TOPIC:

Fresh news: the patent opposition of Doctors of the World is upheld partially.
To read the news, Google translate is necessary:
www.aerztederwelt.org/start/news-details...hepatitis-c-med.html

Reading another article, m.apotheke-adhoc.de/nachrichten/markt/na...tent-eingeschraenkt/ , one can read (translated text with Google tr)
Although the Opposition Division granted the right to the constituents of the active ingredient sofosbuvir, but not on the original patented formula.
"Sofosbuvir is technically so may no longer be protected by a patent," concluded Doctors of the World after the hearing.
The decision was not sufficient to make the drug immediately cheaper but strengthened the position of the governments in Europe, the director of Doctors of the World Germany, François de Keersmaeker said."

I am not clear how this result may help governments....to renegotiate....

RHF

If Gilead fears completely losing their market to generics, they may try to lock in a sale volume at a particular price before the court's decision.

That's what was going on when they offered the Indian, Egyptian and Brazilian governments the $900 price. They specifically contracted the 11 Indian companies to tie their hands in case the patent process failed (as it did, but then got reversed.) They didn't hold to the $900 offer in Brazil.

They came to the bargaining table in Australia when they feared the word about generics was spreading too fast there.

Here's a report on the EPO decision in English from StatNews:

www.statnews.com/pharmalot/2016/10/05/gi...-europe-invalidated/

Seems like both sides are claiming a victory?

Somehow it was to be expected that the decision would not directly favor one of the sides.

Nevertheless, looking at the full half of the glass, I would say that the hearing revealed that:
- Gilead tried to obtain more coverage in the field of HCV with the let's call it, "old patent". Now the coverage has been restricted.
- The news about Gilead trying to make huge amounts of money (aka GREED) will spread faster in Europe and worldwide.
- Doctors from Europe will hear that in the month of October, in Germany, Doctors of the World spoke about the solution provided by HCV GENERIC DRUGS to treat HCV, thus once more it will be emphasized that the generic drugs are REAL and EFFECTIVE and not ghosts .
- BIG PHARMA companies are NOT INTANGIBLE
- The movement started in Germany clearly signals (as in other parts of the world as well) that people started to see the high prices of the drugs as a THREAT to the healthcare systems and may no longer be fooled by the monopoly power granted by the patent.

Cheers,
RHF



I place here an illustration taken from another thread, just to pinpoint the fact that many people still think today that LIFE surrounds the Intellectual Property and may not, yet, see that LIFE must be the very essence when talking about health (sorry for the questionable quality of the drawing):

klhilde wrote: If Gilead fears completely losing their market to generics, they may try to lock in a sale volume at a particular price before the court's decision.

That's what was going on when they offered the Indian, Egyptian and Brazilian governments the $900 price. They specifically contracted the 11 Indian companies to tie their hands in case the patent process failed (as it did, but then got reversed.) They didn't hold to the $900 offer in Brazil.

They came to the bargaining table in Australia when they feared the word about generics was spreading too fast there.

Without any other explanation, it certainly seems reasonable to see things this way. Happy then to have been a small insignificant part of it!


J.

It seems that both parts claim victory ....
According to this article, one noticeable effect was that the patent for Sofosbuvir will probaly expire 4 years sooner (2024 instead of 2028):
www.statnews.com/pharmalot/2016/10/05/gi...-europe-invalidated/
(@Vororo: it is the same link you posted. I thought it would be good to put it here again, because in between the article was updated)

.... "SHOW MUST GO ON !!!" so that people will know more and more about generics.

BR
RHF.

Hi RHF,

It's always interesting to look at the language used in these reports, isn't it? To quote from this article (and not necessarily the people actually being quoted)...

"As a result, a generic version of Sovaldi — the first of the new crop of hepatitis C medications to revolutionize treatment — could become available in Europe in 2024 instead of 2028, according to Tahir Amin, the who heads intellectual property at IMAK, the Initiative for Medicines, Access & Knowledge, a nonprofit that works with patient advocacy groups in challenging patents."

"A Gilead spokesman sent us a statement maintaining the patent, as a whole, was not revoked. “The European Patent Office “confirmed that Sovaldi was covered by a valid European patent,” he wrote us. The patent office “found that claims covering [Sovaldi] within the patent were valid. The board believed that these claims were novel and inventive.” He also insisted there will be no impact on the possibility of generics arriving before 2028."

Hmmm, ... lets just pick out two key phrases: "could become available in Europe in 2024 instead of 2028" ... and "no impact on the possibility of generics arriving before 2028"

While technically this analysis might be be correct, to properly report on the real situation it should be qualified (but isn't) with the words "through corporate sources."

So the corporate propaganda (that they control the market) continues as usual, and as usual ignores the fact that equivalent generic medications are available now through personal importation provisions in the USA and many european countries....

So, yes, I totally agree, THE FIXHEPC SHOW MUST GO ON!

Hi Vororo,

Politics is kind of confusing. Perhaps soon there will be more information about the updated/modified patent for Sofosbuvir. Till then I see the actions of MdM as:
- they let the world know that Gileads practices extremely high prices for a drug that can be much much cheaper produced;
- MdM announced that "we reduced with 4 years the time window until generics will enter the market". To this Gilead reponds "no, you didn't because we have a patent". Only this simple exchange of lines demonstrates that the reason why HCV patients are currently not being mass treated is caused by commercial and financial reasons. And this is a clear signal to the governments about how Gilead and other Big Pharma companies are playing the song of the patent. I would say that the truth about Big Pharma and the high prices has been revealed at an OFFICIAL LEVEL. It strengthens also the fact that political intervention from the governments is further necessary.

BR
RHF

Well, Gilead are always going choose their words very carefully to paint the picture in the best possible light for them. More important is what the umpire was reported to say:

A spokesman for the European Patent Office told us "some of the patent claims were no longer found to be admissible under the patent and, therefore, were changed. It’s true it was changed in scope … The patent stands, but certain features originally in the claims no longer figure.”

The EPO also issued a statement saying that Sovaldi, "as claimed in the version of the patent granted is no longer contained in this form of the patent.” ]

So, um, yeah, the patent still stands......but it has been weakened and restricted in its scope.

Here is a report by the Hep-C Coalition on the EPO case:

www.hepcoalition.org/news/press-releases...tained-following-mdm

Extract:

"Following a two days-public hearing at the EPO headquarter in Munich, Germany, Gilead Sciences arguments to uphold its patent on Sofosbuvir have not been totally accepted by EPO opposition division. The EPO has decided that Gilead’s patent extended beyond the content of the patent application as filed. Technically, the EPO’s decision means that sofosbuvir in itself is not protected by a patent any more...."


Wow! sofosbuvir in itself is no longer protected??? That's the key!!!


But then it goes on:

"The Court has explained that the patent was not so strong at it was supposed to be. This shows that the quality of the patent was weak, and that public intervention in the patent system matters. But in maintaining the patent – even partially – this decision is not enough to reverse the balance of power toward the benefit of the health of population and the financial equilibrium of health insurance systems."

So where are we exactly?

Does anyone know what's going on? There has been almost no press coverage so far....

My view: short and middle term, generic drugs will not enter the market. On long term, perhaps yes with 4 years sooner.
Governments and the healthcare system have a better negotiation power .... Which probably will lead to higher discounts, but the prices will remain still high and waiting lists will continue to exist.
What is uncertain is the extent in which the "rebels" taking generic drugs will act. These "rebels" may go up to 200 million people.
Once all will know that they could get treated for 1000$ or less, will the patent still hold???? Will they still prefer to remain sick and at the mercy of ...... those who in fact aim firstly to make huge amounts of money?

I believe in the end it reduces to "shall I take control of my life" vs "shall I live the control to others".

Well, just some thoughts....

RHF

I am not sure if this is an effect of the sofosbuvir patent challenge made by MdM, but Germany is now reviving an old draft of a law that should limit the earnings of Pharma companies in the first year when a new expensive drug is launched.
German news here: www.journalmed.de/newsview.php?id=49315

Google Translation text here:

Government is launching a new price break for medicines

For new, expensive medicines, a price limit of 250 million euros will be applied in the first year after market launch. This is the draft law for the strengthening of the medicines supply, the Federal Cabinet decided on Wednesday in Berlin. Today, new medicines can be sold at a price free of pharmaceutical companies before their benefits are officially assessed and negotiated through their reimbursement. In the first year, some funds generate enormous gross sales of several hundred million euros.
The law of Health Minister Hermann Gröhe (CDU) also provides that the negotiated reimbursement rates remain secret. Physicians should be better informed about the use of new resources for individual patient groups. In addition, Gröhe wants to ban tenders from the health insurance companies, in which pharmacies can participate, which produce cytostatics - ie special cancer drugs - and supply oncologists with outpatient care. Now the parliamentary deliberations on the draft law begin.

Cheers,
RHF