May 3, 2013
Mercke Sharp & Dohme Corp. developed a drug called Alendronate for treating osteoporosis which is marketed as Fosamax®.
Fosamax has annual worldwide sales of over one billion US dollars. The drug has a number of unpleasant side effects. Merk filed a patent application for reducing the side effects via a different dosage regime. Specifically, Merck’s patent proposes a higher dosage taken less frequently. The patent in question is WO/1999/004773 titled “Method for Inhibiting Bone Resorption” and covers a once weekly oral dosage pill for alendronate and other bisphosphonates for the treatment of Paget’s disease and osteoporosis. It was filed in Israel as a national stage entry of the PCT as IL 153109.
The Israel Examiner allowed the patent, but when it published for opposition purposes, Unipharm opposed the patent claiming lack of novelty, obviousness and that it was essentially for a medical treatment and thus was directed to subject matter considered non-patentable under section 7 of the Israel Patent Law. An article summarizing the original decision by then Commissioner of Patents Dr Meir Noam may be found here. Essentially, Dr Noam (who is a chemist by training) threw out the non-patentable subject matter objection and ruled that that clause was to protect doctors and pharmacists in prescribing and drugs, but the subject matter was patentable. However, he ruled that in light of the prior art, the claimed invention lacked inventive step as it was “obvious to try”. The district court upheld this decision and also the separate decision to award record costs of NIS 550,000 (which is about $150,000).
Merck appealed both the ruling of non-validity and the costs awarded to the Israel Supreme Court.
In a 12 page ruling, Judge N Handel rejected the second appeal, ruling that a further appeal is only justified in cases where there is an important legal principle or particular public interest. He noted that Dr Noam had held 12 days of hearings and had related to all the evidence in a reasoned decision so there was no reason to overturn it. He further noted that the separate decision for costs was based on a reasoned calculation and included NIS 150,000 in expenses and NIS 400,000 in legal fees, whereas the opposers has actually claimed NIS 1,402,854 in legal fees. He rejected charges that were costs were punitive and, in the circumstances, he didn’t consider the costs awarded were unreasonable. He awarded a further NIS 35000 to the defendants for having to fight this additional appeal.
Appeal to Supreme Court 6837/12 Merck vs. Unipharm and Teva. re Fosamax
April 29, 2013
Professor William Fisher of Harvard Law School is giving the Sixth Annual Cegla Lecture on Legal Theory, entitled “Infection: The Health Crisis in the Developing World and What We Should Do About It“. The lecture will take place on Thursday, May 2, 2013 between 6 PM and 8 PM (18:00 and 20:00 for those that prefer the 24 hour convention).
The event will take pace in Tel Aviv University, the Buchmann Faculty of Law, Trubowitz Building, Somia Kossoy Conference Room, Room 207 on the third floor.
Professor Michael Birnhack who is chairing the event refers to Professor William Fisher as Terry Fisher. He also claims that the lecture will deal with patents and the global health crisis. The title and identity of the speaker therefore seem to be somewhat misleading!
That said, I have no doubt that Professors at Harvard Law School who get flown in to give an annual lecture are well worth listening to. I therefore hope that my readers on both sides of the patented medicine – generic debate (which, form feedback I receive seems to include many of the industrialists, patent attorneys and litigators) will come along to listen – and will behave themselves, i.e. polite heckling only, no rotten fruit.
February 20, 2013
Teva Pharmaceuticals and Gilead Sciences Inc. agreed to settle a patent dispute over Viread, a treatment for HIV infection and chronic Hepatitis B, avoiding a trial that was scheduled to start today. Teva will be permitted to begin sales of a generic version of Viread on Dec. 15, 2017. “We believe strongly in the validity of our intellectual property,” John Milligan, Gilead’s president, said in the statement yesterday. “This settlement, however, removes some uncertainty and minimizes further distraction.”
Gilead, based in Foster City, California, sued Teva in 2008 and again in 2010, claiming that Teva’s applications to the U.S. Food and Drug Administration to make drugs to treat HIV infections in adults infringed four of its patents. Teva, based in Petach Tikva, Israel, had said in court papers that Gilead’s patents were invalid and therefore couldn’t be infringed.
The trial in New York has been adjourned until the completion of the settlement agreement.
The case: Gilead Sciences v. Teva Pharmaceuticals USA, 10-01796, U.S. District Court, Southern District of New York (Manhattan).
February 18, 2013
Following a decision of 6 January 2013 not to allow TM Application Number 238745 “Teva Express” as a word mark, See here , but indicating that a stylized logo of the phrase could be registered, the applicant filed a request to allow the stylized logo.
The Deputy Commissioner, Ms Jaqueline Bracha, admonished the applicant for requesting that the decision be corrected instead of filing a request, and pointed out that it was wrong to allow the same request to be considered as being a word mark or a stylized logo at the applicant’s request, depending on how prosecution pans out. Nevertheless, she allowed the stylized logo to be registered.
November 9, 2012
The Canadian Supreme Court has accepted Teva’s contention that Pfizer’s patent for Viagra is invalid opening the way for Teva and others to produce and distribute generic versions of the drug. The Canadian ruling may be found here
The reason that the patent has been invalidated is as follows:
In addition to a patentable invention being useful, new and non-obvious, there are formal requirements for the patent specification, which is required to be enabling. The patent specification is required to provide sufficient details to enable a person in the relevant field of endeavor to provide the invention without undue experimentation. In the US, until recently, there was an additional requirement to teach the best way to achieve the invention known to the inventors.
The problem with the Viagra patent is that the description and the claims as drafted cover astronomical numbers of compounds, of which only one, sildenafil has the effect of causing dilation of blood vessels, which enables its use for treating erectile dysfunction in males. The court therefore ruled the patent specification does enough information to allow another company to produce Viagra.
“Pfizer gained a benefit from the (Patent) Act – exclusive monopoly rights – while withholding disclosure in spite of its disclosure obligations under the act,” wrote Justice Louis LeBel. ”As a matter of policy and sound interpretation, patentees cannot be allowed to ‘game’ the system in this way … (the patent) is invalid.”
Teva, Israel’s leading pharmaceutical manufacturer and the world’s leading generic drug manufacturer has been challenging the validity of Pfizer’s patent protecting Viagra for years. In the past, Pfizer has successfully Viagra in patent lawsuits from Teva in the New Zealand. Norway Spain, and the United States.
August 17, 2011
Teva’s challenge to the validity of Pfizer’s patent for Viagra was dismissed by U.S. District Judge Rebecca Beach Smith of Norfolk, Virginia, in a 110 page opinion.
“Teva has not shown by clear and convincing evidence that the patent is invalid,” wrote Smith who went on to state that “There is utterly no evidence” to support Teva’s claim that Pfizer intentionally withheld documents from the U.S. Patent and Trademark Office. For more information see http://www.bloomberg.com/news/2011-08-15/pfizer-wins-viagra-patent-infringement-case-against-teva-pharmaceuticals.html
June 9, 2011
Lilly Icos LLC applied for Israel Patent Number 147642, a national phase of WO/2001/008688) BETA-CARBOLINE DRUG PRODUCTS. The patent application concerns Tadalafil, a treatment for male impotence due to erectile dysfunction which is marketed as Cialis.
After allowance, the patent application published for opposition purposes and Teva filed an opposition claiming that the invention was essentially using smaller particles as a technique for improving the rate of solubility of the drug and was therefore obvious.
Eventually the sides overcame their differences and the opposition was withdrawn. However, using his authority under Section 34 of the Israel Patent Law, Deputy Commissioner Noach Shalev Shlomovits defended the public interest and refused the patent, ruling that the technique of reducing particle size as a means of increasing rate of solubility lacked any inventive step.
As he was terminating his contract, and in accordance with Ordinance 74 and Section 159, the Deputy Commissioner gave the parties 30 days to file any appeals so he would be able to close the file himself rather than having his replacement learn the material.
Solubility is a surface effect. Since the amount of surface area for a given weight of material increases as particle size decreases, it is clear that shrinking particle size will increase rate of solution. It seems, therefore, that the Deputy Commissioner is correct.
May 9, 2011
The Supreme Court of Canada has announced that it would hear Teva Canada Ltd.’s challenge to Pfizer Inc.’s patent for Viagra. The high court granted Teva Canada’s leave to appeal without comment Thursday, agreeing to review a September 2010 ruling from Canada’s Federal Court of Appeal that barred Teva Canada from producing a generic version of the drug prior to Teva Canada could not produce a generic version of Viagra until Pfizer’s Canadian patent expiring.