Articles Posted in Use Codes

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For those parties required to submit patent information to the U.S. Food and Drug Administration, the Agency has published updated forms: Form 3542 and Form 3542a.  FDA updated the patent information forms as part of final regulations implementing portions of the 2003 Medicare Modernization Act.  The regulations, which FDA issued on October 6, 2016, took effect on Monday, December 5, 2016.  FDA will no longer accept old Form 3542 and 3542a, but it is not necessary to resubmit old forms if they were submitted before December 5, 2016.

The new rules amend 21 CFR 314.53, which governs the submission of patent information to FDA.  Under the new rules, the NDA holder’s proposed use code(s) must describe only specific approved methods of use claimed by a patent for which a claim of patent infringement could reasonably be asserted.  Use codes should not be so broad as to cover indications or other approved conditions of use that are not covered in their entirety by a patent.  In other words, FDA clarified in the new rules that the use code must not extend beyond the patent claim(s) and, within the boundary established by the patent claim(s), the use code must only describe a patented method of use that FDA has approved as reflected in approved product label.  Consistent with these revisions, section 4.2b of Form FDA 3542 now states that the NDA holder must submit the description of the specific approved method of use claimed by the patent that is proposed for inclusion as the “use code” in the Orange Book.  The Forms also require that submission specify the section(s) and subsection(s) of the approved labeling that describe the method(s) of use claimed by the patent.

Another notable change is that FDA will no longer require NDA holders with an NDA supplement to resubmit all previously submitted patent information.  Instead, the new regulation only requires submission of patent forms in certain circumstances, including: (i) to add or change the dosage form or route of administration; (ii) to add or change the strength; (iii) to change the drug product from prescription use to over-the-counter use; (iv) or if the published description of the patented method of use would change upon approval of the supplement.”  See 21 CFR 314.53(d)(2).

Charles Raubicheck, head of our firm’s FDA practice, will chair a panel and deliver an address at the “U.S. & Brazil Conference: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation,” to be held on September 10-11, 2012 in Sao Paolo, Brazil.

The conference, sponsored by The Food and Drug Law Institute (“FDLI”), will bring together representatives of companies, venture capital firms, government agencies, law firms and other groups involved in the drug, device and food industries. They will engage in high-level discussions about respective commercial, trade, legal and other aspects of doing business in this country and Brazil, the world’s 6th largest economy.

Mr. Raubicheck’s panel will focus on the interplay between regulatory and intellectual property issues pertinent to pharmaceuticals. His presentation is entitled “NDAs, ANDAs, FDA’s Orange Book, and Patent Term Extensions.”

Thumbnail image for Thumbnail image for Thumbnail image for federalcircuit.jpgThe U.S. Court of Appeals for the Federal Circuit recently rendered a follow-up ruling on remand from the Supreme Court’s April 2012 decision regarding Orange Book use codes for method-of-use patents Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. The Federal Circuit held, in a July 30 ruling, that: (i) a district court can issue a mandatory injunction requiring the owner of the NDA for the brand product to correct a use code which inaccurately describes the FDA-approved, patented use, but (ii) the court must first give the NDA holder the opportunity to correct the use code, rather than direct the company to use precise language for the code.

Nevertheless, the Circuit went on to state: (i) the NDA holder does not have “unbounded discretion” in proposing a new use code, and (ii) the district court has the power to construe the scope of the patent claims and provide limits on the appropriate scope of the corresponding use code. If the court determines that the new code is inaccurate and/or overbroad, the judge at that point can correct the error.

This latest development comes in the wake of the U.S. Supreme Court’s decision arising from Caraco’s proposed section (viii) labeling carve-out for use of the diabetes drug repaglinide (on which we have previously reported here, for example). The patent at issue claimed use of repaglinide in combination with the drug metformin. Caraco wanted to omit the combination therapy, and label its generic version to treat diabetes with repaglinide only. Novo Nordisk admitted that the patent did not cover the use of repaglanide alone, but then changed its use code in the Orange Book to wording that was broad enough to cover repagalanide alone.
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Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Supreme Court.jpgWhile the unanimous Supreme Court’s decision (see our previous blog post here) made it clear that “Caraco may bring a counterclaim seeking to ‘correct’ Novo’s use code ‘on the ground that’ the [method of use] patent ‘does not claim an approved method of using the drug,'” Justice Sonia Maria Sotomayor’s concurrence indicates that the Court has neither answered all the questions nor fixed all the problems associated with the counterclaim provisions. She initially noted “the counterclaim can only lessen the difficulties created by an overly broad use code; it cannot fix them.” The concurrence summarized how a generic manufacturer now will be able to challenge an overbroad use code: “submit an ANDA with a paragraph IV certification . . . wait for the brand [to sue], file a counterclaim, litigate the counterclaim, and, if successful [in obtaining a corrected use code] . . . file an ANDA with a section viii statement.”

Sotomayor, however, identified two problems with this process. First, the process introduces a delay and litigation expense that the statutory scheme does not envision when the generic applicant deliberately carves out uses protected by a patent and files a section viii statement. Second, there is no guarantee that it would be in the interest of a brand company to instigate a lawsuit against the generic applicant that files a Paragraph IV certification when a section viii statement is initially not available for an overly broad use code that overlaps with an indication for the listed method of use patent. In this case, the generic applicant may obtain approval for the broader use(s) and then be at risk for a claim of induced infringement for selling a product with a label “that suggests that the product be used for a patented method of use.”

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Written by Scot B. Pittman

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Supreme Court.jpgOn April 17, the Supreme Court issued its decision that is likely to have far reaching consequences in pharmaceutical litigation regarding method of use patents. The Court’s ruling overturned the Federal Circuit’s April 2010 Novo Nordisk v. Caraco decision, most recently blogged on here, which had held that 21 U.S.C. § 355(j)(5)(C)(ii)(I) (“the counterclaim provision”) did not provide an avenue for Caraco to compel Novo Nordisk (“Novo”) to modify the “patent use code narrative” associated with a patent listed in FDA’s Orange Book for Prandin® (repaglinide). A unanimous Supreme Court, with a concurrence by Justice Sonia Maria Sotomayor, instead held that “a generic manufacturer may employ [the counterclaim provision] to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using the drug in question.”

The Court, through Justice Elena Kagan, principally addressed the construction of two statutory phrases found in the counterclaim provision; namely, the “patent does not claim . . . an approved method” phrase and the “patent information submitted . . . under subsection (b) and (c)” phrase. Regarding the first phrase, the Supreme Court addressed whether the “not . . . an” language in the counterclaim provision meant “not any” (the view of Novo and the Federal Circuit) or “not a particular one” (the view of Caraco). Kagan noted that the correct meaning of “not . . . an” depends on context and provided a number of real life examples to make her point. Here, the Court found that the context in the statute supported Caraco’s interpretation of “not a particular one.”

Kagan explained that the Hatch-Waxman framework, specifically 21 U.S.C. § 355(j)(2)(A)(viii) (“section viii”), provides generic drug companies with a mechanism to seek approval for less than the referenced drug’s uses, when those uses are listed for patents in FDA’s Orange Book. In essence, the aim of this statutory scheme is to prevent one patented use from blocking the marketing of a generic drug for other non-patented uses. According to the Court’s reasoning, Congress’s reasons for establishing the section viii carve-out and counterclaim provisions would be frustrated by Novo’s reading of “not . . . an.” The Court noted that Congress could have drafted that counterclaim provision to cover Novo’s interpretation by using “not . . . any” instead of “not . . . an.” Kagan elaborated, “We think that the ‘not any’ construction does not appear in the relevant counterclaim provision because Congress did not mean what Novo wishes it had.” The Court concluded that Congress meant for the counterclaim provision to aid the statutory scheme of “facilitating the approval of non-infringing generic drugs under section viii.” The Court next addressed Novo’s argument that Caraco’s counterclaim to correct patent information must fail because a use code is not “patent information submitted by the [brand] under subsection (b) or (c)” of section 21 U.S.C. § 355(j)(5)(C)(ii)(I). Dismissing the fact that the statute does not define “patent information,” the Court readily held that a use code is “patent information,” such meaning that “fits under any ordinary understanding of the language.”
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thethinker.bmpOn March 12, AstraZeneca Pharmaceuticals LP (“AstraZeneca”) sued FDA in the District Court for the District of Columbia requesting declaratory and injunctive relief to prevent FDA from granting final approval to generic versions of Seroquel® (quetiapine fumarate) or Seroquel XR® (extended-release quetiapine fumarate). In its complaint (including AstraZeneca’s original citizen petitions, FDA response, and other documents related to the Seroquel® products’ new drug applications (“NDAs”)), AstraZeneca asserts that FDA could, based on FDA’s denial of AstraZeneca’s citizen petitions, approve generic versions of both products as early as March 27, 2012, after the pediatric exclusivity associated with a product patent expires.

Aside from whether AstraZeneca’s arguments have merit, the heart of the issue appears to be whether AstraZeneca has standing to sue FDA when FDA denied its citizen petitions on March 7, 2012. FDA denied AstraZeneca’s petitions “without comment on whether [FDA] will take the actions that [AstraZeneca] request[s].” While FDA’s actions on citizen petitions are typically considered final agency action, in this case, FDA only has tentatively approved several generic applicants referencing both Seroquel® and Seroquel XR®. Specifically, FDA stated in its response:

FDA has not yet made a final determination with respect to whether to approve or not approve any ANDA relying on Seroquel or Seroquel XR as the RLD. FDA’s decision to approve or not approve a specific application will be based on the particular facts that are applicable to that application at the time of the decision. The periods of exclusivity described above for Seroquel or Seroquel XR may or may not apply or be relevant to the Agency’s final decisions with respect to any individual application and its labeling depending on the particulars of an ANDA and the timing of its approval. Such decisions are made by the Agency on a case-by-case basis in the normal course of the review process.

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by Scot Pittman

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On Monday, the Supreme Court heard oral argument in Caraco Pharm. Labs. Ltd. v. Novo Nordisk A/S (previously discussed here and here) to decide whether a generic drug manufacturer can use the counterclaim provisions of the Hatch-Waxman Act, as amended by the 2003 Medicare Prescription Drug Improvement and Modernization Act, to require a brand company to modify a “patent use code narrative.” The Court’s response to the arguments appears mixed. Justices Scalia and Alito questioned Caraco’s counsel closely while Justices Sotomayor and Kagan scrutinized Novo Nordisk’s counsel with the same degree of attention. The justices were plainly concerned with the statutory construction, the context of the counterclaim provision in the FDCA, and the recourse available to generic applicants who assert misuse of the use code narrative.

Statutory interpretation will play a key role in the Court’s determination. Indeed, the justices debated the correct interpretation of “does not claim either . . . (bb) an approved method.” The majority Federal Circuit opinion construed “an approved method” to mean “any approved method” — not “all approved methods.” Justice Alito asked Caraco’s counsel: “Suppose I said your brief does not cite a Supreme Court decision. Would that be a correct statement?” (emphasis added). In other words, Justice Alito appears to argue that despite the use of the article “a” following the negative “not,” the plain reading of the statute would translate to “any Supreme Court cases” and not “all Supreme Court cases.” Under this interpretation, a counterclaim will be permitted only when the patent does not claim any approved methods of use. Applied to this case, the statute would bar Caraco’s counterclaim because Novo’s patent claims one approved method of use. Based on this discussion, it appears that Justices Scalia and Alito were more sympathetic to Judge Rader’s majority opinion in the Federal Circuit decision.

The justices also struggled with the meaning of “patent information.” At issue is whether “patent information” narrowly covers only the information described in subsections (b) and (c), namely patent number and patent expiration date, or is broad enough to encompass use codes. Again, Justices Alito and Scalia appeared to favor a more literal interpretation covering only patent numbers and use codes. However, Justice Breyer, citing FDA regulations, asked why the Court should not interpret “patent information” to include use codes.
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FDA.bmpOn October 5, FDA’s David T. Read, Regulatory Counsel, Office of Generic Drugs (“OGD”), Center for Drug Evaluation and Research, presented a snapshot of generic drug applications and approvals since the Hatch-Waxman Amendments and the challenges going forward.

Acknowledging that OGD has a backlog of over two thousand abbreviated new drug applications (“ANDA”) with a median 27.88 month review cycle, Read cited to a number of factors contributing the problem. First, OGD needs more resources (i.e., reviewers) to get rid of the backlog, which may be helped by the promised Generic Drug User Fee Act (“GDUFA”) once it becomes law. Read explained that 505(q) citizen petitions (petitions that FDA must respond to within 180 days because they interfere with generic drug approvals among other things) and products with increased complexity also contributed to the problem. Read cited FDA’s response to the enoxaparin citizen petition as an example of the enormous drain on resources caused by complex issues (in that instance, tough questions of “sameness”).

In addition to GDUFA, Read explained that other potential solutions could include the better prioritization of ANDAs, and increased communication of the need for higher quality ANDAs and generic products. Here, Read mentioned ongoing complaints about antiepileptic drugs where practitioners and others continued to complain breakthrough seizures occurring in brand-to-generic switches, generic-to-generic switches, and generic-to-brand switches. The problem, Read noted, was that the “data stinks”: meaning that the complaint of breakthrough seizures is based on anecdotal data rather than well-controlled studies.
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by Andrew S. Wasson

Thumbnail image for Thumbnail image for Supreme Court.jpgThe Supreme Court granted Caraco’s petition for a writ of certiorari to hear its appeal from the Federal Circuit’s decision in Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 615 F.3d 1374 (Fed. Cir. 2010). This case has been closely-watched by generic and brand-name companies alike. In March, the Supreme Court asked for the Solicitor General’s view on whether it should take the case. The Solicitor General recommended that the Supreme Court grant Caraco’s petition. The Solicitor General also took the position that the Federal Circuit’s decision in April 2010 was incorrect. The Supreme Court’s recent action makes sense looking back on the contentious and fractured opinions of the last year. For this blogger, the Supreme Court’s action guarantees a steady stream of topics for the rest of the year.

We have been following this case closely, but for those of you still unfamiliar with the case, in Novo Nordisk, the Federal Circuit determined that Caraco could not compel Novo Nordisk to revert a patent use code narrative to its original form. The Federal Circuit’s determination hinged on the statutory interpretation of 21 U.S.C. § 355(j)(5)(C)(ii), added to Hatch-Waxman Amendments in 2003, and authorizing a generic applicant to file a counterclaim to correct or delete patent information in certain situations. 21 U.S.C. § 355(j)(5)(C)(ii) provides in relevant part:

(ii) Counterclaim to infringement action.–

(I) In general.– If an owner of the patent or the holder of the approved application under subsection (b) of this section for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) of this section on the ground that the patent does not claim either–

(aa) the drug for which the application was approved; or
(bb) an approved method of using the drug.

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by Andrew S. Wasson

444221_93338615.jpgThe Solicitor General filed a brief as amicus curiae urging the Supreme Court should grant Caraco’s petition for writ of certiorari to review Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd. (Fed. Cir. 2010). The Solicitor General’s brief came in response to the Supreme Court’s request for the U.S. government’s views on the matter. The Solicitor General’s brief asserted that the Federal Circuit erred in its April 2010 decision and that the Supreme Court’s review was warranted.

We have blogged on this case a number of times, from a number of angles. In broad strokes, Caraco submitted a section viii statement subject matter related to the combined administration of repaglinide and metformin in an ANDA to market a generic version of Novo Nordisk’s Prandin® product. Indeed, Novo Nordisk had listed a patent in the Orange Book reciting such a combination. Originally, Novo Nordisk had submitted a use code narrative to FDA for this method of use patent which described the combined administration of these two active agents. FDA approved Caraco’s section viii. When Novo Nordisk submitted a broader use code narrative, however, FDA determined that Caraco could not properly submit a Section viii statement, because the use code narrative now overlapped with Caraco’s proposed uses. Caraco filed a counterclaim under 21 U.S.C. § 355(j)(5)(C)(ii), requesting that the court order Novo Nordisk to revert the use code narrative to its original scope. While the District Court granted this request, the Federal Circuit reversed.

Critically, FDA has taken the position that its role vis-à-vis patents is merely “ministerial.” In other words, FDA will not pass on whether the use code narrative properly describes the scope of an Orange Book patent. Nor will FDA pass on whether a generic labeling does not propose to market the drug for a protected patent use. Rather, FDA will merely compare the use code narrative submitted by the NDA holder on its face to the generic labeling. FDA will allow the use of a Section viii statement if no overlap exists between the narrative and generic’s proposed labeling. While we have argued elsewhere that FDA should revisit its ministerial role for the sake of administrative efficiency, it is interesting to note that FDA’s ministerial role plays a major part in the Solicitor General’s argument.
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