The patent situation in India

[citanon]

I have a question for our board members from India. What is the patent situation there today? Would it be worth while for a US based company to file bio-pharmaceutical patents there? Thanks ahead of time for your help! :)

[kuku]

PATENTS (AMENDMENT) ACT, 2005
http://www.ipindia.nic.in/ipr/patent/patent_2005.pdf

Patent Amendment Act of 2005=Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement=TRIPs agreement gives patent protection to pharmaceutical products.

=Get a good lawyer, they dont come cheap.

[Ray]

I am sure you have the money!

Have a ball in India.

They make billionaires of millionaires!

[citanon]

I am sure you have the money!

Have a ball in India.

They make billionaires of millionaires!

In the US, money appears out of thin air for sensible, marketable, and novel ideas, even if you are a poor graduate student, like me. :))

Getting IP professionals isn't a problem. Trouble is, I get the feeling that the ones I have met so far are creatures who deal in the present with an eye towards near term patent law issues. Their attitude on bio-pharma IP is usually to file in the first world markets.

This is fine unless India and China transition into large bio-pharma markets and possibly if one needs to operate there for R&D or production or if transnational trade in medical treatments become important, for example, medical tourism. Unfortunately these two countries have rapidly shifting product protection pictures, so it would be good to get some inside perspective.

It also helps to acquire some independent knowledge in the area in order to figure out how good a given lawyer really is and to probe them in the right way so as not be taken for granted as a total amateur during interactions with the lawyer. :)

Here's a guy whose bloggin about the situation:
Generic Pharmaceuticals and IP

[citanon]

Hmmm...

Patents v/s Medicines... the views from the other side!

We had earlier posted the CIPLA decisions here.


A friend who has been at the forefront of the patent v/s patient debate has sent me his thoughts. I think they are well worth sharing and I am sharing the same here.

Please note that coming from the industry and that too from the patent function, I may/ may not agree to all the points below, but from where my friend stands, he sees these points.

I had discussed the general position of a patent and the possibility of an injunction in case of medicines v/s motorcycles, here.

As has been a standing policy on this blog, I try and put across views on patents from all members of the patent community.

I welcome all of you to share your views on this subject as well.

“Patent decision by the Delhi High Court favours access– Right to life, public interest, access to drugs and irreparable injury are important considerations

In January this year Roche applied to the Delhi High Court seeking a permanent injunction, restraining Cipla from manufacturing, offering for sale, selling and exporting the lung cancer drug Erlotinib. Pfizer was granted a patent in 2007 and its licensee Roche sued to stop the sale of the generic version to patients in India.

In its order dated 19 March 2008, the Delhi High Court did not grant the injunction to prevent the generic manufacture/sale of erlotinib. One of the key factors considered in the decision – the high price of Roche’s erlotinib as compared to the more affordable generic version.

This court decision is important for the following reasons:

1. Balance of Convenience in favour of access to drugs; price difference in the case of life saving or life improving drugs is a critical factor; Article 21 (Right to life under the Indian Constitution) not to be stifled by stopping supply of low cost generic.

The Court referred to a 1977 US case where it was observed that the case of life saving drugs was unique and it was doubtful that in such cases injunctions should be granted. The Court noted that this was reflected in the 2005 Bombay High Court case where Novartis had applied for an injunction on the manufacture of another cancer drug that it had exclusive marketing rights on. In that case, the Bombay HC held that an injunction could be disastrous for patients.

2. The courts should follow a rule of caution, and not always presume that patents are valid. For recent patents injunctions should not be granted as a matter of course, that the mere grant of a patent or rejection of a pre-grant opposition does not indicate validity and that in such cases the merits of the case have to be examined.

3. Unpatented goods are not inferior where they have received a license for sale in India.

4. India has to apply its own patentability standards. The Court held that “The argument that the plaintiff’s products have been patented in several countries, and have remained unchallenged, the present action being the exception, is not of much consequence. The patent regimes of each country differ; crucially, the municipal laws of the respective legal systems would determine the timing and scope of challenge.”

5. Trivial patents could retard progress. The Court held that ”granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may in the case of patents combining previously known elements deprive prior inventions of their value or utility.”

6. Patentability criteria of non-obviousness should not be confused with novelty”

INDIA: Erlotinib... Injunction NOT issued

In true breaking news style...
"The Delhi High Court has NOT granted an injunction against Cipla to Roche for Erlotinib [Tarceva (R) ]."

I was told that the Court will now look in to the patentability merits of Erlotinib v/s prior art as also look at the other issues raised by Cipla in its brief. The next hearing on the matter is scheduled for August 6.

Previous posts on Erlotinib here, here and here [thoughts on injunction].

P.S. At the time of posting this [2:35 p.m.; IST], I don't see news channels/ media reporting the decision as yet... so, we are the first... Thanks to our friends at Delhi.
------
Update:
I note that Moneycontrol/ CNBC has come up with a quick interview with Mr. Lulla [Cipla's Joint MD].
Click here and here to read excerpts from the interview.
Click here for an interview of Pratibha Singh [Cipla's Counsel].

Click here for report from Economic Times [detailed].
Click here for Reuters' report.
Click here for Business Standard report.
Click here for DNA's report [detailed].

NOTE:
This is not the end. This is merely a decision on the interim injunction. The case will go ahead and next be heard in Aug 2008.
Cipla would be liable for any possible infringement, should this patent be held in due course.
and has been asked to keep an account of the sales [for calculation of possible damages].

It is interesting to note the following lines from the Economic Times report:
“Taking note of huge difference in prices of the product manufactured by the two companies, the High Court said the drug should be available in the market as the price differentiation is huge and will affect patients.

The court said the balance has to be tilted in favour of the people when the interest of the company manufacturing the drug and that of those using it is compared.”

This shows that the Courts are looking at a lot of factors while deciding an injunction in patent cases/ issues affecting a large section of public.

The Financial Express reports that:
“In the backdrop of [19/March] Delhi High Court verdict that allowed Cipla to manufacture and sell a patented cancer drug in India, multinational pharma companies plan to urge the Drug Controller General of India (DCGI) to improve its co-ordination with patent offices across the country.

Cipla has been granted marketing approval for Erlotinib, copycat version of Roche’s Tarceva, as DCGI was not aware that Roche had been granted patent for Tarceva, MNCs argue.

Tapan Ray, director general, Organisation of Pharmaceuticals Association of India (OPPI), … told FE, “… DCGI gave the marketing approval to Cipla while the patent for Erlotinib had been granted to Roche by Delhi patent office one year back.” The marketing application that is submitted to the DCGI must contain the details of whether any patent application has been granted over the same molecule,” he added.”


The application for permission to import or manufacture a New Drug in India to be submitted by a manufacturer, has a section on patent status.
But most applicants simply leave the section vacant.

Keeping in view the difficulty in searching for Indian patents, it is a difficult task for generic companies to give the patent status since the Indian Patent Office search database is not very user friendly.
More over, there is no centralised mechanism/ on-line site [like the Orange Book] which the generic applicant can use to update/ check the patent status.
-------

Meanwhile, keeping track of the Natco side of the story for a Compulsory License for export of Erlotinib to Nepal is Latha Jishnu, who has written an interesting piece, here.

[citanon]

Looks like there are some crucial battles to be fought on then enforceability of pharmaceutical patents in India:

Drug companies oppose bid to link marketing, patents - livemint

Drug companies oppose bid to link marketing, patents
Those launching copies of a patented drug run the risk of being sued; industry says courts should deal with this
Bhuma Shrivastava
New Delhi: Domestic drug companies are strongly objecting to the Indian drug quality regulator’s plans to link marketing approval for a drug with its patent status in the country, citing resources required and fears it could block access to affordable medicines by suppressing competitive forces.
Bitter taste: A chemist shop in New Delhi. The drug controller has proposed a new plan to avoid ticklish cases where a generics firm gets the marketing go-ahead for a drug patented by another company. (Photo: Rajeev Dabral / Mint)
Bitter taste: A chemist shop in New Delhi. The drug controller has proposed a new plan to avoid ticklish cases where a generics firm gets the marketing go-ahead for a drug patented by another company. (Photo: Rajeev Dabral / Mint)
The drug controller general of India (DCGI), Surinder Singh, had said in a conference last week that he intended to reject applications to sell copycat versions of a patented drug from other drug makers in India. This could avoid ticklish situations where a generics manufacturer gets the marketing go-ahead from DCGI for a drug patented by another.
Cancer drug Tarceva is a case in point where Mumbai-based Cipla Ltd secured approval from the regulator, decided to launch the drug at risk in India when it was patented by Swiss drug maker F Hoffmann-La Roche Ltd. A related lawsuit is being heard in the Delhi high court.
The implementation of India’s relatively new product patent law, which came into force from 2005, is putting a lot of Indian systems and processes under stress. While the Delhi high court is seemingly trying to balance the rights of the patent holder in the Tarceva case with providing affordable medicines for all, the Union ministry of chemicals and fertilizers is grappling with a formula for negotiating the prices of patented drugs while the DCGI is considering linking patents to marketing approvals for generics.
Meanwhile, Indian drug companies note that companies choosing to launch copies of a patented drug anyway run the risk of being sued for patent infringement by the innovator and courts should remain the forum to deal with such disputes rather than involve the DCGI.
Makers of patented drugs, on the other hand, have welcomed the efforts by DCGI to link the regulatory and intellectual property aspects of medicines. The rules of the Drugs and Cosmetics Act, 1940, will have to be changed as no provision currently bars the DCGI from approving a generic version of a patented drug.
The office of DCGI is gearing up to introduce this change.
“We will have to amend the rules in the Act. We have to put it before the Drugs Consultative Committee first and this could be around the end of this year,” said a senior official in DCGI office, reaffirming the government agency’s intent of establishing the linkage so that no slips happen in the future. Singh was travelling overseas and couldn’t immediately be reached for commens.
Indian Pharmaceutical Alliance’s secretary general D.G. Shah claims that “efficient and effective” patent and regulatory linkage “will need enormous resources in the Office of the DCG(I)” and will run into several glitches.
“We need not put this onerous responsibility on the DCGI,” he said. “It is up to the generic manufacturer to launch its version of a patent protected drug and face the consequences.”
In a letter to Naresh Dayal, secretary of ministry of health and family welfare which oversees the office of DCGI, Shah wrote: ”Data base of patents granted in India is not readily available. How will the DCG(I) obtain this information? Even if it is compiled by third party, how will the Office of the DCG(I) ensure its accuracy?”
The Association, which represent big Indian pharmaceutical manufacturers, has urged the health ministry to abstain from passing any such orders.
Typically, a drug molecule is typically guarded by more than 20 patents—called a patent estate—that cover its manufacturing processes, salts and intermediate raw materials.
”How would DCG(I) decide that the second applicant’s product corresponds to the patent quoted by the right holder?,” Shah wrote, especially when ”patents are routinely challenged and successfully invalidated”. Industry estimates peg the number of patented drugs in India by global drug makers, such as Pfizer Inc., Roche and GlaxoSmithKline Plc, to about a dozen medicines. But, there are no official estimates on the exact number or the size of this segment.
Ranga Iyer, president of the lobby of global drug makers, Organization of Pharmaceutical Producers of India, welcomed the proposed change by the regulator and wants “something similar to the US Orange Book” in India. The Orange Book lists patent information on the approved drugs.
“If a patent has been issued under the laws of the land, it should be respected,” he said. “At this point of time, no alternate system exists (of ensuring generic versions are blocked if patented drug in market) and DCGI is the link that gives marketing nod to a drug. If he wants to check it at that point, it is excellent.”
Iyer agrees that the new system was “bound to have problems initially” but, brushed them away as “minor” issues.
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