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? 

The anti-CGRP market is heating.  Amgen’s ($AMGN) Aimovig® received FDA approval in May 2018, and Teva’s ($TEVA) Ajovy® received approval in September.  Hot on their heels, Eli Lilly’s ($LLY) Emgality® just received FDA approval at the end of September.  The drugs will all be sold for essentially the same price of $6900 / year.  Given the tight competition, can Teva use its patents to kick anyone off the market?

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?

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?

Facebook ($FB) recently sued Blackberry ($BB) in the Northern District of California.  The move appears to be the latest salvo in the patent war heating up between the companies.  Yet, there are a few noteworthy aspects of Facebook’s suit.

The CRISP-Cas9 saga has effectively come to an end.  For now.  On September 10, the Federal Circuit affirmed the decision of the PTAB dismissing the interference between UC and Broad.  What are the implications for UC’s patents? What are the chances UC can successfully appeal to the Supreme Court?

We previously wrote about Corcept’s ($CORT) amended complaint in its Hatch-Waxman patent litigation against Teva ($TEVA) regarding Korlym®.  On July 27, Teva filed another motion to dismiss.  Corcept opposed the motion on August 21, and Teva filed its reply on August 28.  The motion is now fully briefed.  Who will prevail?

​​​​​​​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?

We previously blogged about Pfizer’s ($PFE) antitrust lawsuit against Johnson & Johnson ($JNJ) related to Janssen’s Remicade®.  In short, Pfizer launched Inflectra® in 2016, which is a biosimilar to Janssen’s Remicade®.  Yet, Inflectra® has struggled to eat into Janssen’s monopoly for Remicade®.  Pfizer claims that Inflectra®’s poor sales are due to anticompetitive rebate schemes by Janssen.  Specifically, Janssen forced hospitals and insurers to enter exclusive arrangements and bundled-rebated programs that discouraged them from stocking or covering Inflectra®.  Pfizer sued Janssen in the Eastern District of Pennsylvania.  Janssen moved to dismiss, but on August 10, the Court denied Janssen’s motion to dismiss.  What are the takeaways?

On August 3, Dr. Reddy’s filed three petitions for inter partes review (IPR) against three patents owned by Celgene and listed in the Orange Book for Revlimid®.  Does this indicate that Celgene and Dr. Reddy’s are close to a settlement?  If not, what are the take-aways?

IBM owns patents.  IBM sued Groupon for infringement of those patents.  IBM just won a jury verdict against Groupon for $82.5M.  Does that make IBM a patent troll? 

The Federal Circuit recently issued a strong decision instructing the PTAB to rethink the way that it decides who is an RPI (real-party-in-interest).  While the decision involved RPX, it presents a more existential threat to Unified Patents, which has risen as one of the most prolific non-party filers of IPRs.  Can Unified survive the CAFC’s RPX decision?

We previously discussed Teva’s ($TEVA) motion to dismiss Corcept Therapeutic’s ($CORT) Hatch-Waxman lawsuit commenced in response to Teva’s ANDA for Korlym®.  In response to that motion to dismiss, on July 6, Corcept filed an amended complaint.  What are the implications of that?  And how does the case currently dovetail with the pending patent applications?

 On July 20, in an otherwise unremarkable opinion, the Honorable S. Jay Plager issued a stinging dissent that should resound throughout the patent community—and may, in fact, resound throughout district courts.  See Interval Licensing LLC v. AOL, Inc., No. 2016-2502 (July 20, 2018).  Interestingly, Judge Plager did not dissent from the majority’s holding itself, but rather concurred in the reasoning of the majority.  Instead, and importantly, he dissented in the Federal Circuit’s “continued application of [Alice’s] incoherent body of doctrine.” Judge Plager’s dissent is nothing short of a recommendation that district courts stop applying the Alice doctrine, at least not until resolution of other defenses in the case. Does that matter?

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?

Nevro Corp. ($NVRO) claims to have invented pioneering technology for improving the life of individual suffering from chronic pain.  Nevro’s product, the Senza® system, received FDA-approval in May 2015.  Rather than relying upon opioids, the Senza® system uses innovations for spinal-cord stimulation (SCS) therapy.  In 2016, Nevro sued Boston Scientific ($BSX) for copying its patents protecting its innovative SCS therapy.  The case is scheduled to go to trial in November of this year, but the Court has already issued preliminary rulings that show a mixed bag of wins and losses for both parties.  Where is this case heading?

Every year, it seems, the Federal Circuit issues a precedential decision on damages, which seems to make the whole process more difficult.  The latest of these decisions comes in the long-running patent battle between Power Integrations and Fairchild.  In its latest opinion, the Court addresses the entire-market-value rule.  The Court essentially guts the rule, and leaves open the question whether there is an reasonable scenario where it will ever be applicable.

UC was recently awarded two patents on CRISPR technology.  UC is currently embroiled in a highly-watched dispute with the Broad Institute over who owns the heralded first patents covering CRISPR-Cas9 in plant and animal cells.  (We previously blogged about the dispute here and here.)  While that dispute remains pending, the question remains how important UC’s two new CRISP patents are?  How much will they impact the overall intellectual-property being claimed over the burgeoning CRISPR-Cas9 technology?

The biosimilars are biting.  And they are biting at three big biologics distributed by Roche through its biotech subsidiary, Genentech.  Roche currently faces pending biosimilar competition against Avastin® (bevacizumab), Roche’s biggest selling cancer drug, Herceptin® (trastuzmab), Roche’s breast-cancer drug, and Rituxan® (rituximab), Roche’s immunotherapy drug.  All three drugs are involved in patent litigations. How long will these cases last? And how long can Roche keep the biosimilars out?