Feature

Lengthening Shadows: Biotechnology and Patent Eligibility

Michael A. Sanzo

©2017. Published in Landslide, Vol. 9, No. 5, May/June 2017, by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association or the copyright holder.

On June 27, 2016, the U.S. Supreme Court denied certiorari in Sequenom v. Ariosa.1 The decision is of considerable interest to a biotechnology industry that had been looking for a signal as to whether the Court actually intended the full consequences of its Mayo2 and Myriad3 decisions. More than 20 amicus briefs were filed urging that certiorari be granted, and it was hoped that an appeal would provide an opportunity to better define the scope of patent eligibility as applied to therapeutic methods and recombinant technology.

The denial suggests that the Court is, as a practical matter, indifferent to the problems that its past decisions have created in biotechnology and that the best chance for the preservation of a viable industry in the United States is through congressional action. In the short term, companies will need to develop strategies for protecting intellectual property in the presence of a Supreme Court that appears increasingly unsympathetic to patent rights.

The Supreme Court and Patent Eligibility in the Area of Biotechnology

Beginning in 2012, the U.S. Supreme Court issued three decisions on patent eligibility that have had a devastating effect on biotechnology companies, particularly those involved in gene therapy and gene-based diagnostic assays.4 The decisions were: Mayo Collaborative Services v. Prometheus Laboratories (a case dealing with the patentability of a method for adjusting drug dosage by measuring the level of metabolites in a patient’s blood);5 Association for Molecular Pathology v. Myriad Genetics (which concerned diagnostic assays based on gene mutations and composition claims directed to DNA molecules);6 and Alice Corp. v. CLS Bank (which dealt with subject matter unrelated to biotechnology but in which the Court fully articulated its test for determining patent eligibility).7

The test developed by the Supreme Court consists of two parts. In the first, a claim is examined to determine whether it embodies subject matter that is recognized as not being patent eligible when considered in isolation.8 This includes laws of nature, natural phenomena, natural processes, and abstract ideas. If subject matter of this type is present, the next step is to evaluate each of the elements of the claim both individually and together to see whether, in the absence of the patent-ineligible subject matter, the elements embody an “inventive concept.”9 Essentially, the claim must appear to meet the criteria of patentability after laws of nature, natural phenomena, natural processes, and abstract ideas have been excluded.

From the perspective of many biotechnology companies, the problem with this approach is that, in most gene-based diagnostic methods and gene-based therapies, novelty and nonobviousness stem entirely from the discovery of a relationship between a patient’s genetic characteristics (typically the presence of an abnormal gene expression pattern or gene mutations) and the presence of, or propensity to, disease.10 This relationship is considered to be a natural phenomenon and is therefore excluded before claim elements are evaluated for an “inventive concept.” Because the remaining elements typically constitute routine assay methodology or routine procedures for transferring genes, claims will almost always be judged to be patent ineligible.11

Federal Circuit Decisions Since Mayo, Myriad, and Alice

Biotechnology Decisions Finding Patent Ineligibility (Recombinant DNA and Diagnostic Methods)

Subsequent to the patent eligibility criteria established by the Supreme Court in the decisions noted above, the Federal Circuit has reviewed five cases concerning the patent eligibility of inventions in the biotechnology area. Four of these cases involved recombinant DNA technology and, of these, three related to diagnostic methods. The four cases were: University of Utah Research Foundation v. Ambry Genetics Corp. (involving claims that were present, but not considered, in the Supreme Court’s Myriad case);12 In re Roslin Institute (involving claims to a cloned animal);13 Ariosa v. Sequenom (concerning diagnostic tests for cell-free fetal DNA in maternal blood);14 and Genetic Technologies Ltd. v. Merial L.L.C. (involving claims to a method for identifying allelic sequences in an individual).15 Every claim considered in these cases was found to be patent ineligible, and it is not clear whether there are any claims reciting natural DNA or protein sequences that the Federal Circuit would regard as viable candidates for patenting.

Although the four cases noted above all concerned recombinant methods and compositions, the problems they exhibit with respect to patent eligibility are not confined to this technology area. Virtually all diagnostic methods are based on the discovery of an association between abnormal biological characteristics and the existence or development of a disease state. Except in rare instances in which entirely new methodology is developed to measure these abnormalities, diagnostic tests are likely to be excluded from patent eligibility under the Supreme Court’s present criteria. The patent eligibility of therapeutic compositions that have biologics as active agents is also unclear. This includes not only compositions containing nucleic acids, but also those with immunogens, cells, tissues, and proteins. Even antibiotics could potentially be viewed as unpatentable products of nature.

Some of the inventions that have been excluded, and that are likely to be excluded in the future, are indisputably of enormous benefit and, apart from considerations of eligibility, could validly be patented. However, these considerations are irrelevant under the approach to patent eligibility promulgated by the Supreme Court; inventions may be denied patent protection regardless of how valuable or innovative they may be. The doubtful wisdom of this was expressed by Judge Lourie in the Ariosa case as follows:

[T]he claims here are directed to an actual use of the natural material of cffDNA. They recite innovative and practical uses for it, particularly for diagnostic testing: blood typing, sex typing, and screening for genetic abnormalities. And it is undisputed that before this invention, the amplification and detection of cffDNA from maternal blood, and use of these methods for prenatal diagnoses, were not routine and conventional. But applying Mayo, we are unfortunately obliged to divorce the additional steps from the asserted natural phenomenon to arrive at a conclusion that they add nothing innovative to the process. . . . In sum, it is unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps, or that they claim abstract concepts. But I agree that the panel did not err in its conclusion that under Supreme Court precedent it had no option other than to affirm the district court.16

Biotechnology Decision Finding Patent Eligibility (Transformation)

The fifth case in the biotechnology area considered by the Federal Circuit since the Supreme Court patent eligibility decisions was Rapid Litigation Management v. CellzDirect (referred to by the court as IVT v. LTC).17 Because this is the first post-Alice biotechnology decision in which the Federal Circuit found claims to be patent eligible, it warrants somewhat closer attention.

The case concerned claims to a method of preserving hepatocytes by taking frozen cells, thawing them, and then performing density gradient fractionation to separate viable cells from nonviable cells.18 The viable cells were recovered and then frozen again (without culturing). The inventors found that, when thawed a second time, greater than 70 percent of the cells were viable and could be used in the absence of another density gradient separation step.19 The discovery that hepatocytes can be preserved in this manner was contrary to teachings in the art which suggested that freezing caused such damage that the cells could not be frozen more than once.20

The District Court for the Northern District of Illinois had granted a request by LTC for summary judgment based on claims being patent ineligible.21 The reasoning of the district court was as follows:

Applying Mayo-Alice step 1, this Court concludes that the patent is directed to an ineligible law of nature: the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles. Though the parties cite limited caselaw detailing the meaning of “directed to” patent-ineligible subject matter, the [US]PTO recently issued its 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 C.F.R. 74622 (Dec. 16, 2014), currently subject to public comment, that defines Alice step 1 as requiring that a law of nature, natural phenomenon or abstract idea be “recited (i.e., set forth or described) in the claim.” In this instance Claim 1 of the ’929 Patent claims “a method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes, being capable of being frozen and thawed at least two times,” and the claimed method then outlines a process for freezing the cells twice. Clearly, therefore, the patent recites the natural law that certain hepatocytes are capable of being frozen and thawed more than once. . . . Applying Mayo-Alice step 2, this Court further agrees that the patented process lacks the requisite inventive concept. One of the inventors, James Hardy, said that “the unexpected outcome was that cells twice frozen behaved like cells that were once frozen”—unquestionably a natural characteristic of the hepatocytes, though no one may have remarked it before—and it is undisputed that upon making that discovery Hardy reapplied a well-understood freezing process. [IVT] argues that repetition of that already-well-established process itself constitutes the requisite inventive concept because prior art taught away from multiple freezings. But in determining whether the process warrants patent protection, we ask “what else” is in the patent beyond the patent-ineligible concept. Here the answer is not much.22

It should be noted that, in applying the Supreme Court’s patent eligibility test to IVT’s claim, the district court began by asking whether any part of the claim recited a natural law. The court did not ask whether the claim as a whole was primarily directed to the natural law. Having established that patent-ineligible subject matter was present, the court applied the second step of the Alice test by asking “what else” was present beyond the patent-ineligible concept. Thus, the claim was stripped of contributions to inventiveness stemming from the discovery that hepatocytes can survive multiple rounds of freezing, and because all of the other steps were routine in the art, the claim was found to be patent ineligible. This approach to the Alice test is entirely consistent with the approach historically taken by the Supreme Court in Funk Bros. Seed Co. v. Kalo Inoculant Co.23 and Parker v. Flook,24 two cases cited in the Supreme Court’s more recent patent eligibility decisions and in which claims were found to be patent ineligible.25

On appeal, the Federal Circuit reversed the district court and found that IVT’s claims were patent eligible under either step of the Alice test. With respect to the first step, it stated:

The district court identified in these claims what it called a “natural law”—the cells’ capability of surviving multiple freeze-thaw cycles. We need not decide in this case whether the court’s labeling is correct. It is enough in this case to recognize that the claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims of the ’929 patent are directed to a new and useful laboratory technique for preserving hepatocytes. This type of constructive process, carried out by an artisan to achieve “a new and useful end,” is precisely the type of claim that is eligible for patenting.26

The Federal Circuit’s approach is much more whole-claim oriented than that of the district court or of the Federal Circuit itself in earlier decisions.27 Later, the court attempted to distinguish its holding in IVT v. LTC from other decisions in which it assessed patent eligibility using the Alice test:

The claims in this case are immediately distinguishable from those we have found patent ineligible in cases since Mayo and Alice. In recent cases, we found claims “directed to” a patent-ineligible concept when they amounted to nothing more than observing or identifying the ineligible concept itself. For example, in Genetic Technologies, the claim recited methods for detecting a coding region of DNA based on its relationship to non-coding regions. Because the relationship between coding and non-coding sequences was a law of nature, the claim amounted to nothing other than identifying “information about a patient’s natural genetic makeup.” Likewise in Ariosa, the claims recited methods for detecting paternally inherited cffDNA in the blood or serum of a pregnant female. The existence and location of cffDNA is a natural phenomenon; identifying its presence was merely claiming the natural phenomena itself. And in In re BRCA, the claims recited methods for screening human germline for an altered BRCA1 gene by comparing the target DNA sequence with wild-type sequence. But comparing two sequences to detect alterations is a patent-ineligible “abstract mental process.” Although the claims in each of these cases employed method steps, the end result of the process, the essence of the whole, was a patent-ineligible concept. The same is not true here. The end result of the ’929 patent claims is not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims are directed to a new and useful method of preserving hepatocyte cells. Indeed, the claims recite a “method of producing a desired preparation of multi-cryopreserved hepatocytes.” Through the recited steps, the patented invention achieves a better way of preserving hepatocytes.28

Thus, it appears that the court was attempting to distinguish IVT v. LTC from past decisions in the area of patent eligibility based on whether the end result of a claimed method is the detection of a natural phenomenon (e.g., gene mutations associated with disease propensity) or the production of something new (e.g., hepatocytes resistant to damage caused by freezing/thawing). In this regard, the approach appears somewhat similar to the machine-or-transformation test discussed in Bilski v. Kappos.29

The Federal Circuit also indicated that, even if the claims had been found to be patent ineligible under the first step of the Alice test, they would have been redeemed under the second step.30 In this regard the court stated:

That each of the claims’ individual steps (freezing, thawing, and separating) were known independently in the art does not make the claim unpatentable. It is true that, at step two, a claim that recites only “well-understood, routine, conventional activity already engaged in by the scientific community” will not be patent eligible. Thus, in Mayo, the claims failed step two because the steps of administering the drug, measuring metabolite levels, and adjusting dosage were already being performed by those in the field; adding knowledge of the natural law was insufficient to render the claims patent eligible. Likewise in Ariosa, the steps of preparing, amplifying, and detecting genetic sequences were already being done; performing those same steps on a newly discovered, naturally-occurring substrate (cffDNA in maternal plasma or serum) did not rise to the level of an inventive concept. That is not to say, however, that all process claims that employ only independently known steps will be unpatentable. To the contrary, in examining claims under step two, we must view them as a whole, considering their elements “both individually and ‘as an ordered combination.’” Thus, “a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.31

Here, it appears that the Federal Circuit comes close to compromising very clear prior holdings by itself and the Supreme Court that the contributions of natural laws, abstract ideas, and natural processes are not considered when looking at the elements of a claim under the second step in the Alice test. In previous cases, claims failed step two not because the patent-ineligible subject matter did not provide sufficient innovation for the claim to rise to the level of an inventive concept but because contributions from the patent-ineligible subject matter were not considered at all.

Given the recent Federal Circuit and Supreme Court decisions, it is encouraging to have any biotechnology claims found to be patent eligible when challenged. However, the benefits of the IVT v. LTC case appear to be fairly limited. There is, for example, nothing in the case that would affect our conclusions with respect to diagnostic assays or recombinant DNA technology. It is also difficult to resolve the approach taken by the court in this case with that taken in previous decisions where claims were found to be patent ineligible.

Perhaps the best way to distinguish the IVT v. LTC case from the others is by the machine-or-transformation test.32 Specifically, there was a transformation of hepatocytes from being sensitive to freezing and thawing to being relatively insensitive (accomplished by separating viable cells after an initial freeze-thaw step). On the other hand, with the possible exception of In re Roslin Institute, no transformation occurred in other recent patent eligibility cases. Overall, probably the best that can be done by a patent practitioner in drafting claims that may be patent eligible is to, where possible: (1) avoid expressly stating or emphasizing patent-ineligible subject matter in claims; (2) characterize an invention as an improvement on existing technology (preferably previously patented technology); and (3) express inventions in terms of a transformation whenever possible.

Decisions in Other Technology Areas

In over 30 post-Mayo, Myriad, and Alice decisions by the Federal Circuit in areas other than biotechnology,33 there have been only three in which claims were found to be patent eligible. The first of these, DDR Holdings v. Hotels.com,34 concerned claims to an e-commerce system that can be used by companies marketing products or services at online sites having advertisements. Under the claimed system, when a customer clicks on such an advertisement, he or she is taken to a composite site that retains the look and feel of the host site.35 Applying the second step of the Supreme Court’s test, the Federal Circuit drew a distinction between claims directed to the generic use of the Internet and claims to a system in which the Internet is manipulated in specific ways:

Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result—a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink. Instead of the computer network operating in its normal, expected manner by sending the website visitor to the third-party website that appears to be connected with the clicked advertisement, the claimed system generates and directs the visitor to the above-described hybrid web page that presents product information from the third-party and visual “look and feel” elements from the host website. When the limitations of the ’399 patent’s asserted claims are taken together as an ordered combination, the claims recite an invention that is not merely the routine or conventional use of the Internet.36

The second case in which the Federal Circuit found claims to be patent eligible, Enfish v. Microsoft, differs from the two others in that claims were found to be patent eligible under the first step of the Supreme Court test.37 The court held that claims to a data storage and retrieval system for generating a “self-referential” table represent a patent eligible improvement to the way computers operate.38 The court stated:

We thus see no reason to conclude that all claims directed to improvements in computer-related technology, including those directed to software, are abstract and necessarily analyzed at the second step of Alice, nor do we believe that Alice so directs. Therefore, we find it relevant to ask whether the claims are directed to an improvement to computer functionality versus being directed to an abstract idea, even at the first step of the Alice analysis. For that reason, the first step in the Alice inquiry in this case asks whether the focus of the claims is on the specific asserted improvement in computer capabilities (i.e., the self-referential table for a computer database) or, instead, on a process that qualifies as an “abstract idea” for which computers are invoked merely as a tool.39

Finally, on the same day that the Supreme Court denied certiorari in Ariosa, the Federal Circuit decided BASCOM Global Internet Services v. AT&T Mobility, the third case in which claims were found to be patent eligible.40 The decision concerned the patentability of claims to a system for filtering websites available to end users. The Federal Circuit held that, although the concept of such filtering represents an abstract idea under the first step of the Alice test,41 the unconventional arrangement of software elements was sufficient to provide an “inventive concept” under the second step of the test.

Effect of Software Cases on Biotechnology

Whatever guidance the DDR, Enfish, and BASCOM Global cases may provide in the area of software, they are of minimal help in defining parameters for the patent eligibility of claims in the area of biotechnology. The decisions are highly fact dependent and closely tied to computer-related inventions. At most, the decisions provide support for the idea that biotechnology claims should be patent eligible if they embody inventive changes to the methods used for measurement in an assay, to the combination of agents in a composition, or to the implementation of a therapy. However, this is largely just an affirmation of the second step in the Supreme Court test. Because inventiveness in biotechnology typically depends on a newly discovered relationship between a biological state and physical characteristics, changing the platform by which the relationship is exploited does not so much transform the patent-ineligible application subject matter as it does substitute one invention for another.

Ariosa: A Chance for Clarification

Among the cases decided by the Federal Circuit, Ariosa was of special interest as a vehicle that might provide the Supreme Court with an opportunity to reconsider its holdings on patent eligibility. Both in the case itself as well as in a subsequent decision denying a rehearing en banc,42 several judges of the Federal Circuit expressed opinions that: (1) the Supreme Court had been overly broad in its decisions on patent eligibility; (2) the impact of the decisions were likely to be highly detrimental to the biotechnology industry; and (3) subsequent action was needed by the Court to better define and limit the scope of its holdings. These views can be seen, for example, in the comments of Judge Linn writing in concurrence to the Ariosa decision:

I join the court’s opinion invalidating the claims of the ’540 patent only because I am bound by the sweeping language of the test set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In my view, the breadth of the second part of the test was unnecessary to the decision reached in Mayo. This case represents the consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.43

Similar ideas were expressed by Judges Lourie and Moore in the Federal Circuit’s decision on a request for a rehearing en banc:

The claims at issue in Sequenom’s patent are directed to methods for detecting paternally-inherited fetal DNA in maternal blood samples, and performing a prenatal diagnosis based on such DNA. Following Mayo, which held that certain steps merely recite natural laws and that the remaining steps must be sufficiently innovative apart from the natural laws, the panel in this case held that the claims do not involve patent-eligible subject matter. Appellants and amici have argued before us in briefs that a broad range of claims of this sort appear to be in serious jeopardy. It is said that the whole category of diagnostic claims is at risk. It is also said that a crisis of patent law and medical innovation may be upon us, and there seems to be some truth in that concern.44

Later, Judge Dyk stated:

Yet I share the concerns of some of my colleagues that a too restrictive test for patent eligibility under 35 U.S.C. § 101 with respect to laws of nature (reflected in some of the language in Mayo) may discourage development and disclosure of new diagnostic and therapeutic methods in the life sciences, which are often driven by discovery of new natural laws and phenomena. This leads me to think that some further illumination as to the scope of Mayo would be beneficial in one limited aspect. At the same time I think that we are bound by the language of Mayo, and any further guidance must come from the Supreme Court, not this court.45

A petition for a writ of certiorari by the Supreme Court was filed on March 21, 2016.46 This was followed by a total of 22 amicus briefs from companies, trade groups, and law professors, all of which urged the Supreme Court to take up the appeal.47 The briefs echoed many of the concerns that had been voiced by the Federal Circuit and raised some new ones. Unfortunately, the Supreme Court chose to ignore these requests and denied the petition.48

Conclusion

From a narrow legal perspective, the denial of the petition for certiorari may seem warranted. The Ariosa case was essentially a replay of the issues considered by the Supreme Court in its Mayo and Myriad decisions. However, one would have hoped that the objections raised by the Federal Circuit and by all of the amici that filed briefs would have given the Court reason to reassess the breadth of its decisions and take up the appeal.

What remains is a series of unanswered and troubling questions. Did the Supreme Court really intend to invalidate thousands of issued patent claims and overturn law established by decades of Federal Circuit precedent? Did it appreciate that its decisions undermine biotechnology companies that have been founded based on that law and that these companies require it to flourish? Has the Court focused on the high costs to consumers of patented assays and treatments and lost sight of the fact that the costs are temporary and that, in the absence of patent protection, the assays and compositions might not exist at all?

Whatever the answers to these questions may be, the denial of certiorari is a signal that biotechnology companies must now develop strategies to operate in the presence of a Supreme Court that appears willing to sacrifice innovation for objectives that it considers to be of greater value.

Endnotes

1. See Sequenom, Inc. v. Ariosa Diagnostics, Inc., SCOTUSblog, http://www.scotusblog.com/case-files/cases/sequenom-inc-v-ariosa- diagnostics-inc/ (last visited Mar. 17, 2017) [hereinafter Ariosa SCOTUSblog Case Page].

2. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012).

3. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

4. See, e.g., Michael Sanzo, Genetic Technologies Ltd. v. Merial L.L.C.: Gene-Based Assays in the Wake of Mayo, 35 Biotechnology L. Rep. 89 (2016).

5. 566 U.S. 66.

6. 133 S. Ct. 2107.

7. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014).

8. Id. at 2355; see also Genetic Techs. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1374 (Fed. Cir. 2016).

9. Alice, 134 S. Ct. at 2355.

10. See Michael A. Sanzo, The Patenting of Gene Based Diagnostic Assays in a Post Mayo and Myriad World, 16 J. Marshall Rev. Intell. Prop. L. 1, 4–5 (2016).

11. Id. at 16.

12. 774 F.3d 755 (Fed. Cir. 2014).

13. 750 F.3d 1333 (Fed. Cir. 2014).

14. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

15. 818 F.3d 1369 (Fed. Cir. 2016).

16. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1286–87 (Fed. Cir. 2015) (Lourie, J., concurring).

17. Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc. (IVT v. LTC), 827 F.3d 1042 (Fed. Cir. 2016). The abbreviations chosen by the court were due, in part, to corporate name changes and are of no importance to the present discussion.

18. Id. at 1045 (involving U.S. Patent No. 7,604,929).

19. Id.

20. Id. The claims at issue had previously been found to be valid in a Federal Circuit case in which patent eligibility was not considered. See Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922 (Fed. Cir. 2012).

21. Celsis In Vitro, Inc. v. CellzDirect, Inc., 83 F. Supp. 3d 774 (N.D. Ill. 2015).

22. Id. at 783–84 (emphasis added) (footnote omitted).

23. 333 U.S. 127 (1948).

24. 437 U.S. 584 (1978).

25. See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79, 82–83 (2012); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013); and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358, 2360 (2014).

26. IVT v. LTC, 827 F.3d 1042, 1048 (Fed. Cir. 2016).

27. Later, the court stated: “At step one, therefore, it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Id. at 1050. Again, this seems to be more of a whole-claim approach to patent eligibility than a dissection of claims on an element-by-element basis. It also seems somewhat inconsistent with prior approaches by both the Supreme Court and Federal Circuit. See, e.g., Funk Bros., 333 U.S. 127; Parker v. Flook, 437 U.S. 584; Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

28. IVC v. LTC, 827 F.3d at 1048 (citations omitted).

29. 561 U.S. 593 (2010). Under this test, a claim is patent eligible if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing. It would have been a much clearer decision if the court had relied on this test to distinguish the present holdings from those in its prior decisions.

30. IVC v. LTC, 827 F.3d at 1050.

31. Id. at 1051 (citations omitted).

32. This was not the actual approach taken by the court. However under Bilski v. Kappos, 561 U.S. 593, it is still a viable means for distinguishing between patent-eligible and patent-ineligible claims.

33. Jason Rantanen, Section 101—Pivotal Moment for Clarity on Patent Subject Matter Eligibility, Patently-O (Apr. 21, 2016), http://patentlyo.com/patent/2016/04/section-subject-eligibility.html.

34. DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014).

35. Id. at 1248–49.

36. Id. at 1258–59. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709 (Fed. Cir. 2014), was a case in which claims were found to be patent ineligible.

37. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016).

38. Id. at 1335–36.

39. Id.

40. BASCOM Global Internet Servs., Inc. v. AT&T Mobility LLC, 107 F. Supp. 3d 639 (Fed. Cir. 2016).

41. Id. at 646.

42. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282 (Fed. Cir. 2015).

43. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1380 (Fed. Cir. 2015) (Linn, J., concurring) (citation omitted).

44. Ariosa, 809 F.3d at 1285 (Lourie, J., concurring).

45. Id. at 1287 (Dyk, J., concurring).

46. See Ariosa SCOTUSblog Case Page, supra note 1.

47. Id.

48. Id.

Michael A. Sanzo

Michael A. Sanzo is a patent attorney working in the areas of chemistry, biotechnology, and pharmaceuticals.