New Blog

Check out my new blog link

Patent Protection issue- Novartis, Glivec

KanneBalaji 

A Chennai court has rejected a challenge
to the patent law filed by Novartis in a law-suit against the Indian
government, the Cancer Patient Aid Association (CPAA) and some generic
drug manufacturers in India. While the aid organizations have declared
the ruling as a victory for the “right of patients over patents”,
Novartis claims that the verdict will have long term negative consequences
for the development of better medicines.  

Novartis had claimed a patent for their
anti-cancer drug Gleevec (known in India as Glivec). The cost of Glivec
for a patient for one year is around 1.4 million INR, while other companies
sell the generic version of the drug at about 1/10^th of that
price. The patent was denied by the Court on the basis of Section 3d
of the Indian patent law which disallows patents for incrementally small
innovations.

Had the case gone in favor of Novartis,
it would have prevented the generic manufacturers from  producing
the drug at all. This case was very keenly followed by the international
pharmaceutical industry, global relief organizations working for greater
access to public health and generic drug manufacturers. There are about
9000 patent applications pending before the courts, most of them reflecting
a scenario similar to this one. The way these cases are settled would
thus have a profound influence on the production and sale of drugs for
a wide range of diseases affecting the world.  
 

This issue involves many powerful players
with conflicting interests, with each trying to influence patent protection
clauses for their own benefit. This article is an attempt to understand
the view points of these various stake holders on the broader issues
of patent protection and its consequences to (a) research and development
investments by pharma firms, and (b) access to life saving drugs by
the needy. 

Linked to this is the vibrant growth
of Indian generic drug manufacturers’ role in producing medicines
for export to developing countries, and even to developed nations. As
all these issues are inter-connected I will address them as a whole
and, when it is relevant , discuss specific items. This article is organized
as follows: I first present brief background information to understand
the issues and then present different view points, and finally offer
my perspective on the matter.  

To start with, let us understand the
issue of pharmaceutical patents in the Indian context. A patent is an
exclusive right granted by the Government for an invention. This invention
can either be (a) a product or (b) a process that offers a new way of
doing or making something. Once the patent is granted, the invention
cannot be commercially made, used, distributed or sold without the patent
owner’s consent. The validity of the patent is for a fixed period,
usually 20 years, during which the patent holder can exclusively profit
from the invention. Therefore, it is understandable that large amounts
of money are spent to obtain and protect patents. 

Patents for pharmaceutical substances
can be of two types (a) Product patents, which are given for
a given chemical substance, say a drug, or (b) Process patents,
which are for a specific way of manufacturing the substance. In the
former case, the product patent allows the patent holder to profit exclusively
from the drug, whose manufacture by any method is disallowed
to others. In the process patent, however, others are forbidden only
from producing the drug by the patented method but are free to manufacture
it by another process of their own devising, which in turn could be
patented. 

For a long period of time, India granted
only process patents for pharmaceuticals. Therefore pharma companies
were free to devise a non-infringing process to manufacture a drug even
if it was protected by a (process) patent in India. This changed when
India became a member of WTO. As part of its obligation to comply with
the TRIPS agreement, the Indian Patent Act now allows a product patent
to be granted for a period of 20 years if it satisfies internationally
accepted criteria for patentability. However, the amended law also includes,
in Section 3(d), a provision that is unique to the Indian Act which
states that patents would not be given for “incremental innovations”,
i.e., new forms, uses or minor modifications of existing drugs unless
they have a demonstrated greater “efficacy” than the earlier known
one.  

Given the current evolving
phase of Indian patent laws, and the ambiguity of terms like “incremental”
and “efficacy”, Novartis and other multinational drug manufacturers,
as well as the groups opposing their patent claims, strengthen their
arguments through self-serving interpretations of the Act. These technicalities
and the nuances of patent laws appear obscure and are not the primary
interest of this article. Those interested can refer to Novartis for Novartis’ point of view and to Medicine Sans Frontiers for the alternate argument.   

The main concern of this article is to
reconcile two opposing views. On one hand many people believe that is
ethically untenable that  patent law should offer the inventor
company exclusive rights and monopoly on their invented product, giving
them the freedom to make large amounts of profits from their product
at a price fixed by their own choice, thereby leaving people who cannot
afford the medicine to suffer, or even to die. On the other hand, pharmaceutical
industries claim that protecting innovation, and the gain through innovative
products, is the foundation for R&D investments made in the pharmaceutical
sector. Without patent protection, the latter view goes, there would
be no innovation and no new medicines.  
 

There do exist some provisions which
individual governments can exercise to provide medicines for those who
cannot afford the prices dictated by the pharma companies. These are
in place, at least theoretically, to enable the supply of essential
medicines to poor countries and poor people. Section 3d of the Indian
patent law is one such provision introduced by the Indian government
for public health safeguards. This clause forbids the issue of patents
for incremental innovation.  

There is no clear consensus on what actually
falls into the purview of incremental innovation. Section 3d is aimed
to protect genuine improvement by barring  frivolous tweaking being
passed under the garb of innovation. It was introduced to prevent a
practice  termed "ever greening"--- i.e., drug
companies making minor modifications to existing drugs so as to re-patent
them at the end of their patent period, and selling them as new and
improved products.  

However, Novartis has argued that most
medical progress happens through incremental innovation. And if the
Indian law does not recognize these advances,  it would negatively
affect the development of better medicines.  
 

On the other hand, Medicine Sans Frontiers,
one of the leading NGO voices against Novartis, feels that allowing
patents on minor modifications would actually be a disincentive for
companies to address new medical challenges, for it would be more profitable
to work on minor changes for patents than in investing on breakthrough
innovation. And as an aside, it also argues that pharmaceutical research
is driven by market potential, and as people in developing countries
do not have the purchasing power to attract research funds for the serious
diseases that affect them, pharmaceutical research  primarily
focuses on anti-wrinkle creams and anti-obesity drugs.  

However, while I admit that research
funding decisions are based on a cost-benefit analysis to maximize profit
earnings, I believe that the typical culture of a research organization
will certainly not be driven by such narrow attitudes. Furthermore,
working towards incremental innovation and original inventions are usually
not two exclusively different paradigms. In fact, most breakthrough
inventions are achieved as one quantum leap in an incrementally innovational
process. 

As regards the other problem, of research
focus areas not being relevant to the concerns of developing nations,
this could be better achieved by working out innovative collaborations
with pharma companies, than by denying them patent protection and depriving
them of their profits.  

Let us consider the Indian example. For
a pharmaceutical company, the Indian market is not a homogenous entity.
While there exists a large population of poor people with limited or
no access to health care, there also exists a sizeable affluent population.
A blanket protection against high drug prices, in the name of the poor,
resulting in medicines being offered at cheap prices to affluent people
cannot be a rational policy. Hence the Indian government can try to
work on a differential pricing arrangement with pharma companies for
the different markets that India comprises. The Indian government (or
alternate monitoring/regulatory global bodies) can in return persuade
the pharma companies to invest the profits gained from the affluent
section of its population in medical research of concern to the country. 

Research organizations like Novartis
should work collaboratively with generic drug manufacturers, without
claiming monopoly rights for critical drugs,  to enable greater
medical access to the entire population. The generic pharma companies
in turn should reward the inventor by sharing a part of their profits
for drugs within the patent regime sold in developing countries and
the patent-expired drugs they sell to developed nations. Both players
can thereby evolve a workable business strategy based on mutual trust.  

Let us now consider the much-discussed
issue of public access to drugs. Sustainable access to medicines in
developing countries is a complex issue. Improving access to healthcare
depends on a variety of factors

• existence of trained healthcare
  staff and infrastructure


• accessibility of the healthcare
  facility and quality of care


• availability of affordable
  medicines


• cultural acceptability of
  treatment(e.g. Islamic groups opposition to the polio vaccination drive
  in India recently)

and other factors. 

The availability of medicines at reduced,
off-patent, prices is just one aspect to this complex problem. That
said, it is however a significant factor and a genuine commitment to
address it is needed.  

In the Glivec case, Novartis asserts
that it is strongly committed to ensure that all patients have access
to the medicine they need, and claims that 99% of the people who need
Glivec are given the medicine free of cost through the Glivec International
patient assistance program(GIPAP).  However, this cannot be extended
across the spectrum of other patented medicines. I believe corporate
donations are not a sustainable solution to the problem. On this issue,
all international pharmaceutical companies should come forward to work
with government or non-governmental organizations for greater public
access of patented medicines. This should not be just regarded as a
public relations exercise to demonstrate their corporate social responsibility.
A few things that these pharmaceutical companies can do are to 

• offer not to file for patent
  protection for certain drugs in very poor countries and work with the
  respective government to enable access to the medicines that are needed
  locally. Such an act will gain them greater respect and credibility
  in the eyes of public.

 

•      collaboratively
  work with drug manufacturers in poor nations to deal with

         
Infrastructure and stock-out contingencies. 

An open attitude harmonizing corporate
patent profit objectives with the privileges conferred to generic drug
manufacturers, and concern for a general access to health care with
an acknowledgement of the obvious buying power of the Indian affluent
class, would facilitate policy development on a case by case basis for
individual drugs. Upon such learning from individual cases can be evolved
a generic strategy to attack this most important health case issue of
our time.    
 

 

RajaMohan on resumption of Indo-Pak dialgue

In this impressive http://www.newindpress.com/newspages.asp?page=m&Title=Main+Article& article & RajaMohan presents a very pragmatic approach to the criticism on the resumption of Indo-Pak dialogue. He addresses the popular argument that cross-border terrorism is a conscious state policy of Pakistan, and presents a practical solution to change that situation.

As with most of RajaMohan’s article the framework and the approach that he presents has a larger applicability and can be put to use in most other real-life situations as well. The arguments does not confine itself to the context of foreign policy relations.

Gastro-Intenstinal Cancer Screening in Chennai

Around the CityHindu - Chennai,IndiaThere will be a gastro-intestinal cancer-screening programme for the public at the ... The Excell Career India would be offering free counselling for the civil ...

Website for Cancer Info

Cancer Information, Research, and Treatment OncoLink - The Web's ...OncoLink, the Web's first cancer resource, provides comprehensive information on cancer treatments, cancer research advances, continuing medical education, ...

News alerts: Edited version

I try to edit the news alert(as it most often contains too many irrelevant information) and update regularly in my Cancer Support blog.

Laparoscopy conference excites surgeons from Pakistan, BangladeshAfternoon Dispatch & Courier - Bombay,India... conference last weekend in which 250 surgeons from India and other ... that we covered include bariatric surgery, hysterectomy, cancer hysterectomy, splenectomy ...
TASK FORCE ON CANCER MANAGEMENT GUIDELINES IN INDIAPress Information Bureau (press release) - New Delhi,IndiaThe one day first collaborative meeting of the Task Force on Cancer Management Guidelines in India was inaugurated today by Surg. ...See all stories on this topic
Study finds added gene risk for breast cancerReuters India - Mumbai,IndiaLONDON (Reuters) - Women with close relatives suffering from breast cancer who do not have the main genetic mutations

Daily Alert Cancer from Google search

I get as mail alert from Google on Cancer and Cancer India on a daily basis. I plan to post it in my blog everyday. This would be posted on the Cancer Support blog

Google News Alert for: cancer
£100,000 cash cancer charity pledge gives drive to growScotsman - United KingdomA CHARITY saved from collapse is set for a huge expansion with a new centre dedicated to the support of children with cancer and their families. ...
Lung cancer study shows CAT scans could aid survivalThe Age - Melbourne,Victoria,Australia... The study of nearly 32,000 people in eight countries raises hope that early detection by CT scans might reduce the death toll of lung cancer, much as ...See all stories on this topic
Cancer Society seeks €2 increase in price of 20 cigarettesIrish Examiner - Cork,IrelandThe Irish Cancer Society is calling on the Government to increase the price of 20 cigarettes by at least €2m in this December's budget. ...See all stories on this topic
Body fat blocks cancer-killing pathway in miceCancer Research UK - News & Resources - London,UKMany studies have suggested a link between body fat and some forms of cancer, but working out the biological reasons for this has proved to be challenging. ...See all stories on this topic
NIH grant to further MSU cancer researchMSU Today - East Lansing,MI,USAOctober 26, 2006 - Transferring cancer research from the laboratories to clinics and hospital bedsides is the goal of an MSU project that is being funded by a ...See all stories on this topic
Rockville biotech begins human trials on lung cancer drugWashington Business Journal - Washington,DC,USAEntreMed has launched a first round of human trials on lung cancer patients for a drug already in clinical tests to battle other forms of cancer. ...See all stories on this topic
Breast Cancer :: Update on familial breast cancer guidelineSpiritIndia - New Delhi,New Delhi,IndiaBreast cancer is cancer of breast tissue. Worldwide, it is the most common form of cancer in females, affecting approximately 10 ...See all stories on this topic
Breast cancer screening is not without risksGlobe and Mail - CanadaThe European headlines read something like this: "Breast Screening Concerns Raised" and "Researchers Question Benefits of Breast Cancer Screening.". ...See all stories on this topic
Cancer top cause of death in stateSeattle Times - United StatesBy Susan Gilmore. For the first time in the state, cancer has replaced heart disease as the leading cause of death. According to ...See all stories on this topic
Centralisation of cancer careIrish Health - IrelandHealth Minister Mary Harney has given approval to the HSE to proceed with new facilities for radiation oncology cancer treatment at Beaumont and St James's ...See all stories on this topic
HK scientists identify cancer-blocking proteinReuters AlertNet - London,England,UKHONG KONG, Oct 26 (Reuters) - Scientists in Hong Kong have identified a protein that can help suppress the growth of prostate cancer cells, the third most ...See all stories on this topic
Google Blogs Alert for: cancer
Risks for Cancer Among Latinos Varies According to National OriginThe American Cancer Society, Centers for Disease Control and Prevention, National Cancer Institute, and North American Association of Central Cancer Registries collaborate annually to provide US cancer information, this year featuring ...NSHP - National Society for Hispanic... - http://www.nshp.org
Meet the Bloggers: Dalene EntenmannBy Jacki Donaldson So without further ado, I introduce you to breast cancer survivor and writer ... What advice would you give the newly-diagnosed cancer patient? ... Cancer overshadowed my perspective and hijacked the direction I was headed in before the ...The Cancer Blog - http://www.thecancerblog.com
My uncle has cancerBy TheBigO(TheBigO) I found out about two weeks ago my Uncle Dave has cancer. At that time, I wasn’t really that concerned since this was the second time he was diagnosed with cancer. ... The doctors aren’t sure if it’s the same cancer as before or not. ...TheBigO’s blog - http://thebigo.vox.com/library/posts/page/1/
Researchers: Less drinking, smoking reduces breast cancer riskBy admin Benjamin Paz, panel member and program co-director for the City of Hope Breast Center, told the lunch crowd of young Capitol Hill staffers that one in eight women in the room was likely to develop breast cancer in her lifetime. ...- http://americanobserver.net
Scientists develop nano-probes that can seek out and kill cancer ...UC Davis researchers, working with scientists at Triton BioSystems in Boston, have developed a way to attach nanoscale bioprobes to cancer cells, heat the probes and kill the malignant cells. The system has worked in laboratory mice. ...digg / Health / digg - http://digg.com/health
Cancer Journals Now Subscribed to OnlineBy Health Sciences Library Cancer Research. 1999 to present. Clinical Cancer Research. 1995 to present ... 1991 to present. Molecular Cancer Therapeutics. 2001 to present. Molecular Cancer Research. 2002 to present. Cell Growth & Differentiation. 1999-2001.Health Sciences Library, JABSOM - http://jabsomlibrary.blogspot.com
Cancer Genomes: Discovery and Applications (NIH-Only)Center for Cancer Research - National Cancer Institute Grand Rounds The primary educational objective of these seminars is to provide new information, ideas, and discussion about timely areas of research with impact on the field of ...Videocast Upcoming Events - http://videocast.nih.gov/
Heavy coverage for NEJM paper on lung cancer screening benefitsBy Charlie Petit The idea that regular CAT scans or other screenings for lung cancer are a good idea among smokers or former smokers makes a lot of intuitive sense. That may be why, as AP’s Alicia Chang writes, so many have been paying for them on their ...Knight Science Journalism Tracker - http://ksjtracker.mit.edu
Types of Thyroid CancerBy jwest06 Discover all the types of thyroid cancer current affecting people in the world. Learn how it works and if it's preventable. Channel: Health & Fitness Tags: thryoid thyroid cancer cancer.Netscape.com Health & Fitness Stories - http://www.netscape.com
Lung cancer detection breakthroughBy Jean Enersen It's the biggest breakthrough in lung cancer in 50 years, says Dr. Ralph Aye at Seattle's Swedish Medical Center. In tests led by a New York group in which Swedish participated, researchers found that a high-tech X-ray called a "spiral ...Blogger KING - http://blogs.king5.com/
Lung cancer screening trial - how the news reports...By Emily DeVoto(Emily DeVoto) Today's New England Journal of Medicine presents the results of a study on lung cancer screening. This study purports to test the value of spiral computerized tomography (spiral CT) against lung cancer in smokers and former smokers, ...The Antidote: Counterspin for... - http://health-counterspin.blogspot.com/index.html

Fund Raising Event

Karunashraya is a hospice care center in Bangalore. It provides care, support for the terminal cancer patients. This palliative care center is organising a fund raising event in October. I read about the event in the local newspaper and had called up to find information about the L. Subramaiam's violin concert(the planned event).

The event is planned in a star hotel and the plan for the evening is a banquet dinner, followed by the music concert. It costs 5000INR for a couple. I opted to not buy the ticket, for its beyond what I think as my affordablity range for this cause.

While I do understand the rationale behind such events, it somehow irks me(may not be the appropriate word, would correct it if someone suggests a suitable one) that the events organised for fund raising are so unconnected to the cause. Its hard for me to appreciate that a fun evening in a posh restaurant is the way, a donor would want to offer their support for such a cause. Instead, it would be a lot better if they organise the show in the center itself, and the donors get to spend and see the life of the patients and have the musical event in their company.