End of an Era

May 26, 2017

Esteemed Out-Going Commissioner Asa Kling writes as follows:

Dear friends, users of the Israel Patent Office services,

As you may very well know, at the end of this month I will be completing the statutory 6 year term as Director of the Israel Patent Office (ILPO), Commissioner of Patents, Designs and Trademarks.

Six years ago I was handed a valuable deposit – the leadership of the ILPO. Since then, as my predecessors before me, I strived to maintain and improve this cherished deposit.

Upon departure, I am leaving a robust and growing patent office. In many ways, the ILPO has become a standard setting unit for the Israel government, as well as an example to other Patent Offices around the world. Alongside the significant improvement in the quality of the examination performed by the ILPO, the shortening of pendencies, the accessibility of the online services and the transparency of the ILPO’s operations, the ILPO enjoys a leading international status as befits a patent office of the Start-Up Nation.

Review of the ILPO’s Annual Reports shows the many changes it has undergone in recent years and the continuous increase in the scope and quality of the services provided to its stakeholders. Just to name a some of these achievements: going paperless and then fully online in all ILPO departments; starting International Searching and Preliminary Examination Authority operations under the PCT and successfully sustaining these international operations; promoting the new Designs bill and adapting the Designs Department operations to the anticipated significant changes in this evolving field; setting a high professional bar in examination of trademark applications while the amounts of international applications have grown immeasurably in view of the operation of the Madrid Protocol; preparing examination guidelines in all departments of the ILPO, while openly publishing them for public review and comment; maintaining full transparency, whether via the annual reports or by the ILPO website; promoting the ILPO’s character as a learning organization; introduction of an innovative employee incentive-pay scheme; organizational changes such as the nomination of team leaders and professional officers; and strengthening ILPO’s international status and in particular at WIPO. We also took an active part in the Governmental Regulation Impact Assessment project whereby we considerably updated many Commissioner’s Circulars and reduced their number, conducted an empirical study of the patent pre-grant opposition procedures in order to stimulate an informed public discussion, and improved the regulation of the Patent Attorney certification process towards a reform in this profession. We grew and evolved!

I owe a debt of gratitude to many. These achievements are actually those of the ILPO’s professional staff and managers who share the vision and bare the brunt on a daily basis. Without the support of the various officers of the Ministry of Justice and of many government units who recognized the importance of these tasks, little of would have transpired. It was a great privilege to lead such a formidable unit in the Israeli civil service.

I wish all success to the incoming Director, Mr. Ofir Alon, who will surely receive all your support and assistance for success in this challenging position and will promote the ILPO to even further heights.

COMMENT

klingonCommisisoner Asa Kling’s tenure did indeed bring many changes and improvements. Things are far more automated at the Israel Patent Office. Many of his decisions showed a great deal of sensitivity to complex issues. We wish him luck as he explores strange new worlds, seeks out new life and new civilizations and boldly go where no man has gone before,

 


Retiring Israel Patent Attorney Looking to Sell Business

May 26, 2017

REtirementA well-respected Israel Patent Attorney has had enough and is looking to sell his business as an on-going concern. There are over a hundred  patent, design and trademark files from a nice mix of 20 foreign and domestic clients. Contact me if interested, and I will forward your details to the attorney.

 


New Directives For Examining Israel Patent Applications

May 17, 2017
israel patent officeOn March 23, 2017, the Israeli Patent Office issued two new Directives; No. 034/2016 and 035/2016.  These apply to all patent applications having a first substantive Office Action that issued after March 27, 2017.

Unity of Invention
unityPatent applications may describe more than one invention but the claims should relate to one invention only. In applications where more than one invention is claimed, instead of issuing a lack of unity objection and letting applicant address the issue and elect a claim set to be examined, the Examiner will generally examine the first claimed invention appearing in the claims, but has the discretion to allow the Applicant to elect the invention to be examined. One cannot respond to an office action by replacing the claims to an examined invention by amending the claims to claim what the Examiner considers to be a separate invention. The applicant must file a divisional application to have non-elected inventions examined.
Use Claims
swiss claimsSwiss-type claims  of the form “Use of X in the preparation of a medication for the treatment of Z” are no longer acceptable unless the process for the preparation of the medicament is inventive per se). EPC 2000-style claims (X for use in/as Y) are, however, acceptable.
Extensions for late filing of responses
lateThe number of extensions available for each substantive Office Action during patent examination has been reduced to four months, and the total extensions for the entire examination should not exceed 12 months. This is 3 months less than the 15 months of Extensions that was formerly available. However, this period is only once substantive examination commences and does not include extensions of up to 6 months for responding to the Notice Prior to Examination.

Teva Challenges Gilead Patent Application for HIV Treatment

May 8, 2017

drug cocktailThis ruling relates to a treatment for HIV consisting of a single once-a-day dosage that includes a combination of two or three different active ingredients.

Israel Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. Gilead purchased Triangle so that they would have the capability of producing both  FTC and TDF and in a press release in Bioworld in 2002 which quoted Gilead’s Chairman and CEO, they announced their intention to develop a single dosage formulation that included TDF and FTC, referring to the chemicals by their trade names of Viread and Coviracil. This announcement preceded the priority date and since they announced that they did not anticipate difficulties in formulating the combination, their announcement undermined claims 1 and 12 directed to the combination of TDF and FTC in the standard dosages of Viread and Coviracil. There were additional independent claims for FTC and TDF together with an additional active ingredient – either Reyataz, Kaltera or Sustiva. However, that combination was used in a clinical trial for treating Hepatitis B that was also prior art. This ruling addresses and clarifies the requirements for prior art to be anticipating and what is required to provide an inventive step. It also relates to the issues of claim support, enablement and utility.

History

GileadIsrael Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. On allowance the Application published for opposition purposes and Teva filed an opposition on 26 March 2009 and four months later submitted a detailed statement of case. On 1 February 2010, the Applicant requested permission to correct the application, and on 21 April 2010, Teva requested that the proposed amendments to the claims be refused. There was an intermediate ruling on this by the Commissioner on 22 June 2010, and on 27 June 2010 Teva withdrew their challenge to the amendments and the opposition continued with the amended claim-set. On 8 May 2011, the Opposer submitted an amended statement of case and Gilad submitted their response on 1 January 2012. On 23 September 2012, the Opposer’s evidence was submitted in the form of two affidavits, by Professor Richard Novak and by Professor Joseph Fortunak. On 24 July 2013, Gilad submitted their response in the form of Affidavits by Professor Robert Redfield and Professor G Stahly, and on 10 April 2014 further affidavits were submitted in response to points raised. Read the rest of this entry »


Unipharm Requests Accelerated Examination of Pending Novartis Patent Application

May 7, 2017

novartisIsrael Patent Application No. 249922 is a divisional application of 205208 that was filed on 3 January 2017, and which claims priority from USSN 60/985,668 filed on 6 November 2007. Under Section 16, the filing of the divisional application was published on 29 February 2017.

The ‘922 application relates to “DUAL-ACTING PHARMACEUTICAL COMPOSITIONS BASED ON SUPERSTRUCTURES OF ANGIOTENSIN RECEPTOR ANTAGONIST/BLOCKER (ARB) AND NEUTRAL ENDOPEPTIDASE (NEP) INHIBITOR”.

On 4 January 2017, the Applicant received a Notice Prior to Examination under Section 18 and regulation 36. Examination has not started.

UnipharmUnipharm requested that the examination of the Application be accelerated under Section 19a of the Israel Patent Law. The request was supported by an Affidavit from Mr Zevulun Tomer, Unipharm’s CEO:

I affirm that if IL 249922 to Novartis AG is examined in due course, it will cause a delay in Unipharm’s development of a product that is a high priority. … Making the Examination special will prevent delays and costs and serves the public interest by making drugs more available at lower cost and by opening the market to competition.

EntrestoOn 2 April 2017, Novartis AG opposed the request. Their position was that the request was vague and did not fulfill the conditions of Section 19a(c). Novartis notes that Unipharm did not provide details regarding which drug they intended developing, and if their intent was to develop a generic version of ENTRESTO, Novartis noted that that product was protected by other patents, some of which were pending patent extensions, and so accelerating the examination of ‘922 would not have the allegedly desired consequences.

Novartis also noted that if an Opposition is eventually submitted against IL 205208 under Section 26 of the Israel Patent Law which published for opposition purposes on 31 January 2017, anyway under Commissioner Circulars 035/2017 and 020/2012, no extensions in the Examination of the ‘922 application would be allowed.  The Commissioner noted that on 23 April 2017, the period for submitting an Opposition was still open, so there was no need for him to address this theoretical issue. In response to Novartis’s counter-statement, Unpiharm reiterated their claims.

Section 19a(c) provides the situations where a third-party can request acceleration of a pending application to another:

(c) A person other than the applicant, and who is not associated with the applicant or works on his behalf, may submit to the Commissioner a detailed request along with an affidavit supporting the facts, for an accelerated examination of an application that was published under section 16A, if one of the following occurs: (1) There is an established concern that the examination of the application of the patent according to the set order may cause the applicant of an accelerated examination application, who works in the field of the invention, a delay in the development or in the production of a product or a process claimed in the patent application under this subsection. (2) Time elapsed since the submission of the request is unreasonably long under section 15 or from the day the request entered the national stage under section 48D, and taking into consideration any significantly lengthy time since the lapsed date up to the beginning of the examination of other application of the same type. (3) Public interest; (4) Extenuating circumstances which provide justification.

As established re Israel Patent Application 221842 J. L. Glatt Lift ltd, 14 June 2016: 

 The possibility of accelerating examination under Section 19a is an exception to the general rule regarding examination that is given in Section 9 and regulation 34:

Applying the exception is likely to damage the principle of the first to file is to be awarded the patent and is likely to damage the general quality of patent examinations. For example, prior art that is not yet examined could be overlooked.

It is clear that accelerating examination under Section 19a is reserved for extreme cases where it is justified to deviate from the normal order. The burden of proof is on the Applicant for  Accelerated Examination who is to detail his request and support it with evidence.

Unipharm’s request and Mr Tomer’s affidavit relate in general to Section 19a(c) but it appears that they intend part (1) which relates to ‘delays in developing or manufacturing a product’ that Unipharm intends to manufacture, and to part (3) that relates to the ‘public good’ that is served by greater accessibility to drugs, reduced costs and competition in the market.

Unipharm claims that under their work program, if a patent issues for the ‘922 application, this will prevent them developing and then manufacturing their product.  Unipharm’s affidavit details the managerial program and preferences. The Commissioner Asa Kling does not see any reason not to accept an Affidavit from a CEO who may be presumed to know the company’s plans. There is no need to cross-examine under Section 163a of the Israel Patent Law 1967, and if it should transpire that Unipharm have lied, this Affidavit could be used against them. Therefore, it seems that Unipharm have provided the appropriate support for their request as required by Section 19a(c)(1) of the Law for accelerated examination.

This is not the case with respect to ‘public interest’ under Section 19a(c)(3) of the Law. As explained in the Glat Lift case, accelerated examination under Section 10 is reserved for extraordinary cases that are important to the State of Israel in general. The Application and Affidavit do not point to such a specific condition. It does not explain how accelerated examination will result in competition that will bring about a drop in prices. As Novartis noted, it doesn’t even explain which market sector will have enhanced access. The Section 19a(c)(3) justification is rejected.

However, due to the Section 19a(c)(1) justification, examination of pending application 249922 will be expedited on payment of the relevant fee. Suspension or extensions will be permitted only in accordance with Section 19(a)(1) of the Law. No costs are awarded.

COMMENT

In this instance, as we are dealing with a divisional application, there is no danger of earlier filed not published art being missed due to the patent being examined out of turn. The Commissioner Circulars 035/2017 and 020/2012 explain Patent Office policy to examine divisional applications of opposed applications as fast as possible. There is a real danger that applicants for pharmaceuticals that are opposed will file continuations and divisionals to keep the patent application alive in an attempt to evergreen. So on balance, it seems that the request is reasonable and the Commissioner was right to grant it. If Novartis are acting in good faith, they should be interested in having their patent application examined as fast as possible. They have not provided a justification for delaying, such as wanting to wait for examination of a corresponding application to be concluded so that they can request allowance under Section 17c or similar.

With a justification under Section 19a(c)(1) it does not matter that the Section 19a(c)(3) request was denied. However, I don’t fully understand the Commissioner’s reasoning. If he considers that one has to be facing a drug shortage within an epidemic, that is one thing. However, I don’t think that one should have to explain how allowing generic competition lowers drug prices for the common good. This is self-evident and true for all drugs, and the underlying logic of free markets and really dates back to Adam Smith’s Wealth of Nations. Still, the Law does seem to require something extraordinary.

We note that Unipharm successfully handled this request themselves, without professional representation. This is not the first time that Unipharm have successfully fought inter-partes proceedings at the Israel Patent Office without using an attorney. Nevertheless, others are strongly advised not to follow their example.


Israel Patent Lapses, But Patent Office Remiss For Not Sending Out Patent Certificate

April 30, 2017

The first renewal of IL 206744 to Bet El Zichron Yaakov Industries LTD was due within three months of it issuing. As it issued on 1 May 2016, the renewal was due on 1August 2016 (see Section 56 of the Israel Patent Law 1967), and six months later, on 2 February 2017, it was published as having lapsed (as per Section 57 of the Law).

On 9 March 2017, the Applicant requested reinstatement, but did not submit an Affidavit. At Deputy Commissioner Bracha’s request, the CEO of the company submitted an Affidavit claiming not to have received the Patent Certificate.

After reviewing the Israel Patent Office records, it transpired that due to a problem in the patent office, the Certifcate was indeed not sent out. The Deputy Commissioner considered this was sufficient reason for the renewal fee not being paid.

Since the request for reinstatement included the missing payment, the Deputy Commissioner ruled that the reinstatement should publish for Opposition purposes.


Patent to Astrazeneca  Successfully Opposed by Teva

April 20, 2017

Rosuvastatin_structure.svgRosuvastatin is a member of the statin class of drugs that is used in combination with exercise, diet, and weight-loss to treat high cholesterol and related conditions, and to prevent cardiovascular disease.

Israel Patent IL 166626 to Astrazeneca is the National Phase of PCT/GB2003/003463 filed in August 2003 and titled ” Process for preparing the calcium salt of rosuvastatin 

The Application was allowed and published for opposition in September 20011 and Teva filed an Opposition. A hearing was held in July 2015, and by June 2016 both sides had finished submitting their summaries and counter summaries.

The patent covers a process for obtaining (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid calcium salt. The application included 27 claims of which the first, independent claim is as follows: Read the rest of this entry »