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October 03, 2019 Feature

Small Changes, Big Opportunity: Nanotechnology and Intellectual Property Law

By Brian Reese, PhD, JD, MBA, and Michael Schmitt, PhD

Nanotechnology (NT) research, development, and funding has risen sharply since 2000. In this country alone, there has been more than $27 billion in funding in NT through the National Nanotechnology Initiative (NNI).1 Unsurprisingly, the significant financial resources devoted to the development of NT have led to a corresponding growth in patent applications intended to protect inventions in the field.

The rapidly expanding use of NT to address longstanding technological problems has great potential commercial implications. Accordingly, protection of NT-related inventions must be a focus for commercial entities wishing to establish and/or maintain an effective exclusivity proposition relative to an increasing number of players in the field. While there are several ways to accomplish this, including through patents and trade secrets, patents are the focus of the discussion here. Nearly 20,000 patents and patent applications were published by the U.S. Patent and Trademark Office (USPTO) and 3,500 publications came from the European Patent Office related to the fields of NT in 2016.2 It is clear, investment in and development of nanotechnologies will continue to grow in the coming years,3 likely resulting in continued growth in associated intellectual property.

Nanotechnology and IP

Nanotechnology includes many different areas of research and development and, accordingly, the term “nanotechnology” itself has taken on many different, but related, definitions. A broad, conceptual definition of NT is appropriate in the context of patents. An invention can be considered to be in the field of NT generally when one or more of its purported benefits (e.g., properties and/or performance) are derived from its structure (e.g., size and/or shape). Such a broad and conceptual definition reflects the reality that inventions in the field of NT may result from exploitation of one or more of a wide range of structural characteristics of a material, device, or system. The possible structural characteristics whose manipulation can lead to a patentable invention are nearly endless: size, shape, crystallographic orientation, porosity, surface passivation, and so on. It is of note that patentable inventions may result from synergy between structure and composition, where structure or composition alone is insufficient to achieve the purported benefit(s). The full National Science and Technology Council (NTSC) definition uses some qualification along these lines within its stated size limitations by stating that NT is, within the ~1–100 nm scale, “exploiting the distinct properties and phenomena at that scale as compared to those associated with single atoms or molecules or bulk behavior.”4 Others, including the International Organization for Standardization (ISO), have proposed or adopted similar conceptual definitions for regulatory and research contexts.5 The above definition is invoked with reference to NT in the following discussion.

Patent Rights

At its core, a patent is a time-limited right to exclude others from performing a range of activities encompassed by an issued claim within the jurisdiction.6 The ability for a patent applicant to secure such rights is based upon a quid pro quo exchange—in order to receive a twenty-year monopoly on a claimed invention, an applicant must disclose his or her invention such that one of skill in the art must be able to make and use the claimed invention based on the teachings in the application. Especially in fields such as NT where technological development is rapid and competitive, applying for and obtaining one or several patents that broadly cover a new technology can provide important advantages over competitors.

In order to obtain a patent, there are several statutory requirements that must be met. First, an invention being claimed must meet the utility requirement.7 In order to be considered as meeting the utility requirement, a claimed invention must “provide some identifiable benefit and [be] capable of use[.]” This requirement is fairly simple to meet, though biotechnology-related inventions in particular have had some difficulty under recent case law.8

Second, a claimed invention must meet the novelty requirement.9 A key concept when discussing both novelty and nonobviousness is that of “prior art.” Generally, information made publicly available in any form (e.g., written or oral) that predates a patent application’s priority date can be considered prior art. In order to meet the requirement, the elements of a claimed invention must not be “anticipated,” or fully disclosed, by a single prior art reference. If even a single element of a claim is not found in a prior art reference, then the claim invention satisfies the novelty requirement. One important point is that a prior art reference may disclose an element explicitly or implicitly (i.e., inherently).

Third, a claimed invention must not be obvious to one of skill in the art over teachings in the prior art.10 Whether a claimed invention is obvious to one of ordinary skill in the art can be more difficult to determine than whether it has utility or novelty. To do so, it is necessary to make factual determinations about the scope and content of the prior art, any differences between the claimed invention and the prior art, the level of ordinary skill in the art, and whether there are any “objective indicia” (also known as “secondary considerations”) that indicate the claimed invention was nonobvious based on economic success or motivational issues.11 On the basis of these facts, an obviousness analysis can be conducted. Unlike in a novelty analysis, the teachings of more than one prior art reference may be combined when assessing if a particular claimed invention is obvious. Obviousness rejections are easily the most common rejection faced by patent application in the U.S.

The fourth, fifth, and sixth requirements are referred to as the “enablement,” “written description,” and “definiteness” requirements.12 An applicant must both give sufficient detail for one of ordinary skill in the art to understand what the claimed invention is (written description) and how to make it (enablement) and “particularly point out and distinctly” claim the subject matter considered the invention by way of one or more concise statements or “claims” (definiteness). Although NT can be quite complex, it is generally straightforward to set forth what the claimed invention is and how to make it. Courts have recognized that some amount of experimentation may be needed after reading a patent in order to practice the disclosed invention, but such experimentation must not be “undue.”13 Certain NT-related inventions may therefore require a higher level of detail to be disclosed. For example, a particularly detailed disclosure may be needed to meet the enablement requirement where a specific combination of process conditions is what yields the material, device, or system that is the claimed invention.14

Challenges and Opportunities in Patenting Nanotechnology-Related Inventions

There is no question that the NT revolution has resulted in billions of dollars in value creation, and with this, tens of thousands of patents and patent applications have been published by the USPTO. Some applications proceed quickly to issue, while others struggle for years to achieve issuance of valuable claim scope. There are many reasons for this, and we propose that several facets of NT provide both challenges and opportunities to a patent applicant seeking strong patent protection.

Small Changes . . . But Large Effects

Because many NT-related inventions result from small changes in structural characteristic(s), it can initially appear the differences between the claimed invention and the prior art are insubstantial and therefore obvious. Moreover, where differences from the prior art appear slight, it is easy to inadvertently apply knowledge gleaned from a patent application’s own disclosure of the invention when performing the obviousness analysis, thereby minimizing the significance of the differences, even though the application of such knowledge is impermissible hindsight.15 In many cases, the apparently slight differences between an NT-related invention and the prior art hinge on structural characteristics (e.g., sizes) of the claimed invention, often described using values or as being in certain ranges of values. This can be problematic because prior art need only disclose overlapping or encompassing ranges, or merely a value or range that is close in some cases, to establish a prima facie case for obviousness.16 Moreover, where the prior art discloses a range of usable values for a structural characteristic, optimization through routine experimentation is generally considered obvious, especially when the prior art recognizes a relationship between that structural characteristic and a desirable property.17 The implications for NT-related inventions are that, as more NT research is conducted, more investigation into the structural and other causes for the enhanced properties many NT-related inventions exhibit will occur. This, in turn, will almost certainly make it more difficult for patent applicants as the likelihood increases that particular differences between an invention and the prior art may appear increasingly trivial.

Despite the challenges, NT-related inventions may also offer unique opportunities to defend and/or illustrate a particular invention’s nonobviousness. For example, while optimization of a parameter may be considered likely to enhance a particular associated property of a material, it is not uncommon that small changes in one or more structural characteristic(s) cause “unexpectedly large changes in a beneficial property. Additionally, the change in a particular parameter may even result in the change of a completely different property than what would be expected by one of ordinary skill. Such unexpected results can be used to rebut a prima facie case for obviousness.18 After all, if something is truly unexpected, how can it also be considered obvious?

It is also helpful to present evidence that certain results are unexpected, such as through the offering of experimental data. Conclusory argument or speculation is often insufficient.19 Such evidence is generally easy to provide for NT-related inventions, as they are often developed as a result of extensive experimentation. However, merely changing “form, proportions, or degree” of previous technology does not make a claimed invention nonobvious if the resulting improvement is “in kind” and not therefore unexpected.20 The unexpected properties of an NT-related invention can sometimes result from the synergistic effects of multiple structural and/or compositional characteristics existing simultaneously. In such cases, nonobviousness can stem from the fact that the claimed invention “as a whole” was not obvious in view of the prior art.21 For example, showing that each feature of an invention was known individually in the prior art does not make an invention prima facie obvious unless there is a rationale (motivation) underpinning the combination of the different teachings.22

Where appropriate, additional arguments can be made to make or bolster the case that apparently small changes were in fact nonobvious. For example, as part of the “as a whole” inquiry, recognition of the source of a problem can entitle an applicant to patent a solution, even if the solution is obvious once the source of the problem is recognized.23 In some cases, the small change to structural characteristic(s) was made because the change was found to address a known problem associated with current designs with a previously unknown source. Moreover, any disclosed property of the claimed invention that is inherent must also be considered in the “as a whole” inquiry.24 Evidence of secondary considerations, such as copying by others, long-felt but unsolved need, failure of others, and commercial success, may also further assist arguments for nonobviousness,25 as, especially in NT, “what may be viewed as a mere incremental step could constitute a great leap in innovation.”26

Drawing Inspiration from Established Industries

Ongoing research efforts continue to expand the amount of prior art in NT, which can present challenges for defending the nonobviousness of inventions. Practically, discovery of a beneficial property of a method or material, such as quantum-confinement-based light emission, prompts subsequent testing of a wide range of structural characteristics to determine underlying structure–property relationships, thereby producing a large body of prior art. Such a large body of prior art in a given subfield of NT often results over a relatively short time period after the initial breakthrough. However, having such a large body of prior art may not necessarily be a bad thing.

Analogy may be found in the pharmaceutical industry, where millions of compounds are disclosed in the prior art. There, an applicant for a patent often files an early application directed to certain broad genera of promising compounds and later files another application to its lead clinical candidate, then needing to defend the nonobviousness of the lead compound over the genus from which it is selected. To deal with this obviousness conundrum, the courts and the USPTO have generally adopted a two-prong inquiry referred to as “a lead compound analysis.”27 The analysis involves determining (1) whether one of ordinary skill would have selected one or more lead compounds from the prior art for further development and (2) whether the prior art supplied sufficient motivation to modify the lead compound to arrive at the invention with a reasonable expectation of success.28 A similar framework can be used to defend the nonobviousness of a claimed NT-related invention.

In analogy to the first prong, even when there is extensive disclosure regarding the effects of varying many structural characteristics on a particular property, it is not necessarily obvious to specifically pick any particular one, or combination, of those structural characteristics for further modification absent a detailed teaching of its, or their, particular importance in the prior art.

In analogy to the second prong, even if one of ordinary skill were to pick the particular structural characteristic(s) to modify, the prior art should need to teach modifying the structural characteristic(s) in a substantially similar way as in the invention, and that there is some expectation of a commensurate improvement (e.g., in magnitude) of properties, in order to properly draw a conclusion of obviousness.

Given the range of structural modifications that can be made to a material, device, or system, general teachings in the prior art about possible or acceptable structural characteristics should not necessarily be sufficient to render an invention obvious to one of ordinary skill in the art. It is not obvious to try any one of a large number of possible choices unless there is a reasonable expectation of success based on the teachings of the prior art.29 Therefore, a convincing defense of nonobviousness for a claimed NT-related invention may depend on the applicant’s ability to effectively communicate why the invention resulted from focused effort that one of ordinary skill in the art would not have instinctively made given the vast sea of possibilities available.

What Are the Courts Saying?

A recent example from the Federal Circuit, Par Pharm., Inc. v. TWi Pharms, Inc., is an instructive application of some of the aforementioned concepts.30 Par Pharmaceutical (Par) obtained U.S. Patent No. 7,101,576 for a formulation of megestrol, an appetite stimulant, that used “nano-sized” particles (having “an effective average particle size of less than about 2000 nm”31) instead of the previously used micron-sized particles. The nano-sized megestrol unexpectedly had a reduced food effect (associated nutrient absorption rate) compared to the micron-sized formulation, which was beneficial for patient populations affected by wasting. Par later contracted with Alkermes Pharma Ireland to use its NanoCrystal® technology to form the new nano-sized megestrol particles. The NanoCrystal® technology was prior art to Par’s patent, as was the micron-sized megestrol formulation. This prior art specifically showed that there was a relatively high level of interpatient variability for micron-sized megestrol and that size reducing (by application of NanoCrystal® technology) could improve bioavailability. Both sides agreed that the prior art did not expressly teach a reduced food effect for smaller sizes of megestrol, but the defendant argued that a reduced food effect was an inherent pharmacokinetic property of a smaller formulation because of its increased bioavailability.

The Federal Circuit’s holdings illustrate several concepts discussed herein. The prior art was clear that nano-sizing drug formulations was generally feasible, for example using NanoCrystal® technology, and that nano-sizing was likely to improve bioavailability. Put together, the court found that one of ordinary skill in the art would have been motivated to try nano-sizing megestrol. The observed food effect for nano-sized megestrol may have been unexpected, but, importantly, the unexpectedness of the effect was not substantial when factored against the clear teachings of the prior art. Plaintiffs’ other arguments for secondary considerations (including that patients affected by wasting had a long-felt need for treatment) suffered from minimal evidence and were therefore also unpersuasive in face of the prior art. Nonetheless, the Federal Circuit found that the district court had applied the wrong standard for inherency by accepting reduced size having some impact on food effect as sufficient proof of inherency without considering whether the extent of the impact would necessarily be to the same extent as in the claimed invention. The Federal Circuit vacated the obviousness determination and remanded for further analysis of inherency using the proper standard.

Overall, the Par Pharm. case serves to highlight that the patentability of NT-related inventions is highly fact specific. Referring back to the analogy to the lead compound analysis, the prior art taught a clear reason to choose size as a structural characteristic to manipulate, specifically by reducing it. Further, the prior art taught that a particular benefit, improved bioavailability, was reasonably expected to occur upon modification of the structural property. It is important to note that the claimed invention did not require a particular narrow range of sizes in order for the reduced food effect to be observed; rather, generally nano-sized particles were taught to be sufficient. A specific, narrow required-size range may have caused the Federal Circuit to hold differently. Accordingly, this case serves as a reminder that claim strategies must be carefully considered, and patent applicants should, where possible, include supportive data showing not only positive data, but negative as well, in order to evidence the importance of the particular range to achieving the beneficial effects observed in a claimed invention.

“Tips and Tricks”

In general, patent applicants set out in the hopes of claiming as large of a piece of technological real estate as possible, in order to attract investment and/or keep actual or potential competitors at bay. As discussed herein, convincingly crafting the story of an invention in the field of NT can present particular challenges, in part because the enormous impact on properties and performance realized by an invention can result from only small, seemingly trivial changes to known products, compositions, or methods. The following are some considerations to keep in mind when drafting an application in order to maximize the chance that valuable claims will successfully pass through examination onto issuance, and withstand any post-grant challenges that may arise.

As has been discussed above, it is particularly important for NT-related inventions that the application tell a story. A simple restatement of the technological development may be sufficient to meet the statutory requirements for a patent but prove to be unconvincing during examination or later post-grant challenge. Because NT-related inventions may appear subtle, it is important that the application drafter guide the reader by telling the story of the invention. A good patent story offers some level of insight into how the invention came to be (e.g., some description of problem(s) in the art, and discussion of previous failed attempts to overcome the problem(s)) and how it differs from previous technology, not just a clear simple description of the technical aspects of the invention. In addition, a good story may include acknowledgment that the invention included recognition of the source of a known problem with a previously unidentified source. Of course, care should be taken when drafting an application to not make unnecessary admissions that can be later used against the application.

Additionally, for many NT-related inventions, data are particularly important to include in an application. Data can be used to formulate strong arguments for nonobviousness, especially where particular values, ranges, compositions, or similar are a critical aspect of the invention. Furthermore, providing data for multiple examples that each has the critical structural characteristic can be useful in supporting a broad scope of protection. In contrast, mere conclusory statements made in an application may be insufficiently convincing when the prior art teaches similar or overlapping ranges or values or even open it up to challenges for failing to meet the statutory disclosure requirements. In this regard, including comparative data for examples falling outside a critical range, composition, or value can be useful in establishing that a claimed critical feature is not simply an arbitrary choice meant to circumvent the prior art. For example, if the thickness of a surface layer should be controlled within a certain range, data should be provided that further establish that the purported beneficial properties or performance is achieved when the thickness is within that range and not when values outside the range are used. As the full scope of the prior art is often not known, even to subject matter experts with extensive experience, failure to include data in the original disclosure can result in significantly prolonged examination and thus delayed issuance or, in the worst case, preclude issuance of a patent altogether.

Conclusion

It is clear that our world is in the middle of an NT revolution. Many industries have already enjoyed significant growth as a result of new NT-related inventions including the automotive, consumer good, and pharmaceutical industries. Accordingly, both overall market value for NT and competition are fierce and growing. Appropriately protecting intellectual property for NT-related inventions, thereby excluding others (upon patenting), can be essential to establishing a dominant and sizeable market position.

Endnotes

1. NNI Budget, Nat’l Nanotechnology Initiative, https://www.nano.gov/about-nni/what/funding (last visited July 15, 2019).

2. Using the definition of nanotechnology provided by the International Standards Organization (ISO) Technical Specification 18110 (ISO/TS 18110). See Leading Patenting Countries in Nanotechnology in 2016, StatNano (Jan. 30, 2017), https://statnano.com/news/57346.

3. Global Industry Analysts, Inc., New and Emerging Applications to Drive the Global Nanotechnology Market, Report No. MCP-1031 (May 2019), https://www.strategyr.com/MarketResearch/market-report-infographic-nanotechnology-forecasts-global-industry-analysts-inc.asp.

4. M.C. Roco, S. Williams & P. Alivisatos, Nat’l Sci. & Tech. Council, Nanotechnology Research Directions: Vision for Nanotechnology R&D in the Next Decade, Springer (previously Kluwer) IWGN Workshop Report (Sept. 1999), available at www.wtec.org/loyola/nano/IWGN.Research.Directions.

5. ISO/TC 229 Nanotechnologies, Int’l Standards Org. (ISO), https://www.iso.org/iso/iso_technical_committee.html?commid=381983 (last visited July 15, 2019) (nanotechnology definition); R. Bawa, (2016). What’s in a Name? Defining “Nano” in the Context of Drug Delivery, in Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications, ch. 6 (R. Bawa, G. F. Audette & I. Rubinstein eds. 2016).

6. 35 U.S.C. §§ 271, 154(a)(2).

7. Id. § 101.

8. Cleveland Clinic Found. v. True Health Diagnostics LLC, No. 2018-1218, slip op. (Fed. Cir. Apr. 1, 2019).

9. 35 U.S.C. § 102.

10. Id. § 103.

11. Graham v. John Deere Co., 383 U.S. 1 (1966); Natalie A. Thomas, Secondary Considerations in Nonobviousness Analysis: The Use of Objective Indicia Following KSR v. Teleflex, 86 N.Y.U. L. Rev. 2070 (Dec. 2011).

12. 35 U.S.C. § 112.

13. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).

14. Of course, the specific method may also be separately patentable.

15. See In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971).

16. In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976); In re Geisler, 116 F.3d 1465, 1469–71 (Fed. Cir. 1997); Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985).

17. In re Aller, 220 F.2d 454, 456 (C.C.P.A. 1955); In re Antonie, 559 F.2d 618 (C.C.P.A. 1977).

18. In re Dillon, 919 F.2d 688, 692–93 (Fed. Cir. 1990).

19. In re Mayne, 104 F.3d 1339, 1343–44 (Fed. Cir. 1997).

20. In re Williams, 36 F.2d 436, 438 (C.C.P.A. 1929).

21. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983).

22. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415–21 (2007).

23. In re Sponnoble, 405 F.2d 578, 585 (C.C.P.A. 1969); Leo Pharm. Prods. v. Rea, 726 F.3d 1346, 1356–57, 1377 (Fed. Cir. 2013).

24. In re Antonie, 559 F.2d 618, 620 (C.C.P.A. 1977); In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993).

25. Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 711 F.3d 1348, 1356 (Fed. Cir. 2013).

26. Apple Inc. v. ITC, 725 F.3d 1356, 1375 (Fed. Cir. 2013) (Reyna, J., dissenting in part) (citing Power Integrations, 711 F.3d at 1356).

27. Amerigen Pharm. Ltd. v. UCB Pharma GmbH, Case IPR2016-01665 (P.T.A.B. Dec. 7, 2016); Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1291–92 (Fed. Cir. 2012).

28. Otsuka Pharm. Co., 678 F.3d at 1291–92.

29. In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009).

30. 773 F.3d 1186 (Fed. Cir. 2014).

31. That these particles were as large as 2 microns in size and still considered “nano-sized” in this litigation underscores the inadequacies of a strict definition of nanotechnology.

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By Brian Reese, PhD, JD, MBA, and Michael Schmitt, PhD

Brian Reese, JD, PhD, MBA, is Counsel in the Life Sciences and Intellectual Property Groups at Choate, Hall and Stewart LLP in Boston, MA. Michael Schmitt, PhD, is a Patent Agent at Choate, Hall & Stewart LLP.