T Congress has never attempted to render the pat- homas Jefferson, - PDF document

(~· 41t~- - - -.~- ,, M .- Any Port in a Storm: The Hatch- Waxman's (Ever Expanding) Safe Harbor Provision By Andrew P. Ritter T Congress has never attempted to render the pat- homas Jefferson, Benjamin Franklin, and the ent system ineffective, instead attempting to level multitude of nien and women who helped establish the United States were visionaries in the playing field for future inventors and the many ways. One of the most important of which public, even when the statutes that Congress has was to provide Congress with the power "to enacted have modified or introduced new limita- promote the Progress of Science and useful Arts, tions to address the ever-changing technological by securing for limited Times to Authors and landscape. Inventors the exclusive Right to their respective One such statute, the Drug Price Competition Writings and Discoveries." 1 While the drafters of and Patent Term Restoration Act, or the "Hatch- the Constitution likely understood that this provi- Waxman Act," was passed to address patent issues sion, a mere 27 words, would lead to many patents, related to the amendments to the Federal Food, they likely did not realize that their actions would Drug and Cosmetic Act (the FFDCA) in 1962. This help foster the incredible inventions and discoveries statute effectively granted a patent holder an addi- we have today. Additionally, while the drafters of the tional patent term while one or more third parties Constitution gave Congress the power to regulate sought regulatory approval. However, recent deci- this patent system as Congress saw fit, the Founding sions interpreting a small but important provision Fathers did not intend for certain patent holders to of the Hatch- Waxman Act have left this area oflaw have their rights stifled by future legislative, regula- unclear, potentially giving drug manufacturers free tory, or judicial proceedings. However, in the wake reign, regardless of the relevant patents. of the Federal Circuit's recent decisions in Classen The Safe Harbor provision, as codified at 35 U.S.C. § 271(e)(1) and enacted to level the play- Immunotherapies, Inc. v. Biogen IDEO and Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticafs, 3 ing field between generic drug manufacturers and the right of patent owners, having patents directed holders of patents covering the drug formula- to drugs, medical devices, and other products that tions, protects a party against patent infringement require regulatory approval under a Federal law, in limited circumstances. The statute protects a to pursue infringers has been significantly limited. party using a patented invention "solely for uses These decisions could result in a diminished eco- reasonably related to the development and submis- nomic value of such patents. sion of information under a Federal law which For more than two centuries, Congress has regulates the manufacture, use, or sale of drugs balanced this Constitutional grant. Congress has or veterinary biological products." However, in light of the Federal Circuit's decisions in Classen granted inventors the exclusive right to exclude Immunotherapies, Inc. v. Biogen !DEC and Momenta others from their invention, but only for a lim- Pharmaceuticals, Inc . v. Amphastar Pharmaceuticals , Inc., ited time, so that no one person has a long-term monopoly on a product or process. Since the the Safe Harbor provision has made it difficult first Patent Act of 1790, Congress has enacted for manufacturers and courts alike to make well- numerous legislation governing patents. However, grounded decisions in this area in the wake of the conflicting rulings. This article explores the Safe Harbor provision Andrew P. Ritter is an associate at Sughrue Mion, PLLC in and how this provision should be interpreted in the Washington, DC. His practice focuses on patent prosecution future. In doing so, the history of the FFDCA and and inter partes matters in such areas as computer systems, the Hatch- Waxman Act will be explored, as well as medical systems, and medical devices. He may be contacted at aritter@sughrue . com . related precedential court opinions, to understand Volume 26 • Number 7 • July 2014 Intellectual Property & Technology Law journal I I

Congress' motives in enacting the Safe Harbor pro- were approved for distribution in the marketJ vision and the provision's intended scope. Thus, before any drug was approved for rp.arket use, the manufacturer or distributor was required to Prior to the Hatch-Waxman Act show the safety and efficacy of the drug. While this statutory scheme created long-necessitated safety The Safe Harbor provision and the Hatch- requirements for pharmaceuticals and allowed the WaxmanAct were born from the need for additional safety and efficacy regulations in pharmaceutical FDA to regulate the drug industry, the updated drug testing, to protect the public from danger- FFDCA eventually created issues for generic drug ous and ineffective pharmaceutical drugs. While companies attempting to gain FDA approval once the FFDCA addressed this lack of governmental the patent term of a patented drug ran out. oversight, an "artificial" patent term extension was The Hatch-Waxman Act created due to the lengthy nature of the investiga- tory period. As a result, Congress enacted the Safe In the wake of the 1962 Kefauver-Harris amend- Harbor provision of the Hatch- Waxman Act. ment to the FFDCA, pharmaceutical drugs need to Prior to 1962, the FFDCA only controlled the pass safety and efficacy tests. However, these experi- labeling, contents, and safety of medications, in ments take time, sometimes years. 8 Furthermore, addition to the marketing and distribution pro- if the pharmaceutical drug was covered by a pat- cesses of medication in the United States.4 The ent, which is almost certainly the case, testing and Federal Drug Administration (FDA) had no power human experimentation could not occur until after to control the effectiveness of medications at the the term of the patent had expired. Thus, patent time. However, in 1957, the sale of a drug intend- owners with patents covering products requiring ing to alleviate morning sickness in women caused federal regulatory approval, that is, pharmaceutical Congress to realize that a more thorough examina- drugs, essentially retained an extended patent term tion of pharmaceuticals was needed prior to market of several years. This issue came to bear during approval. This examination paved the way for the patent infringement proceedings in Roche Products, regulations by which the FDA governs pharma- Inc. v. Bolar Pharmaceutical Company, Inc. ceuticals today. In 1957, the William S. Merrill Company was Roche Products, Inc. v. Bolar selling a sedative called thalidomide in Canada and Pharmaceutical Co., Inc. throughout Europe. Thalidomide was intended to Roche Products (Roche) was the assignee ofUS alleviate morning sickness in women during preg- Patent No. 3,299,053 (the '053 patent), with claims nancy. Unbeknownst to the medical community, directed to a chemical compound for flurazepam thalidomide caused birth defects in newborn babies hydrochloride, a compound used in sleeping pills. 9 or stillbirths, and thousands of children were born In 1983, Bolar Pharmaceutical Company (Bolar) with no limbs or truncated limbs.s became interested in exploring the development During this period, the Merrill Company was of a generic drug having the same properties as the attempting to gain FDA approval for thalidomide in compound claimed in the '053 patent.!O Under 35 U.S.C. § 271(a), "whoever without the United States. Thalidomide never reached the US market, however, thanks in part to the medical authority makes, uses or sells any patented inven- officer Frances Kelsey, PhD, MD, who would not . tion, within the United States during the term approve thalidomide for lack of data.& Nevertheless, of the patent therefore, infringes the patent." it was clear that the FFDCA needed to be updated Nevertheless, in 1983, bifore the expiration of the to provide the FDA with additional tools to protect '053 patent, Bolar obtained a small quantity of patients. flurazepam hydrochloride from a foreign manu- Accordingly, in 1962, Congress passed legislation facturer to begin the process of forming dosage drafted by United States Senator Estes Kefauver capsules and performing experiments to obtain the and US Representative Oren Harris, providing requisite information to submit to the FDA.ll the FDA with additional authority. These amend- Roche pursued infringement proceedings ments included, inter alia, efficacy requirements against Bolar as a result of Bolar's actions. During based on clinical studies before the medications these proceedings, Roche requested a motion I 2 Intellectual Property & Technology Law journal Volume 26 • Number 7 • July 2014 I I