Restriction Requirements and Double Patenting

Boehringer Ingelheim Int’l v. Barr Labs and Mylan Pharma (Fed. Cir. 2010)

This decision holds a terminal disclaimer cannot be effective if filed after the expiration date of the earlier patent. The decision expands scope of the safe-harbor created by 35 USC 121 against double patenting allegations. Here, the court held that a divisional-of-a-divisional still qualifies for the safe harbor so long as the later-filed applications do not violate the Examiner’s original grouping suggestions.

(Opinion by Judge Linn and Joined by Judge Prost) Boehringer owns several patents listed in the FDA’s Orange Book as covering the drug Mirapex (pramipexole) used to treat symptoms of Parkinson’s disease. Boehringer filed this lawsuit after the defendant generic-drug manufacturers submitted abbreviated new drug applications (ANDAs) to the FDA as part of their efforts to begin making generic versions of the Mirapex.

The Mirapex patent family began with a 1985 patent application. That family has branched-out into more than fifty world-wide patents, including three US patents. Interestingly, the patent that issued from the original application (the “earlier patent”) is not listed in the Orange Book while a later issued patent is listed. By the time of this lawsuit, the Mirapex patents had passed their ordinary 17–year term of enforceability. However, the term of the later issued patent had been extended by over 4–years based on FDA delay under 35 USC 156.

Late-Filed Terminal Disclaimer : Despite their similarity, Boehringer had not filed a terminal disclaimer in the latest-filed US application. On the last day of trial, Boehringer decided to go ahead and file a terminal disclaimer. In spite of that action, the district court still held Boehringer’s asserted patent invalid under the judicially created doctrine of obviousness-type double patenting. In its opinion, the district court rejected the terminal disclaimer as inoperative because it was filed after the original patent had expired.

On appeal, the Federal Circuit agreed that a terminal disclaimer is not effective if filed after the expiration of the earlier patent.

By failing to terminally disclaim a later patent prior to the expiration of an earlier related patent, a patentee enjoys an unjustified advantage—a purported time extension of the right to exclude from the date of the expiration of the earlier patent. The patentee cannot undo this unjustified timewise extension by retroactively disclaiming the term of the later patent because it has already enjoyed rights that it seeks to disclaim.

Safe harbor of Section 121: Section 121 of the Patent Act provides a safe-harbor for family–member patents that issue after a restriction requirement:

A patent issuing on an application with respect to which a requirement for restriction … has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them…

On appeal, the Federal Circuit first held that Section 121 can apply to protect “a divisional of a divisional” as in this case. Here, the court agreed that the later application was filed “as a result of” a restriction requirement because the restriction requirement in the original application was the original cause of the multiple US patent filings. The court did indicate that this safe-harbor would have been lost if the later-filed application violated the claim groupings of the restriction requirement.

In a prior decision, the court held that Section 121 applies to protect patents against double patenting rejections. See Geneva Pharms, 349 F.3d 1373, 1378 (Fed. Cir. 2003) (“Section 121 intervenes to prevent a nonstatutory double patenting rejection”).

Thus, because of the protection of Section 121, Boehringer did not need to file a terminal disclaimer.

In dissent, Judge Dyk argued that Section 121 should not apply here because the applicant had not strictly following the groupings in the original restriction requirement. Notably, the original restriction requirement divided the claims into ten groups — each group representing a separate invention while the later application was filed with claims from four of the groups.

13 thoughts on “Restriction Requirements and Double Patenting

  1. Tad, that is the case now (i.e., only A & B, not A & C). And no term can be extended from applications that resulted from divisions filed as a result of a restriction.

  2. I think the scope of the safe harbor of Section 121 should be limited. This is because the restriction requirement, in one aspect, is for reducing the burden of examiners. Some examiners apply the restriction requirement easily to reduce their burden and to get points by examining many patents rather than one. On the other hand obvious type double patenting rejection is more substantial, important and public meaning because it can help patients of Parkinson’s disease by avoiding patent terms over almost the same claims from extending more than 20 years. When I compare the reduction of the burden of examiners to the effect of the patent term extention over public, I think the safe harbor should be limited. If examiner says group A and B should be devided, the safe harbor should be applied to between group A and B only. It should not be applied to between group A and C.

  3. Perplexified,
    I have had a fair bit of success with petitions. I would suggest first a phone call to the examiner, and if that goes nowhere (as it frequently does), call the QAS for restriction practice for that TC. The QAS should be able to guide you on whether or not a petition is suitable.

  4. rc cola and moonpie–agreed, but what to do? The only times I’ve tried petitioning, it took forever and got me nowhere. Ditto with trying to convince the Examiner to redo the restriction. Have you had any luck?

  5. XMNR, I agree about the ownership part. But this is largely illusory as normally no one would part with a patent that was an obvious variation of another.

    Except that there is no admission that the two patents are obvious variants of each other when you file a TD. And who’s to say that they are in fact obvious variants? A TD acts to remove the OTDP rejection without having to go through the hassle of arguing obviousness.

    And why exactly are we still even dealing with OTDP? This whole doctrine is a dinosaur that should have become extinct 2 seconds after “20 from earliest non-provisional F/D” came into being. The first basis, unjustified extension, doesn’t fly anymore. And the second, risk of attack from multiple plaintiffs, is the lamest rationalization to keep this doctrine one could imagine. Wow. An infringer might have to answer to more than one plaintiff. Let’s make sure we don’t make the wrongdoers life too inconvenient, shall we?

  6. XMNR, I agree about the ownership part. But this is largely illusory as normally no one would part with a patent that was an obvious variation of another.

    Back before 20-year from effective filing date expirations, though, terminal disclaimers really did have a substantial effect in reducing term in continuations.

  7. Ned Heller: “Twenty years from filing expiration dates today largely confine the relevancy of terminal disclaimers to drug patents. Most divisionals will expire on the same day as the parent.”

    Doesn’t a terminal disclaimer also bind the patents such that they cannot be sold/licensed separately and therefore end up with cross-infringement?

  8. “Twenty years from filing expiration dates today largely confine the relevancy of terminal disclaimers to drug patents. Most divisionals will expire on the same day as the parent.”

    Ned,

    Very good point.

    “Frequently multiple groupings are consolidated as prosecution moves forward either by rejoinder or as the Examiner understands more about the patent/family. It is ridiculus for them to punish the applicant for consolidating the examiner’s groupings.”

    Mike,

    Also a very good point. Judge Linn who was a patent attorney and wrote the majority opinion understands this “practical” issue. Judge Dyk who isn’t a patent attorney obviously does not recognize this “practical” issue.

  9. Twenty years from filing expiration dates today largely confine the relevancy of terminal disclaimers to drug patents. Most divisionals will expire on the same day as the parent.

  10. Frequently multiple groupings are consolidated as prosecution moves forward either by rejoinder or as the Examiner understands more about the patent/family. It is ridiculus for them to punish the applicant for consolidating the examiner’s groupings.

  11. The majority/dissent has an interesting reading of the “as a result of” requirement in the 3rd sentence of 35 USC 121. Like Boehringer argued, before this case, I would have said that this requirement applied only to the patent that was the basis for the double patenting challenge, not the challenged patent. Nonetheless, I think the majority interpretation of this requirement is far more realistic as to when the “safe harbor” applies. What Judge Dyk’s position would require is to file separate divisonals for each of the restricted inventions; as the majority pointed out, that’s taking the “as a result of” requirement way too far and too strictly. All that Boehringer did was to group a portion of the nonelected subject matter and claim it in the first divisional, and then group and claim the remaining portion in the subsequent second divisional; the examiner in each of these divisionals was free to require further restrictions but chose not to do so. As the majority pointed out, Boehringer still kept the appropriate “lime of demarcation” in place between the restricted inventions as stated by the examiner in his original restriction requirement.

  12. Can anyone explain why the CAFC feels compelled to decide more than it needs to decide? They could have resolved the safe harbor issue, and determined that the other issue was moot.

    The only way they needed to reach both issues is if they were going to affirm the D/Ct. Instead, they issued a “holding” with respect to the terminal disclaimer issue, even though it was not necessary to the outcome of the case.

  13. Which is why attention should be paid to bad or ridiculous groupings by an examiner. You can become locked in by these things.

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