D. Alan White, the Doctrine of Equivalents: Fairness and Uncertainty in an Era of Biologic Pharmaceuticals

• Publication year: 2011

THE DOCTRINE OF EQUIVALENTS: FAIRNESS AND UNCERTAINTY IN AN ERA OF BIOLOGIC PHARMACEUTICALS

ABSTRACT

Research in the rapidly developing area of biologic pharmaceuticals promises to improve the lives of millions of patients suffering from disorders that were, until very recently, untreatable. The staggering potential market for such treatments has attracted enormous investment from the pharmaceutical industry, with a concomitant increase in related patent disputes. This investment, coupled with proposed legislation that would pave the way for the creation of "follow-on" biologic treatments via a statutory pathway similar to the one created for generic pharmaceuticals by the Hatch-Waxman legislation of the early 1980s, should ensure that the number of patent disputes involving biologic pharmaceuticals will continue to rise dramatically in the coming years.

This Comment focuses on the patent law concept known as the doctrine of equivalents, and observes that the very complexity that makes biologic pharmaceuticals so valuable for treating previously untreatable disorders also creates difficulties in the field of patent law, particularly when the doctrine of equivalents is involved. This Comment notes that there is considerable evidence that juries have difficulty dealing with cases involving technologically advanced subject matter of the type that is often at issue in biologics cases, and discusses illustrative cases involving the doctrine of equivalents. This Comment also argues that the doctrine of equivalents increases the uncertainty of the scope of biologic patents. This uncertainty has the potential to chill vital biologics innovation in a way that often cannot be overcome by such remedies as cross-licensing. Finally, this Comment proposes solutions to these problems, including the judicious application of legal limitations on the doctrine of equivalents in biologics cases, the impaneling of expert juries that are able to better understand the complex issues involved in such cases, and the denial of injunctive relief in biologics cases where infringement is found under the doctrine of equivalents.

INTRODUCTION .............................................................................................. 753

I. PATENTS, INFRINGEMENT, AND THE DOCTRINE OF EQUIVALENTS ..... 756

II. BIOLOGICS AND THE DOCTRINE OF EQUIVALENTS: TWO

ILLUSTRATIVE CASES ......................................................................... 761

III. FURTHER ANALYZING THE DIFFICULTIES INHERENT IN APPLYING

THE DOCTRINE OF EQUIVALENTS TO BIOLOGICS CASES .................... 767

A. Juries Are Likely to Have Difficulty Resolving Cases Dealing with Biologics ............................................................................. 768

B. The Doctrine of Equivalents Chills Innovations in the

Biologics Arena .......................................................................... 771

C. Licensing Is Not an Acceptable Solution .................................... 775

IV. ENSURING PROPER APPLICATION OF THE DOCTRINE OF

EQUIVALENTS IN BIOLOGICS CASES ................................................... 777

A. Legal Limitations on the Doctrine of Equivalents ...................... 779

1. Prosecution History Estoppel ............................................... 780

2. The All Limitations Rule ....................................................... 783

B. Breaking the "Black Box"-Expert Juries ................................. 785

C. Denying Preliminary Injunctions as a Remedy in Biologics

Cases Involving the Doctrine of Equivalents ............................. 789

CONCLUSION .................................................................................................. 794

INTRODUCTION

Recently, at a local hospital, a patient consulted with her doctor about a problem with her vision. This patient was most likely in her fifties or sixties, and complained of symptoms such as difficulty reading before bed, trouble adjusting to dim light after entering a room from the outside, an inability to perceive fine detail, and blurring of her central visual fields.¹Her symptoms were classic indicators of age-related macular degeneration (AMD), a progressive blinding disease that is the leading cause of blindness in individuals fifty years and older, the primary blinding disorder in developed countries, and the third leading cause of blindness worldwide.²As recently as

2007, her physician would have had few treatment options to offer.³Today, however, her physician is able to prescribe a simple series of monthly injections that may not only prevent her vision loss, but could actually improve her visual acuity.⁴

The vision of this patient, and thousands of others like her, is being preserved by a drug called Lucentis, which the Food and Drug Administration (FDA) approved for treatment of AMD in 1996.⁵To date, Lucentis is the most effective treatment for AMD and is also one of the more expensive medicines on the market, costing around $1,950 per treatment.⁶Lucentis is not a traditional chemical pharmaceutical, but rather a fragment of a humanized antibody, which when injected into the eye inhibits the action of a protein responsible for the formation of new blood vessels.⁷As such, Lucentis represents a very successful example of a relatively new class of pharmaceuticals called biologics, which the FDA defines as comprising "a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins."⁸Sales of biologics totaled around $80 billion in 2008, accounting for more than 10% of global pharmaceutical sales.⁹Recognizing the growth and importance of this class of pharmaceuticals,¹⁰Congress recently passed the Biologics Price Competition and Innovation Act of 2009,¹¹which is intended to facilitate the development of generic, or "follow-on," biologics,¹²in much the same way that the Hatch-Waxman Act of 1982 led to the widespread availability of generic versions of brand-name pharmaceuticals.¹³

The popularity of biologic pharmaceuticals, as well as incentives present in the Patient Protection and Affordable Care Act, should encourage the development of generic follow-on versions of pioneer biologics; accordingly, the future will likely see increased litigation over the patent rights protecting biologic pharmaceuticals.¹⁴As a result, courts will be forced to resolve questions of validity and infringement with respect to patents involving rapidly evolving, cutting-edge therapeutics, and may be hard-pressed to apply traditional doctrines of patent law to such a novel and complex class of technology. One such traditional doctrine of patent law is the doctrine of equivalents.

This Comment argues that the doctrine of equivalents substantially broadens patent scope when applied to disputes involving biologics patents, which could chill innovation in an area of vital interest to the public. Part I of this Comment provides a brief description of patent law concepts, with particular attention to the historical development of the doctrine of equivalents. Part II explores the difficulties that can be encountered when courts attempt to apply the doctrine of equivalents in a biologics context, and briefly discusses two recent cases that illustrate these difficulties. Part III argues that application of the doctrine in such situations should be limited for two reasons: first, because juries have difficulty deciding technologically complex cases, and second, because the uncertainty inherent in the doctrine's application exerts a chilling effect upon biologics innovation, which cannot be effectively addressed through remedies such as cross-licensing. Finally, Part IV of this Comment explores several proposals for limiting the use of the doctrine of equivalents to overly broaden biologics patent rights, including legal limitations on the doctrine, the use of specialized juries to aid in resolving technologically complex biologics cases, and the denial of injunctions (thus mandating compulsory licenses) as a remedy for infringement in biologics cases involving the doctrine of equivalents.

I. PATENTS, INFRINGEMENT, AND THE DOCTRINE OF EQUIVALENTS

Patents exist to provide an incentive for inventors to innovate.¹⁵This incentive comes in the form of a limited monopoly that allows the patentee to prevent others from engaging in certain uses of the patented invention.¹⁶In return for this monopoly, the patent holder must make the details of the invention public, allowing others to study its workings and (hopefully) use the knowledge gained to develop further innovations.¹⁷Patents may therefore be understood as a delicately balanced set of rights in which a patentee is granted the "right to exclude" others from certain uses of her invention,¹⁸but only to the extent that this encourages the spread of new ideas and inventions to the public as a whole.¹⁹This Part begins by briefly reviewing basic patent law concepts and continues on to a more specific discussion of the doctrine of equivalents and its history.

In the United States, a patent consists of a written specification describing the patented invention followed by a list of claims delineating specific elements of the invention that the inventor desires to patent.²⁰Patents do not grant the patent holder a positive right to practice the invention, but rather the right to exclude others from making, using, selling, offering to sell, or importing the patented invention.²¹A patent holder who believes that another party has violated the rights described above may, among other things, initiate legal proceedings against that party with an infringement action.²²If successful, such an action can result in a court order enjoining the infringing party from practicing the patented invention, an award of damages payable by the infringing party to the patent holder, or both.²³In defending against an action for infringement, the accused infringer will...