Supreme Court Takes Case Involving Research Exemption to Patent Infringement

January 7, 2005. The Supreme Court granted certiorari in Merck KGaA v. Integra LifeSciences I. See, Order List [2 pages in PDF], at page 1. This is a drug patent case involving a research exemption to patent infringement. However, it is possible that the Supreme Court will issue an opinion that impacts research in other fields and technologies.

1. Introduction. The U.S. Court of Appeals (FedCir) issued a divided opinion on June 6, 2003. Judge Randall Rader wrote the opinion of the Court, strictly construing Section 271(e)(1) of the Patent Act. Judge Pauline Newman dissented in part, emphasizing the underlying purposes of patent law; she would construe the statute more broadly, and recognize a meaningful common law research exemption. See also, the Court of Appeals' December 3, 2003 errata.

Outline of Article
1. Introduction.
2. The Context of this Writ of Certiorari.
3. Facts of the Case.
4. Proceedings Below.
5. Section 271.
6. Judge Rader's Literal Application of § 271.
7. Madey v. Duke.
8. The Solicitor General and Drug Research.
9. Judge Newman's Defense of Scientific Research.
10. NAS, AIPLA, FTC, and USPTO Activity.
11. Congressional Activity on Research Exemptions.

The Supreme Court wrote in its Order List only that "The motion of Eli Lilly and Company for leave to file a brief as amicus curiae is granted. The petition for a writ of certiorari is granted. Justice O'Connor and Justice Breyer took no part in the consideration or decision of this motion and this petition." (In the absence of Rehnquist, O'Connor and Breyer, this case could be heard and decided by only six Justices.)

2. The Context of this Writ of Certiorari. This case involves 35 U.S.C. § 271 (which is altogether different from § 271 of the Communications Act). This § 271, at (e)(1), provides a narrowly worded exemption from liability for patent infringement for certain research related to certain drugs.

The research covered by § 271(e)(1) is a special case for several reasons. First, § 271(e)(1) applies only to certain research using DNA and genetic manipulation techniques -- not to all research. Second, to protect and commercialize inventions in this field requires not only obtaining patent protection, but also the time consuming and complex process of obtaining Food and Drug Administration (FDA) approval. That is, if there were no exemption from liability for infringing one patent, the inventor of the next drug might not be able to obtain FDA approval for, and bring to market, his invention until long after the expiration of the term of the first patent. Most inventors do not face this FDA hurdle.

Judge Randall, writing for the majority of the three judge panel of the Federal Circuit, wrote an opinion that simply construes the statute. He wrote that most of the use of the patents in suit fall outside of this statutory exemption.

Hypothetically, the Supreme Court, like Judge Rader, could approach this case simply as a matter of interpreting the meaning of § 271. On the other hand, the Supreme Court could take the discussion a little further, or much further.

The Office of the Solicitor General filed a brief urging the Supreme Court to grant certiorari in which it argued that the Appeals Court's opinion is contrary to the policy of promoting more new drug research. Judge Newman in her dissent argued even further, that by not recognizing a common law research exemption, the Appeals Court's opinion will reduce scientific research across a whole range of fields. Her dissent, in effect, urges the Supreme Court to recognize and identify a common law research exemption that would apply to all sciences and technologies.

The Supreme Court might, if only in dicta, engage in an analysis of the relationship of the Constitution's and the Patent Act's goals of protecting inventions, and promoting new scientific research, where that research involves use of the protected invention.

Moreover, while this case may involve how the Constitution, Congressional statutes, and the common law are interpreted, there are also many proposals to address the subject of research exemptions by statutory amendment. The National Academies and the American Intellectual Property Law Association (AIPLA) have both issued reports recommending a statutory research exemption. Also, there has long been Congressional interest in this subject. Hence, how the Supreme Court disposes of this case might impact the future of the legislative process.

3. The Facts of the Case. The plaintiffs and appellants are Integra Life Sciences I, Ltd., the Burnham Institute and Telios Pharmaceuticals, Inc. The defendants are Merck KGaA, The Scripps Research Institute, and David Cheresh. All of the patents in suit (U.S. Patent Nos. 4,988,621, 4,792,525, 5,965,997, 4,879,237, and 4,789,734) relate to a short tri-peptide segment of fibronectin having the sequence Arg-Gly-Asp, also known simply as "RGD peptide". The RGD peptide sequence promotes cell adhesion to substrates in culture and in vivo. The RGD sequence promotes this beneficial cell adhesion by interacting with avß3 receptors on cell surface proteins called integrins.

Judge Rader describes the activities of Merck in detail in his opinion. He wrote, in part, that "David Cheresh, a scientist at Scripps, discovered that blocking avß3 receptors inhibits angiogenesis, the process for generating new blood vessels. Inhibiting angiogenesis showed promise as a means to halt tumor growth by starving rapidly dividing tumor cells. Similarly, anti-angiogenic therapies might also treat diabetic retinopathy, rheumatoid arthritis, psoriasis, and inflammatory bowel disease."

Then, "Merck recognized the importance of Dr. Cheresh's discovery, and hired Scripps and Dr. Cheresh to identify potential drug candidates that might inhibit angiogenesis. Dr. Cheresh's research showed that cyclic peptide EMD 66203 displayed good inhibition of avß3 receptors. Merck then entered into an agreement with Scripps to fund the "necessary experiments to satisfy the biological bases and regulatory (FDA) requirements for the implementation of clinical trials" with EMD 66203 or a derivative thereof."

However, Integra, the owner of the patents in suit, learned of the Merck Scripps Cheresh activity, and asserted that this research infringed its patents. It offered to license the patents, but the parties failed to negotiate an agreement.

4. Proceedings Below. Integra and others filed a complaint in U.S. District Court (SDCal) against Merck and others alleging infringement of several patents. Merck asserted immunity under 35 U.S.C. § 271(e)(1). The District Court held that this provision does not immunize Merck against liability for infringement of four of the five patents in suit. Integra was awarded $15 Million as a reasonable royalty. Judge James Fitzgerald, a Senior Judge from the District of Alaska, presided. Intellectual property cases are rarely tried in the District of Alaska.

Merck appealed. The Court of Appeals affirmed on the liability issues, but reversed and remanded the award of damages as excessive, with guidance for calculating damages.

5. Section 271. 35 U.S.C. § 271(a) contains the general prohibition of patent infringement. It provides that "whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent."

Then, § 271(e)(1) provides that "It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." (Parentheses in original.)

Judge Randall Rader6. Judge Rader's Literal Application of § 271. Judge Rader (at right) is an enthusiastic proponent of patent protection. After college and law school, he went to work for the House Judiciary Committee, and then the Senate Judiciary Committee. He was then appointed to the Court of Federal Claims, and soon thereafter, to the Federal Circuit. He also teaches patent law at George Washington University Law School, and writes on patent law.

Judge Rader wrote in his opinion that the issue in this case is "whether the pre-clinical research conducted under the Scripps-Merck agreement is exempt from liability for infringement of Integra's patents under § 271(e)(1). The Scripps-Merck experiments did not supply information for submission to the United States Food and Drug Administration (FDA), but instead identified the best drug candidate to subject to future clinical testing under the FDA processes. Thus, this court must determine whether the § 271(e)(1) safe harbor reaches back down the chain of experimentation to embrace development and identification of new drugs that will, in turn, be subject to FDA approval."

After a lengthy analysis of the statute, and an application of the facts of the case to the statute, as construed, he concluded that "the language and context of the safe harbor do not embrace the Scripps-Merck general biomedical experimentation". He upheld the District Court on the issue of liability for infringement.

Rader's opinion, unlike Newman's dissent, does not mention the concept of a common law research exemption. Nor did he mention Madey v. Duke. See, discussion below.

Rader also wrote that the $15 Million damages award must be reversed, because it is unsupported by evidence in the trial court record. He offered guidance for the District Court to follow on remand. "After finding patent infringement, a jury may award a patentee ``damages adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer.´´ 35 U.S.C. § 284 (2000). Thus, an injured patentee enjoys at least a reasonable royalty even when unable to show lost profits or an established royalty rate. A reasonable royalty calculation envisions and ascertains the results of a hypothetical negotiation between the patentee and the infringer at a time before the infringing activity began." (Citations omitted.)

7. Madey v. Duke. The present case is similar to another case recently decided by the Federal Circuit, Madey v. Duke. See, October 3, 2002 opinion, which is also reported at 307 F.3d 1351. The Supreme Court denied certiorari, at 539 U.S. 958.

There are several significant differences between the Madey and Merck cases. First, the Madey case did not involve § 271(e)(1). The technology involved was lasers. Second, Madey was a dispute between a patent holding research professor, and the university that fired him. The university, Duke, continued to use his laboratory, equipment, and inventions, thus giving rise to a patent infringement action. In contrast, Integra and Merck are both corporations. Nevertheless, one issue involved in both cases is the common law research exemption.

Granting certiorari, and reversing the Court of Appeals, in Madey, would have rewarded a huge and wealthy university that treated an individual in an unseemly manner. It might also have created the appearance that the research exemption is a university privilege. The Merck case carries none of this baggage.

The Federal Circuit wrote in Madey that "the district court had an overly broad conception of the very narrow and strictly limited experimental use defense. The district court stated that the experimental use defense inoculated uses that ``were solely for research, academic, or experimental purposes,´´ and that the defense covered use that ``is made for experimental, non-profit purposes only.´´ ... Both formulations are too broad and stand in sharp contrast to our admonitions in Embrex and Roche that the experimental use defense is very narrow and strictly limited. In Embrex, we followed the teachings of Roche and Pitcairn to hold that the defense was very narrow and limited to actions performed ``for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.´´"

Judge Newman's dissent has been criticized for not following or addressing Madey. She mentioned it only in passing. However, the Supreme Court will be free to ignore, distinguish, criticize or overturn Madey.

8. The Solicitor General and Drug Research. In the present case, the Office of the Solicitor General (OSG) weighed in by filing an amicus brief urging the Supreme Court to grant certiorari, and reverse the Court of Appeals.

It wrote that "The decision of the court of appeals reflects an incorrect view of the law, and is likely to restrict significantly the development of new drugs. Fairly read, the decision below holds that ``pre-clinical´´ research regarding a potential new drug is not protected by the FDA exemption because that exemption is limited to ``clinical´´ research necessary to obtain ultimate FDA approval of a new drug. That holding is inconsistent with the text of the FDA exemption, reflects a mistaken and unduly narrow view of the types of information relevant to the FDA's two-step process for evaluating potential new drugs, and is in tension with this Court's decision in Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990). Moreover, the court of appeals' decision poses a direct and substantial threat to new drug research by dramatically narrowing the scope of protections enacted by Congress in Section 271(e)(1)."

The OSG continued that "The policy concerns animating the FDA exemption also counsel against limiting the exemption to clinical research. As this Court explained in Medtronic, 496 U.S. at 670, Congress enacted the FDA exemption because ``the combined effect of the patent laws and the premarket regulatory approval requirement was to create an effective extension of the patent term´´ by preventing competitors from undertaking tests necessary to obtain FDA approval until after a patent expired. Congress intended the FDA exemption to eliminate that delay by ``allow[ing] competitors, prior to the expiration of a patent, to engage in otherwise infringing activities necessary to obtain regulatory approval.´´"

It added that "permitting research involving the patented invention to occur prior to the expiration of respondents' patent would facilitate the marketing of a promising cancer-fighting drug to the public as soon as the patent expires" and that "the legal conclusion embraced by the Federal Circuit is likely to reduce the amount of socially valuable and necessary pre-clinical new drug research."

Finally, the OSG wrote that "Although the patent system provides important incentives for innovation, pre-clinical research into investigational new drugs is of tremendous importance to the public health, and the decision below so substantially shrinks the FDA exemption that it cannot help but impede such research. Under the Federal Circuit's decision, a manufacturer aware of a promising new cure involving a patented invention could not undertake the pre-clinical studies needed to secure FDA permission to conduct clinical studies, which in turn are required for FDA approval of a new drug. That cramped reading deprives Section 271(e)(1) of much of its value, and effectively extends the terms of such patents well beyond their expiration dates, frustrating a key purpose of the 1984 Act."

9. Judge Newman's Defense of Scientific Research. Judge Newman obtained a doctorate in chemistry, and worked as a research scientist for industry, before going to law school and becoming an in house patent attorney for her employer. Perhaps it is this background that gives her a different perspective from Judge Rader on research exemptions.

She began her dissent with the statement that "This case raises a question of the nature and application of the common law research exemption, an exemption from infringement that arose in judge-made law almost two centuries ago, and that recently has come into sharper focus. Its correct treatment can affect research institutions, research-dependent industry, and scientific progress."

She concluded that "The purpose of a patent system is not only to provide a financial incentive to create new knowledge and bring it to public benefit through new products; it also serves to add to the body of published scientific/technologic knowledge. The requirement of disclosure of the details of patented inventions facilitates further knowledge and understanding of what was done by the patentee, and may lead to further technologic advance. The right to conduct research to achieve such knowledge need not, and should not, await expiration of the patent. That is not the law, and it would be a practice impossible to administer. Yet today the court disapproves and essentially eliminates the common law research exemption. This change of law is ill-suited to today's research-founded, technology-based economy."

10. NAS, AIPLA, FTC, and USPTO Recommendations and Workshops. The debate over the proper scope of exemption from liability for infringement is not limited to legal cases in the courts. This topic has captured the attention of major policy advocacy groups, including the National Academies and the American Intellectual Property Law Association (AIPLA), and executive branch agencies, including the Federal Trade Commission (FTC) and the U.S. Patent and Trademark Office (USPTO).

The National Academies' Board on Science, Technology, and Economic Policy (STEP) issued a report titled "A Patent System for the 21st Century". It contains numerous recommendations, including one to expand the range of protection from liability for infringement for research activities.

The STEP report made the following recommendation, after the 2002 Madey opinion. "In light of the Federal Circuit's 2002 ruling that even noncommercial scientific research conducted in a university enjoys no protection from patent infringement liability and in view of the degree to which the academic research community especially has proceeded with their work in the belief that such an exception existed, there should be limited protection for some research uses of patented inventions. Congress should consider appropriate targeted legislation, but reaching agreement on how this should be done will take time. In the meantime the Office of Management and Budget and the federal government agencies sponsoring research should consider extending 'authorization and consent' to those conducting federally supported research. This action would not limit the rights of the patent holder, but it would shift infringement liability to the government. It would have the additional benefit of putting federally sponsored research in state and private universities on the same legal footing. A recent Supreme Court ruling shielded state universities from damage awards in patent infringement suits."

The AIPLA then issued its report [49 pages in PDF] titled "AIPLA Response to the National Academies Report entitled ``A Patent System for the 21st Century´´".

It wrote that it "agrees with the recommendation of the NAS Report that Congress act to exempt certain experimentation on patented inventions from liability for patent infringement. However, the NAS Report’s proposal for ``liability shifting´´ as an alternative -- if Congressional action on an exemption is not forthcoming -- represents neither a feasible nor a desirable alternative."

"Some exemption for experimentation on patented inventions must be part and parcel of an effectively functioning patent system." The AIPLA report continued that "The exemption is inherent to a properly functioning patent system at least where experimentation is required to understand what is patented, whether the patent is valid, what basic properties or characteristics the patented invention might have, and to improve upon the invention. In brief, a patent system operates in an appropriate and balanced fashion when what is patented is reserved for the inventor to exclusively commercialize and given to the public to both further examine and improve upon. The inventor need not be denied the former when the public has a limited exemption to accomplish the latter."

The AIPLA report adds that the AIPLA "is endeavoring to craft a narrow, statutory exemption for experimental use for a patent invention that would not impinge upon an inventor’s exclusive right to commercialization, but would open the way for an appropriate range of experimentation on the patented invention."

On October 28, 2003, the FTC released a report titled "To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy". See, Executive Summary [18 pages in PDF] and Report [2.28 MB in PDF]. However, the FTC did not make any recommendation, in this report, regarding exemptions from liability for infringement via research activities. Susan DeSanti was the primary author of this report. See also, story titled "FTC Releases Report on Competition and Patent Law" in TLJ Daily E-Mail Alert No. 768, October 29, 2003.

The FTC, along with the National Academies' Board on Science, Technology, and Economic Policy (STEP), and the American Intellectual Property Law Association (AIPLA) will jointly host a series of public meetings in San Jose, Chicago, Boston, and Washington DC regarding patent reform. See, FTC's notice and agenda [PDF], and story titled "FTC, AIPLA, and National Academies to Host Series of Public Meetings on Patent Reform" in TLJ Daily E-Mail Alert No. 1,043, December 23, 2004. The agenda includes discussion of the research exemption.

Also, the AIPLA held an annual meeting in Washington DC on October 14-16, 2004. On Friday, October 15, there was a half day panel discussion on various proposals for patent reform. The participants included Judge Rader, the FTC's DeSanti, NAS's Steve Merrill, the USPTO's John Whealan, and 3M's Gary Griswold (who spoke for the AIPLA). There was an audience of hundreds. The debate was, at times, spirited.

The NAS proposal for a statutory research exemption was discussed at the AIPLA program.

Judge Rader trashed the proposal. He proclaimed that "there have been five cases in the history of the Republic on the common law research exception". Thus, "it is not a real problem".

He explained why this is a non-issue. When someone infringes a patent for research purposes, but does not commercialize the patent, there is no injury to the patent holder. Hence, the patent holder has little incentive to file a lawsuit, and there are therefore very few lawsuits against researchers. Said Rader, "there is nothing worth pursuing".

In his Merck opinion, Rader recognized no common law research exemption, and narrowly construed § 271(e)(1), but threw out the damages award as excessive.

Rader further criticized the proposals to seek Congressional legislation. Rader, who worked for both the House and Senate Judiciary Committees, said that he opposes "turning Congress loose on a non-problem".

Steve Merrill of the NAS's National Research Council spoke in support of the proposal. While in the Merck case the lead defendant is a corporation, Merrill advocated creating a research exemption as a protection for universities. He said that research universities are receiving patent assertions from patent holders, and demands for licensing fees. He claimed that when this happens, research universities "tend to stop the research".

However, he conceded that they face little risk of patent litigation. Rather, they face the threat of patent "assertions".

The USPTO's Whealan said that universities and companies both own and enforce patents, and both conduct research. Hence, he questioned why they should be treated differently

However, Merrill did not stop here. He continued by associating 11th Amendment immunity with the proposal to create a statutory research exemption. The problem, said Merrill, is that while the Supreme Court held the states (and state universities) have 11th Amendment immunity from liability for damages in intellectual property cases, private universities enjoy no such immunity. He said that he wants to put private universities "on the same footing" as state universities.

Pursuant to some recent opinions of the Supreme Court interpreting the 11th Amendment of the U.S. Constitution, states have sovereign immunity in state and federal courts against money damages suits for intellectual property infringements. Of course, states remain free to sue for damages for infringement of their patents and copyrights.

See, the opinions of the Supreme Court in Seminole Tribe of Florida v. Florida, holding that the Congress lacks authority under Article I of the Constitution to abrogate the States' 11th Amendment immunity from suit in federal courts, Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank, invalidating the Patent and Plant Variety Protection Remedy Clarification Act, and College Savings Bank v. Florida Prepaid Postsecondary Education Expense Board, invalidating the Trademark Remedy Clarification Act.

The Congress cannot by legislation overturn a Supreme Court decision interpreting the Constitution. Hence, one of the approaches of proposed legislation is to give states an incentive to waive 11th Amendment immunity, for example, by eliminating any damages remedy for infringement of state owned intellectual property unless the state has waived its immunity in federal suits for infringement of privately owned intellectual property.

See, for example, stories titled "Legislators Introduce Bills to Address Infringement by States" in TLJ Daily E-Mail Alert No. 302, November 6, 2001; "Sen. Leahy Reintroduces Bill to Close 11th Amendment Loophole to IPR" in TLJ Daily E-Mail Alert No. 394, March 22, 2002; "Senate Judiciary Committee Considers Federalism and Intellectual Property" in TLJ Daily E-Mail Alert No. 522, October 3, 2002; and "Legislators Re-Introduce Bills to Address State IPR Sovereign Immunity" in TLJ Daily E-Mail Alert No. 680, June 13, 2003.

There have long been serious efforts to pass legislation to address the situation created by Florida Prepaid. Although, the efforts have not been directed towards extending the immunity to all universities, as recommended by Steve Merrill. Rather, the effort has focused on undoing Florida Prepaid. It takes considerable support to enact a bill. It takes less support to block a bill. Intellectual property owners (not including states) have been pursuing an offensive strategy of trying to pass legislation to undue Florida Prepaid. The state university lobby, lacking sufficient support to enact legislation, has been playing a defensive strategy.

One of the biggest financial beneficiaries of this 11th Amendment immunity is the California university system. Sen. Dianne Feinstein (D-CA) is a senior member of the Senate Judiciary Committee, and has been successful to date in stopping the Committee from approving legislation to undue Florida Prepaid.

At the AIPLA convention, some members of the audience, especially in house counsel for biotech companies, became livid when Merrill advocated both creating a statutory research university exemption, and extending 11th Amendment immunity to all universities. One person, Paul Lunn, patent counsel at NASTECH, said that universities and companies should not be treated differently because both do research. He made Whealan's point, but with more aggression and volume. He said that universities collaborate with companies. Universities commercialize inventions. And, he snorted, "these people are out to make a lot money".

Many of the participants in the October AIPLA panel discussion will also be participants in the upcoming series of workshops, including DeSanti and Merrill. Also, while the research exemption proposal is on the agenda for the San Jose, Chicago, and Boston meetings, the panels appear to be stacked with supporters of some form of statutory research exemption. Judge Rader is not listed on the agenda.

11. Congressional Activity on Research Exemptions. While the NAS and AIPLA just recently issued reports advocating a statutory research exemption to patent infringement, this issue has been around on Capitol Hill for a long time. For example, 15 years ago, the House considered, but did not enact, a provision that would have codified a research exemption in the Patent Act.

The bill was HR 5598 in 101st Congress, titled the "Patent Competitiveness and Technological Innovation Act of 1990". It was introduced on September 12, 1990, and promptly approved by the House Courts and Intellectual Property Subcommittee, and then by the full House Judiciary Committee. The full House took no action. None of its sponsors continue to serve in the House.

This was a composite bill. Title IV of the bill was titled "Research, Experimentation, and Competitiveness Act of 1990". It would have amended 35 U.S.C. § 271 by adding a new subsection 271(j) containing an exemption for certain research. The key language was as follows:

"It shall not be an act of infringement to make or use a patented invention solely for research or experimentation purposes unless the patented invention has a primary purpose of research or experimentation. If the patented invention has a primary purpose of research or experimentation, it shall not be an act of infringement to manufacture or use such invention to study, evaluate, or characterize such invention or to create a product outside the scope of the patent covering such invention. This subsection does not apply to a patented invention to which subsection (e)(1) applies."

It is perhaps also pertinent that the Congress addressed research exemptions in the copyright protection measure anti-circumvention provisions of the Digital Millennium Copyright Act (DMCA).

Currently, § 1201(a)(1)(A) of the Copyright Act, which was added in 1998 by the DMCA, provides that "No person shall circumvent a technological measure that effectively controls access to a work protected under this title."

Then, § 1201(a)(2)(A) provides that "No person shall manufacture, import, offer to the public, provide, or otherwise traffic in any technology, product, service, device, component, or part thereof, that --- (A) is primarily designed or produced for the purpose of circumventing a technological measure that effectively controls access to a work protected under this title;"

Furthermore, § 1201(b)(1)(A) provides that "No person shall manufacture, import, offer to the public, provide, or otherwise traffic in any technology, product, service, device, component, or part thereof, that --- (A) is primarily designed or produced for the purpose of circumventing protection afforded by a technological measure that effectively protects a right of a copyright owner under this title in a work or a portion thereof;"

To the extent that both § 1201 and the Patent Act give certain persons a cause of action to exclude certain other persons from using certain technologies, § 1201 bears some conceptual similarity to patent protection. And hence, it should therefore not be surprising that § 1201, like § 271, contains a research exemption, and moreover, that the appropriate scope of this research exemption remains a matter of current controversy.

For example, Rep. Rick Boucher (D-VA) and Rep. John Doolittle (R-CA) introduced bills in both the 107th and 108th Congresses that would add to both § 1201(a)(2)(A) and § 1201(b)(1)(A) an exception for when "the person is acting solely in furtherance of scientific research into technological protection measures".

See, stories titled "Reps. Boucher and Doolittle Introduce Digital Media Consumer Rights Act" and "Summary of the Digital Media Consumer Rights Act" in TLJ Daily E-Mail Alert No. 532, October 4, 2002; and story titled "Reps. Boucher and Doolittle Introduce Digital Fair Use Bill" in TLJ Daily E-Mail Alert No. 582, January 14, 2003. This bill was titled the "Digital Media Consumer Rights Act". It was HR 5544 in the 107th Congress, and HR 107 [10 pages in PDF] in the 108th Congress. No version of this bill has been approved by the House. The entertainment industries especially oppose it.

And finally, it should also be noted that exemptions for research, as well as for education and library activities, are frequently advocated in both copyright and patent contexts. The Copyright Term Extension Act (CTEA) includes a provision providing a limited exemption for research. Similarly, the CREATE Act, enacted late last year, contains no research exemption, but does seek to promote research by removing an impediment in patent law to collaborative research.