assume a spherical cow

Lilly Icos produce a drug called Tedalafil, which is used to treat male impotence due to erectile dysfunction. The drug, is marketed as Cialis. When their patent application number IL 146742 covering the drug was allowed, TEVA opposed the patent issuing. After cross examination of expert witnesses but before final summaries were submitted, a commercial arrangement between Lilly Icos and Teva resulted in the opposition being dropped. However, then Deputy Commissioner, Noah Shalev Smylovezh ruled that the ‘inventive step’ on which the patent had been allowed was that fine grinding increased the solubility of the active ingredient. He ruled that this was obvious, and so, under authority of Section 34 of the Israel Patent Law, he rejected the patent anyway. This decision of his is correct. Dissolution is a surface effect and for a given mass of material, the more finely ground, the larger the surface area to volume ratio.

Expressed mathematically:

Assume spherical particles:

For a given mass M, the number of  particles n =  M / (4/3πr^3)

The surface area A of each sphere is 4πr^2

Thus the total surface area A = n 4πr^2 = 3M/r

As r shrinks, the surface area increases.

Since perfect spheres have the lowest surface area to volume ratio of any solid (which is why soap bubbles are spherical), for any other shape, the surface area increases even faster as the dimensions decrease.

The standard of obviousness for patentability in Israel is ‘obvious to try’ – see Fosamax decision by Dr Meir Noam, which was upheld by Israel Supreme Court.

Section 30 is there to prevent patents issuing that shouldn’t. This is a patent that then Deputy Commissioner, Noah Shalev Smylovezh had concluded lacked inventive step, and so  under Section 34 he refused the patent, thus ensuring the integrity of the register, allowing generic competition and allowing impotent men and their partners to benefit from cheaper erections.

An earlier posting on Noah Shalev Smylovezh’ decision may be found here.

The applicants requested further clarification, but Deputy Commissioner Noah Shalev Smylovezh’s contract as Deputy Commissioner had ended and he had returned to private practice. Ms Yaara Shoshani, an adjudicator at the Israel Patent Office took over his open files. She clarified the decision but gave the parties 30 days to respond. After reviewing their submissions, she decided not to use her powers under Section 34 of the Law, and to allow the patent to issue. Her reasoning, which overturns Dr Noam’s ruling regarding obvious to try is found here. Essentially she replaces the ‘obvious to try’ standard, with a ‘not necessarily the first thing one would try’ standard.

Unipharm appealed this decision to the Jerusalem District Court, where Judge Ben-Zion Greenberger heard the case.

Unipharm claimed that there was a chain of events that had resulted in a miscarriage of justice and requested that the Jerusalem District Court rehear the case. They claimed that the onus was on the applicant to prove that they deserved a patent and merely because the opposition was dropped, the basic requirement of a non-obvious inventive step remained missing.

Instead of addressing this issue, agent for patentee argued that Unipharm lacked standing since they were not a party to the opposition and therefore the case should be thrown out under Section 421 of the Civil Procedure Law and / or regulations 101 and 102. Unipharm countered that under the Patent Law, 174(a) anyone who sees himself hurt by a patent office decision has the right of appeal.

The Court ruled that before addressing the substantive patentability issue, it should address the issue of standing and relate to the correct interpretations of Sections 30, 34 and 174(a) of the Israel Patent Law and Section 421 of the Civil Procedure Law and / or regulations 101 and 102.  On this point, it ruled not to allow Unipharm standing, and so the patent remained valid and the decision of the Ms Yaar Shoshani Caspi, overturning Deputy Commissioner Smylovezh’ ruling was not addressed.

COMMENTS

This is an unsatisfactory state of affairs. The reason why the Commissioner (or his delegate) has authority under Section 34 is so that in cases where the parties do a deal and an opposition is withdrawn, but the person hearing the case believes that there are grounds for invalidating the patent, the patent office is supposed to continue in the hearing in-partes and rule on validity on the merits.

Ms Shoshani Caspi’s position disagrees with Dr Noam’s standard of obvious – obvious to try. It also overturns Noah Shalev Smylovezh’ conclusions. Unipharm should have filed an opposition, but missed the deadline. Nevertheless, Judge Ben-Zion Greenberger’ws ruling that Unipharm has no standing means that he is avoiding judicial oversight of this decision and doing so on a technicality.

The arguments put forwards by both parties had the usual dose of ‘smoke and mirrors’. The Judge quoted Barak and claimed to be doing an analysis of what the purpose of the Law was, and decided that the correct balance between patentee and opposers and rest of the public was to allow the opposers to appeal, but not third parties.

There is some logic in interpreting patent law in light of standard civil court procedures. But, clearly all generic manufacturers and importers are affected by this decision, whether or not they were a party to the opposition. indeed, the public – at least the male impotent members subsection of the public – is served by preventing monopolistic pricing on the drug in question. It therefore seems to me that the Court of Appeal should address the issues of patentability, specifically the issue of obviousness on its merit.

Maybe a user of Cialis should have filed the case, perhaps as a class action? Perhaps the way forward is for Unipharm to file cancellation proceedings and to make sure that the issue of inventive step is considered on its merits. Alternatively, they can appeal this decision to the Supreme Court.

We note that in a recent decision the Supreme Court ruled that when hearing an appeal of an opposition ruling, the district court can even hear new evidence if appropriate. In that decision, which also challenged a strange Israel Patent Office decision, the Supreme Court ruled that appeals of Patent Office decisions are different from regular appeals of court decisions and an appeal may, if warranted, be a new trial with new evidence. I think that in the present case, it is likely that the Supreme Court would refer the case back to the District Court to consider on its merits. If that happens, I believe the ruling should be reversed.


Adding Evidence in Israel Patent Opposition

February 2, 2014

abbott

Patent oppositions proceedings in  Israel follow a set path.

the Opposer(s) file their statement of case. The Applicant responds, and the opposer submits evidence. Evidence should be submitted at the first opportunity, and applicants are not allowed to submit further evidence at a later stage, to prevent cases being unnecessarily dragged out.

It happens, however, that evidence may sometimes not be submitted at the first opportunity as the  applicant or opponent does not consider it relevant. The statement of witnesses brought by opposing counsel may make it relevant and necessary to add such evidence at a later stage. The Israel Patent Office regulations enable such late submissions, if there is a prima facie basis for determining that the evidence was not submitted earlier, not in order to drag out proceedings, but because either the evidence was not known to its presenter at an earlier date, or because the presenter was unaware of its relevance which only became clear due to statements made by the opposing counsel.

Israel Patent Application No. 122546 to Abbott was published for opposition purposes on 31 December 2012. On 29th April 2012, Teva Pharmaceutical Industries and Vertex Pharmaceuticals Inc. filed oppositions.

In response to the oppositions, the applicant requested to correct the specification. In Israel it is legitimate to correct the specification at this stage provided that such corrections are in no way widening of the requested monopoly.

Opposers opposed the request to amend the specification on legal grounds and thus did not submit evidence. Abbott’s witness argued scientific grounds for allowing the amendment, and so Opposers requested permission to submit evidence against this request. Abbott’s counsel argued that it was too late to submit such evidence and that the Opposers were widening the grounds for opposition.

The topic in question relates to whether the 3A4 enzyme is an example of the P450 family of enzymes.

In his ruling, Commissioner Adv. Assa Kling ruled that there were no sweeping grounds to forbid submission of evidence and on weighing it up, he would see whether the evidence was indeed submitted in response to Abbott’s witness, or if there was indeed, evidence that opposers were filing evidence as a delaying tactic or to widen the scope of the opposition.  He noted that he could award costs to one side or the other when ruling costs on the amendment to the claims.

COMMENT

I think the patent office is taking the correct approach here. the rules for submitting evidence are there to prevent abuse. If the applicant is claiming abuse, he has to support his case.


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