On June 18, 2015, the FDA issued its final guidance regarding Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. June 2015 Guidance. The final guidance is largely the same as the draft guidance FDA released in December 2013, with the exception of editorial changes made primarily for clarification.
The guidance is intended to address concerns that differences in size, shape, and other physical characteristics between generic tablets/capsules and the reference listed (brand) drug (“RLD”) may affect patient compliance and acceptability of medication regimens or could lead to medication errors.
Per the FDA’s guidance, generic tablets and capsules should closely approximate the size of the brand products they reference. Where the RLD is less than 17 mm in its largest dimension (i.e., either the length of an oval or capsule shaped product, or the diameter of a round tablet), the FDA recommends that:
- the generic version should be “no more than 20% larger than the RLD in any single dimension”;
- the generic version should be “no more than 40% larger than the volume of the RLD”; and
- that no single dimension of the generic product should exceed 17 mm.
If the RLD is equal to or greater than 17 mm in its largest dimension, the FDA recommends that the generic should not be larger than the RLD in any dimension or in volume.
The FDA also recommends that generic products should be similar in shape to the RLD, and have other physical similarities that may impact their ease of swallowing. For example, a product’s tablet coating, weight, surface area, disintegration time, and propensity for swelling should all be similar.
Although the FDA had announced in October 2014 that it was concerned that differences in color between brand and generic products could cause patient confusion and decrease drug regimen adherence, the newly released guidance includes no recommendation that generic tablets or capsules should be the same color as the RLD.
The FDA’s guidance is not binding, and by its own terms, it applies only to new generic drug products submitted to the Office of Generic Drugs via an abbreviated new drug application (ANDA).
Trade dress issues
How the FDA guidelines implicate trade dress issues remains to be seen. The term “trade dress” refers, in general terms, to the “look and feel” of a product or its packaging. To qualify as trade dress, an attribute must meet three criteria:
- it must be nonfunctional;
- it must lead to confusion (or deception) if imitated; and
- it must have acquired distinctiveness or “secondary meaning” among a substantial portion of the relevant purchasing public.
Trade dress may include attributes such as size, shape, color or color combinations, and texture. Brand pharmaceutical companies may adopt certain color patterns and identifiable shapes for their products that can be protected as “trade dress” under the Lanham Act. Perhaps the most famous examples are AstraZeneca’s prescription drugs Prilosec® and Nexium®, both known in the market place as the “Purple Pill.” Pfizer also succeeded in registering the blue diamond shape of its tablets as a trademark for its prescription drug, Viagra® (U.S. Reg. No. 2,593,407).
In practice, courts have been somewhat inconsistent in affording trade dress protection to drug appearance. While courts have allowed such protection when the combinations of a pill’s physical attributes were shown to identify the source of the product, see e.g.,
- SK&F. Co. v. Premo Pharm. Labs., Inc., 625 F.2d 1055 (3d Cir. 1980) (holding unique coloring of prescription drug capsule constituted protectable trade dress);
- Boehringer Ingelheim G.m.b.H. v. Pharmadyne Lab, 532 F. Supp. 1040 (D.N.J. 1980) (finding generic manufacturer’s copying of a brand pill’s color scheme violated Lanham Act);
- Ross-Whitney v. Smith Kline & French Laboratories, 207 F.2d 190 (9th Cir. 1953) (upholding protection for heart-shaped orange and pink tablets).
they have also denied such protection when they found those same physical attributes served another useful purpose, such as making the products more palatable and digestible, see e.g. Norwich Pharmacal Co. v. Sterling Drug, 271 F.2d 569 (2d Cir. 1959) (denying protection for the bright pink color of Pepto-Bismol stomach medicine, concluding that the color was functional in that it was “pleasing” to patients with upset stomachs and thus had a therapeutic value), or making it easier for consumers to determine the pills’ strength. See e.g., Shire U.S. Inc. v. Barr Laboratories, 329 F.3d 348 (3d Cir. 2003) (concluding that the shape and color of Adderall tablets were functional and not protectable because the attributes helped patients distinguish between varying dosages).
Courts appear more likely to permit trade dress protection when the color and shape of pharmaceuticals have been arbitrarily selected, using, e.g., distinctive and/or striking color combinations or unusual tablet shapes. See e.g., S. Naeve, “Heart Pills Are Red, Viagra is Blue… When does Pill Color Become Functional? An Analysis of Utilitarian and Aesthetic Functionality and Their Unintended Side Effects in the Pharmaceutical Industry”, 27 Santa Clara High Tech. L.J. 299 (2010).
It is unclear whether the FDA’s decision not to address product color in its final guidance relates to trade dress concerns. The FDA has stated it will continue studying how differences in the appearance between brand and generic products affect the perceptions of pharmacists and patients. In the near term, however, generic drug companies should be careful that their efforts to adhere to FDA guidance do not expose them to trade dress infringement claims.