Amending the Specification of an Opposed Patent Application

July 7, 2016

abbvie.png

Under Israel Law, allowed patent applications publish for opposition purposes for three months prior to issuing. If an opposition is filed, the issuance may be delayed for rather longer, if the patent issues at all.

As a general rule, the Applicant may amend ‘scribal errors’ i.e., typos in the specification and may narrow the scope of coverage of the claims, but cannot add material or widen the claims to cover something not previously within their ambit. In practice, applicants often request amendments that are allegedly permissible but which the opposer considers as somehow adding material or widening the monopoly sought. Sometimes amendments are opposed as a delaying tactic as until a patent issues, it cannot be enforced.

In the present instance, the application in question is IL 122546 to Abbvie Inc. titled “COMBINATION OF RITONAVIR AND A DRUG METABOLIZED BY CYTOCHROME P450 MONOXYGENASE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME”, which was filed two decades ago on 28 June 1996 by Abbot Laboratories as the national phase of PCT/US1996/0011015 which itself claims priority from a US provisional application (no 60/000654) filed on 29 June 1995. The case was transferred to Abbvie in June 2013.

The case was allowed and published for opposition purposes on 31 January 2012, and on 29 April 2012 oppositions were filed by Vertex Pharmaceuticals and by Teva Pharmaceutical Industries LTD.

Abbvie petitioned to amend the claims and this interim ruling relates to the proposed amendment and examines whether it is supported and whether it is indeed a narrowing of the scope of the claims.

last minuteIn his ruling of 2 May 2016, the Commissioner Asa Kling allowed the amendments to the claims but this is an interim ruling anyway and the patent, if eventually granted, will lapse anyway 20 years from filing on 29th June 2016. This begs the question as to the point of continuing with the opposition?!

The ruling has been carefully translated and is reproduced below but I have added a break as it may not be of interest to everyone…

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Israel Commissioner Vindicated by Supreme Court

June 22, 2016

appealMerck & Co. LTD is the exclusive licensee of IL 110956 for Ezetimibe owned by Schering Corporation. The patent protects the active agent Ezetimibe as found in the pharmaceutical Ezetrol, or Zetia, which reduces the amount of cholesterol in the human body. The original 20 month patent term lapsed on 13 September 2014. However, on 22 September 2005 the patentee received a patent term extension until 23 June 2017. Later however, in September 2014, following a submission by the Association of Industrialists in Israel, the Commissioner of Patents, Assa Kling, ruled that the patent term extension for IL 110956 for Ezetimibe be shortened until 22 January 2016 on the basis of the subsequently issued, shorter patent term extension of the corresponding US patent, and awarded costs of 40,000 Shekels from Merk to the Association of Industrialists.

constitutionalMerck, represented by Liad Whatstein, appealed the ruling, using arguments that failed to persuade the Commissioner, including that the law itself was unconstitutional since it destroyed property rights which were recognized in basic laws (section 8 of the Basic Law of Human Dignity and Freedom. 1980. Furthermore, the fact that the subsequent amendment to this section is not retroactive supports the allegation of lack of constitutionality.

In Appeal number 5407-11-14, the Jerusalem District Court upheld the constitutionality of the Law but recalculated the extension until October 2016 based on the duration of the corresponding German patent.  On 11 April 2014, a tribunal of Supreme Court Judges Danziger, Hendel and Shaham heard an Appeal by Merck on the constitution issue, and one by the Association of Industrialists in Israel wanting the shorter term calculated by the Commissioner to be restored. The Association of Industrialists in Israel were represented by Adv. Tal Band, and the Legal Counsel to the Govt. Ms Shimrit Golan joined the Appeal on behalf of the government.

On Appeal Judge Hendel of the Israel Supreme Court reviewed and justified the various amendments and ruled that shortening the period of a previously ruled Israel Patent Extension Order during the 20 year pendency of the original patent was constitutionally sound, as was doing it on the basis of a subsequently issued shorter protection period from a recognized country.  Judge Handel painstakingly but beautifully explained the background to the patent term extension legislation and why it was filling to link Israeli extension periods on those granted abroad. He jsutified the extension regime which is an exception to patent norms, and threw out Merck’s argument. The rigorous analysis was concluded by a section on comparative law where Judge Handel first related to Mishpat Ivri (Jewish Civil Law) and showed that there were echos of intellectual property rights in the Talmud, and that scholars of the 19th to 21st centuries related to patent law. He argued that the Jewish tradition recognises both quasi-property rights in inventions and creative activity but frowns upon tradesecrets, particularly with respect to pharmaceuticals, noting the case of Rabbi Yohanan a handsome scholar that lived in Zipporis in the Galilee who contracted scurvy, and then broke the trust of a roman matron that cured him, revealing the cure in his sermon, because of the public interest. The analysis of the Jewish sources was masterful. Then Judge Hendel briefly reviewed the US law and its developments, concluded that the US and Israel were both trying to create a fitting balance between the needs of the drug developers to benefit from a real period of protection after obtaining regulatory approval to enable them to sell their drugs at a premium and recoup their investment, and the needs of local generic drug companies to be able to compete with their foreign counterparts but them being able to conduct acts required to obtain regulatory approval during the extension period. Judge Handel noted that there was public interest in encouraging drug development by pharmaceutical companies who had to make enormous investments to bring new treatments to the market. However, there was also significant public interest in widespread and affordable drugs.

Merck’s appeal was rejected by Judge Handel and Judges Danziger and Shaham concurred without comment. Judge Handel noted that were Merck NOT to have appealed, the Appeal by the industrialists on the District Court’s actual calculation would not have been heard, so Merck’s second appeal actually resulted in a shorter patent term extension than they would have received otherwise.

I consider this ruling objectively important and very well written. Due to the significance of the issues raised, I have translated the entire ruling to make it available to non-Hebrew speakers, noting that computer translations were of little value. I have posted the full translation below the following page break as a public service. I have not used the term ‘ethical’ which Judge Handel used to refer to the drug developing countries, and occasionally have not translated idioms, or used an English language metaphor where it appears to be appropriate. The illustrations to the ruling are my contribution. I think they liven things up a bit. If you find them distracting, adjust your settings to view text only! Please note, translating this took a few days and I put billable work aside to the chagrin of various clients. I would appreciate that anyone using this translation has the decency to attribute and to link to this blog.

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Can a Patent Opposition be Suspended?

June 14, 2016

On IL 181596 to Insight Biopharmaceuticals LTD titled “PROCESS FOR PREPARATION OF MIXTURES OF POLYPEPTIDES USING PURIFIED HYDROBROMIC ACID” publishing for opposition purposes, Teva Pharmaceutical Industries LTD filed an Opposition.  However, just before publication, Insight filed a Divisional Application (IL 241702).

Teva requested that the Opposition be suspended, pending Examination of the Divisional application claiming that the claims of the two cases are substantially identical and that Insight agreed to the suspension.

Ms Jacqueline Bracha has given Insight 14 days to agree to concur to the request to suspend the Opposition and to explain why it is an appropriate action to take in this case.

 


Glaxo Receive Patent Term Extension but Warned to be Polite

May 16, 2016

patent term extension

The Glaxo Group LTD requested a patent term extension for IL 178152 titled “4-[HYDROXY(DIPHENYL)METHYL]-1-{2- [PHENYLMETHYL)OXY]ETHYL}-1- AZONIABICYCLO[2.2.2] OCTANE BROMIDE USEFUL FOR TREATING MUSCARINIC ACETYLCHOLINE RECEPTOR MEDIATED DISEASES, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT “.

The Application was filed on 27 April 2005 and was granted on 1 September 2011 and registered in the name of the Applicant. On 21 April 2015 the Applicant requested a Patent Term Extension based on the medication called ANORO ELLIPTA. According to the Ministry of Health, this medication includes two active ingredients: Vilanterol and Incruse Ellipta which includes the active ingredient Umeclidinium which was registered for sale on 8 February 2015.

The active ingredient Umeclidinium is the subject of claim 1 of the patent and the medication itself is claimed in claim 3.

An Affidavit from Mr Fowler, a Glaxo representative, was appended to the Extension request. This affirmed that Anoro Ellipta was the first medication registered for usage in Israel which included the active ingredient Umeclidinium.

The earliest approval for Anoro Ellipta was from the FDA in the United States and issued on 18 December 2013. Even now, the drug has not received a Patent Term Extension in the US, and the request for a Patent Term Extension in Israel is under Section 64 e(5) of the Israel Patent Law 1967 as currently amended.

The Patent Term Extension abroad that is the basis of the request in Israel is the Patent Term Extension Italy, which until the filing of the request for a Patent Term Extension was the only extension given by a recognized (Bolar) country. Since then, France and Spain have issued similar extensions.

In a letter from the Deputy Chief Examiner dated 19 May 2015, the Applicants were asked whether the combination of  Vilanterol and Umeclidinium in Anoro Ellipta creates a new active ingredient, since claim 1 claimed one active ingredient and claim 3 claimed the combination. In the same letter, the Deputy Chief Examiner noted that Vilanterol was already the subject of a patent term extension request and therefore the Application was not the first application as per Section 64(d)4.

In response and with a further Affidavit from Mr Fowler, the Applicant countered that on the basis of this being the first medical usage of Umeclidinium, the medication Umeclidinium deserved a patent term extension and this was the first time this active ingredient was registered. That Vilanterol had previously been registered was immaterial.

The Deputy Chief Examiner disagreed. and on 28 July 2015 ruled that this could not be considered the first usage under the Law, since the Applicant failed to show that the combination created a new medication. Furthermore, if a new medication is indeed created then the basic patent does not support this combination. She went on to affirm that in her opinion, the previous registration of Vilanterol rendered the combination of Vilanterol and Umeclidinium impossible to be considered as a first use and thus entitled to a Patent Term Extension.

The request was rejected and the Applicant appealed to the Commissioner, submitting a further affidavit, this time signed by Helen Quillin, the Deputy President of Glaxo and an employee thereof since 1993. the Affidavit affirmed that Anoro Ellipta is a ground breaking drug for the treatment of chronic lung blockage. The Applicant contends that the application for a patent term extension is legitimate. As far as the request relates to Umeclidinium as claimed in claim 1 of the ‘152 patent; the registration of this drug on 28 January 2015 was the first registration in Israel. Even if Umeclidinium combined with Vilanterol creates a new medication, it still fulfils the requirements of Section 64d(1) of the Law since bot the combination and Umeclidinium alone cannot be considered to have been registered earlier. It is noted that this is the first time that Applicant related to the question raided by the Deputy Chief Examiner.

The Question of the first registration of a drug combination has been related to a number of times by the patent office. What is required is that the registration in question is the first registration of the active ingredient.

Thus, for example, concerning Novartis AG 97219 (decision from 26/12/2005), the then Commissioner ruled that the term composition in section 64a is in the singular, and intends a single active ingredient. The then Commissioner stated that where a patent term extension is applied for on the basis of a patent for a combination of active ingredients and at least one of these had not benefited from prior Ministry of Health Approval, a patent term extension was possible. Furthermore, the District Court related to this in an appeal of the above case to the Tel Aviv District Court (1062/06 Novartis vs. Commissioner of Patents 26/2/2007) where it is stated that the term  חומר – material or matter implies the active ingredient and not the specific formulation, so long as the formulation is not more than the sum of its parts. Furthermore, in the Lundbeck decision concerning Cipralex, the isolated right hand molecule was not considered a new substance when compared to the  racemic mixture.  the court explained that the active ingredient may assume different forms, such as salts, and even if a drug is the first use of a particular form of the active ingredient, if the active ingredient has previously been registered in a different form, the second registration cannot be considered as the first registration of the active ingredient.

Based on the above, one can conclude that Anoro Ellipta is the first permitted usage of Umeclidinium and may be entitled to a drug term extension under Section 64d(3).

Vilanterol has been previously registered. As explained in 117459 Merck vs. Sharp and Dohme Corp. the previous registration of one active ingredient that is found in a new mediation that includes several active ingredients need not necessarily prevent the new medication from benefitting from a Patent Term Extension.

Anoro Ellipta,  like Umeclidinium, is entitled to a patent term extension and claim 3 which states: 

“3. A pharmaceutical composition according to claim 2, which further comprises one or more other therapeutic ingredients.”

does not detract from the fact that the composition contains Umeclidinium and is entitled to protection for that reason.

The Applicant does not consider that  Umeclidinium and Vilanterol form a new compound. This in Ms Quillin’s statement:

“The combination of these two active pharmaceutical ingredients does not create a new compound that differs from each of its components. In fact, each of these active ingredients is stored as a separate dry powder composition within the ELLIPTA™ inhaler of the ANORO™ ELLIPTA™ inhalation product.

The inhaler prevents the two ingredients from coming into contact with each other.

On the basis of the above analysis, the basic patent for ANORO™ ELLIPTA™  is extended by 965 days until 18 December 2027 and this decision will be published for opposition purposes in the forthcoming journal. The calculation is based on the Italian patent term extension and from the first published use in the US.

As an after-note, the Commissioner cautioned the Applicant for making disparaging comments about the Deputy Chief Examiner which should not have been made, and that a certain decorum is required when interacting with examiners.

COMMENT

I think the Deputy Chief Examiner was concerned that allowing a patent term extension for a combination of drugs or a cocktail could enable the unscrupulous to obtain an extension for a drug previously published by combining it with something new or at least not previously published.


Request to Revive Patent Refused

May 10, 2016

mistakes

The Israel Patent Office has ruled that an inadequate payment occurring in a manual docketing system is unreasonable because IP firms should have computerized systems. Despite the client wanting to renew a patent, the attorney of record taking steps to renew, but making a mistake, and attempting to rectify on discovering the error which the Israel Patent Office could have (and in my opinion should have) brought to attorney’s attention, the patent cannot be reinstated!

Asterias Biotherapeutics Inc. owned Israel Patent Number 159324 “A method of differentiating PPS cells into a population of neural cells using TGF-8 super family antagonists”. The patent was filed on 20 June 2002 and issued on 31 July 2o12, so the Applicant’s representative, Colb, should have paid the first, second and third renewals for years 1-6, 6-10 and 10-14. They inadvertently only paid the first and second renewal and the IPO sent a certificate for the second renewal but failed to note that the third renewal should also have been paid. The patent lapsed and this fact published in the August 2013 journal.

Asterias Biotherapeutics, represented by Colb, attempted to reinstate the patent by arguing that there was a mistake by an office worker of the Agent of Record, and only the first and second renewals were paid. The worker docketed the next renewal for 20 June 2016. This date was calculated manually and was docketed in a diary by hand as is clear from an appendix to the submission to reinstate the patent. As the June deadline approached, the status of the patent was checked and it was discovered to have inadvertently lapsed. The Patent Office confirms receipt of the first two renewals and issued a renewal certificate for years 7-10.

The Deputy Commissioner ruled that there is no doubt that the Applicant wanted to renew the patent and that close to realizing that it had lapsed they took steps to revive the patent. However, under Section 60 of the Israel Patent Law 1967, there is a further consideration, namely whether the circumstances leading to the renewal not being paid can be considered reasonable. The Deputy Commissioner, Ms Bracha was not convinced that the Agent of Record had behaved reasonably.  She was unclear as to whether the renewal dates were calculated and recorded manually or whether they used a computerized system as is generally the case. Therefore the request for reinstatement is denied.

COMMENT

I strongly object to this ruling. Any computer system ultimately will require a person to enter data and to correctly act upon it. The Israel Patent Office has successfully computerized itself over recent years but still makes mistakes. I’ve seen papers from other attorneys relating to other applications misfiled by the Israel Patent Office in applications that I am responsible for. Other patent offices around the world still use manual ledgers.Before setting up my own practice, I worked at Seligsohn & Gabrieli which was then run by the late Arnan Gabrieli. He was old-fashioned and didn’t believe in computerization and saw computers as electronic typewriters. Everything was docketed by hand in ledgers by a receptionist. She was diligent as she knew that any mistakes would cost her her job. The system, though primitive, worked.

The Law does not require computerized docketing. Nor do the regulations.  Computerization enables streamlining and staff reductions which may result in lower operating costs that may be passed onto the clients as lower service charges. It is more efficient. It is not, however, more reliable. Ultimately it relies on humans entering data into a computer and a wrong keystroke can result in an error. Mistakes happen in both manual and automated systems.

I really do not know how many IP firms use manual diaries, how many use spreadsheets and how many have expensive software. I do know that some software has proven unreliable. Some vendors have gone out of business and some firms have not got around to selecting renewal or docketing software. The difference is one of setup costs and operating costs. I am not sure that any one is more reliable. Ultimately a person has to look at the record and typed instructions into the IPO website to pay the renewal on line.

In the USPTO website, one has to enter a patent number and the corresponding application number so that the two numbers have to correspond. This safety feature prevents mistyping causing an error in identifying a particular patent. The USPTO renewal interface not only informs the user that a payment is or is not due, but calculates the amount and whether extension fees are required. In contrast, the IPO system is not, or at least was not automated. Typing the patent number, the fee is not calculated automatically. A person still had to type in that he was paying the first, second (and third) renewal, possibly with extension fees. This stage is prone to mistakes. Even if handled by a patent attorney and not a paramedic paralegal mistakes can and do happen.

Until recently, once one had paid online, one had to print out and forward the ruling to the patent office.  Sometimes the system crashes and one has to start again. One pays by credit card on the Israel Patent Office website but at least until recently, one then had to print out the payment slip, send it physically to the patent office and they had to correctly enter the details and then print out a certificate. I had a case that went abandoned and was revived where I could prove that the payment was made and was received by the Israel Patent Office because I paid renewal fees for two separate cases on the same A4 receipt, and only one was docketed by the Israel Patent Office. Since I had paid and sent them the proof of payment, clearly the data was entered wrongly their end. It happens. It happens at the patent attorney end as well and will happen with both computerized systems or manual ones.

Now, Colb has a large and profitable, established practice. The docketing solution appropriate for him may be beyond the reach of smaller practices. But smaller practices grow. When does a firm need to graduate to a dedicated software practice and when can they rely on a spreadsheet or on a manual solution? If Colb successfully managed for decades with a manual system and built up the practice before computerized systems became available, should the firm be forced to change? The Israel Patent Office is justifiably proud of their ISO certification. Some patent firms have such certification, others do not. ISO requires procedures. It does not require these to be computerized.

As Colb has been found unacceptably negligent in not having a reasonable solution, Asterias Biotherapeutics can sue them for negligence and pharmaceutical patents that are worth renewing 12 years after filing and 13 years from priority may be extremely valuable. I do not believe that any IP firm can afford to insure themselves for claims of tens of millions of Shekels. I predict that Colb appeals this ruling to the courts. I hope that and appeal to the IPAA, the AIPPI, the IPR forum and other representative bodies to file amicus briefs supporting such an appeal. 

In a recent posting, I argued that Einav Zilber wasa more appropriate chairperson of the Israel Patent Attorneys Association (IPAA) than her predecessor, the venerable Dr Meir Noam since he was previously the Commissioner of Patents and is thus conflicted if the Association has to challenge a Patent Office ruling or procedure. I think that this type of case amply demonstrates what I mean.

One more comment. Section 60 allows reinstatement if a mistake is reasonable. In one of her first rulings, Ms Bracha allowed a human error by Reinhold Cohen that resulted in a deadline being missed, to be extended. In that case, relating to patent term extensions, the Law (Section 64) requires the mistake to be unavoidable. It does not allow due care or unintentional mistakes to be rectified. Nevertheless she ruled that human errors are unavoidable. That ruling was in 2012, not long before this mistake occurred. Why didn’t she rule that RCIP should have had a computerized docketing system?


Patent Opposition Withdrawn But Applicant Not Entitled to Costs

May 9, 2016

piggy bank

Israel Patent 178249 to ASTELLAS PHARMA INC. titled “Pharmaceutical Composition for Use in Solid Formulation Crystalline Solifenacin or Salt Thereof and a Process for its Preparation” was allowed, and on publication, TEVA filed an opposition. Astellas amended the claims three times and eventually Teva withdrew the Opposition. Astellas then filed for costs, claiming that as the Opposition was withdrawn, they had technically won!

The Deputy Commissioner Ms Jacqueline Bracha took a dim view of this, and noted that although she had awarded costs to Teva for their successfully opposing some of the first set of amendments, the Applicant had been allowed to narrow the claim set and make clarifications under Sections 65 and 66 and the resulting claims were significantly different from those originally allowed.

Astellas and Teva were allowed three sides without appendices for their costs requests but although Teva fulfilled this condition, Astellas submitted reams of paper. Furthermore, even with the opposition withdrawn, Ms Bracha had notified Applicant on 21 February 2016 that she intended exercising her authority under Section 34 and to disallow the patent from issuing as it appeared that a case had been made that there was no novelty or at least no inventive step. That as may be, Astellas could not be considered as having won the Opposition, and she saw no reason to award them (or Teva) costs.

 


Israel Patent Office Refuses to Reject Patent Oppositions Out of Hand

April 10, 2016

patent opposition

When a patent application is allowed in Israel, it publishes for Opposition purposes. Third parties have a three month window to file oppositions. But what happens if the last day of the three month period is a weekend or holiday?

Unipharm filed two Oppositions to pharmaceutical applications that published in the October journal on 29 October 2015.

One application was IL 199215 to Janssen Sciences, Ireland UC titled “POLYMORPHIC FORMS OF A MACROCYCLIC INHIBITOR OF HCV”. The other case was  IL 181734 to Bayer Healthcare LLC, titled “POLYMORPH I OF SORAFENIB TOSYLATE, PHARMACEUTICAL COMPOSITIONS COMPRISING IT AND ITS USE IN THE MANUFACTURE OF MEDICAMENTS”. In both instances, Mr Zeebulun Tomer , the CEO of Unipharm filed the Oppositions himself without bothering with legal representation. In the second case against Bayer, Teva Pharmaceuticals also filed an Opposition (via Shin Horovitz).

The three month period for oppositions ended on 29 January 2016, but this was a Friday. On the first working day, i.e. Sunday 31 January, 2016 the two oppositions were filed.

Bayer and Janssen, both represented by Gilat Bareket and Partners, requested that the Oppositions be rejected as they were not filed in a timely manner, since the three month period had passed.

Now the deadline of three months as stated in Section 30 is not extendable. The Applicant argued that Friday is a working day and despite Section 10(c) of the Law of Interpretation, argued that there was no reason not to have filed the objection on the Friday.

The Applicant (unrepresented!) cited patent office circular 003/2011 to the effect that the Israel Patent Office is open Sunday to Thursday, from 8:30 to 13:30 . The regulations state that the patent office is not open the public on Fridays.

Theoretically, the Applicant could have filed on line on the Friday (or indeed on the Saturday) but the Law does not require him to.

The appeals to dismiss was rejected and the Oppositions will proceed on its merits. Costs of 1000 NIS were awarded to Dr Tomer.

COMMENT

I think this ruling was obvious to practitioners. Possibly it has not previously been litigated, but that imply that it was obvious to litigators as well, as I am sure this is not the first time that the last day for filing has been a Friday. What is fascinating here is that the unrepresented Opposer has been awarded legal expenses, despite not incurring any!

Sometimes, when one sees ridiculous stalling tactics by experienced practitioners rejected in favour of arguments supplied by non-represented opposers one wonders who needs professional representation. I would, however, caution non-practitioners with less experience than the Tomers from trying to file oppositions themselves…

 

 


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