[Ip-health] Fierce Pharma (18 January 2018) - J&J's blockbuster Zytiga falls to patent challenge, boosting threat of 2018 generics

Thiru Balasubramaniam thiru at keionline.org
Wed Feb 14 23:58:44 PST 2018


J&J's blockbuster Zytiga falls to patent challenge, boosting threat of 2018

by Eric Sagonowsky |
Jan 18, 2018 10:31am
Johnson & Johnson suffered a loss at the U.S. Patent Trial and Appeal

After a relatively short but profitable run on the market, Johnson &
Johnson's prostate cancer therapy Zytiga faces the prospect of generics
this year, thanks to a patent-office ruling that stripped away its last
remaining patent.

The U.S. Patent Trial and Appeal Board invalidated Zytiga's 2027 patent
Wednesday, after an inter partes review challenge by would-be generics
maker Argentum Pharmaceuticals. Zytiga copies could hit the market as soon
as October.

J&J says it's "disappointed" in the ruling and will ask for a rehearing or
appeal to protect its blockbuster therapy. The PTAB struck down the patent
on grounds of obviousness after hearing arguments brought by Argentum. "We
believe the '438 patent is valid and will continue to vigorously defend
it," J&J said in a statement.

Branded drug giants have protested loudly about the IPR process, introduced
just a few years ago, but in a statement, Argentum Pharmaceuticals CEO
Jeffrey Gardner said his company is "pleased" with the result.

"The inter partes review process is an important tool by which generic and
biosimilar companies can create prescription drug savings by ensuring that
non-innovative patents do not block competition," he added.

In a note Wednesday, Credit Suisse analyst Vamil Divan wrote that his team
"did not expect the final patent remaining on Zytiga to hold up to
challenge, and we have been anticipating a generic entry following the
expiration of a 30-month stay in October 2018." An official patent
challenge from a generics maker triggers that automatic delay under the
Hatch-Waxman Act.

Other pharma watchers may not have been prepared for the news, though. As
Divan wrote, Credit Suisse's projections for Zytiga sales in 2019 and 2020
are already lower than consensus, so many "analysts and investors may have
been caught by surprise by today's news."

Zytiga brought in $826 million in the U.S. through the first 9 months of
2017; J&J hasn't yet reported full-year 2017 results. In 2016 in the U.S.,
the drug generated $1.1 billion. The patent wasn't set to expire until 2027
and would have shielded years of blockbuster sales if it held up to the IPR
attack and others in federal court.

But more than 50% of Zytiga's sales come from outside of the U.S., where
the drug has protection until 2022, Divan noted, so the drug is likely to
remain a big earner for J&J in any case.

The PTAB's decision is a setback for J&J in its prostate cancer battle with
Pfizer, which sells the blockbuster Xtandi. Currently, Pfizer and J&J's
prostate cancer drugs are used in the same patient group, but both
companies are working to widen their reach.

Pfizer picked up Xtandi in a $14 billion Medivation buyout and posted
positive data in September in patients with premetastatic
castration-resistant prostate cancer, for whom there are no FDA-approved
treatments. J&J has an FDA application in for its experimental drug
apalutamide to treat the same group. It's also awaiting word on its filing
for a new Zytiga indication in newly diagnosed hormone naïve metastatic
prostate cancer.

Zytiga's exclusive protections were relatively short-lived; the drug only
won its FDA approval in 2011. Some blockbuster drugs, on the other hand,
win new patents during their run on the market that stretch their
exclusivity out for many years. AbbVie's Humira, for instance, won its
initial approval in 2002 and the company recently entered a settlement
postponing Amgen's U.S. biosimilar until 2023.

The Zytiga decision could add to pharma's angst about the current U.S.
patent challenge system for pharmaceuticals, in which drugmakers have to
defend their products in both federal courts and at the U.S. Patent and
Trademark Office. The issue came into the public spotlight last fall when
Allergan signed a tribal licensing deal to protect Restasis at the PTAB and
moved to deflect criticism by pointing to the "flawed" patent challenge
system that it said amounts to a "double jeopardy."

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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