For the past couple of years, Novo Nordisk was embroiled in patent litigation with numerous prospective generics for Ozempic.  In the fall of 2024, Novo Nordisk wrapped up existing claims and settled with numerous generics, including Mylan, Dr. Reddy’s, Apotex, Sun Pharmaceuticals, among others.  The terms of those settlement agreements, however, are confidential, leaving investors uncertain as to the expected entry date for generic Ozempic.  Novo Nordisk has two other semaglutide drugs, over which it is currently litigating different patents with generics.  What is the patent landscape for Novo Nordisk’s Semaglutide products, Ozempic, Wegovy and Rybelsus?

Bad facts make bad law.  The case of GlaxoSmithKline’s lawsuit over Teva’s generic Coreg® drug is a case-in-point.  I previously blogged about the case here and here.  Given that the Supreme Court declined to grant certiorari, we’re now stuck with Federal Circuit precedent holding that a generic can still face liability for induced infringement of a method-of-use patent covering a section viii carved-out indication.  What will be the consequences of this?

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.

On November 5, 2020, the Federal Circuit issued a precedential decision, Vaeleant Pharmaceuticals v. Mylan Pharmaceuticals, that is likely to have a significant impact on the litigation of Hatch-Waxman cases—including the possible development of “generic-friendly” districts. In short, if this decision stands, the future of patent pharma litigation against multiple generics for the same drug will likely be spread out, difficult to consolidate, subject to multiple forums determining in parallel common issues related to infringement and invalidity. Costs for brands are likely to go up along with settlement leverage for generics. Although, exactly who wins and who loses from this decision remains to be seen.

Mylan’s biosimilar for Herceptin® has FDA approval since December 2017.  Several months earlier, in March 2017, Mylan reached a global settlement with Roche and Genentech regarding their patents covering the drug.  The terms of the settlement have not been made public, which raises the question – when did Mylan agree to launch? 

Mylan ($MYL) recently prevailed on a motion to dismiss for improper venue in a pending Hatch-Waxman case for the drug Eliquis®.  Mylan successfully argued that Delaware was an improper venue under the recently test for venue in patent cases enunciated by the Supreme Court in TC Heartland.  What are the implications of TC Heartland governing venue in all Hatch-Waxman cases?  Will it lead to “generic friendly” judicial districts?

We previously wrote about Roche’s encroaching biosimilars for Ritxuan®, Herceptin®, and Avastin®.  This week, Roche prevailed on two IPRs covering patents for Herceptin®, but lost a third IPR covering another patent for the same drug. What does this mean? 

​​​​​​​Boehringer Ingelheim has claimed that AbbVie wrongfully created a “patent thicket” around Humira®, and it is delaying biosimilar competition.  While that defense is unique, and may be hard to prove on its face, the FDA appears to agree with Boehringer.  Did AbbVie create a wrongful “patent thicket” around Humira®?

AbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay.  On August 10, AbbVie brought suit against Sandoz ($NVS) asserting that two of AbbVie’s patents will be infringed by Sandoz’s proposed biosimilar.  Sandoz is the fifth biosimilar to throw its hat in the ring.  Does this increase the odds of the US market seeing a biosimilar for Humira® before 2023?

The Federal Circuit has sided against the Tribe and Allergan.  On July 20, the Federal Circuit affirmed the decision by the Patent Trial and Appeal Board that denied the motion by the St. Regis Mohawk Tribe to terminate a series of inter partes review proceedings commenced by Mylan ($MYL) against patents listed in the Orange Book for Allergan’s ($AGN) drug Restasis®.  What are the takeaways from this decision?

On June 4, 2018, the Federal Circuit heard oral argument in Allergan’s effort to assert tribal immunity at the PTAB to shut down six IPRs against its Restasis® patents.  The St. Regis Mohawk Tribe has appealed the PTAB’s prior decision that it cannot assert its immunity as a basis to terminate the IPRs.  While there was no clear indication for how the three-judge panel at the Federal Circuit would rule, there were some interesting exchanges revealing how the Court views these types of transactions, and how viable they may be in the future.

Sandoz recently prevailed in court against Amgen by showing it does not infringe a patent covering two of Amgen’s drugs, Neulasta® and Neupogen®.  No biosimilar has yet to receive FDA approval for Neulasata® within the U.S.  Sandoz recently announced successful Phase 1 data indicating it may be getting closer.  Further, other biosimilars for Neulasta® are in the works.  Given that Neulasta® accounts for a third of Amgen’s sales, will Amgen’s recent loss in its case against Sandoz read-through to other biosimilars?

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.

On December 1, 2017, several friends of the PTAB submitted amicus curiae briefs in connection with the Tribe’s motion to dismiss the pending IPRs challenging Allergan’s Restasis® patents.  What did the amici argue, on both sides of the issue?

The problem with these arguments is that even if they are all true (which is questionable,) they are besides the point.  The issue at stake is whether renting sovereign immunity to evade having to defend the validity of your patent is either permissible or should be permissible.  Indeed, Judge Bryson admonished Allergan for being “conspicuously silent about the broader consequences of the course it has chosen.”  (Allegan v. Teva, Dkt. 522 at 4-5).  Mr. Saunders op-ed in The Wall Street Journal is equally silent.