[Ip-health] India rejects patent for cancer drug Abraxane, for lack of inventive step

Jamie Love james.love at keionline.org
Tue Jun 24 03:23:32 PDT 2014

Below is a story from the Times of india, about the rejection of a patent
for Abraxane, a cancer drug.  Before getting to the story about the patent,
here is some background on the drugs.

The generic name for Abraxane is protein-bound paclitaxel.  Paclitaxel is a
cancer drug first approved in the USA in 1992 (and is the first cancer drug
I studied).

The company that owns the rights to Abraxane is Celgene, having acquired
Abraxix 2010 for $2.9 billion.  The product was first registered with the
USA FDA in January 2005, and since the product was put on the market there
have been several changes in the labeling for the drug, including for new
indications.  In September 2013, the product approved for the treatment of
pancreatic cancer.  The USFDA Orange Book lists 17 patents, and 3 separate
test data exclusivity provisions.

The 2005 approval of Abraxane was supported by evidence from four clinical
trials involving 597 patients, including 472 patients in a single Phase 3
trial for metastatic breast cancer.  In 2009 Abraxane received two Orphan
drug designations, including one for pancreatic cancer (an indication
approved in 2013), and one for melanoma.  Once receiving the Orphan
designation, the company can claim a special tax credit subsidizing 50
percent of the costs of clinical trials, up to the point of FDA approval
for that indication.

According to a 2006 SEC filing, for the five year period of 2001 to 2005,
American Pharmaceutical Partners, Inc. (the name of the company in 2006)
spent $106.7 million on R&D.  These outlays included investments in the
development of Abraxane, but also several other drugs and transplant

year Research and development (exclusive of stock-based compensation, in
2005 $30,162
2004 $25,797
2003 $22,507
2002 $14,474
2001 $13,790


According to Celgene, "ABRAXANE sales for the first quarter of 2014 were
$185 million, a 51 percent increase. U.S. sales of $142 million and
International sales of $43 million increased 51 percent and 49 percent,
respectively. The increase in sales reflects the impact of the ongoing U.S.
launch in pancreatic cancer and early launch success for pancreatic cancer
in Europe."

Now, the new story from India


Indiatimes|The Times of India|The Economic Times|

RELATED KEYWORDS: Indian Patent Office|Anti-Cancer Drug|Abraxis BioSciences

US company denied patent on anti-cancer drug

The application was refused on the grounds of the US firm's claims lacking
of inventive step, not being patentable and insufficiency, legal sources

Rupali Mukherjee, TNN | Jun 24, 2014, 05.45AM IST

MUMBAI: The Indian Patent Office has refused a patent on US firm Abraxis
BioSciences' anti-cancer drug Abraxane, paving the way for domestic
companies to launch affordable versions in the local market. The
application was refused on the grounds of the US firm's claims lacking of
inventive step, not being patentable and insufficiency, legal sources say.

One of the main grounds under which the patent was rejected is Section 3
(d) - the provision under which Novartis lost protection on its blockbuster
drug Glivec last year. The Patent Office relied on the decision of the
Supreme Court in the landmark Glivec case while hearing the application.

The Supreme Court ruling defends Section 3(d) - an important safeguard in
the patent law specifically relevant for pharma and chemical industries,
which prohibits grant of patents to new forms of known substances unless it
results in enhanced efficacy over the known substance.

Since there is now clarity that there is no patent on the US firm's drug,
it may give a boost to generic production, sources say, adding that the US
firm has the option of filing an appeal in the IPAB or a writ petition in
the high court.

Earlier, the Patent Office had denied the patent in 2009 on the grounds of
obviousness and lack of inventive step. The US firm appealed against the
order in the IPAB (Intellectual Property Appellate Board). In January this
year, the IPAB directed the matter to be reheard by the Patent Office for
fresh consideration, and to be decided within a specific time frame. The
matter was heard afresh in April this year, and an order was passed on June
18, rejecting the application again, legal sources say. In addition to the
grounds upon which the application was rejected in the 2009 order, the
application was rejected for being a new form of a known substance under
Section 3(d) as it failed to exhibit enhanced therapeutic efficacy, a
lawyer close to the development told TOI.

Domestic company Natco had filed an opposition before the patent was issued
to the US firm. The company first launched the drug in 2008, challenging a
patent application filed by the US company. Abraxis launched the drug
through Bangalore-based Biocon. When contacted, Natco said that it had not
taken the decision yet to launch the drug.

Natco's version, Albupax, was the first indigenously developed
nanotech-based cancer drug. But it landed into problems after a year of
launch, being charged with safety concerns by the drug controller.

After clearing the hurdles, Natco is yet to launch the drug. Other
companies like Cipla launched the drug Paclitax Nab (nano particle albumin
bound) for the treatment of metastatic breast cancertion in 2012, at around
Rs 11,000 per injection.

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