[Ip-health] Gilead patent for its hepatitis C drug is invalidated by Chinese authorities

Tahir Amin tahir at i-mak.org
Mon Aug 13 17:03:28 PDT 2018

Gilead patent for its hepatitis C drug is invalidated by Chinese authorities

*By* ED SILVERMAN <https://www.statnews.com/staff/ed-silverman/> @Pharmalot

AUGUST 13, 2018

*I*n a setback for Gilead Sciences (GILD
), Chinese authorities have rejected a key patent for its Sovaldi hepatitis
C medicine, opening the door to generic versions of the groundbreaking pill
a few years sooner than might have occurred otherwise.

The decision <http://freepdfhosting.com/ee9024b882.pdf> emerges from an
ongoing effort by different advocacy groups to challenge Gilead patents for
its hepatitis C medicines around the world in hopes of widening access.
Although Gilead’s hepatitis C drugs have revolutionized treatment, they
have also strained budgets, especially among cash-strapped governments with
large numbers of citizens who are infected with the virus.

The decision marks the second time that China has invalidated a crucial
patent for Sovaldi, which costs about $9,000, according to the Initiative
for Medicines, Access, and Knowledge, or IMAK, the group that filed the
challenges. The previous invalidation
in 2015 for a patent covering the way a compound can be metabolized in the
body, while the latest ruling concerns the base patent, or core component.



“Now, the market is potentially open much sooner to generics, because this
was the patent that was ultimately blocking generic entry until 2024,” said
Tahir Amin, who heads IMAK. He noted that 19 generic companies are believed
to be interested in producing versions, given that China is a large market
and Sovaldi is a building block for combination hepatitis C treatments, a
key reason for seeking to challenge patents.

We imagine that Gilead will file an appeal. Meanwhile, we asked the drug
maker for comment and will update you accordingly.

Although Gilead still holds four remaining patent claims on Sovaldi, Amin
maintained that these are not expected to preclude generic entry. He
acknowledged, however, that Gilead also holds data exclusivity, which
refers to the data a generic company needs to make its version, but that
other manufacturers may be able to proceed by instead proving

Gilead patents are also being challenged for a newer hepatitis C treatment
called Epclusa, which is the first pill to treat all six major subtypes of
the liver disease. Late last year, Doctors Without Borders argued
Sovaldi pricing is “prohibitive” and remains concerned about affordability
for Epclusa, since Sovaldi is one of two components in the treatment.

As we have noted previously, filing patent challenges has become an
increasingly common tactic among nonprofit and advocacy groups over the
past two years in response to Gilead pricing.

Since its launch in 2013, Sovaldi helped trigger an ongoing debate over the
cost of prescription drugs. Gilead, in particular, has been widely
criticized in the U.S. — where the drug initially cost $84,000 at list
price — and abroad. In 2014, Gilead attempted to deflect criticism by
striking a licensing deal that allows several generic companies to sell
low-cost versions of Sovaldi in dozens of low-income countries.

But Gilead continued to encounter complaints because some middle-income
governments and individuals are unable to afford Sovaldi, which has since
become the linchpin in the Gilead hepatitis C product franchise. The
company recently expanded the deal to include Ukraine, Belarus, Thailand,
and Malaysia.

Despite its efforts, Gilead has faced patent challenges from advocacy
groups in Europe
Brazil, Argentina, Thailand, Egypt, and Russia. Certain patents were
revoked in Ukraine and Gilead fended off
challenge in India, but that is being appealed and I-MAK filed yet another

In the U.S., however, I-MAK lost a bid to convince the U.S. Patent &
Trademark Office to reject Sovaldi patents. The group contended that
taxpayers could save $10 billion and generics can get to market 14 years
faster if had been successful, despite falling prices due to the arrival of
lower-cost medicines from other manufacturers, such as Merck (MRK
and AbbVie (ABBV

Tahir Amin
Co-Founder and Co-Executive Director
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
Twitter: @IMAKglobal
*Tel:* +1 917 455 6601 <(917)%20455-6601>/+44 771 853 9472

More information about the Ip-health mailing list