On Wednesday, 20 March 2013, we completed our 2012 Pharma IP and FDA Law - Year in Review webinars. We are pleased to include our slides and link to the recording. In sum, we discussed a number of Patentee Friendly, Defendant Friendly, and non-pharma cases, and examined the impact of those cases going forward. For each case review, we included several practice tips. We concluded with a “2013 Year in Preview” of some interesting upcoming issues. The slides have a series of bullet points that summarize, briefly, the primary or prominent issue identified in each case.
Initially, we provided a retrospective on Reissue and Reexamination proceedings by discussing In Re Rosuvastatin (the party seeking reissue was an ANDA submitter); In Re Staats (relating to broadening continuations during Reissue); In Re Baxter (regarding the impact of invalidating claims in Reexamination after losing in “regular” court); and Marine Polymer v. HemCon (concerning intervening rights during reexamination).
These cases taught that Reexamination and Reissue remain valuable tools to broaden the scope of existing patents, fix errors in patents, or narrow patents sufficiently to overcome the prior art while maintaining breadth to encompass infringers. The cases also examined what might be the effect of invalidating claims through Reexamination after a defendant lost in “regular” patent infringement. Although a “losing” defendant may be stuck under the principle of judicial estoppel from using the PTO Reexamination process to overturn a negative prior court verdict (and an award of past damages), practically speaking Reexamination may still be useful to invalidate claims to dissolve any injunction against future marketing or damages.
We then also discussed several infringement and invalidity oriented cases such as: Pozen v. Par [Treximet] (doctrine of equivalents); Hoffman LaRoche v. Apotex [Boniva] (preliminary injunction standards); Dey v. Sepracor [Brovana] (clinical trials as public use); Aventis v. Hospira & Apotex [docetaxel] (inequitable conduct); and several obviousness cases.
An apparent trend in the 2012 obviousness cases was that patentees seemed to win in that it was very difficult for defendants to secure favorable non-obviousness rulings that withstood Federal Circuit appeal. The cases also show that, despite limited use, the doctrine of equivalents may still be used to block generic competitors. Even though Therasense suggested the death of the inequitable conduct defense, at least one Federal Circuit panel was inclined to uphold a finding of inequitable conduct. Nonetheless, we would urge defendants not to read too much into the Aventis case holding and conclude that inequitable conduct claims have a renewed vitality. The Dey case was interesting for it concerned a third party that argued its own clinical trials were sufficient public uses that invalidated another’s patent. A more typical argument is that clinical trails are not sufficiently public so as to invalidate the patent.
Finally, we discussed Momenta v. Amphastar, involving the scope of the §271(e)(1) “Bolar” safe harbor exemption; and the Valsartan 180-Day exclusivity case involving the failure to obtain Tentative Approval in 30 Months. The Momenta case is a wide or liberal interpretation of the safe harbor exemption and it shielded significant post-ANDA approval activity from infringement. As for 180-Day exclusivity, we noted that most often the first-to-file generic company will forfeit any exclusivity for failing to obtain tentative approval in the 30-month window. Here, because of changed circumstances in the ANDA approval process, FDA determined that no forfeiture existed and when challenged, the later courts agreed with FDA.