Sounding an appropriately alarmist note, Bloomberg BNA has issued the results of a study on how the U.S. Patent and Trademark Office is administering its March 4, 2014 Guidance on subject matter patent eligibility developed in view of the Supreme Court's decisions in Mayo v. Prometheus and AMP v. Myriad Genetics. Entitled "Stopped at the Threshold: The Practical Implications of the Supreme Court's Mayo and Myriad Decisions on Biotechnology Patent Practices" (an executive summary of this Report can be found here), and written by Matthew McFarlane, Tara Guffrey Sharp, and John T. Aquino, the byword of the report is that there will be continued uncertainty in subject matter eligibility under these guidances unless and until the Office corrects them (which while unlikely it may ultimately do; the deadline for providing comments on the guidance has been extended to July 31, 2014; see "USPTO Extends Deadline for Providing Feedback on Myriad-Mayo Guidance"). But with Legal Department member June Cohan calling these cases a "game changer" and the guidance a "course correction," it is not hyperbole for the report to state that the guidance has "rewritten the playbook," that "[t]he decisions and the guidance appear to have shaken the life sciences industry at its roots" and that "[the decisions and guidance] could affect the public's access to new and effective medicines and therapeutic approaches in the future."
Congress therefore would appear to have appreciated that it could have restricted patenting for isolated DNA molecules corresponding to human genes such as those claimed [in the Myriad case], yet specifically chose to permit such patents to preserve "economic viability of the biotechnology industry."
The final portion of this Section is a description of the Guidance document itself, with examples from the guidance and PTO materials (PowerPoint presentations, etc.) issued by the Office to help examiners and the public to understand the guidance; the Report notes that "some attorneys felt [that these slides] made the situation more confusing."
Section II shows the results of the survey of PTO actions with regard to "product of nature" claims. The authors reviewed 5,200 applications filed "on or after" April 1, 2011 from about 1,500 "unique [patent] families." Of these, about 1,000 prosecution file histories were reviewed and about 35% of these contained subject matter-eligibility rejections based on Mayo and 23% contained such rejections based on Myriad. The Mayo-based rejections generally involved claims to "measurement of biologically-relevant (sic) molecules in a biological sample" that "will correlate with a definable aspect of patient care." Examples provided in the Report include the existence of a cell-surface marker on a tumor cell that "could identify a patient who would benefit from [a particular] treatment" and other measurements relating to "susceptibility to disease, abnormal genetic sequences, [and] concentrations of relevant metabolites." The bases for rejection is that claims to such methods rely on a "law of nature," based on Mayo. In order to overcome such a rejection an applicant must establish that the claims recite "something more" than the law of nature that is not "conventional or obvious." In the survey, the authors found that making the required showing was not a typical outcome. Using a hypothetical claim directed to a method for detecting a genotype associated with susceptibility to a drug (one of the bases for so-called "personalized medicine"), the Report states that "claims of this type are almost always rejected" on the grounds that the applicant has not supplied that ineluctable "something more" the PTO discerns is mandated by the Mayo decision. Examples of limiting amendments found sufficient to overcome these rejections are provided in this Section of the Report but, as noted by the authors, these "cures" are often worse than the purported "disease," because they involve introducing limitations that can raise validity (under Section 103 or 112) and enforcement (divided infringement) concerns.
With regard to rejections based on Myriad, as is clear from the Guidance, the Office has expanded the scope of Section 101-based rejections far beyond the borders of the Court's decision related to human genomic DNA. Under current Office practice, all "naturally occurring" compounds are presumptively patent-ineligible (in contrast to earlier PTO practice; elsewhere in the Report the authors note that the Office just recently issue its 50,000th "DNA-related patent"). The Report further notes that while many of the claims of these patents were invalidated by the Court's Myriad decision, the timing of the decision (well after the time of "relatively old" biotech patenting involving cloning genes encoding known proteins having particular desirable functions, such as erythropoietin and tissue plasminogen activator) made its effects (if cabined to genomic DNA) minimal and the effect on non-DNA biotechnology patents would be "minor or non-existent." But that isn't how the Office has applied the Myriad decision, and this policy decision impacts (negatively) the protection available to "proteins, antibodies and polypeptides" (sic), as well as "plants, bacteria and many bacterial compounds [such as antibiotics], and chemical and metallic compounds." While the Report focuses on the biotechnology industry, in principle the Office would find a claim to a purified component of crude oil useful as a lubricant to be patent-ineligible under its interpretation of the Myriad decision.
The Report also notes that combinations of naturally occurring compounds may also not be patentable even if the combination does not occur in nature (based, no doubt, on Funk Bros. v. Kalo Inoculants and the Office's gunpowder example, where the combination of charcoal, sulfur and saltpeter is not patent eligible as a mere combination). This subject matter encompassed by the Office's interpretation of the proper standards for patent eligibility is "vast," according to the Report and puts many if not almost all composition of matter claims claiming a "product of nature" at risk. In a series of "horror stories," the Report outlines the type of mischief eminently predictable from the Court's decision; in one, the Examiner refused to acknowledge any difference between a claim that encompassed isolated genomic DNA versus one limited to cDNA (in clear contradiction to the Court's instructions provided that the genomic DNA comprised even one intron), while in other cases kits were deemed not patent-eligible. On the other hand, trivial modifications to natural products, such as attaching a detectable label have been deemed enough to pass Section 101 muster. This Section ends with a Table comprising "thumbnail" analyses of the grounds of rejection in the file histories of patents containing Section 101 rejections based on Myriad or Mayo; these sketches contained several examples of claims otherwise allowable were later rejected under Section 101.
Section III contains "comments" from selected patent practitioners, the comments reflecting varying levels of disdain, disgust, despair, and dread over the Supreme Court decisions and how the Office has decided to implement them. These practitioners note several instances where the Office has applied these decisions to subject matter (such as methods for manufacture and methods of treatment) far outside the scope of the judicial exceptions to patent eligibility. Several of them note the practical consequences of the Office's actions, including protracted prosecution and appeal to the Patent Trial and Appeal Board (and, it must be contemplated, eventually to the Federal Circuit). Some practitioners note that individual examiners have shown "greater openness" and more "flexibility" than the guidances would suggest. One practitioner recalled the tendency for companies to "vote with their feet" over the Bush Administration's stem cell restrictions and relocate to "other jurisdictions" (i.e., abroad), taking those jobs and that innovation with them. There is also some justified grumbling about the subjectivity the current guidance introduces into the law and that the guidance (as do the Court's decisions) impermissibly "read out" the word "discoveries" from the statute. But at least one practitioner thought the problem would resolve itself, because what is now "state of the art" in biotechnology is no longer monoclonal antibodies and isolated nucleic acids but compounds that have been sufficiently modified that they should qualify even under the guidance's rigid standard.
Section IV contains a synopsis of the comments elicited by the Office in its April 16th Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting and its May 9th forum on the guidance.
The PTO's guidance to examiners based on the Myriad and Mayo decisions confirms a shrinking scope of patent-eligible subject matter relating to life sciences and biotechnology concerns. It also establishes a disparity in substantive patent law that moves patent examination in the PTO away from the standards that are accepted under the patent laws of virtually all major U.S. trading partners. Life sciences companies, facing the possibility that U.S. patent law will not allow them to recoup the millions of dollars and years of research spent on getting a life-changing therapy from lab to market, may be less likely to pursue innovative technology or may take it to other countries where the technology more easily could find patent protection.
The Supreme Court decisions and PTO guidance have prompted a re-look at the issues of Chakrabarty, reflecting decades of case law, regulatory decisions and scientific advances.
The PTO has acknowledged that more clarity is needed. It also may be that this reconsideration is a natural progression towards a new standard that appropriately promotes further investment in innovation.
It remains to be seen how future action in the PTO and litigation in the courts will alter the situation, or whether, as the U.S. Constitution provides, Congress will step in to further ''promote the progress of science and useful arts'' relating to valuable innovation in biotechnology and life sciences.
The Report provides important information for anyone thinking of submitting comments to the PTO or trying to overcome a Section 101 ground of rejection (but in truth it is more a case of "misery loves company" than any practical advice). It also is solid evidence that the Office has fatally overreached with this guidance, and as with the infamous "claims and continuation" rules needs to be challenged until the Office realizes how complicit it is being with the Supreme Court in negating the Constitutional mandate that the patent laws "promote the progress . . . of the useful arts."
Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease). View the complaint here.
Allos Therapeutics Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
• Plaintiffs: Allos Therapeutics Inc.; Sloan-Kettering Institute for Cancer Research; Southern Research Institute; SRI International Inc.
• Defendants: Teva Pharmaceuticals USA Inc.; Sandoz Inc.; Fresenius Kabi USA LLC; Dr Reddy's Laboratories Ltd; Dr Reddy's Laboratories Inc.
Infringement of U.S. Patent Nos. 6,028,071 ("Purified Compositions of 10-propargyl-10-deazaaminopterin and Methods of Using Same in the Treatment of Tumors," issued February 22, 2000), 7,622,470 ("Treatment of T-cell Lymphoma Using 10-porpargyl-10-deazaaminopterin," issued November 24, 2009), and 8,200,078 (same title, issued October 30, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Allos' Folotyn® (pralatrexate, used to treat patients with relapsed or refractory peripheral T-cell lymphoma). View the complaint here.
Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of CFT's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia). View the complaint here.
Janssen Pharmaceuticals, Inc. et al. v. Roxane Laboratiores, Inc.
• Defendant: Roxane Laboratiores, Inc.
Infringement of U.S. Patent Nos. RE39,593 ("1-Phenyl-3-Dimethylaminopropane Compounds With a Pharmacological Effects," issued April 24, 2007), 7,994,364 ("Crystalline Forms of (-)-(1R,2R)-3-(3-Dimethylamino-1-Ethyl-2-Methylpropyl)-Phenol Hydrochloride," issued August 9, 2011), and 8,536,130 (""Use of 1 Phenyl-3-Dimethylamino-Propane Compounds for Treating Neuropathic Pain," issued September 17, 2013), licensed to Janssen, following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Janssen's Nucynta® (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults). View the complaint here.
Cephalon, Inc. v. Actavis Laboratories FL, Inc. et al.
• Defendants: Actavis Laboratories FL, Inc.; Actavis Inc.; Actavis Pharma, Inc.; Watson Laboratories, Inc.
Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001), 6,264,981 ("Oral Transmucosal Drug Dosage Using Solid Solution," issued July 24, 2001), and 8,119,158 ("Effervescent Oral Fentanyl Dosage Form and Methods of Administering Fentanyl," issued February 21, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer). View the complaint here.
Teva Women's Health, Inc. et al. v. Watson Laboratories, Inc. et al.
• Plaintiffs: Teva Women's Health, Inc.; Teva Branded Pharmaceutical Products R&D, Inc.
• Defendants: Watson Laboratories, Inc.; Actavis Pharma, Inc.; Actavis, Inc.
Infringement of U.S. Patent Nos. 8,415,332 ("Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens," issued April 9, 2013) and 8,450,299 (same title, issued May 28, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Teva's Quartette® (levonorgestrel/ethinyl estradiol and ethinyl estradiol, used for oral contraception). View the complaint here.
July 20-22, 2014 - 2014 Annual Meeting & Conference (National Association of Patent Practitioners) - Alexandria, Virginia.
As we reported earlier this week, the period for submitting written comments to the U.S. Patent and Trademark Office regarding the Office's Myriad-Mayo guidance memorandum has been extended to July 31, 2014. The Office initially announced a soft deadline of the end of June for submitting written comments at its May 9th forum on the guidance memorandum (officially entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products"). On the USPTO webpage regarding the guidance, the Office noted that "[i]n response to several requests from our stakeholders for additional time to submit comments, the Office has extended the period for submission of public comments until July 31, 2014" (emphasis in original). At the 2014 BIO International Convention, which took place this week in San Diego, Drew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took part in a BIO session that provided some initial observations regarding the written comments that have been submitted to date. Patent Docs will provide a report on that session in our "Docs @ BIO" series, which continues next week.
Earlier today, BIO 2014 presented a session entitled "Navigating Patent Challenges Under the America Invents Act" during which the presenters analyzed the differences between patent challenges in Federal District Court and before the Patent Trial and Appeals Board ("PTAB"). The panelists that discussed this issue were Judge Dana Sabraw of the U.S. District Court for the Southern District of California; Lead Administrative Patent Judge Michael Tierney of the PTAB, Trial Section; and Cliff Ford, Executive Director and Senior Patent Counsel at Isis Pharmaceuticals, Inc. Meaghan Kent of Venable LLP moderated the event.
Ms. Kent began by providing some interesting statistics. As of June 18, 2014, there have been 1,542 Inter Partes Review ("IPR") petitions filed, and of those, 87 related to biotechnology and pharmaceutical patents. Even though this only represents 6% of the total, it is much more than anyone expected when the America Invents Act ("AIA") was passed. In addition, the statistics suggest that IPRs are becoming more popular every month. IPR petitions make up about 88% of all post-grant patent challenges, while the Transitional Program for Covered Business Method Patents ("CBM") constitutes about 12%. There have been no Post-Grant Review ("PGR") petitions to date, most likely due to the fact that they are only available to patents issuing from applications filed since March 16, 2013.
Judge Tierney then provided an overview of the IPR and PGR proceedings. As readers of this blog are likely aware, IPR petitions can only include challenges under 35 U.S.C. §§ 102 and 103, and be based only on patents, published applications, and printed publications. The legal standard for institution is a "reasonable likelihood" that the petitioner would prevail with respect to at least one of the claims. As Judge Tierney explained, if the decision maker is on the fence (50%), the case should be instituted. This is in contrast to the standard for PGR, which is "more likely than not" that at least one claim is unpatentable. This is a higher threshold, because if the decision maker is on the fence (50%), the proceeding should not be instituted. Instead, it is a greater than 50% standard. In addition, unlike IPRs, PGR challenges can be based on 35 U.S.C. §§ 101, 102, 103, and 112 (except for best mode), and the 102 and 103 references are not as limited as for IPRs. Judge Tierney noted that PGR might prove valuable for challenging biotechnology patents because of the section 112 issues that they can present.
Judge Tierney than answered a series of questions from the audience. One participant inquired whether the denial of a PGR petition would estop a challenger from filing an IPR. The simple answer was that if the review was not instituted, there would be no final written decision, and therefore estoppel would not apply. The next question dealt with whether the PTAB has ever proceeded to a hearing despite a settlement agreement by the parties. Judge Tierney explained that such a circumstance is rare, but it has happened in at least one CBM review in which the parties settled on the eve of the hearing. Interestingly, because of the settlement agreement, when the case went forward, the petitioner did not participate. Therefore, only the patent holder was present at the hearing. There was question whether the Board has every handled section 112 issues in IPR proceedings. Even though it is very rare, it has come up in the context of claim construction. For example, Judge Tierney described a case in which a district court had already determined that the claims did not satisfy 35 U.S.C. § 112, ¶ 6 because of a lack of structure in the specification. Even though that court's determination was not binding on the PTAB because of the different standards used by the two institutions, the PTAB also found it could not construe the claims, and therefore could not apply it to the prior art. Finally, someone asked if the Myriad guidelines would be controlling on the PTAB. Judge Tierney explained that the guidelines were just interpretations of case law, so they might be persuasive, but they would not be binding. Whereas those in attendance appeared to approve of this answer, it is unclear if it will be any solution to the problem. After all, eligibility challenges are not permitted in IPRs.
Judge Tierney next outlined the IPR proceeding. With regard to whether a patent owner should file a response before institution, he explained that there were reasons for either strategy. For example, if the patent owner didn't want to tip his hand, he might not want to file a response. On the other hand, if there were serious holes in a petitioners challenge, it might be beneficial to point this out to the Board. Judge Tierney also explained that the institution was on a claim by claim basis and that the PTAB was not required to institute the proceedings based on all ground found in the petition. Part of the reason is because of the short timeframe to resolution – one year. Someone in the audience asked whether there would be estoppel to the grounds not instituted. Judge Tierney admitted that this has not come up yet, but that it would probably be dealt with on a case-by-case basis. Judge Sabraw, however, indicated that district courts would probably apply the estoppel because the entire point of the IPRs is to streamline litigation, and therefore estoppel will likely be liberally applied. A discussion about whether the PTAB was a "death squad" followed. Judge Tierney stated that he believed that, even though initially the PTAB appeared pro-petitioner, things were getting better for the patent owner. For example, IPRs are being instituted less, and the patent owners are winning more often – 8 final written decisions have now left the patent unscathed.
The topic then switched to pending legislation. Judge Sabraw was asked about the 60-70% pass rate to grant motions to stay. He pointed out that in his approximately 10 years on the bench, these new proceedings are a "game changer." In determining whether the institute a stay, Judge Sabraw explained that district courts previously looked to three factors; whether it will streamline the issues in the case, the status of the case, and the prejudice to the parties. In the case of IPRs, he indicated that the streamlining factor was neutral, and required a prediction of whether the PTAB would alter the patent. As for the status of the case, Judge Sabraw pointed out that it was important to bring the petition early. If there has been no claim construction and minimal discovery, the chance of a stay would be significantly higher. With regard to the impact on the non-moving party, he pointed out that in the case of non-practicing entities ("NPEs"), there would generally be no real prejudice. Finally, Judge Sabraw explained that the AIA required a fourth factor when considering a stay – whether the stay will reduce the burden of litigation. This is always "yes," according to the judge, because the litigants will not need to proceed in two forums, and it will decrease the resources required by the district courts. On the subject of stays, Mr. Ford explained that defendants will almost always want a stay, because all of the focus for the next year will be on the validity of the patent, and not on infringement. He did, however, admit that there were cases in which the defendant might not want a stay, such as when inventorship was an issue, so that the notebooks of the patent owner might be desired, or when the accused infringer has deep pockets and wants to keep the pressure on the patent owner.
When asked which forum is better, Judge Sabraw acknowledged that the courts could improve, but that there were already signs that they were. For example, his court in San Diego strives to complete trial in 18 months. This includes streamlining discovery to avoid the proverbial "David and Goliath" effect. Also, the introduction of the patent pilot program and the proliferation of local patent rules were cited as a positive step by the judge. In response to the same question, Judge Tierney explained that the PTAB was meant to be an alternative to litigation. Even though the reports are currently only anecdotal, he believes that IPRs must be cheaper than litigation, and they certainly are timelier. Mr. Ford hypothesized that the accused infringer would almost always prefer the PTAB. This is because the preponderance standard is much easier to meet, and the use of the broadest reasonable interpretation for claim construction is advantageous. However, there are times where presenting the issues to a jury might be advantageous over the patent judges. The only real concern is the estoppel concern, but as Mr. Ford pointed out, it a petitioner loses at the PTAB, they were likely going to have lost at the district court also.
In making the case for who is better suited to review the validity of a patent, Judge Tierney pointed to the patent judges years of experience reviewing patents, which makes them well suited to make these determinations. Judge Sabraw acknowledged that district court judges were not specialists, but that they bring their own skills to bear on the issue. For example, even though trials may be longer and more expensive, both sides have an adequate opportunity to make their case. Also, federal judges are able to use the skills that they have obtained hearing the various cases that they do. Finally, when asked whether these new post-grant review proceedings were good for patents, Mr. Ford pointed out that they were meant to troll-busting provisions, and so they have been successful. However, it was the high tech sector that wanted these procedures, but the problem is that the biotech and pharmaceutical community is stuck with them now also.
The U.S. Patent and Trademark Office (USPTO) wasted no time providing guidance to its examining corps regarding the recent Supreme Court decision in Alice Corp. v. CLS Bank International. Just one week after the Justices struck down all of Alice's method, device, and system claims as being patent-ineligible under 35 U.S.C. § 101, the USPTO has published a memorandum with its preliminary examination instructions.
As an initial matter, the memorandum makes it clear that the decision "neither creates a per se excluded category of subject matter, such as software or business methods, nor imposes any special requirements for eligibility of software or business methods." Instead, examiners are now to apply the framework set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., "to analyze all claims directed to laws of nature, natural phenomena, and abstract ideas for subject matter eligibility under 35 U.S.C. § 101."
This unifies the analysis in two ways. First, the same standard is applied to claims with abstract ideas and laws of nature. Previously, the former was evaluated under Bilski and the latter under Mayo. Second, the same standard is to be used for all statutory classes of claims, not just method claims. Before CLS Bank, it wasn't clear that the holdings of Bilski, Mayo, and their § 101 predecessors impacted more than just method claims.
• Mathematical relationships / formulas.
Claims that do not include such limitations should be rejected as being directed to non-statutory subject matter. Of note is that the USPTO does not address whether prior art should be used to establish that an abstract idea is "fundamental" or to determine that an addition limitation is more than routine or conventional.
This brief memorandum provides a glimpse of the immediate impact of CLS Bank in the USPTO -- applicants are likely to have software and business method claims scrutinized carefully in light of these guidelines. For applications already under examination, an applicant's options may be limited.
However, for new applications, the USPTO has provided something of a roadmap with which one can try to avoid CLS Bank rejections. To the extent possible, draft claims to avoid reciting any of the examples of abstract ideas given above. If that is not possible, include limitations that clearly demonstrate how the claimed invention improves a technological process, device or system. Doing so may result in more focused claims, but this approach may be necessary to avoid § 101 roadblocks during prosecution.
Cephalon Inc. v. Actavis Laboratories FL Inc. et al.
• Defendants: Actavis Laboratories FL Inc.; Actavis Inc.; Actavis Pharma Inc.; Watson Laboratories Inc.
Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001), 6,974,590 (same title, issued December 13, 2005), and 8,119,158 ("Effervescent Oral Fentanyl Dosage Form and Methods of Administering Fentanyl," issued February 21, 2012) following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer). View the complaint here.
Novartis AG et al. v. Glenmark Pharmaceuticals Ltd. et al.
• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.
• Defendants: Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics Inc.
Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-Coated Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-Coated Pharmaceutical Compositions," issued January 9, 2001), and 6,306,900 (same title, issued October 23, 2001) following a Paragraph IV certification as part of Glenmark’s filing of an ANDA to manufacture a generic version of Novartis' Myfortic® (mycophenolate sodium, used for the prophylaxis or prevention of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids). View the complaint here.
Infringement of U.S. Patent No. 5,691,336 ("Morpholine Compounds Are Prodrugs Useful As Tachykinin Receptor Antagonists," issued November 25, 1997) following a Paragraph IV certification as part of Fresenius’ filing of an ANDA to manufacture a generic version of Merck's Emend® (fosaprepitant dimeglumine for injection, used in the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin, and to prevent nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy). View the complaint here.
Amarin Pharma, Inc. et al. v. Andrx Labs, LLC et al.
• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendants: Andrx Labs, LLC; Andrx Corporation; Actavis, Inc.
Infringement of U.S. Patent Nos. 8,293,728 ("Methods of Treating Hypertriglyceridemia," issued October 23, 2012), 8,318,715 (same title, issued November 27, 2012), 8,357,677 (same title, issued January 22, 2013), 8,367,652 (same title, issued February 5, 2013), 8,377,920 (same title, issued February 19, 2013), 8,399,446 (same title, issued March 19, 2013), 8,415,335 (same title, issued April 9, 2013), 8,426,399 (same title, issued April 23, 2013), 8,431,560 (same title, issued April 30, 2013), 8,440,650 (same title, issued May 14, 2013), 8,501,225 ("Stable Pharmaceutical Composition and Methods of Using Same," issued August 6, 2013), 8,518,929 ("Methods of Treating Hypertriglyceridemia," issued August 27, 2013), 8,524,698 (same title, issued September 3, 2013), 8,546,372 (same title, issued October 1, 2013), 8,551,521 ("Stable Pharmaceutical Composition and Methods of Using Same," issued October 8, 2013), and 8,617,594 (same title, issued December 31, 2013) following a Paragraph IV certification as part of Andrx’s filing of an ANDA to manufacture a generic version of Amarin's Vascepa® (icosapent ethyl, used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia). View the complaint here.
Spectrum Pharmaceuticals, Inc. et al. v. Ben Venue Laboratories, Inc.
• Defendant: Ben Venue Laboratories, Inc.
Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Ben Venue’s filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer). View the complaint here.
Vanda Pharmaceuticals Inc. v. Roxane Laboratories Inc.
Infringement of U.S. Patent No. 8,586,610 (“Methods for the Administration of Iloperidone,” issued November 19, 2013) in conjunction with Roxane's filing of an ANDA to manufacture a generic version of Novartis' Fanapt® (iloperidone, used for the acute treatment of adults with schizophrenia). View the complaint here.
ALZA Corp. et al. v. Sandoz Inc.
• Plaintiffs: ALZA Corp.; Janssen Pharmaceuticals Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,163,798 ("Methods and Devices for Providing Prolonged Drug Therapy," issued April 24, 2012) 8,629,179 (same title, issued January 14, 2014) following a Paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the Delaware complaint here.
Infringement of U.S. Patent Nos. 5,709,999 ("Linked Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998), 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 5,837,492 ("Chromosome 13-Linked Breast Cancer Susceptibility Gene," issued November 17, 1998), 6,033,857 (same title, issued March 7, 2000), 6,051,379 ("Cancer susceptibility mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for determining the haplotype of a human BRCA1 gene," issued October 5, 2005), 7,250,497 ("Large deletions in human BRCA1 gene and use thereof," issued July 31, 2007), 7,470,510 ("Methods for Diagnosing Cancer and Determining a Susceptibility for Developing Cancer," issued December 30, 2008), 7,622,258 ("Screening Methods and Sequences Relating Thereto," issued November 24, 2009), 7,838,237 (same title, issued November 23, 2010), 7,670,776 ("MYH Gene Variants and Use Thereof," issued March 2, 2010), 7,563,571 (same title, issued July 21, 2009), based on Pathway Genomic’s manufacture, sale, and offer for sale of its BRCATrue and ColoTrue products and services. View the complaint here.
Infringement of U.S. Patent Nos. 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 6,033,857(same title, issued March 7, 2000), 6,051,379 ("Cancer susceptibility mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for determining the haplotype of a human BRCA1 gene," issued October 5, 2005), and 7,250,497 ("Large deletions in human BRCA1 gene and use thereof," issued July 31, 2007) based on Counsyl’s Inherited Cancer Screen, Inherited Cancer Screen, Counsyl Inherited Jewish Screen, Comprehensive BRCA Test, and BRCA1/2 Sequencing Test offerings. View the complaint here.
Vivus, Inc. v. Actavis Laboratories FL, Inc. et al.
Infringement of U.S. Patent Nos. 7,056,890 (“Combination Therapy for Effecting Weight Loss and Treating Obesity, issued June 6, 2006), 7,553,818 (same title, issued June 30, 2009), 7,659,256 (same title, issued February 9, 2010), 7,674,776 (same title, issued March 9, 2010), 8,580,298 (“Low Dose Topiramate/Phentermine Composition and Methods of Use Thereof,” issued November 12, 2013), and 8,580,299 (“Escalating Dosing Regimen for Effecting Weight Loss and Treating Obesity,” issued November 12, 2013) following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Vivus’ Qsymia® (phentermine and topiramate extended-release capsules, used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management). View the complaint here.
The 2014 BIO International Convention has already begun in San Diego, but most of the sessions and forums get underway beginning on Tuesday, June 24, 2014. Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention. For example, today, we focus on issues surrounding post-grant challenges of patents, both in the U.S. and Europe, and on the issues surrounding the regulatory approval of biosimilars. Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth to discuss these sessions (or whatever other topic is of interest to you) (#1337).
Today we highlight two distinct topics that may be of interest to readers of this blog. The first involves the ability to challenge issued patents at the U.S. Patent Office or EPO instead of in the court system. Many detractors of the U.S. patent system have blamed the Patent Office for issuing too many vague or allegedly invalid patents. The AIA set up new and improved mechanisms allowing potential or alleged infringers to request another look by the Office. Of course, EPO has already had a lot of experience with opposition proceedings. A couple of panels will look at the challenges and considerations involving these mechanisms. The second topic does not necessarily implicate intellectual property, but patent attorneys are certainly paying close attention to regulatory approval pathways for biosimilars. All eyes have been focused on the FDA, but so far the mechanisms established for the approval of biosimiars have not been sufficiently utilized. It is therefore useful to look at the scientific and regulatory issues faced by countries outside the U.S.
With regard to post-grant challenges, we first note that Donald Zuhn of Patent Docs fame will be moderating a panel on opposition proceedings at the European Patent Office on Wednesday, June 25, at 4:15 PM to 5:15 PM. The title of this session is "'Chairman, That Patent Should be Revoked!' -- Join the EPO Opposition Mock Workshop and Help Argue the Case." As the name suggests, representatives of the EPO are scheduled to conduct a realistic opposition proceeding to decide the fate of a contested illustrative patent. Both the proprietor and defendant will be represented by European patent attorneys, but attendees are invited to join either party and help debate the case. The session promises to elucidate how opposition proceedings are conducted within the EPO, explore how the validity of patents are determined, and compare the differences with comparable proceedings in the U.S. The speakers for this session are Siobhán Yeats, Director of Biotechnology at the European Patent Office; Reuben Jacob, partner at RGC Jenkins & Co.; and Aylsa Williams, Partner at D Young & Co LLP.
In addition to hearing the comparisons between the EPO and US systems in the previous session, attendees will also be able to hear an in-depth presentation on post-issuance challenges at the United States Patent Office. On Wednesday, June 25, at 10:15 AM to 11:30 AM, the Intellectual Property track will be feature "Navigating Patent Challenges Under the America Invents Act." Biotechnology and pharmaceutical companies are not immune to such challenges, so it is important to understand the intricacies of these relevantly new procedures. Moreover, the Federal Circuit's Fresenius v. Baxter International decision has made the timing of such a challenge an important consideration. Of course, which process is used and how it is defended can affect not only whether suitable patent protection can be maintained, but can limit or expand defenses available either in court or at the Office. This session will assess the risks and benefits associated with the available actions for challenging patent validity at the Office, in the courts, and at the International Trade Commission. The speakers for this session will be Lead Administrative Patent Judge Michael Tierney, Patent Trial and Appeal Board; Judge Dana Sabraw, U.S. District Court for the Southern District of California; and Cliff Ford, Executive Director and Senior Patent Counsel at Isis Pharmaceuticals, Inc. The session will be moderated by Meaghan Kent from Venable LLP.
With regard to the two sessions we are highlighting with regard to the regulation of biosimilars, unfortunately their times overlap (likely because they are in different tracks/forums). First, the Regulatory Review & Approval track will present "Ensuring the Safety and Commercial Success of Biosimilars in the United States" on Tuesday at 1:45 PM to 2:45 PM. The description of the session notes that there is a debate over what approach the FDA and the industry should take to ensure patient safety on one hand, and promoting market competition and continued biomedical innovation on the other. The session promises to explore several critical issues related to safety, naming and traceability, substitution, product drift, and comparability and similarity. There will be a focus on the lessons learned from Europe in the launch of the new class of biosimilar monoclonal antibodies. With regard to issues of naming products, the "unknown" differences between an approved treatment with known process histories and a new product being studied for biosimilarity will be discussed. The speakers for the session are Marcia Horn, President and CEO of ICAN (the International Cancer Advocacy Network), Phillip Schneider, Associate Dean and Professor at the University of Arizona College of Pharmacy; and Robert Yapundich, Board Certified Neurologist with the Neurology Associates, P.A.
At about the same (1:30 PM to 3:30 PM on June 24), the Emerging Opportunities in Global Markets Forum will present "Biosimilars Regulations: A Perspective from Influential Global Regulators." This session will feature regulatory agency officials from around the globe to discuss both scientific and regulatory issues for biosimilars, especially with regard to the WHO draft guidelines. For example, the discussion of approval requirements will address clinical trials, extrapolation of data, and immunogenicity, among other topics. The session promises to also address issues surrounding naming, labeling, and pharmacovigilance. The panel will include Lic. Mikel Arriola, Commissioner at COFEPRIS; and Dirceu Barbano, President of ANVISA; and will be moderated by Christian Lopez-Silva, Partner with Baker & McKenzie, S.C. in Mexico.
We look forward to seeing you at BIO 2014!
The 2014 BIO International Convention begins this week in San Diego. If you are planning on attending, you probably already know that the amount of information and opportunities available at BIO can be daunting. Therefore, Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention. For example, today, we focus on presentations by influential leaders in the Intellectual Property Community. Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth to discuss these sessions (or whatever other topic is of interest to you) (#1337).
In the United States, two of the entities that have the most impact on U.S. patent practice are the United States Patent and Trademark Office and the United States Court of Appeals for the Federal Circuit. And, on the global scale, it can be argued that no organization has more impact on international patent practice than the World Intellectual Property Organization ("WIPO"). Impressively, BIO will feature at least three current or recent leaders of these three organizations. Therefore, attendees will be able to gain insight from the individuals that play (or have played) a major role in each of these three organizations.
First on our list, Judge Randall R. Rader of the Federal Circuit will be providing his view from the bench on recent developments in biotech patent law in the courts and in Congress. This session will be on Wednesday, June 25, from 8:30 AM to 9:00 AM for the Intellectual Property track. Judge Rader recently stepped down from his position as Chief Judge, and was succeeded by now Chief Judge Sharon Prost. Moreover, five days after his presentation at BIO, on June 30, Judge Rader will be retiring from the court. The title of his presentation is aptly named "Welcome and Farewell -- Judge Randall R. Rader." Judge Rader has also been outspoken on the issue of using § 285 fee-shifting as a mechanism for federal courts to combat patent trolls. It will be interesting to see what he has to say on the recent legislative efforts aimed at the same goal. Along those lines, there will be a separate session later that day at 1:45 PM to 2:45 PM on these Congressional efforts. The title of that session will be "As if AIA Hasn't Brought Enough Change -- Patent Litigation Reform is Looming in the US."
Next up, literally, Acting Director Michelle Lee will participate in a session immediately following Judge Rader, from 9:00 AM to 10:00 AM, June 25, entitled "View from the USPTO -- Address by Acting Director Michelle Lee and Discussion of the Myriad-Mayo Guidelines." Anyone following this blog knows how controversial those guidelines have been, so it will be interesting to hear the perspective of the acting director herself on the issue. With her will be two additional representatives from the patent office, June Cohan, Legal Advisor, and Andrew Hirshfeld, Deputy Commissioner for Patent Examination Policy. They promise to provide the latest thinking on the examination guidelines, and take questions and feedback from the audience. The period for submitting comments to the Office on these guidelines is still open, and in fact has been extended to July 31, 2014. Those attendees interested in this topic might also be interested in the session "Patent Eligibility from the Trenches: Practical Implications of the Supreme Court's Mayo and Myriad Decisions" on June 25, from 3:00 PM to 4:00 PM. The panel for this session includes former Acting Director of the USPTO Teresa Stanek Rea.
Finally (or should we say initially?), Director General Francis Gurry of WIPO will be kicking off the Intellectual Property track on Tuesday, June 24, from 2:15 PM to 2:45 PM. The Director General will be discussing WIPO activities and their impact on the biotechnology sector. Just last month, the member states of WIPO appointed Director General Gurry by consensus to a second six-year term of office. Immediately preceding this presentation, there will be an Intellectual Property Meetup in the "IP Social Spot" from 1:30 PM to 2:15 PM. This Meetup will provide intellectual property professionals to mingle and kick-off the track.
The Biotechnology Industry Organization (BIO) is holding its annual BIO International Convention this week in San Diego, CA. Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.
As part of the Convention, more than 1,700 biotech companies, organizations, and institutions are expected to participate in the BIO Exhibition. Patent Docs Donald Zuhn, Kevin Noonan, Andrew Williams, Sherri Oslick, Michael Greenfield, Josh Bosman, Josh Rich, James DeGiulio, and Nate Chongsiriwatana will also be attending BIO as part of the MBHB contingent, and will be participating in BIO's blogger network throughout the week. Patent Docs readers who may be attending BIO this week are encouraged to stop by booth #1337 to meet the Docs, at the times indicated below, and talk a little biotech patent law.
In addition, most of the Docs will be attending the MBHB reception at Dublin Square Irish Pub & Grill in San Diego's downtown Gaslamp Quarter on Tuesday, June 24 from 8:00 pm to 1:00 am. Additional information about the reception, including invitations for the event, can be picked up at the MBHB booth on Tuesday.
June 27, 2014 - "Navigating the Patent Trial and Appeal Board Post-Grant Minefield" (American Bar Association Section of Intellectual Property Law) - 1:00 to 2:30 pm (ET).
• Why so many petitions are being bounced?
• What the PTAB looks for in a complete rejection?
• Getting the PTAB to change their mind after institution.
The registration fee for the webcast is $150 for members and $195 for the general public. Those interested in registering for the webinar, can do so here.
There's an old saying that "bad facts make bad law," acknowledging that a court's decision regarding an extreme case can result in law that poorly serves less extreme cases. The Supreme Court's recent trio of 35 U.S.C. § 101 decisions, Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories, Inc., and today's unanimous Alice Corp. v. CLS Bank Int'l each involved claims that were probably too broad for their own good. But instead of directly challenging the novelty or non-obviousness of these claims, the patent-eligibility of the claims were the core of the respective disputes. As a result, the lines between §§ 101, 102, and 103 have become blurred, and the Court still hasn't clarified what makes a claim too abstract to be patent-eligible despite using this doctrine to strike down claims in all three cases. Thus, the impact of CLS Bank on less extreme cases -- those with more focused claims for instance -- remains to be seen.
As noted in an earlier overview article by Kevin Noonan, the Court did not bar software or business method patents per se. This case, however, continues the trend of two other patent cases decided this term, Limelight Networks, Inc. v. Akamai Technologies, Inc. and Nautilus, Inc. v. Biosig Instruments, Inc., in which the Court has placed further limits on the scope of patent protection. Consequently, the Court has introduced new avenues for challenging the validity of patents.
The following is a collection of initial thoughts regarding the CLS Bank decision and its impact on software and business method practice.
• The Court declined to clearly define the term "abstract idea." It stated that "we need not labor to delimit the precise contours of the 'abstract ideas' category in this case." Instead, the Justices relied on the conceptual similarity between Alice's claims and those found patent-ineligible in Bilski. Alice argued that abstract ideas must exist apart from any human interaction (e.g., an equation would be an abstract idea, but a process involving human activity would not). The Court would hear nothing of this, couching the abstract claims of Bilski as "a method of organizing human activity."
• In Bilski, the Court held that "while the machine-or-transformation test has always been a 'useful and important clue,' it has never been the 'sole test' for determining patentability." In this case, Alice's computer-readable media and system claims were struck down under § 101, despite reciting general-purpose computer components. Thus, it appears that to pass the machine-or-transformation test, claims must be tied to a particular machine and not just a generic computer.
• To that point, the Court has taken a rather dim view of the ability of general purpose computing to lift an otherwise abstract idea above the § 101 bar. For instance, the Court stated that "method claims, which merely require generic computer implementation, fail to transform [an] abstract idea into a patent-eligible invention," "[t]he fact that a computer necessarily exist[s] in the physical, rather than purely conceptual, realm is beside the point," "each step [of Alice's claims] does no more than require a generic computer to perform generic computer functions," and "nearly every computer will include a 'communications controller' and 'data storage unit' capable of performing the basic calculation, storage, and transmission functions required by the method claims." It is now abundantly clear that recitation of generic computer structure will not save a claim that is drawn to an abstract idea.
• 1980's Diamond v. Diehr noted that "[t]he question therefore of whether a particular invention is novel is wholly apart from whether the invention falls into a category of statutory subject matter." After today, it appears as if novelty (or lack thereof) can play a major role in determining whether claims are statutory under § 101. In finding Alice's claims drawn to the abstract idea of "intermediated settlement," the Court cited several references (some of which might not qualify as prior art under §§ 102 or 103) to establish that such undertakings were "fundamental economic practice long prevalent in our system of commerce." Similarly, when considering the impact of the recited (or stipulated) computer implementation, the Court stated that "all of these computer functions are well-understood, routine, conventional activities previously known to the industry."
• Justice Breyer's two step test for § 101 worthiness introduced in Mayo was thought by some to be an aberration or a temporary departure from the Court's previous holdings. Others criticized it as being subjective and too difficult to apply in practice -- the test certainly divided the Federal Circuit judges. With the Justices relying on the test, it is now evident that the Mayo framework was no passing fad.
• The first prong of the Mayo test is to "identify the abstract idea represented in the claim." In doing so, the Court did not focus on the language of the claims, but instead focused on a summary of the claimed invention. But almost any invention can be made to look abstract or conventional through summarization, or by downplaying certain aspects of the claim.
• The second prong of the Mayo test is to determine whether a claim directed to an abstract idea recites "an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself." But we have little guidance as to what "significantly more" entails. In the last 40 years, the only example of a claim meeting the § 101 bar in the Supreme Court is that of Diehr.
• The Court seems to use the word "technological" as something of a synonym for "physical." Thus, novel and non-obvious algorithmic improvements might not be patent-eligible unless they are integrated somehow with a physical process. For instance, the Court wrote that "the claims in Diehr were patent eligible because they improved an existing technological process, not because they were implemented on a computer." This fixation on physicality may demonstrate an underlying predisposition against software, which is technology that operates in a mostly unseen fashion.
Alice's claims could have, and probably should have, been attacked as being anticipated or obvious. After all, this decision relies on the existence of prior art that could have been used for such a purpose. Instead, the Court has fully opened the § 101 Pandora's Box that it peeked into with Mayo.
This morning, in Alice Corp. v. CLS Bank, the Supreme affirmed the Federal Circuit's per curiam opinion in CLS Bank v. Alice Corp. in a unanimous opinion by Justice Thomas with a concurring opinion by Justice Sotomayor joined by Justices Breyer and Ginsberg. The decision appears to be an incremental one, insofar as it does not strike down all software patents and is crafted as an application of the Court's earlier precedent, particularly Bilski v. Kappos and Mayo Collaborative Serv. v. Prometheus Labs.
We have "repeatedly emphasized this . . . concern that patent law not inhibit further discovery by improperly tying up the future use of " these building blocks of human ingenuity" [quoting O'Reilly v. Morse as cited in Mayo]. "At the same time, we tread carefully in construing this exclusionary principle lest it swallow all of patent law" because "[a]t some level, "all inventions . . . embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas" [citing Mayo].
Accordingly, in applying the §101 exception, we must distinguish between patents that claim the "'buildin[g] block[s]'" of human ingenuity and those that integrate the building blocks into something more, thereby "transform[ing]" them into a patent-eligible invention. The former "would risk disproportionately tying up the use of the underlying" ideas and are therefore ineligible for patent protection. The latter pose no comparable risk of pre-emption, and therefore remain eligible for the monopoly granted under our patent laws" [citing liberally from the Mayo opinion].
First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts. If so, we then ask, "[w]hat else is there in the claims before us?" To answer that question, we consider the elements of each claim both individually and "as an ordered combination" to determine whether the additional elements "transform the nature of the claim" into a patent-eligible application. We have described step two of this analysis as a search for an " 'inventive concept'" -- i.e., an element or combination of elements that is "sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself."
The Court also considers its jurisprudence from Gottschalk v. Benson, through Parker v. Flook, Bilski and to Mayo to be consistent in both the underlying principles and how the analysis should be done. The opinion distinguishes its seemingly contrary decision in Diamond v. Diehr in a way that may be useful in making decisions regarding what is patent-eligible subject matter (and how it should be claimed): "In other words, the claims in Diehr were patent eligible because they improved an existing technological process, not because they were implemented on a computer" (emphasis added). And, in a footnote, the Court declares that its Mayo analysis is consistent with the patent law principle that the claims should be considered as a whole because the Mayo decision instructs a court to consider the elements of the claim at issue both individually and as a whole.
The Court's opinion expressly ties its decision here to the decision in Bilski, based on the perceived similarity between attempts in each case to preempt a preexisting human activity (hedging in Bislki, intermediated settlement here) as being abstract ideas (and once again conflating Section 101 with Sections 102 and 103), the Court stating that "[i]t is enough to recognize that there is no meaningful distinction between the concept of risk hedging in Bilski and the concept of intermediated settlement at issue here. Both are squarely within the realm of 'abstract ideas' as we have used that term." And after a brief discussion of the Court's understanding of how a conventional general purpose computer works, the Court opines that how the computer implements the claimed (and ineligible) method is not "enough" to render the system claims patent eligible because said implementation is entirely conventional.
The method claims do not, for example, purport to improve the functioning of the computer itself. ("There is no specific or limiting recitation of . . . improved computer technology . . . "); Brief for United States as Amicus Curiae 28–30. Nor do they effect an improvement in any other technology or technical field. Instead, the claims at issue amount to "nothing significantly more" than an instruction to apply the abstract idea of intermediated settlement using some unspecified, generic computer. Under our precedents, that is not "enough" to transform an abstract idea into a patent-eligible invention [citations omitted].
Put another way, the system claims are no different from the method claims in substance. The method claims recite the abstract idea implemented on a generic computer; the system claims recite a handful of generic computer components configured to implement the same idea. This Court has long "warn[ed] . . . against" interpreting §101 in ways that make patent eligibility 'depend simply on the draftsman's art.'"
The Court's decision is entirely consistent with its disinclination to enunciate broad proscriptions against patenting particular areas of technology, as evidenced by its decisions in Bilski (which did not rule all business method claims to be patent-ineligible), Association for Molecular Pathologists v. Myriad Genetics (which was limited to rendering genomic DNA patent-ineligible but did not disturb patent-eligibility for cDNA, and contained express proscriptions against reading the decision to encompass methods or other applications of the knowledge of the BRCA genes, despite the PTO's recent Guidelines that appear to ignore these proscriptions) and even Bowman v. Monsanto, which cautioned against interpreting the Court's decision in that case to apply to all "self-replicating technologies."
Justice Sotomayor's concurring opinion is brief and to the effect that the Justice believes business method patents to be patent ineligible per se because they do not fall within the ambit of a "process" under the Patent Act. Justices Breyer and Ginsberg join her here, as they did in Justice Stevens' concurring opinion in Bilski. The other Justices apparently are not yet ready to make all business method claims ineligible for patenting, provided that they satisfy the rule reiterated here that there must be something that improves existing technology or otherwise does not merely adapt methods for controlling human activity for implementation by a computer.