[Ip-health] Vijaylaxmi Rathore: Xtandi Patent Fight May Delay Entry Of Essential Drugs At Affordable Prices

Jamie Love james.love at keionline.org
Thu Aug 10 04:05:05 PDT 2017


>From the article by Vijaylaxmi Rathore:

-------
"In India, Astellas is selling Xtandi at the estimated cost of $45 for each
40 mg pill and $179 (Rs. 11521.33) per day, a way expensive then the daily
income of a person in India (As per the World Bank report 2015, the
estimated daily income of a person in India is $4.36 (Rs. 280.00)).
However, these exorbitant pricing and ongoing patent fight for Xtandi has
been opposed at various level. For e.g. the Union for Affordable Cancer
Treatment (UACT) together with 56 organizations has requested the reagent
of University of California, Los Angeles (UCLA) to back off its petition
filed to Delhi high court against the IPO decision of patent denial. As
this ongoing patent fight may delay the generic version of Enzalutamide
(Xtandi) in the country; and its supply to other low economic countries
where the said drug has no patents and/or not affordable anyway18.

. . . ,Indian Pharmaceutical Alliance, Fresenius kabi, BDR Pharma and few
individuals filed opposition against this application on 2012, 2013 and so
on. Later in 2016, the IPO rejected the application on the grounds of; lack
of inventiveness, section 3(d) and Section 3 (e) of the Patents Act.
Consequently the reagent of UCLA filed a petition before the Delhi high
Court challenging the IPO decision of patent refusal and looking forward
for the next hearing.
-------


How KEI sees this: When UCLA licensed enzalutamide, it made a mistake in
not having any provisions in the license on pricing and access.
Subsequently Astellas has been very aggressive in pricing this drug
everything, with particularly harsh outcomes in the United States, where
the price is far higher than anywhere else, and in developing countries,
where the price is often higher than in Japan, Canada or Europe, despite
far lower incomes.

Now that Astellas pricing polices are well known, the Board of Regents for
the University of California and the President can not longer act as if the
pricing issues don't exist.   And the University of California, which is a
public institution, can abandon its aggressive litigation in India, and let
India be a source of affordable generics, or it can continue to press India
to grant a patent, and delay access to affordable versions of this
important cancer drug, to countries where there is no patent or where a
domestic compulsory license has been issued.

In was in Hyderabad and Mumbai in July, where I meet with three generic
drug manufacturers.  Each of them see the California Regents recent efforts
to get a patent in India a significant disincentive to invest the
development of generic versions of this drug.

The next meeting of the Regents in a meeting of the Health Committee,
chaired by Sherry Lansing, in Los Angles, on August 16.

Jamie


http://www.mondaq.com/india/x/617494/Patent/Xtandi+Patent+Fight+May+Delay+Entry+Of+Essential+Drugs+At+Affordable+Prices

India: Xtandi Patent Fight May Delay Entry Of Essential Drugs At Affordable
Prices
Last Updated: 8 August 2017
Article by Vijaylaxmi Rathore

The Indian pharmaceuticals with its proven product standards and national
and International regulatory compliance is the 3rd largest producer and
suppliers of cost-effective generic medicines worldwide. The effort to make
affordable lifesaving drugs availability for the general population is a
huge task performed only if pharmaceutical firms and regulatory authorities
go along. In India, the affordability of drugs is monitored and regulated
by National Pharmaceutical Pricing Authority (NPPA), a regulatory agency
under Department of Pharmaceuticals. NPPA plays a major role in bringing
down the prices of essential lifesaving medicines in the country. As a
result, the lifesaving drugs are available in India at a more reasonable
and economical price compared to other countries. Moreover, the Indian
Patents Office (IPO), while being dedicated towards the innovation support
by grant and protection of patents, also allows for certain exclusions to
monopoly especially with respect to innovations in pharmaceutical sector.
Here we are discussing the measures taken by IPO and NPPA towards drugs
affordability in India.

National Pharmaceutical Pricing Authority (NPPA):

NPPA is a regulatory and executive agency to implement Drug Price Control
Order (DPCO), 1913, under Essential Commodities Act, 1955. The NPPA
regulates the price of schedule-I drugs, thereby list of essential
medicines updated by regulators time to time. The NPPA fix the maximum
ceiling price of Schedule-I drugs and publish through National List of
Essential Medicines (NELM) periodically. Moreover, apart from the price
control of scheduled drugs, the certain provisions of DPCO are specifically
to monitor the price of non-scheduled drugs.

Non-scheduled drugs and NPPA: The NPPA's right to control the prices of
non-scheduled drugs (drugs not listed in schedule-I) is performed under
Para 19 of DPCO, 2013. Likewise, the NPPA monitors the price of
non-scheduled drugs under Para 20 of DPCO, 2013, as explains below-

===========
* Paragraph 19 of DPCO prescribes that, notwithstanding anything contained
in this order, the Government may, in case of extra-ordinary circumstances,
if it considers necessary so to do in public interest, fix the ceiling
price or retail price of any drug for such period, as it may deem fit and
where the ceiling price or retail price of the drug is already fixed and
notified, the Government may allow an increase or decrease in the ceiling
price or the retail price, as the case may be, irrespective of annual
wholesale price index for that year.
===========


Note- the internal guidelines of Para 19 of the DPCO, 2013 was withdrawn by
immediate effect on 19.09.2014 vide letter no. 31026/ 53/ 2014-PI-II12.
However, Department of Pharmaceuticals (DoP) has formed a new
inter-ministerial committee and instigated them to examine and frame a
method that targeted to bring down the exorbitant price of patented drugs
within the country either by negotiation or reference pricing13.

* Paragraph 20 of DPCO, 2013: Monitoring the prices of non-scheduled
formulations-

1. The Government shall monitor the maximum retail prices (MRP) of all the
drugs, including the non-scheduled formulations and ensure that no
manufacturer increases the maximum retail price of a drug more than ten
percent of maximum retail price during preceding twelve months and where
the increase is beyond ten percent of maximum retail price, it shall reduce
the same to the level of ten percent of maximum retail price for next
twelve months.

2. The manufacturer shall be liable to deposit the overcharged amount along
with interest thereon from the date of increase in price in addition to the
penalty.
Patented Drugs and NPPA: The non-applicability of the provisions of DPCO is
being prescribed under Para 32 of DPCO, 2013.

* Paragraph 32 of DPCO, 2013: Stipulates that the provisions of DPCO shall
not apply to certain cases :

1. A manufacturer producing a new drug patented under the Indian Patents
Act, 1970, (product patent) and not produced elsewhere, if developed
through indigenous Research and Development, for a period of five years
from the date of commencement of its commercial production in the country.

2. A manufacturer producing a new drug in the country by a new process
developed through indigenous Research and Development and patented under
the Indian Patents Act, 1970 (process patent) for a period of five years
from the date of the commencement of its commercial production in the
country.

3. A manufacturer producing a new drug involving a new delivery system
developed through indigenous Research and Development for a period of five
years from the date of its market approval in India.

Provided that the provisions of the above paragraph shall be applicable
only when a document showing the approval of such "new drugs" by the Drugs
Controller General of India (DCGI) is produced before the Government.

The Indian Patents Act (IPA):

There are certain provisions of the IPA, which play a major role in
pharmaceutical related invention, and its affordability and availability.
Sections such as Section 3(d) and Section 3(e) are important with respect
to pharmaceutical inventions, and Section 84(1b) and 92(1) encapsulates for
drug affordability and availability respectively under special
circumstances.

Section 3(d) and 3(e) narrows down the scope of patentability for
insignificant or incremental pharmaceutical discoveries and supports the
true innovations in terms of efficacy.

* Section 3(d) prescribes that the mere discovery of a new form of a known
substance which does not result in enhancement of the known efficacy of
that substance or the mere discovery of any new property or new use for a
known substance or of the mere use of a known process, machine or apparatus
unless such known process results in a new product or employs at least one
new reactant is not patentable.

* Section 3 (e) prescribes that a substance obtained by a mere admixture
resulting only in the aggregation of the properties of the components
thereof or a process for producing such substance is not patentable.

The Section 84(1) relates to compulsory licensing provisions under IPA,
whereby, the Controller of Patents is empowered to grant compulsory
licenses after expiration of three year from the date of the grant of the
patent under prescribed grounds-

a. That the reasonable requirements of the public with respect to the
patented invention have not been satisfied, or

b. That the patented invention is not available to the public at a
reasonably affordable price, or

c. That the patented invention is not worked in the territory of India.

It is to be noted that the clause (b) above mandates the patentee make the
patented drug available to the public at a reasonably affordable price, so
as to avoid the said patent from being considered for compulsory licensing.

Further, Section 92(1) prescribes that if the central government is
satisfied that in circumstances of national emergency or in extreme urgency
or in case of public non-commercial use, it is necessary that the
compulsory license should be granted to work the patent, it may make a
declaration to that effect by notification in the official gazette,
whereupon-

1.   The Controller shall on application made at any time after the
notification by any person interested grant to the applicant a license
under the patent on such terms and conditions as he thinks fit;

2.  In settling the terms and conditions of license granted under this
section, the Controller shall endeavor to secure that the articles
manufactured under the patent shall be available to the public at the
lowest prices consistent with the patentees deriving a reasonable advantage
from their patent rights.

Accordingly, in case of said extreme circumstances and upon Gazette
notification by the Central Government the Controller is empowered to grant
compulsory licenses with respect to the notified patents and while doing so
the Controller is required under aforementioned provision (ii) to make the
patent available to the public at lowest prices consistent with the
patentees deriving a reasonable advantage from their patent rights.

Upon considering the provisions of the NPPA and IPA, it can be said that
the affordability and availability of pharmaceuticals is directly and/or
indirectly affected by DPCO, 2013 and Indian patent system, which is to the
benefit of public at large in India. However, it has been seem at some
instances that the said systems create a hurdle in pharmaceutical growth
and expansion in the country, since the pharmaceutical companies do become
indecisive with respect to launching of their products in India as compare
to U.S. and European countries.

Xtandi Vs Indian Patent Office:

Xtandi (generic name-Enzalutamide), a synthetic non-steroidal,
anti-androgen drug developed by a group of researchers from University of
California, Los Angeles (UCLA), who then licensed its patents to a US based
biopharmaceutical company called Medivation. Later in 2009, Medivation in a
joint venture with Astellas, a Japanese pharmaceutical company started
developing, marketing and commercializing Enzalutamide globally14. In
August 2012, USFDA approved MDV3100 (Enzalutamide) for the treatment of
metastatic castration-resistant prostate cancer. At present apart from
Medivation and astellas, Pfizer also got the right over Xtandi as a result
of medivation acquisitions in 201615.

Xtandi is a potent, best-seller but also a high-priced anticancer medicine
by Astellas for the treatment of the second most common cancer in men.
Despite the claims of providing coupons, Medicare and some patient
assistance programs to uninsured or underinsured cancer patients by
Astellas 16. The Drug still appears costly especially for economically
disadvantaged African-Americans in U.S., as Xtandi price is much higher
costing around $129,000 in a year in USA than the other high income
countries. As a result, the US congress and lawmakers are demanding an open
and transparent public hearing on Xtandi pricing; and the major concern of
demand is the exorbitant pricing of Xtandi in USA despite its being
developed in their own country by using their own funds17.

In India, Astellas is selling Xtandi at the estimated cost of $45 for each
40 mg pill and $179 (Rs. 11521.33) per day, a way expensive then the daily
income of a person in India (As per the World Bank report 2015, the
estimated daily income of a person in India is $4.36 (Rs. 280.00)).
However, these exorbitant pricing and ongoing patent fight for Xtandi has
been opposed at various level. For e.g. the Union for Affordable Cancer
Treatment (UACT) together with 56 organizations has requested the reagent
of University of California, Los Angeles (UCLA) to back off its petition
filed to Delhi high court against the IPO decision of patent denial. As
this ongoing patent fight may delay the generic version of Enzalutamide
(Xtandi) in the country; and its supply to other low economic countries
where the said drug has no patents and/or not affordable anyway18.

Unfortunately, It's been a decade for Xtandi patent fight in India, the
UCLA application for Xtandi patent was first filed at Indian Patent Office
(IPO), Delhi in 2007 (Application Number – 9668/DELNP/2007). Thereupon,
Indian Pharmaceutical Alliance, Fresenius kabi, BDR Pharma and few
individuals filed opposition against this application on 2012, 2013 and so
on. Later in 2016, the IPO rejected the application on the grounds of; lack
of inventiveness, section 3(d) and Section 3 (e) of the Patents Act.
Consequently the reagent of UCLA filed a petition before the Delhi high
Court challenging the IPO decision of patent refusal and looking forward
for the next hearing.

CONCLUSION

Xtandi will either win the patent fight or not, but in both the situations
it will have a vital impact on the affordability of said drugs amongst the
cancer patients in India. The ongoing fight for patent is already a reason
for delay in availability of the generic version of Enzalutamide (Xtandi)
for the cancer patients in India.

If Xtandi does not receive the patent protection-

* The Pharmaceutical industries in India may manufacture the generic
version of Enzalutamide on the grounds of no patent, and

* The provision to bring down the price of non-scheduled formulations under
paragraph 19 and 20 of DPCO, 2013 will be also applicable.

If Xtandi receives the patent protection- The Indian government will have
two options to bring down Xtandi's price:

* The provision to grant compulsory license after expiration of three year
from the date of the grant of the patent based on aforementioned
circumstances under Section 84(1) and Section 92(1), will be applicable.

* The provision to bring down the price of non-scheduled formulations under
paragraph 19 and 20 of DPCO, 2013 will might be applicable. As Xtandi has
not developed through indigenous/ domestic R&D process would be out of the
Paragraph 32 exclusion as stated above.

Footnotes

12
http://www.dpco2013.com/files/data/pricefixationunderpara19/20331472541493.pdf

13
http://pharmaceuticals.gov.in/sites/default/files/CommitteePatentedDrugs_0.pdf


14
http://files.shareholder.com/downloads/MDV/1855075331x0x326521/3a8e7d97-2e58-43fd-8e13-f0022dcf224d/MDVN_News_2009_10_27_General_Releases.pdf

15
http://www.latimes.com/business/la-fi-pfizer-medivation-acquisition-20160822-snap-story.html

16 https://www.keionline.org/node/2485

17
http://www.fiercepharma.com/regulatory/updated-astellas-cancer-med-xtandi-draws-fire-as-u-s-lawmakers-demand-a-pricing-hearing

18
https://cancerunion.org/2017/05/24/uact-55-others-ask-university-of-california-to-drop-appeal-of-prostate-cancer-patent-in-india/

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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