Page 10 - Litigation

S10 | MONDAY, APRIL 13, 2015 | Litigation
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Patent Eligibility
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ing,” and “predicting” steps simply tell users to apply the natural law and do not add any- thing to allow the process to qualify as patent eligible.
Amplifying and Detecting DNA. Courts have also addressed claims that, in addi- tion to correlation steps, also require cer- tain steps involving amplifying, sequencing and/or hybridizing DNA. In Ariosa Diagnostics v. Sequenom, for example, the district court analyzed patent claims directed to certain methods of amplifying and detecting cell-free fetal DNA (cffDNA). The parties agreed that neither cffDNA nor the discovery of cffDNA in maternal plasma or serum was patentable, because the presence of cffDNA in maternal plasma or serum is a natural phenomenon. The issue before the court was whether method claims reciting the steps of “ampli- fying a paternally inherited nucleic acid from the serum or plasma sample” and “detecting the presence of a paternally inherited nucle- ic acid of fetal origin in the sample” were patent eligible.23 The court held they were not, finding that the claimed processes at issue—apart from the natural phenomenon of paternally inherited cffDNA—involve no more than well-understood, routine, con- ventional activity, previously engaged in by those in the field. In addition, the court considered whether the claims posed a risk “of preempting a law of nature, natural phe- nomenon, or abstract idea,” and found that they did because alternative methods for detecting cffDNA were “not commercially viable” and “the effect of the patent in practice would be to preempt all uses of the natural phenomenon.”
In other cases—Genetic Technologies v. Agilent Technologies24 and Genetic Technolo- gies v. Bristol-Myers Squibb25—two different courts considered a method claim involving “amplifying genomic DNA with a primer pair that spans a non-coding region sequence” and then “analyzing the amplified sequence to detect the [target].”26 In Agilent, the court held that the claim was arguably limited to a pat-
Spoliation
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messages, litigants should make use of all the tools at their disposal to gather them in discovery. For instance, interrogatories can be used to determine whether and how parties used such apps and to gather informa- tion that will inform the types of document requests that may yield relevant information. Document requests should include requests for self-destructing messaging app messages and other electronic information (e.g., date, time, and sender) regarding these messages. Subpoenas to third parties that may pos- sess data relating to the messages should be considered. Depositions can be used to obtain testimony about both the use of such apps and the underlying facts that may have been contained in any messages, particularly when self-destructing message apps work as
entable application of natural law, noting that “the application of primer pair amplification to intron sequences ... may well have been ‘novel and unconventional’ [and] whether those in the field would consider applying genomic amplification to non-coding regions conventional or routine is a factual question better addressed at a later stage.” In Bristol- Myers, however, the court concluded that “the ‘amplifying’ step is insufficient to meaningfully limit the claims” because “the ‘said primer pair’ limitation merely recites the natural phe- nomenon itself—the linkage correlation—just as the ‘wherein’ steps in Mayo recited the characteristics of the metabolite correla- tions.” The court in Bristol-Myers concluded that the “primer-pair” limitation merely “sets forth a condition that is inherently required in order to implement the natural law and, therefore, does nothing to impart an ‘inven- tive concept.’”
Sequencing and Hybridizing DNA. Simi- larly, in University of Utah Research Founda- tion v. Ambry Genetics, the court concluded that certain method claims involving the use of BRCA1 or BRCA2 sequences were not patent eligible, where the only “inventive concepts” in the claims at issue were the patent ineligible naturally occurring BRCA1 and BRCA2 sequences themselves.27 The court found that the claimed steps relating to “DNA amplification, sequencing, compari- sons, detecting alterations in sequences, [] hybridizing probes to alleles” and “design- ing or using probes, primers, or arrays” were merely “conventional activities that were well-understood and uniformly employed by those working with DNA.” Because the claims covered the use of PCR, “the most widely used means to amplify DNA,” the court held that the claims preempted the field as they would “effectively construct a wall around the naturally occurring BRCA1 and BRCA2 genetic sequences.”
Conclusion
Following the Supreme Court’s decisions in Mayo and Myriad, federal courts have ana- lyzed the patent eligibility of certain nature- based claims, including claims directed to
advertised and electronic records and data no longer exist.
Technology Outpacing The Law
Self-destructing messaging apps create new issues for attorneys advising clients on both document retention requirements and efforts to obtain discovery. The increas- ing popularity of these apps may bring the issues before courts soon. In the meantime, litigators should make themselves knowledge- able about the technology and proceed cau- tiously given the uncertain treatment courts may afford self-destructing message apps in addition to the uncertainty surrounding a message’s longevity and obtainability. Courts and lawmakers should also carefully consider the ramifications of rigidly apply- ing precedent that may be outdated in the context of the new realities of communication methods.
compositions reflecting genetic information (e.g., certain primers, man-made mutations and clones) and method claims involving natural materials and biomolecules (e.g., certain methods for correlating, amplifying and sequencing DNA). As the PTO’s Guid- ance document demonstrates, however, there are numerous other types of nature-based claims—including claims directed to certain bacterial mixtures, genetically modified bac- teria, purified proteins and antibodies—many of which are likely to be litigated at both the Patent Office and in the courts in the years to come.
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1. Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289, 1296 (2012).
2. 133 S. Ct. 2107, 2120 (2013).
3. 79 Fed. Reg. 74618-33 (Dec. 16, 2014) (to be codified at 37 C.F.R. pt. 1). The Guidance directs patent examin- ers to determine whether the claim is directed to a pro- cess, or composition of matter. If it is, examiners must determine if the claim is directed to a law of nature or natural phenomenon. For nature based products to meet eligibility criteria, the claim must recite elements that amount to “significantly more” than the natural product or law of nature.
4. See Univ. of Utah Research Found. v. Ambry Genet- ics (In re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litig.), 3 F. Supp. 3d 1213 (D. Utah 2014); In re Ros- lin Inst. (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014); In re Bentwich, 566 F. App’x 941 (Fed. Cir. 2014).
5. See Ambry Genetics, 3 F. Supp. 3d 1213; Genetic Techs. v. Lab. Corp. of Am. Holdings, 2014 U.S. Dist. LEXIS 122780 (D. Del. Sept. 3, 2014); Genetic Techs. v. Bristol- Myers Squibb, 2014 U.S. Dist. LEXIS 154443 (D. Del. Oct. 30, 2014); Genetic Techs. v. Agilent Techs., 24 F. Supp. 3d 922 (N.D. Cal. 2014); Ariosa Diagnostics v. Sequenom, 19 F. Supp. 3d 938 (N.D. Cal. 2013).
6. 133 S. Ct. at 2116.
7. 35 U.S.C. §101 (2012).
8. 133 S. Ct. at 2116.
9. Id.
10. See Univ. of Utah Research Found. v. Ambry Genet-
ics, 3 F. Supp. 3d 1213, 1266 (D. Utah 2014), aff’d, 774 F.3d 755, 761 (Fed. Cir. 2014). The claim at issue recited:
A pair of single-stranded DNA primers for deter- mination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction, the se- quence of said primers being derived from hu- man chromosome 17q, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.
11. 3 F. Supp. 3d at 1260-62.
12. 774 F.3d at 760.
13. Id. at 761.
14. Ass’n for Molecular Pathology v. U.S. Patent &
Trademark Office, 689 F.3d 1303, 1310 (Fed. Cir. 2012) aff’d in part, rev’d in part sub nom. Ass’n for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013).
15. Id. at 1336.
1. Bruno J. Navarro, “Mark Cuban takes on Snapchat with new messaging app,” CNBC, Aug. 27, 2014, http:// www.cnbc.com/id/101952557.
2. Aaron Timms, “Mark Cuban’s Plan for Limiting Scope of Discovery in Lawsuits,” Inst. Inv., Sept. 10, 2014, http://www.institutionalinvestor.com/article/3378986/ banking-and-capital-markets-trading-and-technology/ mark-cubans-plan-for-limiting-scope-of-discovery-in-law- suits.html#.VJg65QAY.
3. Gillian Wong, “Alibaba Deal Values Snapchat at $15 Billion,” Wall. St. J., March 12, 2015, http://www. wsj.com/article_email/alibaba-invests-in-snapchat- 1426128199-lMyQjAxMTE1MDEyMjMxODI1Wj.
4. Zubulake v. UBS Warburg, 220 F.R.D. 212, 216 (S.D.N.Y. 2003) (quoting West v. Goodyear Tire & Rubber, 167 F.3d 776, 779 (2d Cir. 1999)).
5. Id. (quoting Fujitsu v. Fed. Exp., 247 F.3d 423, 436 (2d Cir. 2001)).
6. No. 10-cv-1090-ES-SCM, 2013 WL 1285285, at *2 (D.N.J. March 25, 2013).
7. Id. at *3, *5.
8. Id. at *3 (quoting Scott v. IBM, 196 F.R.D. 223, 248 (D.N.J. 2000)).
9. 736 S.E.2d 699, 703 (Va. 2013).
10. N.Y.S. Bar Ass’n, Com. & Fed. Litig. Sec., Social Media Ethics Guidelines 11 (March 18, 2014), http:// www.nysba.org/Sections/Commercial_Federal_Litiga- tion/Com_Fed_PDFS/Social_Media_Ethics_Guidelines. html.
11. Cyber Dust’s responses to frequently asked ques-
16. 750 F.3d 1333 (Fed. Cir. 2014). A claim at issue recit- ed: “A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.”
17. 2015 WL 728501, at *26 (W.D. Wis. Feb. 19, 2015). The claim at issue recited:
A method for quantifying at least one metabolite in a biological sample comprising the steps of ... providing one biological sample ... providing one set of known normative data specific to a reference metabolite ... contacting the biologi- cal sample with an analytical device ... detecting the presence of at least one test metabolite in the biological sample with the device ... normalizing the biological sample ... and quantifying the con- centration of at least one test metabolite in the biological sample by comparing a ratio between the concentration of the test metabolite from the patient to the set of known normative data spe- cific to the reference metabolite concentration.
18. 689 F.3d at 1309.
19. Id. at 1334.
20. 496 F. App’x 65, 66 (Fed. Cir. 2012).
21. Id. at 71.
22. 2014 U.S. Dist. LEXIS 122780, at *40-41. A claim at
issue recited:
A method to predict potential sprinting, strength, or power performance in a human comprising: ... predicting the potential sprinting, strength, or power performance of the human, wherein the presence of two copies of the 577R allele is positively associated with potential sprinting, strength, or power performance.
23. Ariosa Diagnostics v. Sequenom, 19 F. Supp. 3d 938, 941 (N.D. Cal. 2013). A representative claim at issue recited:
A method for detecting a paternally inherited nucleic acid of fetal origin performed on a ma- ternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.”
24. 24 F. Supp. 3d 922 (N.D. Cal. 2014).
25. 2014 U.S. Dist. LEXIS 154443 (D. Del. Oct. 30, 2014). 26. 24 F. Supp. 3d at 926. The claim at issue recited:
A method for detection of at least one coding region allele of a multi-allelic genetic locus com- prising ... amplifying genomic DNA with a primer pair that spans a non-coding region sequence ... and ... analyzing the amplified DNA sequence to detect the allele.
27. 3 F. Supp. 3d at 1269. The claim at issue recited:
A method for screening germline of a human sub- ject for an alteration of a BRCA1 gene which com- prises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline se- quences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
tions: Why does Cyber Dust slow down?, http://cyber- dust.com/faqs.html.
12. Cyber Dust’s responses to frequently asked ques- tions: When exactly do my messages disappear?, http:// cyberdust.com/faqs.html.
13. Confide’s responses to frequently asked ques- tions: How secure is this and do messages really disap- pear?, https://getconfide.com/faq.
14. See, e.g., Sophie Curtis, “Is Snapchat as private as it seems?,” The Telegraph, March 12, 2014, http://www. telegraph.co.uk/technology/internet-security/10692856/ Is-Snapchat-as-private-as-it-seems.html.
15. “Hackers get their hands on 100K ‘deleted’ Snap- chat images,” FoxNews.com, Oct. 12, 2014, http://www. foxnews.com/tech/2014/10/12/hackers-eye-release-100k- deleted-snapchat-images/.
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