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Conceptus v. Hologic

Why Adiana Has Been Discontinued

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Updated August 02, 2012

Conceptus v. Hologic

Conceptus v. Hologic

Photo © 2011 Dawn Stacey

In July 2009, the FDA granted approval for Adiana -- a permanent contraception method created to be a less-invasive, non-surgical option to tubal ligation. Adiana was manufactured and marketed by Hologic and was making its way into doctor’s offices by early 2010.

Unfortunately, on the economic front, Hologic decided that the Adiana Permanent Contraception System was not generating the revenue it was expected. On April 30, 2012, Hologic officially announced that the company will discontinue the manufacturing, marketing and sales of Adiana in the United States as well as worldwide.

Yet, it seems that the main reason for the decision to discontinue the manufacturing of Adiana appears to stem from a long-standing legal battle over patent infringement between Hologic and Conceptus, the manufacturer of Adiana’s main competition, Essure Permanent Birth Control.

Major Litigation Highlights - Conceptus v. Hologic:

November 6, 2009: Conceptus filed a motion in U.S. District Court for Northern California asking for a preliminary injunction that would prohibit Hologic to introduce the Adiana permanent contraception system to the U.S. market. Judge William Alsup denied this motion.

October 3, 2011: Conceptus filed suit, again in the U.S. District Court for the Northern District of California, alleging that Hologic’s Adiana permanent contraception system infringed upon specific claims of Conceptus’ patent for Essure. This patent, officially called the "Contraceptive Transcervical Fallopian Tube Occlusion Devices And Methods" was assigned to Conceptus on October 21, 2003.

Conceptus argued that Hologic infringed upon three “claims” of this patent:

  • Claim 8: This claim had to do with the actual contraceptive device, defined as a tissue in-growth contraceptive device for use in a fallopian tube. Claim 8 had three distinct components to describe this device. The jury found that the Adiana matrix/insert did not meet all of these descriptions; thus finding that Hologic was NOT guilty of patent infringement with respect to this claim.

  • Claims 37 and 38 (which both have references to Claim 36): These claims have to do with the actual method of birth control. Claim 36 provides a description of this intra-fallopian contraceptive method and how it works. Claim 37 specifically identifies that the growth of tissue in the tubal wall will form around the Essure insert, and Claim 38 adds that this tissue growth blocks the fallopian tubes thereby preventing conception from occurring. The jury found that, through its sale of Adiana, Hologic contributed to the direct infringement of method claims 37 and 38 and indirect infringement of Claim 36.
  • So, after a two-week trail, the jury found that the Adiana system directly and indirectly infringed upon certain method claims of Conceptus’ Essure patent. The actual Adiana insert was not found to violate the Essure patent, but the jury determined that the procedure for how it works was considered to infringe upon the method claims in the lawsuit. Conceptus was awarded $18,807,241 in damages as well as a 20% royalty rate award for ongoing damages. Conceptus, though, chose to reject this royalty rate, claiming that it was inadequate to compensate for the company’s ongoing lost profits/damages.

    January 9, 2012: Conceptus motioned for a permanent injunction against the Adiana system and to increase awarded damages. At this hearing, California District Judge William Alsup denied Conceptus’ motion for a permanent injunction (which would have required Hologic to stop manufacturing Adiana).

    As per Judge Alsup,

    "Adiana is not a copycat product. It was independently developed and provides important advantages over Essure for patients. ...The public interest would undoubtedly be harmed by an injunction. Enjoining the sale of Adiana would leave only one product for transcervical hysteroscopic sterilization. Public health has benefited, and will continue to benefit, from having a choice of products for transcervical hysteroscopic sterilization. This is especially important because the products are different. Removing Adiana from the market would have eliminated an important alternative for patients.

    Essure and Adiana are not interchangeable products and procedures. ...In this action, the public benefit of having two products with different qualities in the transcervical hysteroscopic sterilization market militates strongly against an injunction."

    Judge Alsup also stated that although Hologic is a larger and more diversified company, it has established that considerable hardship would occur if a permanent injunction was enforced. Finally, because Judge Alsup felt that the monetary award from the infringement trial would sufficiently compensate for Conceptus’ harm, he denied the motion for permanent injunction.

    At this time, Conceptus also filed for supplemental damages as well as pre- and post-judgment interest. The judge denied the company’s request for supplemental damages as well as Conceptus’ motion for $717,471 in pre-judgment interest. Citing that the jury award was generous enough coupled with the fact that the debt Conceptus was claiming had acquired before the Adiana system was launched and was unrelated to Hologic’s infringement guilt, the judge denied the company’s request for pre-judgment interest. During this hearing, Hologic asked that the court to overturn the jury infringement verdict and to order a new trial -- Judge Alsup denied this motion as well.

    April 29, 2012: Conceptus and Hologic entered into a license and settlement agreement. Both companies agreed to withdraw their respective appeals and to file joint motions seeking a consent judgment to the voluntary injunction of Hologic’s sale of Adiana. As part of this settlement, Conceptus agreed that Hologic would not have to pay them the $18.8 million in damages awarded by the jury in return for Hologic’s agreement to a permanent, worldwide ban against the manufacturing, sale and distribution of the Adiana system. Lastly, under this settlement arrangement, Hologic provided Conceptus with licensing rights to Adiana’s technology, limited to use only in the field of permanent contraception. Even though Conceptus now has these licensing rights, the company has no intention of promoting or selling the Adiana system.

    What Does This All Mean?

    It is important to stress that the decision to discontinue Adiana had absolutely NOTHING to do with the safety or effectiveness of this permanent contraceptive system. Even though Adiana has been discontinued, Hologic still stands firmly behind this product. If you have had the Adiana procedure done, there is no need for you to worry at all. Even though Hologic has stopped the manufacturing of Adiana, if you have undergone the procedure less than 3 months ago, it is still important that you return to your doctor after 3 months have passed to have your hysterosalpingogram test to confirm that your fallopian tubes are fully blocked. This test will make certain that your Adiana procedure has been successful. The effectiveness of Adiana remains the same (98.4%) -- but the effectiveness is based on your doctor confirming that your tubes are completely blocked.

    Under the Conceptus/Hologic agreement, doctors were able to order Adiana systems until May 18, 2012. Even though Adiana production and sales are now discontinued, your doctor may still provide you with the Adiana inserts as long as he/she still has Adiana inventory, and the products have not expired. Given that Adiana is safe and the reasons for discontinuing it have nothing to do with how the product works, Hologic did not require any doctors to return their previously purchased Adiana systems. This means that if you are still interested in seeking Adiana, you may be able to find a doctor who can do the procedure... at least until all the product has run out! As of the publishing of this article, Hologic was not able to confirm how much Adiana inventory is still in circulation.

    Sources:

    "Conceptus, Inc.: Form 10-Q for the Quarter Ended March 31, 2012." 10 May 2012; Part II: Legal Proceedings, p. 31. Online. Company Financial Information/SEC Filing Disclosure Reports. Accessed August 1, 2012.

    Conceptus v. Hologic. No. C 09-02280 WHA; United States District Court, N.D. California. January 9, 2012. Web. Accessed August 1, 2012.

    Conceptus v. Hologic. 771 F.Supp.2d 1164; No. C 09-02280 WHA; United States District Court, N.D. California. December 16, 2010. Web. Accessed August 1, 2012.

    Conceptus v. Hologic. No. C 09-02280 WHA; United States District Court, N.D. California. November 6, 2009. Web. Accessed August 1, 2012.

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