2014-05-10 Lachman CONSULTANTS

专利再颁 — 如何影响180天专营权和30个月停审期? FDA采用所罗门审判

2014年4月24日致Celecoxib的ANDA申请人信函中，FDA解释了关于如何对待因涉及到180天专营权和30个月停审期的再颁专利的相当复杂的观点。另外，在这个案例中，FDA没有对任何Celecoxib申请作出180天的专营权决定，因为除非一份ANDA处于180天专营期中或被这类已获批的ANDA阻止，否则不能作出专营权的决定。前一种情况，FDA将表明具有获得180天专营权的资格，而后一种情况，FDA应发布暂时批准（Tentative Approval）函表明该申请（尽管满足所有其它批准要求）因另一申请在180天专营期内而不能获得最终批准。就目前情况看来，有三家公司拿到了暂时批准函（Mylan、Teva和Watson）。

FDA的信中还涵盖了一系列非常具体的事实并仅针对MMA（Medicare Modernization Act，医疗保险现代化法案）之前的申请。这种情况下，没有任何首个提交者获得最终批准。曾有专利诉讼发现原始专利无效。在任何ANDA获批之前，重新发布原始专利（再颁专利纠正了原始专利中的错误，或可能缩小或扩大专利要求）。再颁专利与原始专利具有相同的有效期。接下来问题是，第IV段认证（需要解决再颁专利和重登记专利）提供给自己额外30个月的停审期，还是针对再颁专利首个提交申请者的额外180天专营期？第二部分对FDA很简单，由于再颁恢复了原始专利，是原始专利的延续，因此，不应有与新的第VI段认证相关的额外30个月停审期。

至于180天专营权问题，FDA认为，即使首个专利被认定无效（依据MMA之前的标准，这应引发180天专营权的计时），首个申请人不应该受到攻击专利的惩罚，因此，只要及时针对再颁专利提出认证，首个申请人仍应有权获得原始第IV阶段认证的180天专营权。

FDA在决议书中引用了他们曾不得不面对的，与再颁专利相关的3个案例，并说明了处理办法。尽管这3个例子都具有不尽相同的情况（其中两例比较类似，申请人因直接或由授权仿制药公司首个上市，触发180天专营权），并且首个上市总是触发专营期开始，这些情况本身就存在差异。在第3个例子中，在ANDA获批后专利再颁，但是FDA引用信中概述的专利捆绑方法，因此，尽管该公司获得再颁专利（未发现侵权），事实上专营权已经通过赢得原始专利而触发，并且仅剩2个月的专营权期限。FDA在信中指出：
虽然没有大量的针对180天专营权和再颁专利的先例，FDA之前已经针对涉及MMA之前背景下的再颁专利采取了以下行动。在这些案例中，FDA对于再颁专利和180天专营权一致使用单一的专利“捆绑”，并得出结论认为，原始专利与再颁专利一起形成180天专营期。

并接着指出：
如上所述，在这3个决定中，FDA将原始专利和再颁专利作为专利权利的单一“捆绑”处理。在Mircette案例中，Barr公司（针对Mircette的‘843号专利，首个提交第IV段认证），没有反对FDA的决议，决议内容为单一180天专营期由法院判决没有侵犯再颁专利之日起引发。即使其ANDA批准时仅剩余两个月的180天专营期。

FDA没有采取最终行动批准任何Celecoxib的仿制药申请；然而，2014年4月29日发布的新闻指出，Actavis和Mylan公司起诉FDA的裁定备忘录，因为根据其条款将给予作为针对原始专利首个提交的Teva公司180天专营权。继续关注这一案例并看看最终决定将会是非常有趣的。我不是律师，仅能冒昧的猜测法庭可能发现诉讼还不成熟，因为FDA裁定备忘录可能不构成FDA的最终行动（即，Teva申请的事实批准）。

Lachman CONSULTANTS - Bob Pollock先生 2014-04-30
编译：识林-椒 2014-05-10

Patent Reissue- How Does it Impact 180-day Exclusivity 30-Month Stays? FDA Split the Baby
Written by Bob Pollock • April 30, 2014

In a letter issued April 24, 2014 to ANDA applicants for Celecoxib, the FDA explained its rather complicated view of how to treat reissue patents as they relate to 180-day exclusivity and 30-month stays (here). And, in this case, the FDA did not provide a decision on 180-day exclusivity for any Celecoxib applicant because exclusivity determinations are not made until an ANDA that may be subject to either 180-day exclusivity or may be blocked by such are approved. In the former case, FDA would indicate the eligibility for the 180-day exclusivity, and, in the latter, would issue a Tentative Approval letter indicating that the application (while meeting all other approval requirements) cannot receive final approval due to another applicant being eligible for 180-day exclusivity. As things stand today, there are three firms that have tentative approval letters (Mylan, Teva, and Watson).

The FDA letter also covers a very specific fact set and deals only with pre-MMA applications. In this case, none of the first filer(s) have received final approval. There was patent litigation that found the original patent invalid. Prior to any approval of any ANDA the original patent reissued (a reissue patent corrects some error in the original patent or otherwise may narrow or broaden the patent claims). [MS1] The reissue patent also has the same expiration date as the original patent. The question then is, does the paragraph IV certification (which is required to address the reissued and relisted patent) lend itself to another 30-month stay and/or another 180-day period of exclusivity for first filer(s) to the reissue patent? Part two was simple for FDA and they indicated that, because the reissue kind of reinstates the original patent, that it is a continuation of the patent, and, thus, there should not be a second 30-month stay associated with the new PIV certification.

As far as the 180-day exclusivity goes, the FDA believes that even though the first patent was found invalid (which would, under pre-MMA standards, trigger the running of the 180-day exclusivity period) that the first applicant should not be penalized for attacking the patent and, thus, the first applicant should still be entitled to 180-day exclusivity for their original PIV certification, as long as a timely certification to the reissue patent was made.

FDA cited three examples in their decision letter that they have had to face, relative to reissue patents and describes how they dealt with them. While none of the three situations had quite the same fact pattern (two somewhat similarly situated applicants triggered their 180-day exclusivity by first commercial marketing either directly or by distribution of an authorized generic) and since first commercial marketing always triggers the exclusivity period, those situations differed in and of themselves. In the third example, the reissue patent came after the ANDA approval, but FDA applied the Bundle of Patent approach outlined in their letter referenced above; thus, even though the firm won on the reissue patent (was found not to infringe), the exclusivity was, in fact, triggered by the win on the original patent and there was only 2 months left on the exclusivity. FDA noted the following in their letter:

Although there is not a great deal of precedent with respect to 180-day exclusivity and reissued patents, the Agency previously has taken the following actions involving reissued patents in a pre-MMA context. In these cases, FDA has consistently applied its single “bundle” of patent rights approach regarding reissued patents and 180-day exclusivity and has concluded that the original and reissued patent together give rise to a single 180-day exclusivity period.

And went on to note:

As noted above, in each of these three decisions, FDA treated the original and reissued patent as a single “bundle” of patent rights. In the case of Mircette, Barr (the first to file a paragraph IV certification with respect to the ‘843 patent for Mircette) made no objection to FDA’s decision that a single 180-day exclusivity period was triggered by the court’s decision that the reissued patent was not infringed, even though, at the time of its ANDA approval, only about two months remained on its 180-day exclusivity period.

FDA has taken no final action to approve any Celecoxib ANDA; however, in a news article published on 4/29/14, it was noted that Actavis and Mylan sued FDA on its Decision Memo because under its terms it would award 180-day exclusivity to Teva as a first filer to the original patent. It will be interesting to watch this case and see how the ultimate decision unfolds. Not being a lawyer, I would only venture to guess that the court may find the suit is not ripe because the FDA Decision Memo may not constitute final Agency action (i.e., the actual approval of the Teva application).

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