May 8, 2017
This 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.
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. 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 »
April 20, 2017
Rosuvastatin 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 »
April 2, 2017
Because of the upcoming Pesach (Passover) holidays theIsrael Patent and Trademark Office (ILPTO) will be closed from Monday, April 10, 2017 – Monday, April 17, 2017 (inclusive).
In general, when a deadline falls on a day that the patent office is closed, the deadline is extended to the first subsequent working day, so any deadline for submissions, including PCT applications, national phase entries and Paris Convention deadlines falling from 10th April to 17th April can be submitted on 18th April 2017.
Note, the Patent Office is always closed on Fridays and Saturdays so will be closed on 7th and 8th of April, BUT since Sunday is a regular working day and so deadlines falling on 7, 8 or 9th April must be filed on 9th April.
Additional Israel Patent Office closures are as follows:
- Israel Independence Day on Tuesday, May 2, 2017
- Shavuot (Pentecost – the Feast of Weeks) – Tuesday, May 30, 2017 and Wednesday, May 31, 2017.
March 30, 2017
Sometimes clients want to save on professional fees. The truth is that quality patent attorney work is not cheap. Patent Attorneys only have so many hours a day and set their fees to maximize income.
Filing abroad may seem to be overly expensive. More and more often I am approached directly by overseas inventors wanting to file national phases into Israel of their PCT applications, thereby trying to save on their local attorney fees.
Probably because of this blog, I also seem to receive more than my fair share of requests for help from inventors trying to file directly into Israel using the online interface. I don’t think that DIY filing is a good idea. Like many such things, one learns how not to do it by making mistakes. Most of the time, the inventors give up and pay me to file for them and also give me Power of Attorney.
Recently someone contacted me via the blog and by the time I got back to him, he’d managed by himself. So he has a number and filing date. I wonder if he will receive Office Actions without an address in Israel. From his name, I am fairly sure that he was not Jewish (well he may have been a converso as I believe was his namesake who (re)discovered the New World in 1942), and so suspect that he will have a problem with correspondence in Hebrew even if he does receive it. Each to his own.
Today I was contacted by someone in India who filed directly into Israel and only had trouble paying the official fee, and wanted my to help them, and were sure that I’d do it for $150 dollars since they had another two cases in the pipeline. Well I looked at the Application and noted that although they managed to courier the application with forms to the Patent Office within 30 months of filing, to receive a filing date they needed to pay the fees in 30 months. That deadline passed nearly a month ago. I quoted for preparing affidavits and submitting a request for late filing and my estimated charge is more than I take for filing national phase applications. I also warned them that the standard for late entry into Israel is “Due Care”. Is waiting until the last-minute and then trying to file directly without professional assistance in a foreign country via an interface in a foreign language, Due Care? Well, if they are willing to pay my fees, I will argue that it is to the best of my ability. I did, however, warn them that it may be difficult to convince the Commissioner of Patents that due care was taken.
March 26, 2017
This ruling relates to an opposition against a patent application by Novartis for Panobinostat which is a hydroxamic acid that acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). On 23 February 2015 the drug received FDA accelerated approval for use in patients with multiple malignancies, and on 28 August 2015 it was approved by the European Medicines Agency for the same use.
The Opposer claimed that the drug was described in the Applicant’s earlier published PCT application and was thus both anticipated (known) and obvious. The Commissioner rejected the anticipation claim but accepted that in light of the earlier publication, it was obvious and lacked an inventive step.
Due to the ruling being rather interesting but only available in Hebrew, and since these Israeli rulings can and do have an effect on validity of corresponding patents elsewhere, I have translated the decision in full. At the end I have made some general comments.
Novartis AG filed Israel Patent Application Number 195087 titled “ANHYDROUS LACTATE SALTS OF ANHYDROXY-3-[4-[[[2-(2-METHYL-1HINDOL-3 YL)ETHYL]AMINO]METHYL] PHENYL] – 2E-2-PROPENAMIDE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME” as a national phase of PCT/US2007/070558 that was filed on 7 June 2006 and claims priority from US 60/804523 and US 60/869993, two US provisional patent applications filed in June and December 2006 respectively. The Israel national phase entry was submitted on 3 November 2008 and, on allowance, published for opposition purposes on 31 October 2012.
Unipharm opposed the application on 3 January 2013. Subsequently, on 26 June 2013, Novartis requested to correct the application and, since neither Unipharm nor anyone else opposed this, the application was corrected and this ruling concerns an opposition to the amended application.
The parties submitted their claims and evidence and a hearing was held Read the rest of this entry »