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Dreyfuss, Rochelle Cooper --- "Implications of the DNA Patenting Dispute: A US Response to Dianne Nicol" [2012] JlLawInfoSci 18; (2012) 22(1) Journal of Law, Information and Science 1

Implications of the DNA Patenting Dispute: A US Response to Dianne Nicol


1 Introduction

Researchers and physicians in the United States have their backs against the wall. Increasingly, fundamental research inputs and medical outputs are patented, yet the traditional tools for balancing public and private interests are largely broken. The basic research defence was gutted by the Court of Appeals for the Federal Circuit;[1] that court has, at times, also limited standing to challenge patent validity.[2] US law does not include compulsory licensing provisions that might prevent patentees from withholding permission to use their inventions.[3] At one time, the patent misuse doctrine may have compensated for that omission. However, it too has been largely eliminated.[4] For its part, the Supreme Court has never adopted an essential facilities doctrine.[5] Indeed, it has decided that monopolists have a right to refuse to deal, making antitrust law equally unavailable to safeguard access interests.[6] And while the Supreme Court has suggested that public-regarding uses may not be the subject of injunctive relief,[7] “doing equity” at the end of an infringement suit is no way to assure researchers at the outset of their projects that they will remain free to complete and use their work.

It is no wonder, then, that subject matter challenges have been on the upswing in US courts. Cases like AMP v USPTO — the so-called Myriad case which challenges the patentability of isolated DNA and DNA diagnostic and screening methods — are symptoms of a disease: attacks on patentable subject matter appear to be the only avenue left for protecting the viability of upstream research and its efficient translation into downstream products. Thus, while scholars in other countries are heavily focused on the specific question of whether patents on DNA have a detrimental impact on life sciences research, the interest in defining patentable subject matter in the United States extends to a broader range of fields — witness Bilski v Kappos and In re Comiskey (on business methods),[8] WildTangent v Ultramercial[9] (on internet systems), and In re Nuijten[10] (on electronic signalling). The culmination of that trend (so far) came in 2012, when the Supreme Court decided Mayo v Prometheus, a case involving the relationship between the therapeutically appropriate dose of a drug and the blood level of a metabolite the drug produced. Holding that claims to laws of nature are not patentable if they add no more to the art than “well-understood, routine, conventional activity previously engaged in by scientists in the field,” the Court raised the possibility that many other fundamental advances do not constitute statutory subject matter either.[11] And although the decision in Mayo did not alter the Federal Circuit’s view in Myriad that isolated DNA sequences are patentable, the Supreme Court recently granted certiorari to review that question. Needless to say, the biotechnology community, along with computer scientists and the financial services industries are now in a “minor panic.”[12]

Given that context, Dianne Nicol’s essay, Implications of DNA Patenting: Reviewing the Evidence,[13] raises particularly apt questions for observers of US patent law. In it she asks whether efforts should continue to be spent on the subject matter issue or whether the legal system ought to consider other ways to ease the blockage problems that upstream patents can create. Notably, the US tax bar has successfully dealt with its scepticism regarding patents on tax avoidance schemes by convincing Congress to enact a provision deeming all tax strategies within the prior art.[14] Taxpayers are thus placed on a level playing field while messy decisions on what is too abstract to patent are avoided. Additional — hopefully, more nuanced — techniques for protecting public interests would eliminate the need to continually struggle with metaphysical questions concerning the difference between “discovery” and “invention” or “law of nature” and its “application.”

I begin with an underlying contention in Nicol’s essay: that the problem posed by gene patents is transient. I then move on to discuss the evidence that these patents are not problematic, focusing especially on whether the evidence she cites can be generalised to the United States. I look at the public-interest safeguards that existed when Judge Learned Hand decided Parke-Davis v Mulford,[15] the seminal case holding isolated natural products patentable, and then consider how these doctrines might be revived and modernised.

2 Is the Patent Problem Transient?

The Nicol essay makes three principal points: that gene patents are necessary to the biotechnology industry; that there is little evidence they have harmed either research or consumer access; and that even if there once was a problem, it is diminishing over time. I begin with the third contention: that DNA patenting is disappearing. I do not quarrel with the observation. DNA isolation and sequencing, along with translating protein sequence information into DNA coding information, have become so straightforward that it is unlikely that new DNA molecules will be considered nonobvious (inventive) enough to patent.[16] Furthermore, it is likely that as new sequencing techniques develop, it will be possible to sequence the genome without isolating DNA or literally infringing the patents covering the sequenced material.[17]

Patents on isolated DNA are, however, only the tip of the iceberg. “Gene patents” include a broad array of advances. Some product patents are framed so broadly, US courts may regard them as infringed even by sequencing techniques that do not require isolation.[18] And certainly, if isolated DNA were claimed as a therapy (for example, as inserted into a vector for delivery), the product would be considered inventive enough to patent. More important, many gene patents cover processes, not products. Some are for methods for screening potential therapeutics or for using genetic material therapeutically. These techniques are likely to involve novel materials and new methodologies. Accordingly, they too are probably inventive enough to patent. (And even after Mayo, they are likely to constitute patentable subject matter.[19]) Finally, some patents claim methods for diagnosing vulnerabilities to disease. Very simple associations that disclose previously unknown relationships (such as Myriad’s claimed relationships between BRCA mutations and early-onset breast cancer) are inventive enough to patent (although after Mayo, they may no longer be patentable subject matter). Furthermore, even after Mayo, there is likely ample room for patents on more complex diagnostics.

Consider, for example, companion diagnostics.[20] These are methods for diagnosing whether a pharmaceutical product (such as a cancer therapy) will be safe or effective for patients with particular genetic endowments. Developing a companion diagnostic is expensive: firms must engage in drug trials to find the patients who are harmed or especially benefitted by the drug, search for the genes and mutations that cause the observed variance, and scale-up diagnostic methods for testing the relevant patients. Once the companion test is developed, further clinical trials on the drug will likely be required by regulatory authorities in order to gain marketing clearance. Patents may not be needed to encourage the development of diagnostics that identify patients for whom a drug is safe. These are their own reward, for they enable a manufacturer to sell a product that might otherwise be rejected on the ground that it harms a significant portion of the population. However, identifying patients for whom the drug is ineffective could reduce the size of the pharmaceutical firm’s market. Without a patent (and perhaps, a mandate by government regulators), there may be little incentive to develop these tests.

Patents on companion diagnostics will, however, raise significant questions concerning access for both researchers and patients. At present, there is considerable competition to find new treatments for disease. But once a companion diagnostic is developed for one treatment, the patent on that diagnostic could prevent other firms from working on the same condition. After all, these firms will need to differentiate among the same sets of patients; the diagnostic essentially operates as a research tool — a screening technique for finding effective and safe therapies. The patent will, in essence, create an exclusive innovation opportunity for the firm that finds the first drug and develops its companion diagnostic.

These patents will also create access problems. Presumably, drug companies will be forced to offer the diagnostic in cases where the issue is safety (otherwise the drug would not have been approved). But pharmaceutical companies will have a strong incentive to charge high prices for tests that identify patients for whom the drug is not efficacious because the identification will shrink the market. They may also seek to retain control over such testing by doing it themselves or licensing the patent to a single provider. As the US Secretary of Health and Human Service’s Advisory Committee on Genetics, Health and Society (SACGHS) found, sole source providers often do not have dealings with all insurers, leaving some patients to fend for themselves; patients that can barely afford the therapy may not be able to find the resources to pay for a test to determine its efficacy.[21] And yet these patents are likely valid. The work to develop them is complicated, the output is novel, and the diagnostics will be claimed, like the presumptively valid patents in Myriad, as screens for new treatments.

As important, information about the coding regions of genes does not signify the end of scientific advancement in the life sciences. While genes may play a special role in the public’s imagination and therefore generate the most controversy, there are many other biological products on the horizon. As Nicol notes, it is becoming increasingly clear that non-protein-coding regions play an important role in regulating gene function.[22] There is also much more to be learned about the structural aspects of proteins (such as the dimensions of the spaces where possibly therapeutic molecules can fit), about RNA, and about disease pathways. These developments are critical to drug development and it is not at all clear that finding these products will be too uninventive to support patenting.[23] But like the current crop of gene patents, exclusivity will be a problem because, as with DNA, there is no way to invent around this information.

3 What Can be Concluded from the Evidence?

Professor Nicol’s second point is that even if patents continue to issue, there is no reason for concern as there is little evidence that DNA patents have impeded either research or consumer access. In support of this proposition, she cites her own work on the landscape in Australia[24] as well as research by groups in Belgium and the United Kingdom.[25]

To properly evaluate this evidence, however, it must be assessed against the background rules in which the patent system operates. To take the example of the European Union, there are several ways in which patent holders there are severely constrained. Most European countries have exemptions that excuse upstream research from patent infringement liability.[26] Some of these countries also limit the scope of patents to the utility recited in the patent application; other uses fall into the public domain.[27] Several EU countries’ patent laws include the possibility of awarding compulsory licenses when patent holders interpose obstacles to access.[28] These licensing provisions are rarely invoked, but they can have significant in terrorem effects. The Court of Justice of the European Union (CJEU) has also played an important role in regulating the power of right holders. In Monsanto v Cefetra, the CJEU held that gene patents are infringed only when the gene is performing its function.[29] And in the Magill case, the Court denied a right holder who lacked business justification the power to refuse to license to a party who would bring to market a product consumers desire.[30] It is no wonder, then, that observers of the scene in the United Kingdom and Belgium would not find significant problems. To be sure, Australia has lacked a research exemption,[31] and it may be unclear whether refusals to deal constitute misuses of market power,[32] but at least there are no cases like the United States’ Madey v Duke,[33] and Verizon v Trinko,[34] which make it explicit that there is no common law research exemption or any control over refusals to deal. The clarity of these rules makes compromise and workarounds in the US context much less likely.[35]

Of course, not all Nicol’s evidence comes from Europe or Australia. She draws her conclusions, in part, from the absence of significant litigation over the validity of gene patents in the United States and from empirical work conducted by Wesley Cohen and his co-authors on US scientists.[36] But as she herself notes, the evidence is hardly unambiguous. Thus, other factors may account for the absence of litigation. As noted above, the Federal Circuit’s standing jurisprudence has been parsimonious in the extreme. Originally, the court granted only litigants who had an objectively reasonable apprehension of suit the authority to challenge patent validity.[37] While the Supreme Court has attempted to expand standing doctrine in patent suits, the Federal Circuit has largely stuck to its guns.[38] Since only those who are using a patent can be sued, standing is, in effect, largely limited to competitors — that is, to litigants who would not want to eliminate from patentability a category that includes their own assets. The result is that validity suits are unlikely when a field is at its inception and the application of patent law to the facts is unpredictable.[39] The effect of the standing doctrine is exacerbated by opinions such as Judge Moore’s in the Myriad case, where she held certain of the challenged DNA sequences patentable largely because such patents had been granted for a long time and the industry now enjoyed “settled expectations and extensive property rights.”[40]

At this juncture, it is also not clear what litigants would sue about: there is currently a lull in pharmaceutical productivity.[41] Until there are ways to translate the advances in the science of biotechnology into products, patent holders may be very happy to let researchers infringe, in the hope that the infringers will find therapies (or methods for developing them). Once that occurs, the litigation picture could change dramatically. While research uses are difficult to price, courts can be expected to be rather generous when asked to remedy infringement that produced a highly valuable product.

Wes Cohen’s work also bears careful scrutiny.[42] Much of the information was gleaned from surveys of academic biomedical researchers, who were asked whether they experienced delays on account of patent licensing problems.[43] Most said no. It is unclear, however, whether the interviewees were bench scientists or the heads of laboratories. The latter juggle many projects simultaneously and may not be fully aware when specific work is obstructed. And to the extent they said no because they had, as the authors claim, developed a norm of ignoring patents, that should be worrisome to anyone who takes the rule of law seriously (or thinks that patent holders are simply waiting for products to develop before they sue).

In addition, it is worth noting that many of Cohen’s interviewees complained about how long it took to negotiate material transfer agreements (MTAs). The authors saw withholding materials as another avenue for appropriating the benefits of research, and hence as substitutes for patents. They therefore concluded that patents have little impact on research. However, the difficulty in negotiating MTAs is often caused by fights over the allocation of patent rights in the research output.[44] Thus, the MTA issue may, in fact, be a proxy for a patent problem. Most important, while Cohen’s work generally stands for the proposition that patents can be worked around (or ignored), the authors were careful to state that clinical diagnostic research, including genetic research, is an exception to the general rule.[45]

There is another difficulty with survey evidence: certain types of information may never be reported. For example, behind closed doors, geneticists will describe a diagnostics underground: laboratories (usually in universities) that provide second opinions when a patient’s medical history contradicts the results of a test conducted by a commercial sole source provider. Underground labs often find systemic problems with the commercial tests — and their work can even lead the provider to alter its procedures. These efforts do, however, infringe patents. Accordingly, the underground does not publish its findings, making the work almost impossible to document.[46]

Significantly, non-survey evidence supports the notion that exclusivity is a problem both upstream and downstream. In a series of citation studies, Fiona Murray and co-authors demonstrated that researchers are less likely to do work in a particular area after significant findings are patented and, conversely, that more researchers come into a field and conduct more varied research after significant patented inputs become generally available.[47] At the downstream end, Heidi Williams studied databases subject to exclusive rights. She found that, relative to information in the public domain, the data in the protected databases were less often translated into products and that the effect persisted even after the material became freely available.[48]

4 Policy Implications

In passing, Professor Nicol suggests that neither side can sustain the burden of proving the impact of gene patenting.[49] But the same would be true on the question of whether patents are necessary. There are many other incentives to innovate, especially in the biological realm where so much of the work is accomplished in academia or medical offices and motivated by curiosity or the desire to help patients. Still, I will accept Professor Nicol’s third contention, that the biotechnology industry is heavily reliant on patenting. Indeed, gene patenting was founded on exactly that premise. By virtually all accounts, Learned Hand’s 1911 opinion in Parke-Davis, which upheld a patent on purified adrenaline, was the basis for finding isolated DNA to constitute patentable subject matter.[50] At least one observer has suggested that Hand’s decision was “profoundly incorrect,” arguing that it conflicted with earlier cases holding the results of extraction, purification, and isolation to be unpatentable products of nature.[51] Hand, however, was a quintessential legal pragmatist. As recounted by Graham Dutfield, at around the time of the decision, the US chemical sector was at a crossroads. Germany excelled in synthesis; the United States’ comparative advantage lay in isolation and purification. Because the resulting substances could be easily reverse engineered, patent protection was essential. By holding that purified adrenaline was different from the natural product because it had new functionality, Hand found a way to protect this nascent industry.[52] The fruits of biotechnology, when used therapeutically, will almost certainly deserve the same solicitude: the efforts are risky and bringing new therapies through clinical testing is extraordinarily expensive.

Importantly, however, Hand was also a firm believer in competition. His decision (on behalf of the Supreme Court) in US v Alcoa[53] is heavily cited, often for the proposition that

[t]hroughout the history of these [antitrust] statutes it has been constantly assumed that one of their purposes was to perpetuate and preserve, for its own sake and in spite of possible cost, an organization of industry in small units which can effectively compete with each other.[54]

While Alcoa was decided toward the end of his illustrious career, Hand paid careful attention to competition throughout his life, most especially in the intellectual property cases he entertained. Crescent Tool v Kilborn is illustrative.[55] In that case, the manufacturer of a wrench claimed its shape as a trademark. Hand took seriously the effort required to establish a new mark, but he considered the shape to be functional. Emphasising that a trademark holder can only protect the “nonessential” features of his product, Hand held that “in no event may the plaintiff suppress the defendant’s sale altogether.”[56] His subsequent decision in Shredded Wheat v Cornell helped lead the Supreme Court to make the doctrine of functionality the law of the nation.[57] Finally, in assessing Parke-Davis, it must be remembered that Hand was writing against the backdrop of an experimental use exemption, which had been developed by none other than Joseph Story, one of the foremost jurists ever to sit on the US Supreme Court.[58]

It is fair, then, to say that were Hand alive today, he would not have allowed the progeny of Parke-Davis to give unbounded control to US patent holders. Indeed, Shredded Wheat demonstrates one of the avenues he might have pursued. In that case, the shape of cereal biscuits served as a trademark, but it was also intrinsically desirable to consumers. Recognising the dual nature of the configuration, Hand worked to fashion relief in a manner that accommodated both interests. Genes are similarly of a dual nature: they function as chemicals and also as carriers of information. Thus, doctrinal developments in trademark law — and also in copyright law, where there is a similar duality — might be used to inform the application of patent law to genetic advances. Indeed, several scholars have recommended the development of a patent fair use doctrine, akin to the one that facilitates transformative uses of copyrighted materials (or expressive uses of protected marks).[59]

Reviving the background rules under which Hand operated — the common law research exemption and antitrust scrutiny — would also go a long way to improving the situation for the scientific community as a whole. As to the research exemption, the Supreme Court appears to be in agreement. It has interpreted the so-called Bolar exception, a statutory exemption for information destined for submission to the Food and Drug Administration, broadly enough to cover some preclinical experimentation.[60] How far upstream that extends remains to be seen.[61] Better would be the reintroduction of a general research exemption, one that would be independent of the goal of satisfying regulators, and that would deal with all kinds of research, including very basic (pre-pre-clinical) work, as well as research in the many other areas where there is scepticism about patenting because of its potentially adverse impact. Even on the Federal Circuit, there appears to be sentiment in favour of narrowing the reach of Madey. As Judge Pauline Newman has stated:

Today’s accelerated technological advance is based in large part on knowledge of the details of patented inventions and how they are made and used. Prohibition of research into such knowledge cannot be squared with the framework of the patent law.[62]

With respect to antitrust scrutiny, the prospect for change is not as rosy. Trinko concerned the power of a telephone company to bar its rivals from using its operations support systems, which are needed to access customers; it did not involve exclusivity obtained through a patent. However, most observers believe that the Supreme Court would apply Trinko even to cases where an intellectual property right holder refuses to license.[63] Still, there is a tenuous argument that gene patents are distinguishable. In Trinko, the systems at issue could be duplicated, albeit at high cost. Similarly, most of the advances covered by intellectual property rights can be invented around, perhaps at even higher cost. But for most uses, gene patents cannot be circumvented at any price. Accordingly, it is conceivable that the Supreme Court would treat hold ups regarding this technology differently. In addition, even though the doctrine of patent misuse has fallen by the wayside, copyright misuse has become an important defence. [64] As noted previously, gene patents resemble copyrighted materials in terms of the need to access certain informational content. Thus, courts and legislators might reconsider reviving the misuse doctrine for these cases, as well as for other sciences suffering similar problems.

But even more will be required. Because there is so much doubt concerning the level of inventiveness, utility, and disclosure required of a gene patent, a cheaper and more accessible avenue for challenging them is important. In this regard, the United States’ new patent statute, the America Invents Act (AIA),[65] will be significant because it provides a post-grant review procedure in the patent office, where validity issues can be resolved at lower cost and by adjudicators with experience in patent matters. Importantly, the AIA makes these challenges available to anyone concerned with the patent, including parties who do not enjoy standing in court.[66] The procedure is available for only nine months after a patent issues, but now that the potential effects of gene patents are better understood, the time limit may not be a significant problem.

Ostensibly, the AIA also deals with the issue of patient access. It creates a prior user defence, which will insulate laboratories that were utilising genetic advances before they were patented, but had failed to make their work public enough to create prior art.[67] But because clinical work is often shared (and thus made public), it is improbable that this defence will have a significant impact. More generally, the AIA instructs the Director of the Patent and Trademark Office to “conduct a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist.”[68] In reality, however, this effort is also unlikely to solve access problems. Its proponents apparently have in mind the establishment of independent laboratories to furnish second opinions. Unfortunately, most geneticists doubt that such labs could be commercially successful. The labs would be required to maintain skills, reagents, and certification across a broad range of diagnostic tests, including in areas where the patient population is very small and the tests would be administered infrequently. The labs would also have to deal with multiple insurance companies and the demands of clinicians working in diverse settings. As noted earlier, there appears to be a second opinion underground, but it is largely composed of academic labs staffed by researchers interested in particular diseases. There is no way to know whether collectively these facilities could offer comprehensive coverage.

More important, an exemption covering second opinions would not help patients who lack insurance coverage or resources to obtain first opinions. To deal with that problem, SACGHS suggested a diagnostics exception that would exempt “anyone making, using, ordering, offering for sale, or selling a test ... for patient care purposes.”[69] The proposal is very broad and would, in fact, strip inventors of all financial incentive to develop these tests. If it is believed that their development merits patent protection, a less inclusive exception would be preferable. For example, a tactic analogous to the one the United States uses for medical and surgical methods could be adopted. That provision immunises health care providers’ use of a patented method from all remedies, but retains their liability for infringement.[70] In that way, a patent holder who has been deprived of compensation from the infringer has recourse against anyone who contributes to the infringement — for example, by supplying materials uniquely suited to performing the method — or induces infringement — for example, by instructing the practitioner on how to practice the method. At the same time, health care providers retain the ability to do testing. Knowing that competition is always possible, patent holders would hopefully become less enamored of the sole-source provider business model and drop it in favor of licensing multiple laboratories.

The development of personalised medicine — companion diagnostics as well as multiplex testing (simultaneous analysis of large arrays of genes) and whole genome sequencing (the analysis of each person’s entire genetic endowment) — furnishes an example of how these strategies might work to better accommodate the interests of all relevant parties. A research exemption of the type common in Europe, which can be interpreted as limiting users to research “on” the patented advance, not research with the patented advance,[71] would enable researchers to perfect these diagnostics. But unless construed more broadly, it would not prevent pharmaceutical companies from using patents on companion diagnostics to exclude rivals who wish to develop therapies for patients who cannot benefit from the patent holder’s drug. The promise of greater antitrust scrutiny or the revitalisation of the patent misuse doctrine might, however, induce patent holders to license. A fair use exception could also be helpful in this situation. While copyright and trademark fair use do not require royalty payments, Maureen O’Rourke has suggested that when valuable products are developed from patented advances (and especially when the second developer diverts the first developer’s customers), royalties may be appropriate.[72]

As to patient access, a diagnostic exemption would help assure the availability of companion diagnostics. But holdups could be a serious problem with regard to commercial tests that require multiple genes and therefore multiple patented inputs. European observers suggest that patent pooling should be used in this situation, as it is in the electronics sector.[73] However, there are important differences between these fields: in electronics, no patent holder can bring a product to market without technology exclusively held by others. In contrast, gene patent holders can exploit their rights on their own. Accordingly, pools may not be as attractive. In Europe, compulsory licensing could solve holdup problems; the potential application of antitrust law could have a similar effect, as licensing is a possible remedy. In misuse cases, a patent is unenforceable as long as the misuse persists. Thus, the availability of a misuse defence could similarly induce licensing.

4 Conclusion

Unlike other patentable advances, genes and like biological information cannot be invented around. The temptation to obsess about their suitability for patent protection is, accordingly, powerful. But genetic advances do more than furnish hereditary information; they are likely to become the basis for dramatic new therapies. Stripping genetic inventions of patent protection is therefore a risky move, one courts and legislators are unlikely to undertake. Thus Dianne Nicol is surely right that attention should shift to strategies for dealing with the adverse impact that these patents can have on fundamental biological research and on the practice of medicine. This Comment suggests several approaches that are worthy of more detailed consideration. Most could be adapted to other industries where inventing around is impossible and patenting is problematic.

The Comment is also intended to serve another purpose: to explain to observers outside the United States that they should not automatically take US obsessions as their own. Background rules are important and it is clear from Nicol’s evidence that many countries already have a set of rules that make patent holdups in the genetic arena unlikely. The United States should be paying more attention to developments elsewhere — not vice versa.

[*] Pauline Newman Professor of Law, New York University School of Law. I was a member of the US Health and Human Services Secretary’s Advisory Committee on Genetics, Health, and Society and served on its task force on Patient Access to Genetic Tests. The views expressed here are, however, my own. I wish to thank the Filomen and D’Agostino and Max E Greenberg Research Fund for its financial support and Nitika Gupta, Class of 2013, for her research assistance.

[1] Madey v Duke University, [2002] USCAFED 222; 307 F 3d 1351 (Fed Cir 2002).

[2] See, eg, Janssen v Pharmaceutica, NV v Apotex, Inc, 540 F 3d 1353 (2008); Prasco, LLC v Medicis Pharmaceutical Corp, 537 F 3d 1336 (Fed Cir 2008). See also Association for Molecular Pathology (AMP) v USPTO, 653 F 3d 1329, 1344-48 (2011), certiorari granted, decision vacated, and remanded, 132 S Ct 1794 (2012), decision reinstated in all respects, 689 F 3d 1303, 1319-1321 (2012) (denying standing to most of the nominal plaintiffs), certiorari granted on other issues, Association for Molecular Pathology v Myriad Genetics, -- S Ct --, 2012 WL 4508118 (US), 81 USLW 3199 (30 November 2012) (“Myriad” case).

[3] Cf Dawson Chemical Co v Rohm and Haas Co, [1980] USSC 173; 448 US 176, 215 (1980) (describing attempts to include compulsory licensing provisions in US patent law).

[4] See ibid; 35 USC § 271(d)(4).

[5] See Verizon Communications Inc v Law Offices of Curtis V Trinko, LLP, [2004] USSC 4; 540 US 398, 410-411 (2004).

[6] Ibid.

[7] eBay Inc v MercExchange, LLC, 547 US 388 (2006).

[8] Bilski v Kappos, 130 S Ct 3218 (2010); In re Comiskey, 442 F 3d 967 (Fed Cir 2009).

[9] Ultramercial LLC v Hulu, LLC, 657 F 3d 1323 (Fed Cir 2011), cert granted, judgment vacated, and case remanded subnom; WildTangent, Inc v Ultramercial, LLC, 2012 WL 369157 (US 21 May 2012) (No. 11-962).

[10] 500 F 3d 1346 (Fed Cir 2007).

[11] Mayo Collaborative Serv v Prometheus Laboratories, Inc, 132 S Ct 1289, 1294 (2012).

[12] The Economist, Prometheus unsound: America’s Supreme Court wallops the biotech industry (24 March 2012) <>

Corporate Counsel, Of Patentability, “Laws of Nature,” and the Mayo Ruling (11 April 2012) <> .

[13] Dianne Nicol, “Implications of DNA Patenting: Reviewing the Evidence” (2011) 21(1) Journal of Law, Information and Science 7.

[14] Leahy-Smith America Invents Act, Pub L No 112-29, 125 Stat 284 (2011), § 14.

[15] Parke-Davis & Co v HK Mulford Co, 189 F 95, 115 (SDNY 1911), affd in part, revd in part, 196 F 496 (2d Cir 1912).

[16] See Helen Berman and Rochelle Dreyfuss, ‘Reflections on the Science and Law of Structural Biology, Genomics, and Drug Development’ (2006) 53 UCLA Law Review 871; in re Kubin, 561 F 3d 1351 (Fed Cir 2009) (holding that genes may be obvious in light of the protein for which they code).

[17] C M Holman, “The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation” (2007) 76 University of Missouri at Kansas City Law Review 295, 326.

[18] Holman does not agree, see ibid. However, until these patents are interpreted by a court, it is difficult to know their scope.

[19] The screening technique at issue in Myriad was upheld, both before and after the Supreme Court required the Federal Circuit to reconsider its decision, AMP v USPTO, 653 F 3d, 1357-1358; 689 F 3d 1303, 1335-1337 (2012). Furthermore, the recent grant of certiorari in that case is limited to the question whether human genes are patentable, Association for Molecular Pathology v Myriad Genetics, -- S Ct --, 2012 WL 4508118 (US), 81 USLW 3199 (30 November 2012).

[20] See, eg, Asher Hodes, Note, “Diagnosing Patentable Subject Matter” (2011) 26 Berkeley Technology Law Journal 225; Jeanene Swanson, Companion Diagnostics Take Off, GenomeWeb (October 2009)

<http://> .

[21] US Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS), Gene Patents and Licensing Practices and their Impact on Patient Access to Genetic Tests (April 2010) US Department of Health and Human Services


[22] G Kolata, “Bits of Mystery DNA, Far from ‘Junk,’ Play Crucial Role”, NY Times (online) 5 September 2012 < & pagewanted=all> (suggesting that this material contains millions of gene switches controlling chemically and physically adjacent genes).

[23] See, eg, Arti K Rai and Rebecca S Eisenberg, “Bayh-Dole Reform and the Progress of Biomedicine” (2003) 66 Law & Contemporary Problems 289, 291; E Ashihara, E Kawata and T Maekawa, “Future Prospect of RNA Interference for Cancer Therapies” (2010) 11(3) Current Drug Targets 345-360; S Lopez-Gomollon and T Dalmay, “Recent Patents in RNA Silencing in Plants: Constructs, Methods and Applications in Plant Biotechnology” (2010) 4(3) Recent Patents on DNA & Gene Sequences 155-166; See, eg, US Patent Application 20100003709 (7 January 2010).

[24] Nicol, above n 13, 25, 30-34.

[25] Ibid 16, 25.

[26] See, eg, Belgian Patent Act art 28 § 1(b) (“The rights conferred by the patent shall not extend to acts done for scientific purposes with or on the subject matter of the patented invention”); Danish Patents Act § 3(3)(3) (“The exclusive right shall not extend to: ... acts done for experimental purposes relating to the subject-matter of the patented invention.”); UK Patents Act § 60(5)(b) (excluding an act if “it is done for experimental purposes relating to the subject-matter of the invention”). See generally Mireille Buydens, Belgian Group, Report 202: The Impact of Public Health on Exclusive Patent Rights (2002).

[27] For Germany, see Gesetz zur Umsetzung der Richtlinie über den rechtlichen Schutz biotechnologischer Erfindungen [Statute Implementing the European Council’s Biotechnology Directive], 21 January 2005, BGBl I, 2005, 146, §1a (4) (FRG). France has adopted a similar approach. See Code de la Propriété Intellectuelle (France) Art L613-2-1.

[28] See, eg, Patents Act, 1977 c 37, § 48A(1)(b)(i) (Eng); 2 JW Baxter, World Patent Law and Practice § 8.02 (2001).

[29] Case C-428/08, Monsanto Tech LLC v Cefetra BV et al, 2011 FSR 6.

[30] Telefis Eireann & Independent Television Publications Ltd v Commission of the European Communities[1995] EUECJ C-241/91P; , 1995 ECR I-743 53, 54 (joining Cases C-241/91P and C-242/91P) (copyright case).

[31] Australian Government, Advisory Council on Intellectual Property, Patents and Experimental Use (2005)

< & %20Experimental%20Use%20final%20report%20FINAL.pdf> . A research exemption was, however, recently enacted, see Patents Act 1990 (Cth) s 119C as inserted by Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) Schedule 2, Part 1, s 119C.

[32] See Competition and Consumer Act 2010 (Cth). The issue may be resolved in a pending case between Samsung and Apple, see “FRAND Obligations to be Aired in Australian Court” on Mark Summerfield, Patentology (1 November 2011) <> .

[33] Madey[2002] USCAFED 222; , 307 F 3d 1351.

[34] Verizon Communications Inc[2004] USSC 4; , 540 US 398 (2004).

[35] Nicol also puts weight on a 1998 article by John Doll, then director of Biotechnology Examination, who thought the problem would work out, as it had in the polymer industry. See J J Doll, “The Patenting of DNA” (1988) 280 Science 689, cited by Nicol, above n 13, 17. Significantly, the Doll article was written before Madey and Trinko were decided. The analogy he draws to polymers is also imperfect as these can be invented around for virtually all purposes.

[36] Nicol, above n 13, 23, 28.

[37] See, eg, Shell Oil Co v Amoco Corp, [1992] USCAFED 509; 970 F 2d 885, 887 n 2 (Fed Cir 1992).

[38] MedImmune, Inc v Genentech, Inc 549 US 118 (2007); see above n 2. See generally, Nicholas D Walrath, “Expanding Standing in Patent Declaratory Judgment Actions to Better Air Public Policy Concerns” (forthcoming April 2013) 88 New York University Law Review.

[39] See Michael J Burstein, “Rules for Patents” (2011) 52 William and Mary Law Review 1747.

[40] The treatment of most of the plaintiffs in the Myriad case serves as an example, above n 2.

[41] See, eg, Global Pharmaceutical R&D Productivity Declining According to Thompson Reuters, CMR International, Thomson Reuters (1 July 2010) <> Iain M Cockburn, “Is the Pharmaceutical Industry in a Productivity Crisis?” (2007) 7 Innovation Policy & Economics 1.

[42] Nicol cites J P Walsh, A Arora and W M Cohen, “Effects of Research Tool Patenting and Licensing on Biomedical Innovation” in W M Cohen and S A Merrill (eds), Patents in the Knowledge-Based Economy (National Academies Press, 2003) < (“Research Tool Patenting”) and J P Walsh, A Arora and W M Cohen, “Working Through the Patent Problem” (2003), 299 Science 1021. The authors also conducted a second study, see W M Cohen and P Walsh, “Access – or Not – in Academic Biomedical Research” in Rochelle C Dreyfuss, Diane L Zimmerman and Harry First, (eds) Working Within the Boundaries of Intellectual Property (Oxford University Press 2010) 3 (“Working Within”); Wesley M Cohen and John P Walsh, “Real Impediments to Academic Biomedical Research” (2007) 8 Innovation Policy & Economics 1 (2007) <> (“Real Impediments”).

[43] See Real Impediments, above n 42, 10-11.

[44] Cf Rebecca S Eisenberg, “Bargaining over the Transfer of Proprietary Research Tools: Is the Market Failing or Emerging?” in Rochelle Cooper Dreyfuss, Diane Leenheer Zimmerman and Harry First (eds), Expanding the Boundaries of Intellectual Property (2001) 223.

[45] See Research Tool Patenting, above n 42, 317-318. Indeed, Nicol cites a study supporting the point, see Nicol, above n 13, 24, citing M K Cho, S Illangasekare, M A Weaver, D G B Leonard and J F Merz, “Effect of Patents and Licenses on the Provision of Clinical Genetic Testing Services” (2003) 5 Journal of Molecular Diagnostics 3.

[46] The literature includes one example: the discovery of large scale rearrangements, such as deletions and insertions, in the BRCA gene, which Myriad did not catch, see E R Gold and J Carbone, “Myriad Genetics: In the Eye of the Policy Storm” (2010) 12 Genetics in Medicine S39

<> .

[47] Kenneth G Huang and Fiona E Murray, “Does Patent Strategy Shape the Long-Run Supply of Public Knowledge? Evidence from Human Genetics” (2009) 52 Academy of Management Journal 1193; Fiona Murray and Scott Stern, “Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons Hypothesis” (2007) 63 Journal of Economic Behavior & Organization 648.

[48] Heidi L Williams, “Intellectual Property Rights and Innovation: Evidence from the Human Genome” (National Bureau of Economic Research, Working Paper No 16,213, 2010) <> .

[49] Nicol, above n 13, 28.

[50] See, eg, AMP v USPTO, 689 F 3d 1303, 1328-1330 (Lourie, J) and 1338-1339 (Moore, J, concurring) (2012).

[51] See M Harkness, ‘Dicta on Adrenaline: Myriad Problems with Learned Hand’s Product-of-Nature Doctrine’ (2011) 93 Journal of Patent & Trademark Office Society 363, citing Ex parte Latimer, 1889 Dec Comm’r Pat 123 (1889) and Am Wood-Paper Co v Fibre Disintegrating Co, 90 US [1874] USSC 189; (23 Wall) 566 (1874).

[52] Graham Dutfield, Intellectual Property Rights and the Life Sciences Industries (World Scientific, 2d ed, 2009) 85-89, 108-109.

[53] United States v Aluminum Co of America, 148 F 2d 416 (2d Cir 1945).

[54] Ibid 429.

[55] Crescent Tool Co v Kilborn & Bishop Co, 247 F 299 (2d Cir 1917).

[56] Ibid 301.

[57] Shredded Wheat Co v Humphrey Cornell Co, 250 F 960 (2d Cir 1918); Kellogg Co v National Biscuit Co, [1938] USSC 189; 305 US 111 (1938).

[58] Whittemore v Cutter, 29 F Cas 1120, 1121 (CCD Mass 1813) (“[I]t could never have been the intention of the legislature to punish a man, who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.”)

[59] See, eg, Katherine J Strandburg, “Patent Fair Use 2.0” (2011) UC Irvine Law Review <> Maureen A O’Rourke, “Toward a Doctrine of Fair Use in Patent Law” (2000) 100 Columbia Law Review 1177.

[60] Merck KGAA v Integra Lifesciences I Ltd, 545 US 193 (2005). In Australia, this exemption was also extended to non-pharmaceutical products: see, Patents Act 1990 (Cth) s 119B as inserted by Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), Schedule 2, Part 1, s 119B.

[61] In Classen Immunotherapies v Biogen IDEC, 659 F 3d 1057, (Fed Cir 2011), the Federal Circuit gave the provision limited scope, however, the Supreme Court is currently considering a petition for certiorari in the case.

[62] Integra Lifesciences I Ltd v Merck KGaA, [2003] USCAFED 118; 331 F 3d 860, 876 (Fed Cir 2003) (Newman J, dissenting), revd, Merck KGAA v Integra Lifesciences I Ltd, 545 US 193 (2005).

[63] See, eg, Michael A Carrier, “Refusals to License Intellectual Property after Trinko” (2006) 55 DePaul Law Review 1191.

[64] Tom W Bell, “Codifying Copyright’s Misuse Defense” 2007 Utah Law Review 573.

[65] Leahy-Smith America Invents Act, Pub L No 112-29, 125 Stat 284 (2011).

[66] Ibid § 6; Changes to Implement Post-Grant Review Proceedings, 77 Fed Reg 28 7061 (proposed 10 February 2012) (to be codified at 37 CFR pt 42).

[67] Ibid § 5 (codified at 35 USC § 273).

[68] Leahy-Smith America Invents Act, § 27.

[69] SACGHS Report, above n 21, 4.

[70] 35 USC § 287(c) (2006).

[71] See above n 26.

[72] O’Rourke, above n 59.

[73] See Geertrui Van Overwalle, “Of Thickets, Blocks and Gaps” in Geertrui Van Overwalle (ed), Gene Patents and Collaborative Licensing Models (2009) 383-463.

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