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.


Teva’s at risk launch of a generic version of Atripla for treatment of AIDS withstands challenge in Canada

January 15, 2014

Atripla    atripla 3

On January 13, 2014, the Canada Federal Court dismissed an application by Bristol-Myers Squibb, Gilead Sciences, LLC and Merck Sharp & Dohme Corp.  under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance for Teva’s generic version of its Atripla® tablets (2014 FC 30).

Atripla® tablets are a combination of three anti-retroviral medicines that is used to treat HIV/AIDS.  The three active ingredients are efavirenz, emtricitabine and tenofovir disoproxil fumarate.

Merck et al. sought an order prohibiting the Minister from issuing a Notice of Compliance to Teva until after the expiry of Canadian Patent No. 2,279,198  on February 2, 2018.  The 198 Patent disclosed and claimed novel processes for making a particular crystalline polymorphic form of efavirenz called “Form I”.  However, the only claims at issue were those that claimed Form I per se.

For Teva to infringe the patent, the patent has to be valid and Teva’s actions have to infringe.

Teva alleged that claims 1 to 3 of the Patent were invalid on several grounds, including obviousness, double patenting, claims broader than the invention made or disclosed, lack of utility and anticipation.

With respect to non-infringement, the central issue was whether the crystalline form of efavirenz in the Teva tablets (“Form Teva”) would convert to the claimed Form I during or after the manufacturing process.  As a preliminary point, Merck argued that an adverse inference ought to be drawn for Teva’s refusal to produce samples of its final tablets.  No adverse inference was warranted, however, since Form Teva could be made from a publicly available process and Teva had provided details of its manufacturing process.  With this information, Merck was able to perform experiments in an attempt to establish that Teva’s tablets contained Form I efavirenz.

Merck’s conversion experiments on Form Teva included grinding with a mortar and pestle, heating, and combined grinding and heating in an attempt to demonstrate conversion to Form I. 

Justice Barnes found that the experiments were irrelevant because they were not representative of the Teva manufacturing process.  Specifically, Merck’s expert did not grind the ingredients in a manner analogous to Teva’s manufacturing process. In the grinding experiments, the expert was unaware of the size of the samples that were ground, did not record the grinding pressure applied, and could not recall if he was present for the grinding.  As a result, the Court was unable to conclude that the energy applied during Merck’s grinding studies accurately approximated the forces applied during Teva’s manufacturing process.  Accordingly, the court found that Merck failed to meet its burden of proving that the Teva tablets will contain Form I efavirenz and the application was dismissed.

The Court declined to rule on Teva’s invalidity allegations, instead basing its judgment solely on Teva’s justified allegations of non-infringement.

In this respect, Justice Barnes noted that voluminous evidentiary record, the relatively short period of time remaining in the 24-month automatic stay period, and his finding with respect to non-infringement made it “unnecessary and probably unwise to attempt to resolve the validity issues.”  Nonetheless, Justice Barnes did observe that Teva presented a stronger obviousness case than was previously before him in the Mylan case which dealt with the same patent (2012 FC 1142).


Perrigo attempts to cancel IL 122910 to Genentech

January 8, 2014

PerrigoGenentech

IL 122910 to Genentech is titled “STABLE ISOTONIC LYOPHILIZED PROTEIN FORMULATION”. Perrigo is opposing this patent issuing.

On 17 November 2013, Genentech filed to amend the claims of their application and to close the opposition proceedings. In response, Adjudicator Ms Yaara Shoshani Caspi ruled that the patentee could file any claims that they considered still warranted consideration as per the District Court Order of June 2013. Due to the large number of previous submissions, she gave the patentee 30 days to file a statement of not more than 10 pages with the standard spacing and margins.

Should the patentee not consider additional submission necessary, he was invited to state that this was the case within a week, and Ms Yaara Shoshani Caspi would then rule on the basis of the material in the file

Ruling of 9th December 2012.


Pharmaceutical Patent Term Extensions – Israel Patent Office Considers Request to Grant Extension for Requesting Extension

January 7, 2014

scar jel

Israel Patent Application Number 217056 to Advanced Biotechnologies LTD. is titled Silicone Scar Treatment Preparation.  The patent application is still pending. According to applicant, the patent covers medical equipment marketed in Israel as Kelo-Cote Jell, Kelo-Cote Spray and Kelo-Cote UV. The products were authorized for sale in Israel from 9 June 2013 and are listed in the medical equipment register of the Ministry of Health. On 26 October 2013, the Applicant requested a three month extension to file a request for patent extension in the event that the patent application is allowed and a patent is granted.

64D. States that:

The Registrar shall not grant an extension order, unless the following conditions have been met:

(1) The material, the process for its production or its use, or the medical preparation that incorporates it or the medical equipment was claimed in the basic patent and the basic patent remains in effect;
(2) in respect of a medical preparation—a medical preparation that incorporates the material is registered in the Register of Medical Preparations under regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746—1986 (hereafter: Pharmacists Regulations);
(3) the registration said in paragraph (2) is the first registration that allows the material to be used in Israel for medical purposes;
(4) no extension order was granted previously in respect of the basic patent or in respect of the material.

Section 64(O)a of the Israel Patent Law grants 60 days for filing a request for a patent term extension and this deadline was missed. HOWEVER, Section 64(O)a relates to ‘medical preparations’.

Despite the contention of the applicant that he was requesting an extension for filing a request for a pharmaceutical preparation, the Commissioner considers that the products in question are not medical preparations but rather ‘medical equipment’, and doesn’t think that the time period of Section 64(O)a of the Israel Patent Law refers to ‘medical equipment’, so there is a lacuna as to what the window for filing the request is.

Medical Equipment is certainly included in Section 64 of the Law:

“medical preparation”—any form of therapeutic drugs that underwent processing, including a preparation for use in veterinary medicine and a preparation of nutritional value intended to be injected intravenously;
“material”—the active component of a medical preparation or salts, esters, hydrates or crystal forms of that component;
“the basic patent”—the patent that protects any material whatsoever, including a process for the production of a material, use of a material, a medical preparation that incorporates a material, a process for the production of a medical preparation that incorporates a material or medical equipment that requires a license in Israel (hereafter: medical equipment).

and it would appear that the requirements to allow a proper period for filing a request for extension are analogous for ‘medical preparations’, see  Re Asta Medica Aktiengesellschaft 101537, 108704, 92904 from 2002.

Consequently, the Commissioner ruled that Applicants have three months in which to submit a request for a patent term extension of the basic patent, from the basic patent No 217056 issuing, if it eventually issues.

COMMENTS

Section 64 A defines a “medical preparation” as any form of therapeutic drugs that underwent processing, including a preparation for use in veterinary medicine and a preparation of nutritional value intended to be injected intravenously. Section 64O. States that an application for the grant of an extension order shall be submitted in the prescribed manner, after the fee has been paid and not later than 60 days from the registration day of the medical preparation under the Pharmacists Regulations.

In this ruling, Commissioner Kling has decided that these materials are medical equipment and not medical preparations, and therefore the 60 day deadline does not apply. There is no deadline for medical equipment, so he is creating one and setting it as ninety days from patent issuing and not sixty days from receiving regulatory approval.

I can see cosmetic preparations being not considered as medical preparations, but in that case they would not be considered as medical equipment either. The title of the application implies that these are preparations, if not necessarily therapeutic. Apart from the hair splitting, I fail to see the logic of granting ninety days from patent issuance for medical equipment but sixty days from regulatory allowance for medical preparations. If there is a lacuna, then the time period for medical equipment should be learned from and be the same as the period for medical preparations.

The preamble of the main claim is “A spreadable preparation for aiding in the healing of wounds”. I think this is a medical preparation and the deadline was missed, not for the first time by the agents of applicant, see here. The time frame is extendible by the commissioner, but the standard should be despite the applicant exercising Due Care. We have no indication what happened and why the application wasn’t made within 60 days.

We note that in the Novartis case then Acting Commissioner Yisrael Axelrod gave a liberal interpretation of the patent term extension rules  in accordance with the 1998 amendment and was subsequently sideways promoted to the Beer Sheva District Court, i.e. literally out into the desert, and the Knesset reworded the law to make his interpretation untenable. The intention of the Knesset was not to grant a reasonable extension under reasonable conditions, but to make it as hard as they could to get patent term extensions. Each amendment to make getting extensions easier was under US political pressure. Each amendment not under US pressure was to make it more difficult.

This is an ex-partes ruling but we suspect that if and when the patent issues, the request for an extension will be opposed and eventually the courts will have their say, if the law concerning patent term extensions is not amended AGAIN in the meantime.  It is probably the numerous amendments to this chapter of the Law under US pressure that has resulted in these “lacunae”.

In the meantime, it appears that RAFA is supplying the product in Israel. See here 


Pfizer Settles Viagra Patent Litigation With Teva…Bit of a Letdown

December 17, 2013

Viagra

NEW YORK, Dec 17, 2013 (BUSINESS WIRE) – Pfizer Inc. announced that it has settled its litigation against Teva Pharmaceuticals, USA Inc., relating to Pfizer’s patent covering the use of Viagra(R) to treat erectile dysfunction (sildenafil citrate 25, 50, and 100 mg tablets), which expires in April 2020 (including pediatric exclusivity). As a result of the settlement, Teva will be allowed to launch a generic version of Viagra(R) in the United States on December 11, 2017, or earlier under certain circumstances. Teva will pay Pfizer a royalty for a license to produce its generic version. The terms of the settlement agreement are otherwise confidential. Teva has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Viagra(R).

Teva obtains a licence to launch before patent term runs out. Pediatiric exclusivity? What are kids taking this for?


Oramed Receives European Patent for Oral Delivery of Insulin

November 20, 2013

Oramed

Oramed is an Israel company that is doing clinical trials for orally delivered insulin. This is a holy grail for diabetes sufferers who currently have to have regular injections which is unpleasant and can cause infection. For hemophiliacs with diabetes, injections are obviously particularly problematic.

Oramed has now received a European patent for their invention. See here. The patent in question was drafted by Dr Moshe Tritel who unfortunately for me, stayed with JMB, Davis Ben-David, when JMB Factor & Co. disbanded a couple of years ago. Oramed, of course, stayed with Dr Tritel.

Testing for insulin still requires pricking one’s thumb and extracting a drop of blood. One of my Israel clients, AD Integrity, has developed a non-invasive way of monitoring glucose content in blood.

These Israeli inventions are set to revolutionize the lives of the growing number of diabetes sufferers.


Revision to the Israel Patent Law Revision Regarding Patent Term Extensions Revised Again

November 18, 2013

bullyingSpecial 301 Reportwatching you

Back in January 2010, an agreement was reached in Washington in talks headed by Israel Ministry of Industry, Trade and Director General Sharon Kedmi, under which Israel agreed to amend the Patent Law to make it more difficult for Israel’s pharmaceutical industry to launch generic equivalents of patented drugs. Instead of one country needing to have approved the patented drug for 9 years, now two countries, the US and a major European market, will have to have approved the drug, giving the drug developer more opportunity to capitalize on the investment made. The bait offered to Israel to make the required amendments, was that Israel would be taken off the Special 301 List of IP offenders, and be regulated to the Watch list. For more details, see here. 

As Israel did not make the required amendment, the country was returned to the blacklist of IP offenders in 2011. For more details, see here.

The proposed amendment, Amendment 13 to the Patent Law, may be found here. It is due to be debated by the Knesset this week.

COMMENT

The US pressure is the result of lobbying by US drug industries, and has little to do with Israel breaking international copyright and patent treaties. The main ramifications of this amendment is that drugs will become more expensive and Teva may have to make further cutbacks.


Copaxone survives attack by Mylan in Dutch Court

October 7, 2013

Copaxone2

The District Court of the Hague (Netherlands) has rejected a patent revocation suit brought by Mylan B.V., a subsidiary of Mylan Laboratories Inc., against the patent covering Copaxone, a treatment for Multiple Schlorosis that is patented by Teva Pharmaceutical Industries Ltd. The Dutch court upheld the validity of Teva’s European Patent, which will remain in force until May 2015. The favorable ruling follows a similar ruling by the English Court of Appeal in July 2013, which also affirmed the validity of Teva’s patent.


Reinstatement of 160368 to Pfizer

October 3, 2013

The third renewal for Israel Patent Number 160368 to Pfizer titled “PACK CONTAINING MEDICAMENT AND DISPENSING DEVICE” should have been paid in August 2012 and wasn’t. The application lapsed six months later and the fact that it had lapsed published in March 2013.  During July 2013 inquiries were made and in September 2013, a request for reinstatement was filed.

In this case, the first and second renewal fees were paid by the agent of record (Luzatto and Luzatto), but the applicant transferred the renewal to a renewal service to pay the third renewal. Now the renewal service was supposed to pay the third renewal and informed the patentee that it was paid. The agent of record noted that the patent had lapsed and made inquiries. Since the patentee could show intent to pay renewal fee and since the time that past from patent lapsing until request for reinstatement wasn’t more than a few months, Deputy Commissioner Ms Bracha allowed the patent to be reinstated.

COMMENT

Renewal services are difficult to compete with on price. On the other hand pharmaceutical patents are sometimes very valuable indeed. For a renewal agency, a patent is a number. For an agent who prosecuted it, the patent is often a little more tangible. One wonders if Pfizer changed renewal agencies after this development?

Superficially, this case bears some resemblance to the just reported lapsed patent for Baruch Cohen. Cohen’s patent was for a pack containing food, whereas Pfizer’s patent is for a pack containing a medicine. Both went abandoned due to lack of payment of the renewal fee. The differences are significant. I think both decisions are reasonable.

 


Follow

Get every new post delivered to your Inbox.

Join 256 other followers