Recently in Use Codes Category

September 11, 2012

Charles Raubicheck to Speak at "U.S - Brazil" Conference

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."

August 13, 2012

Federal Circuit Weighs in on Use Code Remand

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.

Continue reading "Federal Circuit Weighs in on Use Code Remand" »

April 18, 2012

Use Code Counterclaim Provision Needs Fixing by Congress or FDA Says Justice Sotomayor in Concurrence

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."

Sotomayor concluded by criticizing FDA's minimal guidance on this issue. She highlighted how "remarkably opaque" FDA's guidance on what is required of a brand manufacturer when submitting use codes and even noted that "FDA's opacity" was part of the reason this case came to the Supreme Court. While recognizing that Novo's interpretation of the counterclaim provision is erroneous, Sotomayor expressed some sympathy for the drug company, because it only changed its use code to "correspond" to new labeling required by FDA. She noted that a fix to this statutory scheme likely would require a fix from Congress or FDA, and that "[a]bsent greater clarity from FDA concerning what is required of brand manufactures in use codes, Congress' fears of undue litigation may be realized."

Over a year ago, prior to the Court's ruling and Sotomayor's observations, FLH Partners Brian J. Malkin and Andrew S. Wasson published a FDLI Policy article, "Should FDA Undertake More Than a Ministerial Role With Respect to Patent Information?" In this article, Malkin and Wasson noted that for many years FDA has argued that it lacks the resources and expertise to review patents substantively, calling its hands-off role as "ministerial." While many courts have upheld FDA's position, they note, it is not the case that courts have mandated that FDA take this position. Instead, the authors suggest that hiring a few competent patent attorneys, trained in biotechnology or the pharmaceutical sciences, could result in the more efficient administration of the Hatch-Waxman Act Amendments to the Federal Food, Drug, and Cosmetic Act. Following Sotomayor's concurrence, perhaps their recommendations should be considered again.

April 18, 2012

Use Code Counterclaims Permissible Supreme Court Says in Caraco v. Novo Nordisk Opinion

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."

Continue reading "Use Code Counterclaims Permissible Supreme Court Says in Caraco v. Novo Nordisk Opinion" »

March 15, 2012

AstraZeneca Sues FDA Over Denying Citizen Petitions Regarding Generic Seroquel and Unresolved Labeling Issues


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.

Continue reading "AstraZeneca Sues FDA Over Denying Citizen Petitions Regarding Generic Seroquel and Unresolved Labeling Issues" »

December 6, 2011

Supreme Court Hears Oral Argument in Caraco v. Novo Nordisk

by Scot Pittman

Thumbnail image for 444221_93338615.jpg

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.

Continue reading "Supreme Court Hears Oral Argument in Caraco v. Novo Nordisk" »

October 6, 2011

Use Codes Dilemmas and More Discussed by FDA's David Read at ACI's Maximizing Pharmaceutical Patent Life Cycles Yesterday


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.

Continue reading "Use Codes Dilemmas and More Discussed by FDA's David Read at ACI's Maximizing Pharmaceutical Patent Life Cycles Yesterday" »

June 28, 2011

Patent Use Code Case Granted Certiorari by Supreme Court

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.

Continue reading "Patent Use Code Case Granted Certiorari by Supreme Court" »

May 31, 2011

Solicitor General Urges High Court to Take Up Patent Use Code Case

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.

Continue reading "Solicitor General Urges High Court to Take Up Patent Use Code Case" »

April 13, 2011

Patent Use Code Narratives and Empirical Analysis

by Andrew S. Wasson

444221_93338615.jpgThe Supreme Court is currently considering whether to grant Caraco's petition for certiorari with regard to the Federal Circuit's decision in Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd. in April 2010. In fact, the Supreme Court recently asked the Solicitor General for its view on the matter. I reviewed use code narrative word counts to assay whether use code narrative practice has changed dramatically over the last years and since the Federal Circuit's decision.

The facts in Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd. have been reiterated several times, so there is no need to rehash them here. Briefly though, the NDA holder submits a description of each method of use patent that it lists in the Orange Book (a "use code narrative"). The Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act allow a generic applicant to leave out subject matter from its prescribing information which is protected by patent or exclusivity by filing a statement under subsection viii of Hatch-Waxman. FDA will allow a generic applicant to use this pathway if there is no overlap between the use code narrative and the generic prescribing information. In Novo Nordisk, Caraco failed in its bid to compel Novo Nordisk to change the use code narrative for Prandin® back to its previous version by using 21 U.S.C. § 355(j)(5)(C)(ii). Because FDA does not review these narratives for accuracy, some in the generics industry are concerned that given this unchecked power, the brand could formulate a use code of unsurpassed breadth and could shut down the subsection viii pathway altogether. The Generic Pharmaceutical Association articulated this sentiment when in its amicus curiae brief supporting Caraco's request for en banc Federal Circuit review, stated: "If the panel's ruling stands, Novo's manipulative actions will become a playbook for all brands."

I sought to test this hypothesis by analyzing use code narrative word counts dating back to 2005. The underlying idea is that if brand actors were truly so emboldened by the Federal Circuit decision, it would somehow be reflected in the length of the use code narratives. For example, consider U-1078 ("treatment of acne") with U-917 ("treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris"). The broader use code (and thus more difficult to excise from a generic labeling) would clearly be the former. My results:
Use Code Chart

Continue reading "Patent Use Code Narratives and Empirical Analysis" »

February 23, 2011

Brian J. Malkin and Andrew S. Wasson Published in FDLI's Food and Drug Policy Forum on FDA's Role With Respect to Patent Information

FDLI Policy Forum Vol 1, Issue 4

"Should FDA Undertake More Than a 'Ministerial' Role With Respect to Patent Information?" by and Andrew S. Wasson can be found in FDLI's current Food and Drug Policy Forum. For many years FDA has argued that it lacks the resources and expertise to review patents substantively. FDA refers to its hands-off role as "ministerial." Indeed, many courts have upheld FDA's position. It is not the case, however, that courts have mandated that FDA take this position. In fact, several leading judges have questioned whether it is good policy. Therefore, the authors suggest that hiring a few competent patent attorneys, trained in biotechnology or the pharmaceutical sciences, could result in the more efficient administration of the Hatch-Waxman Act Amendments to the Federal Food, Drug, and Cosmetic Act. The authors do not believe that adding these individuals to FDA's staff would be unduly burdensome.

The timing of the article may not be the best-word from GPhA's Annual Meeting 2011 is bleak regarding FDA's always-epic workload-but the authors believe that it is important to underscore that a more direct way to administer the statute exists.

FDA Lawyers Blog also would like to introduce its readers to FDLI's new Food and Drug Policy Forum. FDLI's Food and Drug Policy Forum is a peer-reviewed venue for the examination and discussion of pressing policy issues in food and drug regulatory law. FDLI published the first issue in January of this year. FDLI's Food and Drug Policy Forum includes an electronic discussion space for refining and debating ideas-so if you'd like to join in the discussion, commenting is encouraged--and the authors will be watching and responding!

January 25, 2011

Biosimilars: Contemplating an Orange Book

by Andrew S. Wasson

dna.jpgFor drug products, FDA publishes patent information submitted by the new drug application (NDA) holder in the publication (now electronic) Approved Drug Products with Therapeutic Equivalence Evaluations, generally known as the "Orange Book." For each new drug product with an associated patent, FDA creates an entry in the Orange Book that lists the product, the associated patent number, the expiration date, and other relevant information, such as the patent use code (if applicable, for a method-of-use patent). By contrast, the Biologics Price Competition and Innovation Act ("Biosimilars Act") contains no mechanism for listing patent information. Instead of an Orange Book, the Biosimilars Act proposes a complex and private exchange of patent information between the innovator and proposed biosimilar applicant.

It does not appear that there was much public debate on whether to include a public central repository of patent information like the Orange Book in any proposed biosimilars legislation. Understanding the Orange Book's influence on scientific progress generally will help us understand the implications of leaving a central repository out of the Biosimilars Act. Of course, the Orange Book plays an important role on the incentives set forth by the Hatch-Waxman Amendments. Less attention appears to have been devoted, however, to understanding how the Orange Book generally influences scientific progress in the pharmaceutical arts.

Thus, I ask a simple question: are patents listed in the Orange Book cited more frequently than patents not listed in the Orange Book? The connection to scientific progress is provided by the underlying theory that "the number of times a patent is cited from other patents provides an indication of its technological importance." E.g., Henk F. Moed, Citation Analysis in Research Evaluation 18 (2007). Thus, it may be the case that if Orange Book patents are cited more frequently, then they have greater technological importance. It could be possible that the technologies disclosed by Orange Book patents achieve greater prominence and therefore ostensibly have some stronger directing force on the focus of scientific inquiry.

Continue reading "Biosimilars: Contemplating an Orange Book" »

July 30, 2010

Patent Use Code Misuse Challenge Will Not Be Reheard by Federal Circuit

by Andrew S. Wasson

444221_93338615.jpgOver the clamorous arguments of the generic pharmaceutical industry, on July 29, the Federal Circuit refused to review en banc its April 2010 decision in Novdisk A/S v. Caraco Pharm. Labs. Ltd., where it nixed a district court injunction compelling Novo Nordisk to modify a patent use code narrative relating to the drug Prandin® (repaglinide). Judges Gajarsa and Dyk entered spirited dissents, potentially setting the stage for legislative remedy or Supreme Court review.

Caraco, its parent company Sun Pharmaceutical Industries, and six other amicus curiae from the generics industry, requested that the Federal Circuit rehear the case en banc. Caraco and Sun argued that the original decision misconstrued the language of the Hatch-Waxman Act and failed to read the statutory language in the context of the full provision itself and with other provisions of the Act, such as subsection viii. Continuing the thread of Judge Dyk's dissent in the original opinion, the request also argued that the ruling failed to give the appropriate deference to FDA in its interpretation of "patent information."

Despite these arguments, the Federal Circuit refused to rehear the case, with Judges Gajarsa and Dyk dissenting. Writing the dissent, Judge Gajarsa stated that the April opinion "eviscerates Section viii" and that "[w]ith the majority's blessing, pioneering drug manufacturers now have every incentive to follow Novo's lead and draft exceedingly broad use codes thereby insulating themselves from generic competition and rendering Section viii a dead letter." Judge Gajarsa stated that it was an "untenable and absurd result" that even though the Orange Book patent would admittedly not cover Caraco's proposed carved-out labeling, Caraco would be effectively blocked from marketing until that patent's expiration in 2018. In addition, Judge Gajarsa argued that the opinion "effectively invalidates" he FDA's effort to define patent information broadly.

Continue reading "Patent Use Code Misuse Challenge Will Not Be Reheard by Federal Circuit" »

April 21, 2010

Use Code - Carve Out Challenge Fails in Federal Circuit

by Andrew S. Wasson

Thumbnail image for 444221_93338615.jpgOn April 14, The Federal Circuit held in Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd. (Fed. Cir. 2010) that Caraco could not compel Novo Nordisk to modify the "patent use code narrative" associated with U.S. Patent No. 6,677,358 ("the '358 patent"), listed in the Orange Book for Prandin® (repaglinide). The '358 patent recites a method for the combined administration of repaglinide and metformin. Caraco submitted its ANDA with a "section viii statement", stating it would not infringe the patent because it had "carved-out" the uses associated with the '358 patent. FDA will approve a "section viii statement" if there is no overlap between the description of the patent scope given by the NDA holder (a "use code narrative") and the proposed ANDA labeling. FDA assigns each use code narrative a "use code number", which is then listed in the Orange Book.

Novo Nordisk originally submitted a description of the '358 patent: "use of repaglinide in combination with metformin to lower blood glucose" (U-546). However, Novo Nordisk later requested that the FDA change the use code narrative to read: "a method for improving glycemic control in adults with type 2 diabetes mellitus" (U-968). While Novo Nordisk's request followed a labeling change initiated by FDA in November 2007, it also came immediately after FDA's approval of Caraco's section viii statement with regard to the initial use narrative.

While FDA originally approved Caraco's section viii statement based on U-546, FDA eventually disallowed Caraco's section viii statement based on U-968. In a counterclaim, Caraco requested the court change the use code from U-968 to the original U-546. The district court granted Caraco's request in summary judgment, finding that Novo Nordisk filed an improperly overbroad use code narrative.

Continue reading "Use Code - Carve Out Challenge Fails in Federal Circuit " »