Willowood v. Syngenta Petition for Certiorari Asks Supreme Court to Weigh in on Copyright Protection for Generic Pesticide Labeling

Registration of Generic Pesticides

Owing to the inherent risk associated with the use of drugs and pesticides, both products are subject to a pre-marketing approval process intended to ensure that the benefits of the product outweighs its risk, at least if used within the parameters of the product's labeling. In particular, FIFRA requires that all pesticides sold or distributed in the U.S. be registered with EPA, and prior to registration a firm seeking to market a pesticide must submit for EPA's review data relating to the composition, manufacture, use, and safety of the product, along with proposed product labeling. ⁹

The approval process for a pesticide containing a new active ingredient is costly and time-consuming for the applicant, due in large part to the cost of generating the data necessary to demonstrate the safety and efficacy of the product, as well as to delineate parameters for the safe and effective use and disposal of the product. For applicants seeking registration of a generic pesticide, using only an active ingredient (or ingredients) that is already registered, FIFRA substantially alleviates this regulatory burden through its data-sharing provisions, which allow the generic applicant to reference data previously submitted by the innovator company in connection with the registration of the pioneer product, rather than generating the data de novo. Congress intended FIFRA's data-sharing provisions to promote competition in the market for pesticides, by discouraging data duplication and streamlining the registration process. ¹⁰ This aspect of FIFRA is analogous to Hatch-Waxman's ANDA for generic drugs, but there are some significant differences between how FIFRA and Hatch-Waxman handle data sharing.

In an attempt to maintain adequate incentives for innovator companies to bring new products to market and, in particular, to generate the data necessary to secure marketing approval, both statutes provide the innovator with some period of data exclusivity. Under Hatch-Waxman, an innovator who gains approval for a new active ingredient (i.e., new chemical entity) is granted five years of data exclusivity, during which time no ANDA referencing that data can be filed by a would-be generic competitor. Innovators can earn additional periods of data exclusivity by engaging in certain activities that Congress wished to encourage, such as performing pediatric studies or securing approval for a new indication. Significantly, Hatch-Waxman does not require generic drug applicants to compensate innovators for this use of their data.

FIFRA, on the other hand, provides 10 years of data exclusivity for innovators. After the 10 years have elapsed, FIFRA allows for “data sharing,” which in the context of generic products means that EPA can use data submitted by the pioneer company relating to the product's safe and effective use in the approval of the identical/substantially similar product. ¹¹ In contrast with Hatch-Waxman, FIFRA requires the generic pesticide maker to agree to compensate the innovator for the use of the data. Under the statute, if the two parties cannot agree on the amount of compensation, they are required to submit the matter for arbitration to a private arbitration award, with no right of review in the courts. ¹²

Labeling of Generic Drugs and Pesticides

Before delving into the law and policy of drug and pesticide labeling, it is important to note the law's distinction between a product's “label” and “labeling,” as well as the broad definitions of these terms under the FDCA and FIFRA, particularly as those statutes have been interpreted by EPA and FDA. The FDCA defines “label” as “a display of written, printed, or graphic matter upon the immediate container of any article.” ¹³ The term “labeling” is broader, and is defined as encompassing “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” ¹⁴ The term “accompanying” has been interpreted liberally by FDA and the courts. FDA regulations define “labeling” as including

In SmithKline, a user's guide and audiotape explaining the use of a nicotine gum product to quit smoking were deemed to constitute labeling of the product. ¹⁶

FIFRA includes explicit definitions of “label” and “labeling” that closely track the FDCA definitions. In particular,

[t]he term “label” means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers. … The term “labeling” means all labels and all other written, printed, or graphic matter: (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device, except to current official publications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, the Department of Health and Human Services, State experiment stations, State agricultural colleges, and other similar Federal or State institutions or agencies authorized by law to conduct research in the field of pesticides. ¹⁷

One significant difference between the labeling of drugs and pesticides is that under FIFRA it is “unlawful for any person … to use any registered pesticide in a manner inconsistent with its labeling.” ¹⁸ In contrast, the unapproved (i.e., off-label) use of drugs by health care providers is allowed under the FDCA, and indeed, for some important drugs, including some cancer drugs, a majority of the use is off-label. ¹⁹

Labeling plays a singularly important role in the safe and effective use of both drugs and pesticides. Both are more likely than most other products to present a risk for consumers, sometimes life-threatening. In addition, the improper use or disposal of pesticides can harm the environment. At the same time, these products, when used properly, can provide tremendous benefits. A drug or pesticide will generally be approved for marketing so long as the regulating agency determines that the benefits of the product outweigh its risks, even if the potential for adverse events is substantial. Marketing approval is premised on the product being used correctly, for the proper purposes and in the proper manner, and, if necessary, being disposed of properly. The parameters defining safe and effective use of a product are set forth in the product's labeling, and for that reason the labeling of drugs and pesticides is considered an integral part of these products, and generally cannot be substantively modified absent agency approval. ²⁰ EPA-approved labeling is the primary means through which EPA establishes and enforces the terms of the registration and regulates the use of the pesticide. ²¹

The applicant seeking marketing approval for a drug or pesticide is responsible for drafting its labeling, which is then subject to rigorous vetting by the appropriate agency prior to a grant of marketing approval. Comprehensive instructions for the safe and effective use of a drug or pesticide will generally require many pages of fine print and highly technical text, often accompanied by tables, figures, and/or illustrations. Anyone who has read (or at least attempted to read) the package insert encompassing a prescription drug, or the multiple pages of small print attached to the label of a pesticide, knows that the information provided by the labeling accompanying these products can be overwhelming and confusing, particularly to a consumer lacking familiarity with the technical concepts involved. The two pesticide product labels at issue in Syngenta, for example, comprise 54 and 29 pages of “small-type text and charts” providing detailed directions for the use, storage, and disposal of the products, as well as first-aid instructions and environmental, physical, and chemical hazard warnings. ²²

It is critically important that labeling not only provide a comprehensive and often highly technical explanation of the effective and safe use the product, but, to the extent possible, that it does so in a manner that does not overwhelm and confuse the reader. There is always the danger that in an attempt to provide comprehensive information the labeling will become so voluminous and dense that the most critical and salient information will be buried. For that reason, FDA requires the use of bold text, box warnings, and the like to highlight the most critical information.

Similarly, FIFRA requires the information on the label to be “placed thereon in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” ²³ EPA regulations likewise require that a pesticide's directions for use “be stated in terms which can be easily read and understood by the average person likely to use or to supervise the use of the pesticide.” ²⁴

The EPA's Office of Pesticide Programs' Label Review Manual (LRM) emphasizes the importance of clarity and concision in the labeling of pesticides:

Clarity. The text in the Directions for Use section should be expressed in complete sentences unless a bulleted format is used in a chart. These sentences should be direct and to-the-point, while covering all necessary information. Directions should be expressed as clearly and concisely as possible. Long or complicated paragraphs of narrative instructions should be avoided wherever possible. ²⁵

The statutory provisions relating to the labeling of generic products differ between Hatch-Waxman and FIFRA. In fact, it is this difference that the Federal Circuit pointed to in Syngenta when it concluded that FIFRA, at least on its face, does not seem create the same irreconcilable conflict with the copyright laws that the Second Circuit found with respect to Hatch-Waxman in SmithKline. In particular, Hatch-Waxman requires that, except for changes related to the manufacturer name or approved difference in the drug, “[a]n abbreviated application for a new drug shall contain … (v) information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug.” ²⁶

FIFRA, on the other hand, does not explicitly require that the generic product use the “same” labeling as the pioneer product. The closest that FIFRA comes to prescribing the required content of a generic pesticide label is its provision requiring expedited EPA review of applications for registration of an end-use pesticide that (1) “would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application” or (2) would “differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.” ²⁷ The EPA's LRM provides that “[f]or identical or substantially similar product (formerly known as “me-too”) submissions, the pesticide product and the proposed use must be identical or substantially similar to a currently registered pesticide or may differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.” ²⁸

The LRM further provides:

If the application is for a product identical or substantially similar to another (see Chapter 4), reviewing the directions for use is fairly straightforward: The label reviewer should make a side-by-side comparison of the proposed set of use directions to the use directions on the label for the registered product(s) which are identified in the identical or substantially similar application. … The format for the presentation of use information on the identical or substantially similar label need not be identical to the format on the registered (cited) label as long as the critical information as described above remains the same and the identical product meets applicable legal requirements on labeling. ²⁹

Copyright in Product Labeling

Beyond question, the creative aspects of product labels can be copyrighted, and those copyrights enforced. The courts have often proven unreceptive, however, in cases where it appears that the assertion of copyright in a product label is actually intended to impede competition in the underlying product. As well stated by a leading treatise, Nimmer on Copyright (“Nimmer”):

[A] danger lurking in copyright protection for labels is that the tail threatens to wag the dog—proprietors at times seize on copyright protection for the label in order to leverage their thin copyright protection over the text (or graphics) on the label into a monopoly on the typically uncopyrightable product to which it is attached. Used in that fashion, the copyright count serves “primarily as a means of harassing competitors,” and thus fails “nine times out of ten.” Implicated here are diverse copyright doctrines, ranging from grey market importation to copyright misuse to scope of injunctive relief. ³⁰

In Dow Jones & Co. v. Bd. of Trade of Chi., for example, the court cited Nimmer for the proposition that copyrightable writings “do not include labels which simply designate or describe the articles to which they are attached and which have no value separate from the articles, and no possible influence upon ‘science and useful arts.’” ³¹ In refusing to grant a preliminary injunction in a case alleging infringement based on the copying of the lists of component stock used by Dow Jones in preparing its Dow Jones Averages, the district court stated:

Nothing in the record, however, indicates that the lists themselves have any value. They have never been sold or licensed as independent units. Rather, their contents are disclosed without charge via brochures and telephone, and they are included in various Dow publications for sale. … No credible evidence has been received on the question of potential impairment of the value of the Wall Street Journal or the News Service from the copying of Dow's lists.” ³²

In some cases, a product label will be found so lacking in originality that it fails to meet the low threshold set by the Supreme Court in decisions such as Feist, ³³ particularly if the label does little more than describe what a product is and how it is used, and especially if the content of the label was dictated by external pressures, such as governmental regulation. When there are only a limited number of ways of expressing the same information, such that copyright in any particular expression of the idea would threaten to restrain the copying of the underlying idea, the doctrine of merger precludes copyrightability for any means of expressing information. Even if a label is found to be copyrightable, its functional nature and the limited number of ways of expressing it will often result in thin copyright protection, which will only be infringed by verbatim or near-verbatim copying. ³⁴ Courts have also pointed to the functional, utilitarian nature of product labeling as a basis for hesitating to find liability for copyright infringement in a case where aspects of the label had been copied. ³⁵

In Am. Direct Mktg. v. Azad Int'l, Inc., the court refused to enter a preliminary injunction where it was clear that the plaintiffs were:

attempting to enjoin the use of the images and text on the package so as to interfere with the defendants' sale of the product within the package. … While not quantified in this record, it is clear that the copyrighted images and text on the insert are a trivial addition to the saleability of the enclosed product. … I cannot ignore the reality that the plaintiffs here are attempting to limit competition in an unpatented product and using copyright to sidestep the showing required under trademark. I conclude that the proper remedy for infringement of the copyright in the images on a package which has withstood a trade dress claim between the same parties is most likely a fee based on the shown value of the image. ³⁶

Some of these principles would likely come into play in a case in which the court directly addresses the question of whether the copying of a pesticide label constitutes copyright infringement.

Smithkline Beecham Consumer Healthcare, L.P. V. Watson Pharm

The drug product at issue in SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharm., Inc. was a nicotine gum sold over-the-counter (OTC) and intended to help cigarette smokers overcome their cigarette habit, marketed by SmithKline Beecham under its Nicorette brand. ³⁷ Nicorette gum was originally sold by prescription only, and SmithKline produced a user's guide and audiotape for the product as part of its efforts to obtain FDA approval for OTC sales. FDA only approved the user's guide and audiotape after multiple rounds of review and revision. Ultimately, the tape and guide were included as part of Nicorette's FDA-approved OTC labeling.

Shortly after the patent and exclusivity period for Nicorette had expired, Watson Pharmaceuticals obtained FDA approval to market a generic version of OTC Nicorette. To obtain that approval, Watson had to comply with the requirement imposed by the Hatch-Waxman Amendments that “the labeling proposed for [its] new drug [be] the same as the labeling approved for” Nicorette. ³⁸ Thus, Watson's generic nicotine gum was “accompanied by a user guide and audio tape that [we]re virtually identical to SmithKline's.”

SmithKline sued, alleging willful copyright infringement of its guide and tape. The district court granted a preliminary injunction that effectively stopped Watson from shipping or selling its product. The district court relied on an FDA letter recounting that the agency had explained to Watson that “the ‘same labeling’ requirement d[oes] not require that the generic's behavioral support materials be identical to the innovator's materials” and indeed that “generic sponsors, like all other sponsors of nicotine-based smoking cessation aids, have discretion to design their own audio support materials.” Based on this representation, the district court “concluded that the FDA would have permitted Watson to use a user's guide and audio tape that deviated to some extent from SmithKline's materials … [and] that were sufficiently different in wording and otherwise to avoid copyright concerns.”

After the preliminary injunction was entered FDA dramatically altered its position, and “[i]n essence … determined that Watson had to copy verbatim substantially all of the text used in the SmithKline user's guide.” Watson attempted to avoid copyright infringement by revising its guide and tape to render them “comparable, but not identical, to SmithKline's,” but FDA rejected the revised user guide. In light of FDA's new position, the district court dissolved the preliminary injunction and SmithKline appealed.

The Second Circuit found that the guide and tape were creative works that had required substantial investment by SmithKline, and expressed “no[] doubt that SmithKline has demonstrated the existence of substantial issues under the copyright laws, at least when they are considered in isolation. It went on to find that “[n]either fair use nor implied license is clearly a defense in the present circumstances, because Watson's use of SmithKline's copyrighted works in its labeling is rather different from the sorts of copying traditionally deemed to constitute a fair use, e.g., copying for purposes such as criticism, comment, news reporting, teaching … , scholarship, or research,” and because courts have found implied licenses only in “narrow” circumstances where one party “created a work at [the other's] request and handed it over, intending that [the other] copy and distribute it.” The court found it unnecessary to seriously examine these possible defenses, however, because in its view:

the case could more easily be disposed of on the straightforward ground that the Hatch-Waxman Amendments to the [FDCA] not only permit but require producers of generic drugs to use the same labeling as was approved for, and is used in, the sale of the pioneer drug, even if that label has been copyrighted. Because those Amendments were designed to facilitate rather than impede the approval and OTC sale of generic drugs, the FDA's requirement that Watson use much of SmithKline's label precludes a copyright infringement action by SmithKline.

The court emphasized the inconsistency between holding Watson liable for copyright infringement and the purpose of Hatch-Waxman, i.e., accelerating the FDA's approval of generic products and in order to promote price competition. More importantly, Hatch-Waxman requires that an ANDA “show that the labeling proposed for the [generic] drug is the same as the labeling proposed for the [pioneer] drug … except for changes required because of [approved] differences [between the pioneer and generic drug] or because the [generic] drug and [pioneer] drug are produced or distributed by different manufacturers.” ³⁹ The court found that, beyond question, the guide and video constituted “labeling” under the broad statutory definition and FDA's regulations interpreting that definition. The court also pointed out that “if SmithKline's copyright claim has merit, then Watson cannot realistically use the ANDA process to sell its generic nicotine gum because it will either have to change the label and lose FDA approval or be enjoined from using a label that infringes SmithKline's copyright.”

The Second Circuit applied the canon that, where two laws are in conflict, courts should adopt the interpretation that preserves the principal purposes of each. In this case, the court found that the purposes of the Hatch-Waxman Amendments would be severely undermined if copyright concerns were to shape the FDA's application of the “same” labeling requirement.

The court also found that requiring generic manufacturers to paraphrase pioneer drug labels to avoid copyright infringement would not “advance[e] public health and safety to any perceptible degree.”

In contrast, the court found that refusing to hold Watson liable for copyright infringement would not significantly undermine the purpose of the copyright laws. The pertinent purpose of the copyright laws, according to the court, is to “encourage the production of creative works by according authors a property right in their works so that authors will not have to share profits from their labors with free riders,” a purpose that is “not seriously implicated by allowing the ‘same’ labeling requirement to trump a copyright under the Hatch-Waxman Amendments.” The court also “firmly believe[d] that Congress obviously would have provided explicitly that the Hatch-Waxman Amendments trump the copyright laws had it foreseen the statutory conflict exposed by the present action.” The court found it inconceivable that “if we reject SmithKline's claim, pioneer drug producers will so fear the copying of labels by future generic drug producers that some pioneer producers—or even one of them—will lack the incentive to create labeling needed for FDA approval.”

Finally, the court emphasized that even though under its ruling an owner

The Second Circuit found that Hatch-Waxman's requirement that generic drugs use the “same” labeling as the pioneer product does not require that the language be identical, and thus some paraphrasing might be permitted under the statute. Nonetheless, the court concluded that the language of the generic label would have to be so close to the pioneer that it would generally fall within the copyright law's infringement test of “substantial similarity.” The court pointed out that the “legislative history of the Hatch-Waxman Amendments suggests that whatever difference may exist between ‘same’ and ‘identical’ is narrow and intended to prevent misstatements rather than infringement.”

FMC CORP. V. Control Solutions, INC.

Five years after SmithKline, a district court in Pennsylvania was presented with essentially the same question, albeit this time in the context of a generic pesticide label, i.e., does copying a pioneer's label subject a generic pesticide manufacturer to liability for copyright infringement? In FMC Corp. v. Control Solutions, Inc., the district court arrived at the opposite conclusion, holding on a motion for preliminary injunction that FIFRA's registration requirements did not preclude a claim of copyright infringement, and that the pioneer pesticide manufacturer was likely to prevail on its claim of infringement. ⁴⁰ The court recognized the apparent conflict with SmithKline, but reasoned that that the opposing outcomes were dictated by differences in the relevant statutory text discussed earlier in this Report. ⁴¹ In particular, FIFRA does not explicitly state that the label of a generic pesticide must be the “same” as the pioneer product. Instead, the court found that FIFRA allows for expedited registration not only of products that “would be identical or substantially similar in composition and labeling to a currently-registered pesticide,” but also products that “would differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.” ⁴²

The FMC court found the outcome of SmithKline to have been dictated by the fact that Hatch-Waxman “require[s] identical labeling for generic versions of pharmaceutical products, and the [FDA has strictly interpreted] the law to require nearly verbatim copying by generic producers.” ⁴³ In contrast, the court found that “the plain wording of [FIFRA and EPA] regulations do not mandate copying, but rather suggest generic companies draft their own language.”

I would challenge FMC's interpretation of the two statutes. In SmithKline, the Second Circuit explicitly recognized that a generic drug label does not have to be “identical” in order to be the “same” within the meaning of the statute. FIFRA, on the other hand, does not suggest that generic drug companies come up with new language for the labels of identical/substantially similar products, it merely provides for the expedited registration for a pesticide that is “identical or substantially similar in composition and labeling” to a pioneer product.

In any event, the court also found it significant that the defendant had never

The outcome in FMC might have been influenced by EPAs failure to weigh in on the matter, as opposed to what occurred in SmithKline, where the government submitted an amicus brief on behalf of FDA explaining FDA's position that under the statute the generic label must be so similar to the pioneer label that it would be difficult if not impossible to avoid copyright infringement. In contrast, the FMC court noted that it:

has neither discovered, nor have either of the parties submitted evidence from which the Court could conclude, that the EPA established an opinion or protocol consistent with either of the parties' positions in the instant matter with respect to the handling of various categories of submissions to the EPA. Thus, the Court must look to the plain words of the applicable statutes and regulations while bearing in mind the contemporaneous request for copyright protection. Nothing in the statutory or regulatory provisions expressly applicable to this product (as opposed to other products discussed as a comparison scheme, infra) requires, mandates or excuses unauthorized copying of a competitor's product label. ⁴⁴

The court suggested that a generic pesticide producer could secure expedited approval without facing liability for copyright infringement by “either (a) paraphrasing the label from the pioneer product to create a substantially similar label or (b) negotiating and contracting with the pioneer producer to use nearly verbatim language from the original label.” Note that in SmithKline the Second Circuit never acknowledged this second possibility, i.e., that the generic producer could negotiate a license to use the copyrighted text of the original label. The problem with this approach, of course, is the potential for holdup—the innovator might demand a licensing fee for the copyrighted text that greatly exceeds its value per se, as a means to delay market entry of the pesticide itself, i.e., the tail wagging the dog scenario mentioned by Nimmer.

THE Impact of FMC on Generic Pesticide Companies and EPA

The FMC decision created challenges for both those seeking expedited registration of generic products and EPA regulators. A group of 41 companies holding generic pesticide EPA registrations filed an amicus brief with the Federal Circuit in Syngenta describing “the costs, delays, risks, and challenges [they had incurred] trying to (re)write their labels so as to avoid copyright infringement claims,” and the “significant adverse impact” the decision had had on their ability to conduct their generic pesticide businesses. ⁴⁵ They argued that prior to FMC it had always been their understanding and experience that “once EPA has determined the appropriate directions for use, warnings, precautions, and other information on a pesticide label, EPA wants substantially similar products, i.e., generic versions of the already-registered product, to bear the same or a very similar label.” Not only does “consistency of labels among similar products reduces the likelihood of confusion and product misuse on the part of ultimate consumers[,] consistent label language for similar products also reduces the workload on EPA in reviewing registration applications for similar products [and] streamlines the registration process, consistent with the pro-competitive purpose of FIFRA.” The practice “ensured that EPA would accept their proposed label with very few comments or revisions, and thus facilitated EPA's timely review and approval of their registration applications.”

After FMC, many of the generic companies began taking steps to avoid copyright infringement in their labeling of generic products, but it has proven difficult. Because “there are no bright line tests or other standards by which a company can determine whether and when a label has been sufficiently changed to eliminate copyright liability[,] even after making changes to the label, amici are left uncertain whether they could still be vulnerable to copyright infringement claims.” At the same time, if EPA regulators feel that the paraphrasing has altered the meaning of the instructions, or even just made them more difficult for the end user to understand and follow, they will reject the proposed generic label and require the applicant to submit a new revised label. The amici state that these rejection-revision cycles have led to delays in the approval registrations.

The amici argue that there are only a limited number of ways to express the basic factual information on how to use a product safely, which makes paraphrasing without risking infringement under the substantial similarity standard difficult.

Some of the amici reported that they have hired consultants, or even law firms, to prepare revised labels, which they argue drives up the cost of bringing these products to market, while serving no independent business purpose. In the wake of FMC, generic companies have been threatened with lawsuits by original registrants, and on a few occasions, lawsuits were actually filed. As of the date the amicus brief was drafted, the amici had been able to settle the lawsuits by agreeing to revise the label. They warned, however:

[at] a minimum, a ruling by [the Federal Circuit] that pesticide labels are protected by copyright would impose significant costs and registration delays on amici and other generic registrants, and encourage additional label copyright infringement litigation. At worse, such a ruling could place amici in a Catch-22 situation in which it is nearly impossible to register a generic product because of the conflicting label requirements imposed by EPA and copyright law.

The EPA has expressed its own misgivings with FMC. Shortly after the decision issued, EPA sent a letter to a trade association expressing the agency's concern about the potentially harmful policy implications of FMC. ⁴⁷ The letter stressed how important it was for the protection of the environment and public health that “products that are similar and intended for similar uses have clear and consistent labeling,” and stated that ever since Congress amended FIFRA to provide for expedited approval of generic pesticides the agency had:

strongly encourage[d] “me-too” product labels to be identical or substantially similar to the labels of the products on which the registrations are based. When they are not, [EPA] may be unable to conclude that the products meet [FIFRA's] standard for issuing “me-too” registrations. … Similar products need to communicate instructions and warnings in a clear and consistent fashion to ensure that the products are used appropriately. Conveying application instructions and safety messages for similar products in different ways increases the likelihood of the product will be misused. It also diminishes the Agency's ability to enforce pesticide labeling in a consistent manner.

The EPA reported that problems had already occurred. For example, precautionary language on mosquito control products, intended to manage risk to aquatic life, has varied considerably from product to product, causing confusion among users and enforcement personnel.

The EPA also pointed to the fact that there can be hundreds of me-too versions of the pesticide, stating that it “is difficult to imagine how many different ways companies might come up with to convey the same information, and it is equally hard to imagine the amount of staff time that would be required to conduct a detailed review of each label. … Users are bound to be confused if all of these products' labels convey their instructions for use in different ways.”

In copyright infringement lawsuits that were filed against generic pesticide producers in 2006 and 2009, senior EPA officials submitted detailed declarations to the courts explaining why the agency considers application of copyright law to pesticide labels to be antithetical to FIFRA's statutory scheme, and in direct conflict with EPA's interpretation and implementation of the statute. ⁴⁸ One EPA official declared that

The official further declared that “[t]here is a real concern that these copyright infringement actions complicate the Agency's ability to ensure protection of human health and the environment.” As one example of how attempts to paraphrase pesticide labels could lead to misuse, the official reported how some companies who have sought amendments of their labels to avoid copyright infringement claims have submitted labels in which language that was mandatory on the original label is paraphrased as discretionary on the generic label.

Syngenta Crop Protection, LLC V. Willowood, LLC

The issue addressed in FMC came up again in 2017 in the case of Syngenta Crop Protection, LLC v. Willowood, LLC, but this time the district court arrived at the opposite conclusion, holding on a motion for summary judgment that FIFRA “precludes copyright protection for the required elements of pesticide labels as against the labels of me-too registrants.” ⁵⁰ The court provided little analysis in support of its decision, beyond noting that it was consistent with SmithKline. The court found the analysis of FMC to be “unconvincing.” The court concluded:

FIFRA contemplates that a “me-too” applicant will copy from the original pesticide label in ways that would otherwise infringe a copyright. 7 U.S.C. § 136a(c)(3)(B)(i)(I). Even with some changes, use of the original pesticide label as a “go by” for the new label will result in copyright infringement. See 17 U.S.C. § 106; Lyons P'ship, L.P. v. Morris Costumes, Inc., 243 F.3d 789, 801 (4th Cir. 2001) (discussing substantially similar standard for copyright infringement). In enacting FIFRA, Congress intended a narrow exception to copyright protection for the required elements of pesticide labels as against me-too registrants.

The different outcomes in Syngenta and FMC might have been influenced by the government's decision to intervene in Syngenta on behalf of the defendant and argue EPA's position that a generic's copying of pioneer pesticide label does not constitute copyright infringement. ⁵¹ In the statement of interest filed with the district court, the government argued that FIFRA “endorses” copying by generic applicants and furthers Congress's intent of expediting market access for generic pesticides. Furthermore, the government argued that Syngenta had granted Willowood an implied license by participating in FIFRA's labeling scheme, and that the copying did not constitute copyright infringement under principles of merger and fair use.

On appeal, the Federal Circuit reversed the district court's decision, concluding that it had been premature in holding that FIFRA “precludes copyright protection for the required elements of pesticide labels as against the labels of me-too registrants.” ⁵² The Federal Circuit found that FIFRA, unlike Hatch-Waxman, does not, on its face, require a me-too registrant to copy the label of a registered product, and that the statute only conflicts with the Copyright Act to the extent that some particular element of Syngenta's label is both protected under existing copyright doctrine and necessary for the expedited approval of Willowood's generic pesticide product. According to the Federal Circuit, it is impossible to make this determination without reviewing the merits of the copyright claims, something the district court had failed to do. The case was remanded to allow the district court to make this determination in the first instance.

The Federal Circuit emphasized that, under traditional rules of statutory interpretation, courts are required to apply a stringent standard in assessing whether a later-enacting statute has implicitly repealed an earlier one, even in part, and as a consequence implicit repeal is a “rarity.” In the absence of an “irreconcilable conflict,” statutory provisions acting upon the same subject should be interpreted and applied in a way that “gives effect to each” and “preserves the purposes of both.”

The court emphasized that, under its reading of the statute, FIFRA does not require a me-too applicant to ensure that its product label is identical to a registered label; nor does it require applicants to otherwise derive the elements of its label from that of the registered label. Instead, the statute provides for expedited review so long as any differences between the proposed and registered products “would not significantly increase the risk of unreasonable adverse effects on the environment.”

The Federal Circuit suggested that established doctrines limiting the scope of copyright protection might be sufficient to allow a me-too applicant to draft labeling for a generic product that would satisfy EPA regulators while avoiding copyright infringement. For example, the court suggested that the concern that there are only a limited number of ways to express the information conveyed by pesticide labeling might be readily addressed using copyright law's well-established “merger” doctrine, under which courts have denied copyright protection to works when the underlying fact, procedure, or idea can be expressed in so few ways that “protection of the expression would effectively accord protection to the idea itself.” Responding to the argument that differences in labeling between pioneer and generic pesticides might confuse users, with adverse consequences for the environment, the court suggested that this sort of predicament is “more appropriately addressed, at least in the first instance, under copyright law's own ‘equitable rule of reason’: the fair use doctrine.”

The Federal Circuit instructed the district court, on remand, to begin by:

discern[ing] whether the Copyright Act, as interpreted under existing copyright doctrines, would prohibit Willowood's use of any portion of Syngenta's label. … Only if the district court concludes that the Copyright Act would in fact prohibit Willowood's conduct in a manner inconsistent with the purposes of FIFRA should it revisit the question of whether and to what extent FIFRA precludes Syngenta's copyright claims for any part of its pesticide labels. It is possible that after a full assessment of the requirements of copyright law and FIFRA as applied in this case, there may come to light a truly irreconcilable conflict between Copyright Act liability and implementation of FIFRA. In the absence of a clear facial conflict, however, we decline to wield the blunt tool of preclusion before the full factual and legal contours of any latent problem have been examined.

The Federal Circuit's hesitancy to go beyond copyright law in resolving the issue is understandable and consistent with precedent and long-standing policy concerns. In most cases, when a finding of liability for copyright infringement would be contrary to public policy, courts have attempted to stay within the boundaries of established copyright law to conclude that the accused party is not liable, rather than relying on other legal doctrine to nullify copyright law.

For example, in Am. Soc'y for Testing & Materials, et al. v. Public.Resource.Org, Inc., the question was whether a party could be held liable for copying from a copyrighted work that has been incorporated by reference into federal, state, or local statutes or regulations. ⁵³ Public.Resources.Org (PRO), the public interest group that brought the action, raised a constitutional challenge to copyright protection for such works, but on appeal the D.C. Circuit rejected this approach, stating:

Although PRO raises a serious constitutional concern with permitting private ownership of standards essential to understanding legal obligations, we think it best at this juncture to address only the statutory fair use issue—which may provide a full defense to some, if not all, of the SDO's infringement claims in this case—and leave for another day the question of whether the Constitution permits copyright to persist in works incorporated by reference into law. This approach not only allows us to resolve the appeal within the confines of the Copyright Act but is also more faithful to our responsibility to avoid passing on questions of constitutionality unless such adjudication is unavoidable. … To be sure, it may later turn out that PRO and others use incorporated standards in a manner not encompassed by the fair use doctrine, thereby again raising the question of whether the authors of such works can maintain their copyright at all. In our view, however, we ought exhaust all remaining statutory options and only return to that question, if we must, on a fuller record.

The Federal Circuit appears to apply the same principles to the copyright issue raised by Syngenta, encouraging the district court to attempt to resolve the issue in favor of the generic pesticide manufacture under the doctrine of fair use, or perhaps some other established doctrine of copyright law, rather than through implicit nullification of the Copyright Act. If the courts are ultimately unable to resolve it within the parameters of copyright law, the other potential route to a finding of no liability would be for the court to interpret FIFRA, or at least the EPA's reasonable implementation of FIFRA, as rendering it so difficult for generic producers to come up with suitable labeling without exposing themselves to the threat of copyright liability that Congress would have intended FIFRA to trump the copyright laws, for the same reasons articulate by the Second Circuit in SmithKline.

On March 17, 2020, Willowood filed a petition for certiorari with the U.S. Supreme Court. ⁵⁴

Congress Likely Intended Fifra to Trump Copyright LAW

The SmithKline court “firmly believe[d] that Congress obviously would have provided explicitly that the Hatch-Waxman Amendments trump the copyright laws had it foreseen the statutory conflict exposed by the present action.” I think it's safe to say that the same applies to the conflict between FIFRA and copyright law. When Congress created the expedited approval process for identical/substantially similar pesticides, it clearly intended to reduce the burden experienced by both generic applicants and EPA's regulators. Requiring generic applicants to circumnavigate the vagaries of copyright law in preparing labels for previously approved products makes the process substantially harder for both the applicant and the EPA, while in no way furthering the objectives of FIFRA, i.e., making useful pesticides available to the public in a manner that, to the extent possible, maintains the safety of humans while protecting the environment. At the same time, a carefully tailored exemption shielding generic pesticide producers from copyright liability for copying EPA-mandated elements of the approved label would cause little if any harm with respect to the policy objectives embodied in U.S. copyright law.

The Federal Circuit's conclusion in Syngenta that FIFRA does not, on its face, require a generic pesticide producer to copy from the pioneer's label stems from language in the statute allowing EPA the discretion to grant expedited registration to two types of products: (1) identical/substantially similar products, i.e., generics; and (2) products that are not identical/substantially similar to an already approved product, but that differ only “in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.” Pesticides falling within this second category are more akin to biosimilar versions of biologics than they are to generic drugs (or interchangeable biologics for that matter), and, as is the case with biosimilars, it makes sense to permit differences in product labeling that account for differences between innovator and follow-on products. ⁵⁵

But I think it is a mistake to infer from the fact that FIFRA allows EPA the discretion to grant expedited registration to this second category of follow-on pesticides that Congress intended products falling within the first category, i.e., identical/substantially similar products, to be labeled in a manner that is substantially different than their pioneer counterparts. I do not believe that Congress intended to render the labeling of generic pesticides substantially more difficult and cumbersome than the labeling of generic drugs, nor did it seek to burden pesticide users with a proliferation of substantially different labels on functionally identical products. In my opinion, the EPA's interpretation of FIFRA as allowing the agency to require generic pesticide manufacturers to employ labeling that is substantially the same as the original product. It might be useful for the EPA to engage in notice-and-comment rulemaking and explicitly interpret FIFRA as requiring a product that is identical/substantially similar to a previously approved product, and registered through the expedited process, to adopt identical/substantially similar labeling, analogous to the requirement applied to generic drugs. ⁵⁶

In FMC, the district court found it reasonable to require the generic seller to “paraphrase” the language of the original product label. But the experiences of generic pesticide producers and EPA post-FMC, as discussed above, belie that conclusion. ⁵⁷ Permitting the copying of the required elements of a pioneer product's label, on the other hand, would do little violence to the valid objectives of copyright law. As the court pointed out in SmithKline, innovators are required to produce these labels in order to legally market their products, and there is little danger that they will stop producing new products if denied copyright protection for their labels. The EPA regulation provides the incentive for these innovators to create these labels in a complete, clear, and concise manner, irrespective of copyright. Some might object to allowing generic pesticide producers to free-ride off the efforts of pioneers in producing these labels. Syngenta argued, for example, that it had expended significant time and resources in drafting and securing approval for its labels. But FIFRA specifically contemplates and encourages generic pesticide producers to take advantage of the efforts of innovators so as to reduce the cost and time required to bring generic pesticides to market.

Innovators are compensated for their efforts through the registration of their product, which generally allows for a de facto period of marketing exclusivity. There are also FIFRA's data compensation provisions. ⁵⁸ One could argue that the money paid to the innovator by the generic producer as compensation for the use of the data should also encompass use of the EPA-approved labeling, which is a practical manifestation of that data. In order to address free-riding concerns, the calculation of data compensation could explicitly take into account the value of the copyrighted expression of the data incorporated into the required elements of the product's labeling.

The Possibility of a Bright-Line Safe Harbor

The generic pesticide companies' amicus brief explains the need to resolve this issue in a manner that provides a bright-line safe harbor for generic pesticide producers. ⁵⁹ As a practical matter, even the plausible threat of liability would compel generic pesticide producers and EPA to engage in the wasteful, and potentially detrimental, rewriting of pesticide labels. The question then becomes how the courts, EPA, and/or perhaps even Congress might effect this outcome.

Congress could, of course, resolve the matter by amending the Copyright Act—it already includes many statutory exemptions from infringement liability. Alternatively, Congress could amend FIFRA, perhaps so as to require that identical/substantially similar pesticides use the “same” labeling as the pioneer, i.e., introduce essentially the same statutory provision that appears in Hatch-Waxman and which proved significant in SmithKline.

Even absent congressional action, I think that the court could find that the conflict between the language and purpose of FIFRA and the Copyright Act warrants a bright-line defense for a generic manufacturer that has copied no more than the EPA-mandated elements of the pioneer label. In SmithKline, the Second Circuit explicitly found that Hatch-Waxman's requirement that a generic drug use the “same” language does not require identical language, and that indeed it might be possible, at least in some cases, for a generic drug producer to come up with labeling language that is the “same” as the pioneer product but still different enough to avoid copyright infringement. In other words, SmithKline did not conclude that it would be “necessary” for the generic company to infringe copyright in order to avail itself to Hatch-Waxman's abbreviated approval process. The Second Circuit's decision was based largely on the purpose of Hatch-Waxman, as opposed to the specific statutory language requiring the “same” labeling, with the court finding that, regardless of whether a generic company might potentially be able to avoid copyright infringement, the high likelihood of copyright infringement liability created burdens for the generic company and for FDA regulators that were at odds with the purpose behind Hatch-Waxman.

Although FIFRA does not expressly call for the use of the “same” language, as discussed in a previous section of this Report, I think the statute could be reasonably interpreted as contemplating that a pesticide that is identical/substantially similar in composition to a pioneer product will employ labeling that is identical/substantially similar to that product's label. The Federal Circuit could find that the language and purpose of FIFRA conflict with copyright liability for essentially the same reasons as the Second Circuit did in SmithKline, and could likewise create a bright-line defense against a charge of copyright infringement.

Alternatively, the courts might ultimately create a bright-line safe harbor by applying established principles of copyright law. As discussed above, courts have often been unreceptive to allegations of copyright infringement involving product labels that share certain characteristics with pesticide labeling. As a general matter, for example, courts have not been hospitable to claims of copyright infringement when the purpose of a copyright suit is to hinder a rival from lawful, non-copyright competition.

The courts might create a safe harbor for generic manufacturers under a theory of implied license. Case law provides a number of examples of implied nonexclusive licenses that were created by the conduct of a copyright owner. ⁶⁰ In one somewhat analogous case, a party attempted to assert copyright in pleadings it had filed in connection with a lawsuit, in order to limit the ability of other parties' access to the documents. The Second Circuit held that initial permission to use the complaint in litigation acted as “irrevocable authorization to all parties to the litigation, present and future, as well as to their attorneys and to the court, to use the documents in the litigation thereafter.” ⁶¹

Similarly, one could argue that by submitting materials to the EPA for marketing approval, an innovator implicitly agrees to EPA's use of the materials as set forth in FIFRA, and in furtherance of the objectives of FIFRA. Part of the objective of FIFRA is to provide a streamlined and efficient process for bringing generic versions pesticides to market, which includes allowing EPA to authorize generic pesticide makers to use the same labeling is the innovator product. A pioneer pesticide manufacturer gains a valuable benefit when it receives EPA's marketing approval for its product, and in return, one could infer that as part of the bargain the pioneer company implicitly agrees not to stand in the way of generic approvals, which would include an implied license to use its labeling.

In SmithKline, the U.S. government raised this argument in its amicus brief, asserting that a pioneer drugmaker's submission of proposed labeling to FDA, in conjunction with a request for approval to market a drug with that labeling, creates an implied, nonexclusive license for generic applicants to copy that labeling for use on their products. The government argued that “[i]n addition to the costs of the extensive studies required to demonstrate safety and efficacy, the price of [marketing] approval included the grant of a nonexclusive license to any generic manufacturer who obtains FDA approval of an ANDA based on Nicorette.”

It should be noted, however, that in SmithKline the Second Circuit proved unreceptive to the government's implied nonexclusive license argument, finding it not “clearly a defense in the present circumstances,” and asserting that courts have found implied licenses only in “narrow” circumstances where one party “created a work at the other's request and handed it over, intending that the other copy and distribute it.” The court further found the implied license argument “somewhat superfluous in that the license would have to be inferred from the Hatch-Waxman requirement that copyright labels be infringed. If that view of Hatch-Waxman is correct, as the present opinion holds, then the outcome is dispositively determined without further discussion of the doctrine of implied license.” The court also expressed concern that if the government's argument were to prevail, “some new law, essentially judge-made, would have to be fashioned.”

In Syngenta, the Federal Circuit suggested that the pioneer's pesticide label might not be copyrightable under the “merger” doctrine, pursuant to which courts have declined to protect against copying when there are so few ways to express an underlying fact, procedure, or idea that “protection of the expression would effectively accord protection to the idea itself.” In principle, the courts could create a bright-line rule that pesticide labels are not copyrightable due to merger. However, in view of the length and complexity of these labels, a court might be reluctant to find that there are so few ways of paraphrasing the language that expression has merged with the underlying ideas.

Even in the absence of merger, a court might reasonably find that, because of the limited number of ways the technical content of pesticide labeling can be effectively communicated, pesticide labels only receive thin protection. The copyright of a thinly protected work will generally only be infringed by near-verbatim copying. Unfortunately, a holding of no liability in Syngenta based solely on thin protection and a lack of substantial similarity could be seen as case-specific, and thus fail to provide the necessary bright-line safe harbor.

Then of course there is the fair use defense, which the Federal Circuit pointed to in Syngenta as a potential means to resolve the issue, referring to it as copyright law's own “equitable rule of reason.” Section 107 of the Copyright Act provides that the fair use of a copyrighted work for purposes such as criticism, comment, news reporting, teaching (including multiple copies for classroom use), scholarship, or research, is not an infringement of copyright. In determining whether the use made of a work in any particular case is a fair use the factors to be considered shall include: (1) the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes; (2) the nature of the copyrighted work; (3) the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and (4) the effect of the use upon the potential market for or value of the copyrighted work. ⁶²

The defendant in SmithKline raised the fair use defense, but the Second Circuit chose to decide the case on other grounds, opining that fair use was not a clear defense on the facts of the case. The court suggested that the copying of a pharmaceutical label is “rather different from the sort of copying traditionally deemed to constitute fair use, e.g., copying for purposes such as criticism, comment, news reporting, teaching … , scholarship, or research, i.e., the nonexhaustive list of examples of fair use provided in the statute.” I would differ with the court on this point; there are many examples of fair use that fall well outside the nonexhaustive list provided in the statute. ⁶³

In FMC, the district court found that the fact that the generic producer had engaged in wholesale copying, while using none of its own creative activity, was sufficient in and of itself to rule out the fair use defense. ⁶⁴ This view of fair use is, with all due respect, inconsistent with the case law. In Sony, for example, the Supreme Court held that noncommercial recording of copyrighted television broadcasts for purposes of time-shifting is fair use, even though it is wholesale copying and does not involve any creativity on the part of the infringers. ⁶⁵

There is case law that would support a finding of fair use in this case, based on the nature of the work and the alleged infringing activity. For one thing, the labeling is mandated by federal law, and a prerequisite for Syngenta to sell its pesticide. For another thing, the primary product is not the allegedly copyrighted work, but the pesticide. The labeling is a prerequisite for selling the product, but is not the product itself. These factors were found relevant in Gulfstream Aerospace Corp. v. Camp Systems International, Inc., a somewhat analogous case in which the fair use argument prevailed. ⁶⁶

The plaintiff in Gulfstream was an aircraft manufacture, and the allegedly infringed material was an aircraft operation manual. The manual was required by regulations promulgated by the Federal Aviation Administration, and produced in accordance with those regulations, in the same way pesticide labeling is mandated and regulated by EPA. The defendant was a company that sold a product for tracking aircraft maintenance, which comprised qualitatively significant extracts copied from the manual. The court, applying the four statutory fair use factors, found that the first factor, i.e., the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes, weighed slightly against the defendant, because the purpose of the copying was commercial and non-transformative. The second factor, the nature of the copyrighted work, was found to weigh in the defendant's favor, given the highly factual and utilitarian nature of the manual. The third factor, the amount and substantiality of the portion used in relation to the copyrighted work as a whole, weighed slightly against the defendant, because a significant quantity of copyrighted material was copied.

In Gulfstream, it was the fourth factor, the effect of the use upon the potential market for or value of the copyrighted work, which proved decisive, leading to a finding of fair use. The court found this factor to weigh heavily in favor of the defendant, because, in the view of the court, copyright law is not intended to protect an “author” who has done nothing more than to produce a federally mandated manual, and whose “desire for copyright protection has nothing to do with needing an incentive to create its manuals.” Instead, the court found that Gulfstream was attempting to use its claim to copyright in its manuals to gain a judicially enforced monopoly on its maintenance-tracking services, an outcome that:

would be injurious to the free-market public policy advanced through antitrust and restraint-of-trade laws. It would be especially egregious since Gulfstream is required by federal regulations to produce the manuals anyway. Again, those federal regulations leave Gulfstream little room to make decisions regarding either the format or the content of those manuals.

The U.S. government argued in its amicus brief filed with the Federal Circuit that Willowood's copying of Syngenta's labels constituted fair use. With respect to the first fair use factor, for example, the government argued that FIFRA encourages the use of identical or substantially similar labeling, “substantially mitigat[ing] the commercial and non-transformative use at issue here.” The purpose of the copying, according to the government brief, was to comply with FIFRA requirements and EPA mandates, which also weighs in favor of fair use under the first factor. The government also argued that the highly functional nature of pesticide labeling weighs in favor of fair use under the second factor. I would argue further that, under the second factor, courts should also take into account the fact that the objective of innovators in creating pesticide labeling is to obtain EPA registration of the pesticide, and the value of the labeling is driven by EPA registration and subsequent sales of the pesticide, not by the creativity with which the technical information is expressed on the label.

While fair use could provide a defense for Willowood in this particular case, a potential concern is that the doctrine typically does not provide the desired bright-line defense. As the Supreme Court recently observed in Georgia v. Public.Resource.Org, Inc., while “[s]ome affected parties might be willing to roll the dice with a potential fair use defense[,] that defense, designed to accommodate First Amendment concerns, is notoriously fact sensitive and often cannot be resolved without a trial.” ⁶⁷ Similarly, in Campbell v. Acuff-Rose Music, Inc., the Court noted that the “task [of evaluating whether use of copyrighted material is fair use] is not to be simplified with bright-line rules, for the statute, like the doctrine it recognizes, calls for case-by-case analysis.” ⁶⁸ Fortunately, there is some precedent for the creation of bright line determinations of fair use for certain well-defined activities. For example, in Sony the U.S. Supreme Court held that private, noncommercial recording of copyrighted television broadcasts for the purpose of time-shifting is fair use. ⁶⁹

Even in the event that the court were to find a generic pesticide manufacturer like Willowood liable for copyright infringement, the nature of the infringer might be reflected in the remedy provided by the court. In particular, a court might reasonably decide not to enter an injunction, and instead award money damages reflecting the value of the copyrighted expression embodied in the labeling (excluding the value of the uncopyrightable technical content and the pesticide product itself), which could be nominal.

Something along these lines occurred in a 1992 case in which the plaintiff sought a preliminary injunction to stop the defendant from selling a competing tooth-whitening product, based on alleged infringement of copyrighted text on an insert to plaintiff's product. The court found that the copyrighted text constituted a trivial addition to the market appeal of the underlying (uncopyrightable) product, and that the true purpose behind seeking an injunction was to interfere with the defendant's sales of the product itself. In declining to issue an injunction, the court noted that “the proper remedy for infringement of the copyright in the images on a package which has withstood a trade dress claim between the same parties is most likely a fee based on the shown value of the image.” ⁷⁰

Implications For Biosimilar and Interchangeable Biologics

It is interesting to consider the implications of Syngenta for biosimilar and interchangeable biologics. Many of today's most important (and expensive) blockbuster drugs are biologics. Until recently there was no abbreviated pathway for follow-on versions of biologics, owing in part to the unpredictability and complexity associated with producing therapeutics in biological systems, the resultant difficulty ensuring the functional equivalence of a biologic produced by a different firm.

In 2010 Congress enacted the BPCIA, which created abbreviated approval pathways for biosimilar and interchangeable biologics. A biosimilar is not a generic version of a biologic; it is not necessarily equivalent in terms of safety and efficacy, and cannot be substituted for a pioneer biologic prescribed by a physician. It is, however, similar enough to the pioneer product to rely, at least in part, on data generated for the pioneer product in demonstrating the required safety and efficacy for purposes of FDA approval. A number of biosimilar products have already been approved.

The BPCIA also provides for the accelerated approval of interchangeable products, which are basically biosimilar products that have been shown to be equivalent to the pioneer, and thus can be substituted/interchanged with the pioneer product without the authorization of the prescriber. So far, interchangeable products are still an aspiration; to my knowledge FDA has yet to approve one. However, if and when interchangeable biologics start being approved, they will essentially be the biologic equivalent of generic drugs and pesticides.

Significantly, the BPCIA, like FIFRA, does not include Hatch-Waxman's requirement that a biosimilar/interchangeable biologic use the “same” labeling as the pioneer product. ⁷¹ In fact, as far as I know, the BPCIA does not include any specific provisions relating to the relationship between a biosimilar/interchangeable label and the corresponding pioneer product. If the ultimate outcome of Syngenta is that a generic pesticide manufacturer can be held liable for copying the pioneer's label, then it's hard to see how the same would not apply for biosimilar and interchangeable biologics. For reasons that I think are obvious, uniform and consistent labeling of biosimilar/interchangeable biologics is just as important as it is for other drugs, and requiring follow-on biologic manufacturers to paraphrase labeling that provides critical information on the safe and effective use of these drugs runs counter to sound policy and the objectives of the statute.

A document published by FDA in 2018 provides the following guidance to industry with respect to the labeling of biosimilar biologics:

In sections of the biosimilar product labeling that are based on the reference product labeling, it is anticipated that the text will be similar to the corresponding text in the reference product labeling. Text based on the reference product labeling need not be identical to the reference product labeling and should reflect currently available information necessary for the safe and effective use of the biosimilar product. Certain differences between the biosimilar and reference product labeling may be appropriate. For example, biosimilar product labeling conforming to PLR and/or PLLR may differ from reference product labeling because the reference product labeling may not be required to conform to those requirements at the time of licensure of the biosimilar product. In addition, biosimilar product labeling may include information specific to the biosimilar product that is necessary to inform safe and effective use of the product, including administration, preparation, storage, or safety information. This information may differ from that of the reference product labeling when it reflects differences between the biosimilar product and the reference product that do not preclude licensure of the biosimilar product. ⁷²

Note that FDA “anticipates” that the text of the biosimilar label and the reference product will be similar. FDA does not require the labels to be identical, but that simply reflects the fact that, as a general matter, biosimilar products are not identical to the corresponding pioneer product. The FDA guidance point out specific reasons labeling might differ, such as differences between the products and differences in the available information at the time of labeling. But to the extent the products are the same and the available information relating to their use is the same, then I think the proper reading of the guidance is the FDA wants to see the same labeling on biosimilar and reference products.

Significantly, the FDA has yet to address the labeling of interchangeable products. The biosimilar labeling guidance document does state that recommendations for the labeling of interchangeable products will be provided in future guidance. Since interchangeable products are essentially generic versions of biologics, it would make little sense for FDA to require the same labeling for generic drugs but not for interchangeable biologics, nor for Congress to intend that companies producing interchangeable drugs be forced to paraphrase around copyright law in the labeling of their products.

So far, I do not believe the question of copyright infringement of a biologic label has made its way to the courts. But if it does, perhaps in the context of an interchangeable product, Congress and the public might take notice. On the other hand, if the Federal Circuit can figure out a way to provide a bright-line rule protecting generic pesticide manufacturers from the threat of copyright liability, it might at the same time resolve the issue for the makers of biosimilar and interchangeable biologics.