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Summary

  • Celgene's current suit against Actavis asserting 18 patent awaits Markman decision.
  • On the day of the Markman hearing, Celgene filed a new suit against Actavis, asserting 4 more patents.
  • Celgene is also already seeking patent protection that could extend the Revlimid franchise to 2031.

Last week, I commented on the Markman hearing that took place in the pending patent infringement suit brought by Celgene (NASDAQ:CELG) against Actavis' (NYSE:ACT) related companies, Natco, Arrow and Watson, regarding Revlimid. I pointed out that Celgene had many more patents protecting Revlimid than those that were currently being asserted, and that I expected Celgene may assert some of those additional ones against Actavis in new suits. I also suggested that Celgene may apply for new patents that could extend protection of Revlimid past 2027, when the currently asserted patent families expire. Both have indeed happened, as I discuss in more detail below.

Celgene Files New Patent Infringement Suit Against Actavis

On Thursday, while most people following Celgene were focused on the Markman hearing in the current suit against Actavis over Revlimid, Celgene quietly filed a new suit against Actavis, asserting 4 more patents. Those 4 newly asserted patents are U.S. Patents Nos. 8,530,498, 8,589,188, 8,626,531 and 8,648,095, which expire in May 2023, Aug 2018, Oct 2020 and May 2023, respectively.

These 4 patents were issued to Celgene just this past fall and winter, which is why they were not included in the original suit. As I said in my comments Friday, Celgene still has several patent applications pending at the Patent Office and, as they issue, I expect Celgene may continue to assert more patents against Actavis.

Asserting more patents against Actavis makes it that much more unlikely that the generic will be able to enter the market for Revlimid before Celgene's patents expire. The currently asserted Revlimid patents don't all expire until 2027.

Celgene Seeking New Revlimid Patents Expiring Past 2027

In my review of Celgene's Revlimid patent portfolio, I identified the 6 patent families containing 56 patents currently issued to Celgene for Revlimid. I also noted how I expected Celgene would continue to innovate to improve Revlimid, making it safer and more effective. As Celgene achieved innovations, it could seek patents on those improvements, and those patents could extend the protection for Revlimid well past 2027, when the current patent protection will expire.

I had a few moments to take a look and see if Celgene already had some patent applications pending on improvements for Revlimid that would provide patent protection past 2027, and I found at least one set of pending applications that seemed precisely to do that. In December 2011, Celgene submitted a patent application for the combination of Revlimid with CDK inhibitors to improve safety. As described in the application:

In certain embodiments, the invention provides a method for improving the safety and efficacy of a treatment with lenalidomide (Revlimid®), wherein the method comprises administering a CDK4/CDK6 inhibitor to the patient being treated with lenalidomide (Revlimid®). In certain embodiments, safety is improved if any side effects of treatment with lenalidomide is reduced by at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 600%, 700%, 800%, 900%, or by at least 1000%.

Any patent issued from that application would not expire until 2031. This is just one of what I expect will be several examples of Celgene pursuing new patents relating to Revlimid that will extend far past the expiration of its current patents.

Source: Celgene Asserts More Revlimid Patents, Seeks New Ones To 2031