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October 1, 2012 8:40 pm

Celgene likely to prevail in Revlimid litigation against generic drug developers

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This article is provided to readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market.


Celgene (NASDAQ:CELG) has a good chance of prevailing against generic drug developers in the ongoing litigation over its cancer blockbuster, Revlimid (lenalidomide), intellectual property attorneys told BioPharm Insight. The patent portfolio covering Revlimid is strong and is likely to present a challenge for generic defendants, they indicated.

Natco Pharma (BOM:524816), Arrow International and Watson Laboratories (NYSE:WPI) are the challengers. Natco is partnered with Arrow and Watson to market and distribute its generic drug products.

Celgene and Natco did not respond to requests for comment.

Celgene has a broad patent portfolio for Revlimid that will present a challenge for generic defendants to overcome, said Douglas Robinson, associate, Harness Dickey, St. Louis, Missouri.

Revlimid was first approved in December 2005 for use in multiple myeloma, a blood cancer. It has since been approved for transfusion-dependent anemia due to myelodysplastic syndromes associated with a 5q deletion. It is projected to have global sales of USD 7.7bn by 2017, according to BioPharm Insight data. Celgene reported 2011 sales of USD 3.2bn, noting a 30% increase from 2010.

On 30 August 2012, Natco first sent a written notice to Celgene about filing an application with the US Food and Drug Administration for its Revlimid generic, called an Abbreviated New Drug Application (ANDA). On 8 October 2010, Celgene filed an infringement action against Natco asserting 10 patents including patent number 5,635,517 (’517) and patent number 7,465,800 (’800).

The ‘517 and ‘800 patents represent the key patents protecting Revlimid until 2019 and 2027, respectively.

A second notice of additional Natco ANDA certifications was sent to Celgene on 12 June 2012. Celgene filed another complaint on 20 July 2012. In addition to the ‘517 patent, claims from three additional patents were alleged by Natco as invalid, unenforceable, and noninfringed by the ANDA.

The second lawsuit triggered a new 30-month stay, through December 2014, preventing the US Food and Drug Administration from approving the generic Revlimid ANDA until a legal resolution has been reached.

Strong patent portfolio

Considering the number of patents, the defendants are apt to face an uphill battle, Robinson said added.

Robinson indicated the situation is reminiscent of the ANDA litigation concerning Teva’s (NASDAQ:TEVA) Copaxone, in which the plaintiff had a “ton” of patents. Teva ultimately prevailed, earlier this year, against defendants Mylan Pharmaceuticals (NASDAQ:MYL) and Novartis’ (NYSE:NVS) generic division Sandoz.

While all the defendants’ invalidity and unenforceability arguments have not yet been disclosed, Celgene appears to be in a similarly good position to prevail, said Lana Gladstein, partner, Pepper Hamilton, Boston. Keith McWha, partner, McCarter & English, Newark, New Jersey, agreed Celgene’s composition and method of use patents create a strong portfolio that will bolster the plaintiff’s argument.

Furthermore, all 10 claims of the ‘517 patent survived on reexamination, which presents an even higher hurdle for the defendants to prevail, McWha and Robinson said.

The ‘517 patent describes a “method of reducing TNF-alpha levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines.” The ‘800 patent, known as the polymorph patent, describes “Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione.”

It is difficult to attack polymorph patents as they cover unique molecules, said Katherine Kowalchyk, attorney, Merchant & Gould, Minneapolis. Unless there is a attack based on the fact that there is previously published information on the polymorph, the ‘800 patent appears strong and would be difficult to challenge from a validity standpoint, she said.

Yet because each polymorph is unique, the defendants may be able to get around ‘800’s claims with a different crystal structure, Kowalchyk said. As a result, she explained, the generics will likely try to adopt a noninfringement argument for the ‘800 patent.

Regarding the ‘517 patent, the generics will be less likely to avoid a compound claim for noninfringement, Kowalchyk said. Therefore, she noted, generics are apt to try to challenge the patent’s validity.

Further ‘517 patent extension unlikely

While the ‘800 patent was recently extended from 2026 to 2027, attorneys noted no other extensions are possible for the ‘517 patent.

The ‘517 patent received a 1,167-day extension on 27 March 2008, Gladstein said. The patent was issued 3 June 1997 and was set to expire 2016, Kowalchyk noted.

All the regulatory delay has been taken into consideration and a substantial extension was already granted, therefore further extension is unlikely, Gladstein added. Several attorneys agreed with this assessment, noting the 2019 expiry already reflects an extension.

Celgene’s current market cap is USD 33.6bn.


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