10 Million Shequel Claim for at Risk Launch of Generic Viagra Thrown Out

tarim-100_8-engThe original patent for Viagra (Israel patent IL 98482) had very broad and sweeping claims that covered billions of molecules, only a small number of which cause blood vessel dilation that allows treatment of erectile dysfunction. Teva managed to invalidate the patent in Canada invalidate the patent in Canada and settled with Pfizer to produce a generic version of the drug whilst still patent protected in the US.

Pfizer had a further patent for Viagra that was a selection of better performing molecules. This was filed in Israel as IL 109873. The patent was filed in June 1994 and issued in 1999. It lapsed in June 2014.

Back in May 2013, we reported that Unipharm, an Israel generic drug producer, was doing an at-risk launch of Tarim – a generic Sildenafil treatment for erectile dysfunction.

Pfizer sued Unipharm for $10,000,000 in damages for the at-risk launch.

Scientific Overview of Viagra

The active ingredient of Viagra is Sildenafil.

The male erection is caused by release of Nitrous Oxide (NO) into the penis. The Nitrous Oxide activates an enzyme called GC and creates GM which dilates the blood vessels in the penis, resulting in more blood entering, and subsequent erection.

Sildenafil is a selective inhibitor of an enzyme known as pDE5 which breaks up the cGMP. Sexual arousal causes release of the NO and syndefil inhibits the PDE5 which keeps a high level of cGMP in the tissue and this results in enhanced blood flow to the erection, Without sexual arousal, sildenafil in recommended dosages does not cause erections.

Viagra was discovered by accident. During research into PDE5 inhibition for treating cardiovascular diseases such as high blood pressure in the lungs and heart, healthy men reported erections as a side effect. Thus the patent is for a new use of the old drug, that is a new use for a drug that was previously known for a different purpose.

The Case

Viagra.jpgThe plaintiff 2, Pfizer Ireland, is the named patentee. Pfizer Ireland is owned by Pfizer which is a US Pharmaceutical company. Pfizer Israel is a further subsidiary, which had regulatory approval to sell Viagra in Israel. The plaintiffs are referred to collectively as Pfizer.

The defendant, Unipharm, markets and distributes drugs. Tarima Medical Products Israel LTD manufactured Viagra for Unipharm which marketed the medicament as Tarim (literalize Arise).

Pfizer claims that Viagra is the first oral formulation that treats erectile dysfunction, and that prior to Viagra, there was no effective treatment for erectile dysfunction. They claimed to have invested enormous resources into educating impotent men and the medical establishment, and by education and intensive marketing, Pfizer managed to overcome preconceptions and shame and to create a market for the medical formulation they’d developed.

Pfizer claims that the patent teaches and claims sildenafil and other chemicals for the oral treatment of impotence, and that it is one of 9 chemicals listed in preferred formulations, and that Unipharm had marketed an infringing formulation under the name Tarim (Hebrew for Rise Up) which includes sildenafil and is intended for treating impotence, and that its distribution, import, manufacture and marketing all infringed the patent; at least claims 12, 13, 15 and 16 thereof.

In addition to alleging infringement, Pfizer also sued under the tort of Unjust Enrichment, claiming that Unipharm had hitched a ride on Pfizer’s investment in developing the drug and building up a market, but this claim was not discussed and seems to have been forgotten.

packs of israeli shekelThe lawsuit called for an injunction and a revealing of accountancy records, and sued for 10,000,000 Shekels. However, as the patent has now lapsed, the injunction is no longer relevant.

In their Statement of Defense, Unipharm claims that the patent was no longer in force and that it was not insignificant that Pfizer did not request a temporary restriction.

Unipharm further alleged that the patent lacked novelty and inventive step, and that the claims were not fairly based on the description, were unclear, greedy and were drafted in bad faith.

Unipharm objected to the allegations that the patent was infringed and claimed that its actions were legitimate since the registration of the invalid patent whilst withholding important information from the Patent Office prevented legitimate competition.

Unipharm referred to the proceedings as Sham Litigation since it was an artificial attempt to revive a patent that had lapsed in 2012 (Israel patent IL 98482), after Pfizer had benefitted from 20 years monopoly and massive profits from Viagra, and that they were trying to keep the monopoly indefinitely.

Unipharm further claimed that the Statement of the Defense that Unipharm requested and obtained regulatory approval to sell sildenafil containing formulations for treating erectile dysfunction and for treating high blood pressure, and that there were two other treatments sold in Israel that used active ingredients selected from the trillions of compositions covered by the claims of the patent – Bayer’s Levitra and Lilly’s Cialis – which infringed one of Pfizer’s patents, however Pfizer was not chasing infringers but was trying to tie up the market, which is why Unipharm related to the charge as sham litigation. Unipharm claims that Viagra was not the first treatment for men suffering from erectile dysfunction and that Unipharm had sold Tsoplemed for many years for the same purpose. Viagra was not an invention, but a discovery, whose inventor had followed obvious instructions in a paper and that

Advocates Adi Levit and Debbie Kaziz representing Unipharm managed to get the case dismissed with the District Judge Tamar Avrahami ruling that Pfizer had acted in bad faith by filing a second patent for the same invention and that the IL 109873 patent should never have issued. However, due to their summation pointing to the wrong parts of the protocol, the Judge decided not to rule costs.

Pfizer is appealing to the Supreme Court.

13-05-28676 Pfizer vs. Unipharm, Ruling by Judge Tamar Abrahami, 19 September 2019

COMMENT
Adi Levit is responsible for the name Tarim used by Unipharm for its generic Viagra. He is also indirectly for the name of Bayer’s product Levitra meaning Levit is bad/evil and was named ain his honour.



Categories: ever-greening, infringement, Israel IP, Patents, pharmaceuticals, pharmaceuticals and Biotechnology, Uncategorized, בית משפט, עשיית אושר, פטנט, פטנטים

2 replies

  1. Dear IP

    “The patent was filed in June 1994 and issued in 1990”.

    How can a patent issue prior to the date of the filing of the APPLICATION?!!!!!!

    Are there are further errors in your Case Summary?

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