Amgen patents on
Repatha invalid, judge rules in reversal
A federal judge on Wednesday ruled two patents held by Amgen
on its cholesterol drug Repatha are invalid, reversing a February jury verdict
that had upheld the California biotech's claims in its legal battle with rivals
Sanofi and Regeneron. Judge Richard Andrews' decision will not remove Repatha
from market, and Amgen said it plans to appeal. Still, it's a setback that
strengthens the position of Sanofi and Regeneron, which sell the competing drug
Praluent. Both Repatha and Praluent are antibodies that lower cholesterol by
binding to a protein called PCSK9..…
Delhi High Court
Revoked the Patent on Novartis’ Ceritinib
The Court suspended the earlier interim relief granted to
Novartis, which had restrained the manufacture and sale of the generic version
of the cancer drug by Natco Pharma. It was only end-May the Delhi High Court
had restrained Natco from carrying out any fresh manufacture of drugs
comprising the API ceritinib, a non-small cell lung cancer (NSCLC) treatment. The
Court’s May decision came on a plea filed by Novartis seeking an order
restraining Natco from manufacturing and selling ceritinib. The Swiss company
submitted that, in March 2019, it came across Natco’s product under the
trademark Noxalk at a pharmaceutical conference in Kolkata.…
Del HC Vacates
Interim Orders Restraining Dr. Reddy’s & Ors. from Selling AstraZeneca’s
Ticagrelor
On 8th August, the Single Bench of the Delhi High Court
vacated the interim orders granted in favour of AstraZeneca (‘plaintiff’)
preventing Micro Labs, Natco Pharma and Dr. Reddy’s Laboratories (‘defendants’)
from selling, marketing or dealing with TICAGRELOR (an effective platelet
aggregation inhibitor) or any other product violating the plaintiff’s
registered patents- IN 907, IN 984 and IN 674. The case relates to two important
issues, namely, selection patents and the difference between coverage and
disclosure in a patent. The interim applications dealt with in the instant case
were IA 3986/2018 in CS (Comm.) 749/2018, IA 4771/2018 in CS (Comm.) 792/2018,
IA 9332/2018 filed in CS (Comm.) 1023/2018 filed by the plaintiffs, and IA
5096/2018 in CS (Comm.) 749/2018 filed by the defendants seeking vacation of
the interim orders..…
Parties Agree That
Mylan's Pegfilgrastim Biosimilar Does Not Infringe Amgen's Patent
Amgen, maker of the brand-name pegfilgrastim (Neulasta), and
Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have
entered a joint status report in the District Court for the Western District of
Pennsylvania. In the status report, they agree that Amgen cannot maintain a
claim of infringement against Mylan with respect to US Patent Number 8,273,707,
which covers a process for purifying proteins by mixing a protein preparation
with a solution involving 2 salts. This latest development stems from an
earlier decision in another case related to the same patent; in March 2018, a
Delaware court dismissed a lawsuit brought by Amgen over a different biosimilar
developer’s alleged infringement of this same patent; in that case, Amgen
alleged that Coherus BioSciences infringed on its patent because Coherus’
biosimilar pegfilgrastim, later approved as Udenyca, mixed salts that, in
combinations, were equivalent to Amgen’s patented combinations. According to
the court, Amgen had previously acknowledged that Coherus did not literally
infringe on the patent..
Baxalta Loses Motion
for Patent Infringement Retrial Against Bayer
A federal court in Delaware has denied Baxalta’s request for
a new trial in a suit brought by Bayer over patent infringement by Baxalta’s
hemophilia A drug Adynovate. The Takeda
subsidiary sought a new trial on the grounds that its clotting factor VIII drug
could not infringe on Bayer’s patent for factor VIII because the patent was
invalid. Bayer sued Baxalta and Nektar
Pharmaceuticals in 2016 alleging that they infringed on its patent by making,
selling and importing Adynovate. Nektar had worked with Bayer on its version of
the drug, but also helped Baxalta develop Adynovate, according to Bayer’s
complaint. The FDA approved Jivi,
Bayer’s factor VIII hemophilia A treatment, in August 2018. In a trial held
earlier this year, a jury found that Baxalta did infringe on Bayer’s patent,
and the company was ordered to pay $872 million in royalties and $155 million
in damages.…
Purdue Pharma
proposes $12B settlement to clean up opioid mess — report
After months of negotiations with states and federal
plaintiffs accusing it of instigating the opioid crisis through aggressive and
deceptive marketing tactics, Purdue Pharma is ready to pay $10 to $12 billion
to settle it all. The potential deal would cover hundreds of lawsuits being
waged against the company by states, cities, towns and tribes, which is being
overseen by United States district judge Dan Polster in Cleveland, alongside
cases involving other prescription opioid makers. As part of the deal, the
Sackler family — who had been charged with building a “multibillion-dollar drug
empire based on addiction” — will give up ownership in Purdue..
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