Patent Law | Expert Legal Commentary

July 13, 2009

Abbott Labs v. Sandoz: Defining Infringement for Product-by-Process Claims

Abbott Labs v. Sandoz

By Yuri Mikulka of Stradling Yocca Carlson & Rauth and Spyros Lazaris

Abbott Labs v. Sandoz: Defining Infringement for Product-by-Process Claims

The Federal Circuit has resolved prior inconsistencies in its case law and established a bright line rule to define infringement in product-by-process claims, holding that such infringement requires practice of the claimed process by the alleged infringer. In Abbott Labs v. Sandoz, 566 F.3d 1282 (Fed. Cir. 2009), the Federal Circuit held that the process terms of a product-by-process claim serve as limitations in determining infringement, such that similar products made by a different process do not infringe on the patent.


Abbott Labs has a patent on a drug called Omnicef, an antibiotic often used to treat children’s ear infections. The FDA approved a generic version of Omnicef developed by Lupin Limited, and Lupin subsequently sought a declaratory judgment in the Eastern District of Virginia that its generic version did not infringe upon Abbott Labs’ patent, as Lupin had used a different process to make its drug. The district court ruled in favor of Lupin, and Abbott appealed.

On appeal the case was combined with a separate action that Abbott had filed in the Northern District of Illinois against several other generic drug manufacturers (including Sandoz Inc. and Teva Pharmaceuticals, among others), claiming infringement of the same patent. The district court had denied Abbott’s motion for a preliminary injunction in that case, and Abbott had appealed.

In a single opinion, the Federal Circuit affirmed both district court decisions. Abbott Labs v. Sandoz, 566 F.3d 1282 (Fed. Cir. 2009).

Product-by-process claims and the split in precedent

A product-by-process claim allows a patent applicant to claim a product that is at least partly defined by its manufacturing process – for example, “Product X, produced by the reaction of A and B.” For more than a decade, federal courts have grappled with the question of whether Product Y, essentially identical to Product X, infringes on the Product X patent if made by a different process – for example, if Product Y was produced by the reaction of C and D.

The Federal Circuit has reached contradictory opinions on this issue. In 1991, a Federal Circuit panel determined that the resulting product defines infringement of a product-by-process claim, regardless of the process used to create it. Scripps Clinic v. Genentech, 927 F.2d 1565, 1583 (Fed. 1991). In other words, Product Y in the example above would infringe on the Product X patent simply by virtue of being essentially identical, even though created by a different process.

In 1992, however, a different Federal Circuit panel held that all of the process steps in a product-by-process claim must be performed in order for infringement to occur. Atlantic Thermoplastics v. Faytex, 970 F.2d 834, 846-847 (Fed. Cir. 1992). In other words, Product Y in the example above would not infringe on Product X, despite being essentially identical, because it was created using a different process than the process identified in the Product X claims.

Federal Circuit overrules Scripps, says same process is required for infringement

In Abbott Labs, the Federal Circuit resolved this long-standing inconsistency and upheld the view expressed in Atlantic Thermoplastics that “process terms in product-by-process claims serve as limitations in determining infringement.” 566 F.3d at 1293 (citing Atlantic Thermoplastics, 970 F.2d at 846-847). The Court expressly overruled Scripps to the extent that it conflicted with this ruling. Id. The Court determined that this view comported with the Supreme Court’s opinion in Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997), in which the high court stated that “(e)ach element contained in a patent claim is deemed material to defining the scope of the patented invention.” 520 U.S. at 19.

The Court acknowledged the validity of product-by-process claims, though it made clear that the process terms are limiting in terms of enforcement. The court based its holding on the public notice function of patent claims, holding that where a patent holder claims a new product solely in terms of a particular process, infringement must be determined by “comparison of the claimed and accused infringing processes.” 566 F.3d at 1294.

Three judges led by Judge Newman filed a long dissent, arguing that the majority opinion overturned a century of precedent that allowed patent applicants to protect a new product whose structure is not fully known or readily described by merely including sufficient reference to the process required to create it. 566 F.3d at 1299-1300. The dissent calls for a “rule of necessity” for difficult-to-define inventions. Id. at 1300.

In response to the dissent’s call for a special “rule of necessity,” the majority found it “both unnecessary and logically unsound to create a rule that the process limitations of a product-by-process claim should not be enforced in some exceptional instance when the structure of the claimed product is unknown and the product can be defined only by reference to a process by which it can be made.” 566 F.3d at 1294. The majority stated that such a rule would expand the scope of patent protection beyond what the inventor specifically claimed, and it would put the Court in the questionable position of having to ascertain whether an allegedly infringing product is really the same or different from a patented product, when the patented product is described in terms of how it is made. Id. at 1294-1295.

The dissent also points to a conflict created by the majority, which seems to delineate different legal standards for validity and infringement: “According to the majority, a patentee can continue to obtain product claims using process descriptors, but such product claims are treated as process claims for infringement. The applicant would still have to demonstrate patentability of the new product as a product (independent of the process), while enforcement of the patent against an identical product would be limited to the infringer’s use of the process steps used as a descriptor. For the first time, claims are construed differently for validity and for infringement.” Id. at 1317.

The majority cites its 1985 decision in In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985), for the historical reliance upon different standards for patentability versus infringement: “Even though product-by-process claims are limited and defined by the process, determination of patentability is based on the product itself.”

The Abbott Labs Court further noted that “the inventor is absolutely free to use process steps to define this product. The patent will issue subject to the ordinary requirements of patentability. The inventor will not be denied protection. Because the inventor chose to claim the product in terms of its process, however, that definition also governs the enforcement of the bounds of the patent right. This court simply cannot ignore as verbiage the only definition supplied by the inventor.” 566 F.3d at 1294.


The Abbott Labs holding has broad implications for patent holders and applicants, patent practitioners, and those who may be accused to infringing a product-by-process claim. Patent applicants should be cautious about including any process limitations or claims directed to the product that may later open a door for infringement through a different process. Parties with pending product-by-process claims might consider whether they can and should seek additional coverage within the patent application. Finally, those who may be accused of infringement can avoid literal infringement by using a process to develop their product that is different from the one described in the original claims.

About the Author

Yuri Mikulka serves as Chair of the Intellectual Property Department of Stradling Yocca Carlson & Rauth, a law firm that represents high tech companies

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Companies Mentioned

Abbott Laboratories

Astellas Pharma, Inc.

Par Pharmaceutical

Par Pharmaceutical Companies, Inc.

Ranbaxy Laboratories, Ltd.

Ranbaxy, Inc.

Sandoz GMBH

Sandoz, Inc.

Teva Pharmaceuticals Industries, Ltd.

Teva Pharmaceuticals USA, Inc.

Also See:

MDS (Canada) Inc. v. RAD Source Technologies: 11th Circuit Finds Federal Circuit Does Not Have Exclusive Jurisdiction When Patents at Issue in Breach of Contract Claim

AMP v. Myriad Genetics, Inc.: Unanimous Supreme Court Limits Patentability of Human Genes

CLS Bank Intl. v. Alice Corp. Pty. Ltd.: En Banc Federal Circuit Cements Confusion Over Patent-Eligibility for Software

Bowman v. Monsanto Co.: Growing Patented Soybeans for Replanting is Infringement

Gunn, et al., v. Minton: Supreme Court Denies Federal Jurisdiction for Patent-Related Malpractice Suit

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Companies Mentioned

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The following companies are mentioned in Patent Law Updates:

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Microsoft Corp.

Samsung Electronics America, Inc.

Stryker Corp.

Cordis Corp.

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Smithkline Beecham Corp. (d.b.a. GlaxoSmithKline, plc.)

Johnson & Johnson, Inc.

United States Patent and Trademark Office

Honeywell International, Inc.

HT Window Fashion Corp.

Mylan Laboratories, Inc.

Mylan Pharmaceutical, Inc.

Ortho-McNeil Pharmaceutical, Inc.

Acumed, LLC

Stryker Sales Corp.

Teva Pharmaceuticals USA, Inc.

Glamourmom LLC

Audiovox Communications Corp.

Stryker Orthopaedics

Target Corp.

McKesson Information Solutions, Inc.

Howmedica Osteonics Corp.

Kohl’s Department Stores, Inc.

Bridge Medical, Inc.

J.C. Penney Company, Inc.

Smith & Nephew, Inc.

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Waters Corp.

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Ranbaxy, Inc.

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SmithKline Beecham Corp. d.b.a GlaxoSmithKline

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