Patent Valuation, Monetization and Investments

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Markman Advisors Patent Blog

by Zachary Silbersher

Posts tagged Merck
Can Microspherix knock out Merck’s prior-inventorship defense in its Nexplanon patent suit?

Microspherix has been embroiled in a long-running patent suit against Merck and its spinoff Organon.  The suit alleges that Organon’s drug, Nexplanon, is infringing multiple Microspherix patents.  Nexplanon is a contraceptive implant that accounts for 10 percent of Organon’s sales.  After several years, the suit is finally teeing up for trial in October 2023.  Yet, Microspherix has recently tried to short-circuit the trial by asking the court to knock out one of Merck’s primary defenses in the case before trial.  Will Microspherix’s ploy work?

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What can the Patent Office do to prune Keytruda’s patent thicket?

In February 2023, United States Senator Elizabeth Warren penned a letter to Kathi Vidal, Director of the USPTO, asking what the Patent Office can do to blunt Merck’s use of patents to stall entry of lower-cost alternatives for Keytruda.  Unfortunately for consumers, the answer may be, not that much.

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Eylea: How do courts solve a problem like a patent thicket?

Senator Warran recently asked what the Patent Office can do about patent thickets. Yet, the courts are in the unique position of having to contend with scores of patents asserted within a single suit.  When a brand pharmaceutical company shows up with 20, 60 or 100 patents in a single suit, those challenges can be exacerbated by orders of magnitude. So, how have courts face this challenge?  Regeneron’s pending patent suit against Mylan over its prospective biosimilar for Eyelea® is an interesting example.

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Can Merck resurrect its $200M Sovaldi patent judgment against Gilead at the Supreme Court?

Merck ($MRK) lost a $200M patent judgment against Gilead ($GILD) after the Court found that Merck engaged in business and litigation misconduct.  Merck is now appealing to the Supreme Court, asking to resurrect that judgment.  Will it prevail?

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Will MorphoSys win the Darzalex patent case against Janssen and Genmab?

In 2016, MorphoSys ($MOR) sued Janssen ($JNJ) and Genmab for patent infringement.  MorphoSys claims that Janssen’s anti-CD38 antibody, Darzalex®, infringes three of its patents.  The case is scheduled to go to trial in February 2019.  The stakes are big because the patents purport to cover the actual protein used in Darzalex®, which could mean material royalty rates on sales of Janssen’s drug.  What are the strengths and weaknesses of each party’s case?

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When do biosimilars launch at risk?

The biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010.  Since then, drug companies have been filing biosimilar applications with FDA.  And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.

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