Patent Docs

PTAB Update — Biopharmaceutical Edition

February 26, 2015

By Andrew Williams —

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And unlike the case of the first set of Orange-Book related FWDs (see "PTAB Update — Hatch-Waxman-Watch Edition"), the Board determined that all challenged claims were unpatentable. The drug that these patents covered is Myozyme, or alglucosidase alfa, which is an enzyme replacement therapy for treating Pompe disease (or glycogen storage disease type II). This disease is caused by a deficiency of the lysosomal enzyme acid α-glucosidase ("GAA"), resulting in an accumulation of glycogen in tissues such as the heart and skeletal muscle. Pompe disease is treated by administering to the patient a therapeutically effective amount of the protein. Myozyme is a recombinant human version of this protein (rhGAA), and is produced in precursor form in Chinese hamster ovary (CHO) cell cultures. The drug is marketed by Genzyme, the patent owner of two related patents involved in these IPR proceedings. The third related to an unrelated patent, which is owned by Duke University. BioMarin Pharmaceutical Inc. filed the three petitions in 2013. The PTAB determined that the claims of the two Genzyme patents were obvious in view of various combinations of references, including a Duke Press Release announcing the FDA's approval of an application for Orphan Drug Designation, a PCT application disclosing the production of phosphorylated lysosomal proteins using transgenic mammals, and three other references reporting research related to GAA. In addition, the PTAB determined that the claims of the Duke patent were either obvious in view of similar cited art, or were anticipated by the oldest Genzyme patent involved in these proceedings. It is unclear if there are other patents that cover this product, but Genzyme has at least one continuing application pending at the Office. In today's post, we will take a closer look at these first two IPR proceedings related to the Genzyme patents.

IPR2013-00534 and IPR2013-00537

The patents related to the first two IPR petitions related to methods of treating human patients afflicted with Pompe disease by intravenously administering a therapeutically effective amount of Human GAA in order to reduce and/or arrest further accumulation of glycogen. The patents at issue were U.S. Patent Nos. 7,351,410 and 7,655,226. The '410 patent only has one claim:

1. A method of treating a human patient with Pompe's disease, comprising intravenously administering biweekly to the patient a therapeutically effective amount of human acid alpha glucosidase, whereby the concentration of accumulated glycogen in the patient is reduced and/or further accumulation of glycogen is arrested.

Claim 1 of the '226 patent is similar, except it does not contain the limitation for biweekly administration.

The '410 patent was invalidated on two separate obviousness grounds. The first was in view of the combination of Reuser (WO 97/05771), Barton (a New England Journal of Medicine article from 1991), and Van der Ploeg (a Pediatric Research journal article from 1988). Reuser was described as teaching "the production of phosphorylated lysosomal proteins using transgenic nonhuman mammals for use in enzyme replacement therapy as treatment for lysosomal enzyme deficiencies." This reference mentioned that a Pompe disease treatment in mice had been tested with a purified GAA, and that pharmaceutical compositions for intravenous administration were contemplated by the reference. Barton was cited as teaching a clinical trial with Gaucher Disease (another lysosomal enzyme deficiency disease), wherein patients received enzyme replacement therapy on a biweekly intravenous administration schedule. Finally, van der Ploeg allegedly described "an in vitro study using cultured skeletal muscle cells from a patient with Pompe disease." The Patent Owner argued that "a person of ordinary skill in the art would not have had a reasonable expectation of success for a method of treating a human patient with Pompe disease using GAA administered biweekly . . . ." Moreover, it argued that there would have been no motivation to combine because of the differences between Gaucher disease and Pompe disease. Finally, the Patent Owner alleged that the objective indicia of non-obviousness supported the patentability of the claim.

The Board did agree that as of the priority date, it could not have been predicted with "absolute certainty" that Pompe disease could be treated safely and effectively using GAA. However, they also concluded that there was sufficient motivation to pursue the clinical development of treatment as disclosed in Reuser. The only missing element was the biweekly dosing schedule. But, because the experimentation needed to achieve this treatment regime was "nothing more than" routine, it required skills more akin to an artisan rather than an inventor. Important in the Board's analysis was that the prior art did not merely teach a promising field of experimentation with numerous parameters to try, but instead provided sufficient motivation to select a suitable dose and dosing schedule. And, because the enzyme replacement therapy would have needed to be administered for life, a repeated spaced administration of GAA would have been understood.

With regard to the secondary considerations, the Board found a nexus lacking between the evidence related to long-felt but unmet need, skepticism, praise, and commercial success. This was because the Board characterized the invention as limited to the biweekly administration feature. Therefore, because the secondary considerations related to the merits of the therapeutic compositions of GAA, they were inapplicable to the present invention. This seems to be an unfair characterization of the invention, however, because even if such compositions were known, they were not being used as a safe and effective treatment of Pompe disease (including the biweekly administration schedule).

The other obviousness argument combined Barton and Van der Ploeg with a Duke Press Release announcing the approval of an Orphan Drug application for the GAA drug. This release is described as providing "details [of] a proposed FDA clinical trial study in which infants with Pompe disease would be injected with recombinant GAA to evaluate the safety and efficacy of the recombinant enzyme treatment." Genzyme had argued that the Press Release was silent as to the dosing regimen, and therefore the cited art did not contain all of the limitations of the claim. However, the Board found the use of the term "injected" to teach "intravenous administration." Also, the Press Release did not disclose the source of the enzyme, but the Board found this was cured by Van der Ploeg. In other words, "the concept of using human GAA to treat Pompe disease was known in the art." And, even if clinical trials were unpredictable, their design was essentially routine to those skilled in the art.

The IPR related to the '226 patent was similar in nature. In fact, it was essentially easier to establish the obviousness of the claims because they did not contain the limitation related to the dosing regimen. Therefore, because this important impediment was removed, institution was only sought and granted on obviousness challenges incorporating the Duke Press Release. And, not surprising in view of the other IPR FWD, all challenged claims were found to be unpatentable.

In a future post, we will analyze the FWD related to the Duke patent.
Venture Funding Reaches Highest Level in More Than a Decade

February 25, 2015

By Donald Zuhn —

Last month, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for 2014. The report, which is prepared by NVCA and PriceWaterhouseCoopers LLP using data from Thomson Reuters, indicates that venture capitalists invested $48.3 billion in 4,356 deals in 2014, which constituted a 61% increase in dollars and a 4% increase in deals over the prior year (see chart below, which shows total venture funding from 2005 to 2014; data from NVCA; click on chart to expand).

Last year, the software sector reached its highest level of funding since 2000, with the sector capturing $19.6 billion in funding (a 77% increase in funding over 2013). The software sector also accounted for 41% of total venture investment in 2014, which constituted the highest percentage since the first MoneyTree Report was issued in 1995. Biotechnology funding in 2014 increased to $6.0 billion, which was a 4% increase over biotechnology funding in 2013, and which was good enough to place the biotechnology second among all sectors. Life Sciences funding (which combines the biotechnology and medical device sectors) reached $8.6 billion in 204, which was the highest level of Life Sciences funding since 2008. Life Sciences funding accounted for 18% of total venture capital investments in 2014. Overall, fourteen of the seventeen sectors tracked by the NVCA saw increases in dollars invested in 2014.

The report also noted that in the fourth quarter of 2014, $14.8 billion was invested into 1,109 deals (see chart below, which shows venture funding by quarter from 2011 to 2014; data from NVCA; click on chart to expand).

In the fourth quarter of 2014, the software sector remained the top sector, capturing nearly four times as much venture funding as the second sector (media and entertainment), with $5.8 billion going into 461 deals. The software sector has now held the top spot in venture funding for 21 straight quarters. Life Sciences funding in the fourth quarter of 2014 was up 62% over the third quarter to $2.8 billion.

For additional information regarding this and other related topics, please see:

• "Third Quarter Venture Funding Declines 27% from Second Quarter," October 22, 2014
• "Software Sector Leads Pack in 2Q Venture Funding and Biotech Sector Finishes Second," July 20, 2014
• "Software Sector Leads First Quarter Venture Funding to Thirteen Year High; Biotech Sector Finishes Second (Again)," April 30, 2014
• "Biotech Venture Funding Rebounded in 2013 After Strong Fourth Quarter," January 26, 2014
• "Biotech Venture Funding Sees Second Quarter Rebound," July 22, 2013
• "Biotech Venture Funding Down 33% in First Quarter," April 30, 2013
• "Annual Venture Funding Drops for First Time in Three Years," February 4, 2013
• "Biotech Venture Funding Up 64% in Third Quarter," October 29, 2012
• "Venture Funding in Life Sciences Sector Drops 9% in Second Quarter," July 22, 2012
• "Biotech Venture Funding Drops 43% in First Quarter," May 3, 2012
• "Venture Funding Increased 22% in 2011," February 2, 2012
• "Life Sciences Venture Funding Drops in Third Quarter," October 27, 2011
• "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
• "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
• "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011 
• "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010 
• "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010 
• "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010 
• "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
• "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009 
• "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009 
• "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009
23andMe Receives FDA Approval for Genetic Diagnostic Test

February 23, 2015

By Kevin E. Noonan —

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare genetic disease. The news is tempered by the company's further announcement that it will not offer the test to consumers "until it completes the regulatory process for additional test reports and can offer a more comprehensive product offering."

Readers may recall that the FDA effectively stopped 23andMe from selling its genetic analysis kit, which the company marketed as Personal Genomic Services (PGS) in November 2013 by issuing a Warning Letter to the Company (see "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing"). According to the FDA, genetic diagnostics assays fall under the agency's purview and authority because they are medical devices (21 U.S.C. § 321(h)). According to the letter, the testing service offered "is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body." At that time, the agency professed a desire to work with the company to assist in developing the type and quantity of evidence required for approval, but warned that it had spent "significant time" evaluating the PGS test and providing feedback to 23andMe. It appears that the company complied with the agency by submitting the evidence for approval of a much more limited test (i.e., limited to Bloom's Syndrome), compare to the tests offered previously (which included more that 250 "diseases and conditions" such as BRCA gene mutations, diabetes, coronary artery disease, an sensitivities to drugs such as warfarin, clopidigrel and 5-fluorouracil).

The test is described as a "spit test kit and a chip array platform," and approval is limited at this time to detecting genetic markers for Bloom's syndrome. Bloom's syndrome is a genetic disease inherited in an autosomal recessive manner, that predisposes individuals to certain cancers and is also associated with short stature, sensitivity to sunlight exposure and shortened lifespan. The locus of the mutation is in the BLM gene on chromosome 15 (at 15q26.1) and encodes a DNA helicase. Defects in this gene cause a dramatic (~ten-fold) increase in homologous recombination in cells from affected individuals, resulting in genomic instability. Genetic testing is the only way to predict risk for passing the disease to offspring, as parents having only one copy of the gene show no symptoms.

The FDA's decision to permit 23andMe to offer the test, while important to the company and to those individuals who may be at risk for passing on the Bloom's syndrome trait to their children, is also significant for the type of testing the FDA required and the evidence it mandated for approval. For example, 23andMe in an announcement stated that it "conducted extensive comprehension studies with consumers from different backgrounds, education levels and incomes," as well as test accuracy and validity.

The company's future in the genetic diagnostics space remains uncertain, however, in view of the following disclaimer on its website:

Updated February 19, 2015b: 23andMe provides ancestry-related genetic reports and uninterpreted raw genetic data only. We intend to add some health-related genetic reports in the future once we have a comprehensive product offering. At this time, we do not know which health reports might be available or when they might be available.

A disturbing note was struck by Alberto Guitierrez, Director of the Office of In Vitro Diagnostics and Radiologic Health in the agency's Center for Devices and Radiologic Health, who stated that "[t]he FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information," and that the FDA intended to "exempt these devices from FDA premarket review." How disturbing this sentiment may be will depend on how widespread access to genetic testing becomes and the extent to which providers such as 23andMe provide information to consumers receiving this information; indeed, the company's disclaimer suggests that FDA action has encouraged it not to provide any interpretation for the "raw genetic data" it supplies to consumers. For all the criticism that has been leveled against Myriad (some of which may have been justified) the company acted responsibly by ensuring that its customers had access to genetic counselors who explained the significance of their test results and provided options for accommodating the consequences of any propensities their genetics disclosed. Among all the negative press Myriad received there were two types of stories that did not appear: one, that the company had provided a misdiagnosis (of either type); and two, that someone had decided to end their life because they misinterpreted the results of their test or its implications on their health. Minimizing the risk of the latter outcome will depend even more heavily on adequate counseling as more individuals have more tests for more genetic diseases, particularly as those diseases expand to include those that are less determinative than tests like the BRCA test or 23andMe's Bloom's Syndrome test and as there are more opportunities for behavioral modifications that could modulate patient outcomes. Mr. Gutierrez is also reported to have said that authorization of 23andMe's test "supports innovation and will ultimately benefit consumers." But that innovation will be costly if it is not accompanied by the appropriate amount of interpretation so individuals can make the best-informed choices for themselves.
Court Report

February 22, 2015

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc.
2:15-cv-01283; filed February 18, 2015 in the District Court of New Jersey

• Plaintiffs: Novartis Vaccines and Diagnostics, Inc.; Novartis Pharma AG
• Defendant: Pfizer, Inc.

Infringement of U.S. Patent Nos. 7,576,176 ("Neisseria Meningitidis Antigens and Compositions," issued August 18, 2009), 8,524,251 (same title, issued September 3, 2013), 8,394,390 ("Neisserial Antigenic Peptides," issued March 12, 2013), 8,398,988 ("Adjuvanting Meningococcal Factor H Binding Protein," issued March 19, 2013), 8,840,907 ("Isolated Protein and Compositions Comprising the Protein," issued September 23, 2014), and 8,834,888 ("Adjuvanting Meningococcal Factor H Binding Protein," issued September 16, 2014) based on Pfizer's anticipated manufacture and sale of its recently approved Trumenba® product (a meningococcus B vaccine, bivalent rLP2086, used to vaccinate against meningitis). View the complaint here.

Novartis AG et al. v. Ezra Ventures LLC
4:15-cv-00095; filed February 13, 2015 in the Eastern District of Arkansas

• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. LTD
• Defendant: Ezra Ventures LLC

Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of Ezra's filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis). View the complaint here.

Forest Laboratories LLC et al. v. Alembic Pharmaceuticals Ltd. et al.
1:15-cv-00158; filed February 13, 2015 in the District Court of Delaware

• Plaintiffs: Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendants: Alembic Pharmaceuticals Ltd.; Alembic Global Holding SA; Alembic Pharmaceuticals Inc.

Infringement of U.S. Patent No. 5,763,476 ("Sublingual or Buccal Pharmaceutical Composition," issued June 9, 1998) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Forest's Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder). View the complaint here.

AbbVie Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-01402; filed February 13, 2015 in the Northern District of Illinois

• Plaintiffs: AbbVie Inc.; AbbVie Deutschland GmbH & Co. KG
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Laboratories Ltd.; Mylan Laboratories Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 8,025,899 ("Solid Pharmaceutical Dosage Form," issued September 27, 2011), 8,268,349 (same title, issued September 18, 2012), 8,309,613 (same title, issued November 13, 2012), 8,377,952 ("Solid Pharmaceutical Dosage Formulation," issued February 19, 2013), 8,399,015 ("Solid Pharmaceutical Dosage Form," issued March 19, 2013), 8,470,347 ("Self-emulsifying Active Substance Formulation and Use of this Formulation," issued June 25, 2013), and 8,691,878 ("Solid Pharmaceutical Dosage Form," issued April 8, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AbbVie's Kaletra® (lopinavir and ritonavir, used to treat HIV infections). View the complaint here.

Helsinn Healthcare S.A. et al. v. Gavis Pharma LLC
3:15-cv-01228; filed February 13, 2015 in the District Court of New Jersey

• Plaintiffs: Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant: Gavis Pharma LLC

Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Gavis' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting). View the complaint here.

Novo Nordisk Inc. et al. v. Sun Pharmaceutical Industries Ltd. et al.
3:15-cv-01287; filed February 12, 2015 in the District Court of New Jersey

• Plaintiffs: Novo Nordisk Inc.; Novo Nordisk Femcare AG
• Defendants: Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries, Inc.

Infringement of U.S. Patent No. 7,018,992 ("Hormone Composition," issued March 28, 2006) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Novo Nordisk's Vagifem® (estradiol vaginal tablets, used to treat atrophic vaginitis due to menopause). View the complaint here.
Conference & CLE Calendar

February 22, 2015

February 25, 2015 – European biotech patent law update (D Young & Co) – 3:00 am, 6:00 am, and 11:00 am (ET)

February 25, 2015 – "Prevailing Before the PTAB 'Death Squad': Practical Considerations for Petitioners and Patent Holders" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

February 26, 2015 – "Coordinating Post-Grant Patent Opposition in Europe and the U.S. — Navigating Timing, Grounds for Opposition, Discovery, and Amendments to Maximize Protection in Both Jurisdictions" (Strafford) – 1:00 to 2:30 pm (EST)

February 27, 2015 – 59th Annual Intellectual Property Law Conference (The John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

March 3, 2015 – "Patent Eligibility Requirements in Life Sciences" (Maschio & Soames) – 2:00 pm CST (Chicago)

March 4, 2015 – "Patent Eligibility Requirements in Life Sciences" (Maschio & Soames) – 12:00 noon AEDT (Melbourne) and 12:00 noon GMT (London)

March 4-5, 2015 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

March 5, 2015 – "Drafting and Prosecuting Patent Applications to Withstand PTAB Scrutiny — Building Reasonable Claim Construction to Avoid Unpatentability and Using Declarations to Survive Post Grant Proceedings" (Strafford) – 1:00 to 2:30 pm (EST)

March 5-6, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

March 10-11, 2015 – FDA Boot Camp*** (American Conference Institute) – New York, NY

March 19, 2015 – "Abstract Ideas after Alice Corp. v. CLS Bank Int'l: The USPTO Issues Interim Guidance and Examples" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

March 25-26, 2015 – Post-Grant PTO Proceedings*** (American Conference Institute) – New York, NY

March 30-31, 2015 – Post-Grant Patent Challenges at the PTAB*** (Momentum) – San Jose, CA

***Patent Docs is a media partner of this conference or CLE
Conference on Post-Grant Patent Challenges at the PTAB

February 22, 2015

Momentum will be holding its 2nd IP Counsel Exchange on Post-Grant Patent Challenges at the PTAB on March 30-31, 2015 in San Jose, CA. The conference will offer presentations on the following topics:

• Perspectives from the Chief Administrative Patent Judge — Hon. James D. Smith, Chief Administrative Judge Patent Trial and Appeal Board, U.S. Patent & Trademark Office
• Interpreting What the Past 12 Months of CBM Challenges and IPR and PGR Proceedings Reveal About Party Successes and Failures Across Industries
• Proven Strategies for Asserting or Defending A Patent Challenge at the PTAB — Tips for Avoiding Common Procedural Pitfalls and Effective Litigation Techniques for Obtaining Successful Results
• Discovery, Evidence, Claim Construction and Addressing Key Evidentiary Issues That Arise During the Co-Pendency of Counterpart Patent Proceedings
• Stays, Estoppel and the Management of Joint Proceedings — Perspectives from the Federal Bench on the Procedural Impact of PTAB Decisions on Pending and Parallel Federal District Court Litigation
• Perspectives from the Director of the Silicon Valley Office of the USPTO
• Behind the Scenes with the PTAB Bench
• Exploring Circumstances for When Pursuing an IPR, PGR or CBM May Not Be the Right Litigation Option for Achieving Your Unique IP Litigation Goals and Business Objectives
• What Other Industries Can Learn from How the Pharmaceutical Industry Is Strategically Utilizing and Responding to the Heightened Use of PTAB Proceedings
• A Perspective on the Treatment of PTAB Proceedings By Way of Appeal
• Legal Analytics for PTAB: Using Data-Driven Insights Into PTAB Trials and District Court Cases to Set IP Litigation Strategy

In addition, two additional sessions will be offered during the conference. The first session is entitled "A Guide to Successfully Navigating PGRs, IPRs and CBMs for Petitioners and Interested Parties: Insights for Selecting the Best Challenge for Your Unique IP Litigation Goals and Business Objectives," and the second is entitled "Master Class: A Practitioner's Guide to Most Effectively Utilizing Experts and Witnesses in PTAB Proceedings: Dissecting the Nuances of Witness Presentation and Posturing at the PTAB."

The agenda for the Post-Grant Patent Challenges at the PTAB conference can be found here. Those interested in registering for the conference can do so here.

Patent Docs is a media partner of Post-Grant Patent Challenges at the PTAB conference.
ACI Conference on Post-Grant PTO Proceedings

February 20, 2015

American Conference Institute (ACI) will be holding a conference on Post-Grant PTO Proceedings on March 25-26, 2015 in New York, NY. ACI faculty will help attendees:

• Evaluate and audit existing patent portfolios to identify patents which are most vulnerable to these new post grant challenges;
• Analyze the impact of CLS Bank v. Alice Corp. and Nautilus, Inc. v. Biosig Instruments, Inc. on 101 patent eligibility and 112 claim construction/indefiniteness relative to post grant proceedings;
• Explore trends in IPR decisions and devise best practices for petition drafting and discovery;
• Examine novel uses of CBM review proceedings;
• Appreciate the infinite possibilities and infinite grounds for which PGRs can be brought;
• Understand how Congressional action and pending legislation may affect post grant proceedings and related activity;
• Develop patent litigation strategies which account for parallel proceedings before the PTAB and District Court; and
• Master protocols and rules of engagement for appearing before the PTAB.

In particular, ACI's faculty will offer presentations on the following topics:

• Keynote Address — The Honorable James Donald Smith, CAPJ, Chief Judge, Patent Trial and Appeal Board, U.S. Patent and Trademark Office
• Evaluating Patent Portfolio Planning and Due Diligence Analysis in the Era of New Post Grant Proceedings
• Oyez, Oyez, Oyez!: Analyzing the Impact of the Supreme Court's Decisions in Alice Corp. and Nautilus on AIA Post-Grant Proceedings
• Survey of Developments in New Post Grant Proceedings: Inter Partes Review: A Procedural, Substantive and Cross-Industry Retrospective
• Harnessing the Power of Covered Business Method Patent Review
• Post Grant Review: Predictions for the Next Big Thing in Patent Law
• The Politics and Policy of Post Grant Proceedings: An Update on the Latest Legislative Developments Which May Impact and Amend the AIA and related Post Grant Proceedings
• New PTO Proceedings Playbook: Developing Strategies for PTO Patent Trial Practice
• May It Please the Court: Rules of Engagement for Appearing Before the PTAB

In addition, a pre-conference workshop entitled "Post-Grant PTO Proceedings Boot Camp: Assessing the Impact of New PTO Procedures Under the AIA on Patent Litigation" will be offered from 2:00 to 5:30 pm on March 24, 2015, and a post-conference workshop entitled "Anatomy of a PTO PTAB Patent Trial" from 1:30 to 4:00 pm on March 26, 2015.

An agenda for the conference can be found here (Day 1) and here (Day 2), and additional information regarding the workshops can be found here and here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is $2,195 (conference alone), $2,795 (conference and one workshop), or $3,295 (conference and both workshops). Special rates are available for in-house counsel (see brochure). Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Post-Grant PTO Proceedings conference.
Global Biotech IP Update

February 20, 2015

Maschio & Soames will be offering a Global Biotech IP Update webinar on "Patent Eligibility Requirements in Life Sciences" on March 3, 2015 at 2:00 pm CST (Chicago), and Wednesday, March 4 at 12:00 noon AEDT (Melbourne) and 12:00 noon GMT (London). Robert Dempster of Maschio & Soames IP Ltd., David Gass of Marshall, Gerstein & Borun LLP, and Karen Innes of FB Rice will review what biotech inventions are patentable in major jurisdictions, and discuss recent court decisions and practice changes, including the new USPTO guidelines.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here.
Webinar on Drafting and Prosecuting Patent Applications to Withstand PTAB Scrutiny

February 20, 2015

Strafford will be offering a webinar/teleconference entitled "Drafting and Prosecuting Patent Applications to Withstand PTAB Scrutiny — Building Reasonable Claim Construction to Avoid Unpatentability and Using Declarations to Survive Post Grant Proceedings" on March 5, 2015 from 1:00 to 2:30 pm (EST). Anthony M. Gutowski, Thomas L. Irving, John Mulcahy of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel for drafting and prosecuting U.S. patent applications to achieve the broadest claim interpretation and avoid unpatentability and yet still be able to prove infringement, and offer best practices to solidify novelty, non-obviousness, enablement, and written description positions. The webinar will review the following questions:

• How can practitioners draft and prosecute patent applications and claims to minimize the threat and/or efficacy of a third-party’s post-grant challenges?
• How can patent owners obtain broad claims to keep competitors at bay while countering attempts to render those broad claims unpatentable under the broadest reasonable interpretation standards before the PTAB?
• How can practitioners introduce strong grounds for patentability under §§ 102, 103, and 112, in the specification and prosecution history so that IPRs and PGRs are either denied or otherwise ineffective against the challenged instituted claims?

The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those interested in registering for the webinar, can do so here.
USPTO Holds Forum on Interim Guidance — Part III

February 19, 2015

By Donald Zuhn —

In a forum held last month on the U.S. Patent and Trademark Office's Alexandria campus, Office representatives discussed the Interim Guidance on Patent Subject Matter Eligibility, which was released in December, and received additional input from the public regarding that guidance. The forum, which ran almost four and a half hours, began with some opening remarks by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy at the USPTO, and then Raul Tamayo, Senior Legal Advisor in the Office of Patent Legal Administration at the USPTO, followed Mr. Hirshfeld's presentation with an overview of the Interim Guidance. The remainder of the forum was devoted to two groups of public presentations — in which the presenters were essentially divided into those on the life sciences side (group one) and those on the hi-tech side (group two) — and an "open participation/question/answer" session, in which attendees were allowed to give statements or ask questions of USPTO representatives participating in the forum. A replay of the forum can be viewed here.

Summaries of Mr. Hirshfeld's and Mr. Tamayo's presentations were provided in Part I of our series on the forum, and highlights from the first group of public presentations were provided in Part II of the series. Today, we provide some of the highlights from the second group of public presentations, the majority of which addressed how the Interim Guidance dealt with the Supreme Court's decision in Alice Corporation Pty. Ltd. v. CLS Bank International. The second group consisted of ten presenters: Bob Stoll of the Partnership for American Innovation (PAI); Jim Crowne of the American Intellectual Property Law Association (AIPLA); Robert Hardy of the Council on Governmental Relations (COGR); Micky Minhas of Microsoft Corp.; Thomas Isaacson of Novak Druce Connolly Bove + Quigg LLP; Kate Gaudry and Angel Lezak of Kilpatrick Townsend & Stockton LLP; Robert Sachs of Fenwick & West LLP; Sigram Schindler of TELES Patent Rights International GmbH; and Clark Jablon of Panitch Schwarze Belisario & Nadel LLP.

Leading off for the second group of presenters was the former Commissioner of Patents, now representing PAI, which describes itself as "a group of companies that represent diverse industries working together to promote a climate of technology innovation by telling the story of IP's value." Declaring the Interim Guidance to be "in quite good shape," and a "substantial improvement" with respect to nature-based products, Mr. Stoll indicated the Office had made "good on its promise to improve" the Myriad-Mayo guidance. However, he encouraged the Office to expand on its guidance regarding the impact of the Alice decision.

While pointing out areas in the guidance where the Office had positively responded to criticism, Mr. Crowne, who represented the AIPLA, noted that some work still needed to be done. In particular, he argued that there was a "certain circularity" to the Office's definition of claims that are "directed to" a judicial exception and those "involving" a judicial exception. He also contended that in defining "directed to" as including "reciting," the Interim Guidance included "vestiges of the original guidance" that continued to distort the examination of subject matter eligibility.

Mr. Hardy, who noted that in addition to COGR, he also represented the Association of American Universities (AAU), Association of Public & Land Grant Universities (APLU), and Association of University Technology Managers (AUTM), commended the Office for its "valiant effort" in navigating the "maze of sometimes contradictory court decisions" to craft the Interim Guidance. He observed that the Federal Circuit's decision in In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation ("Myriad II") indicated that the CAFC had a different way of looking at the markedly different standard than the way the standard was discussed the Interim Guidance. He also encouraged the Office to develop additional examples and provide analysis of those examples, as well as to provide more clarification for claims reciting combinations of nature-based products.

After Mr. Hardy, the remaining presenters in the second group focused on the impact of the Interim Guidance on subject matter in the Alice space. Despite this focus, however, several presenters offered suggestions that seemed to resonate with practitioners and applicants in the Myriad/Mayo space. For example, Mr. Isaacson presented five proposals for improving the evaluation of subject matter eligibility for software applications, but which would likely improve the eligibility analysis in any Art Unit. His five suggestions included: (1) requiring examiners to use claim language in their analysis and not stray from the claim language (stating that "[t]he 'name of the game is the claim' must remain"), (2) placing a prima facie burden on examiners to provide some articulated reasoning with some rational underpinning to support ineligibility determinations (akin to the requirement for making obviousness rejections), (3) requiring examiners to produce evidence to support ineligibility determinations, (4) requiring examiners to consider applicants' rebuttal evidence, and (5) lowering the § 101 hurdle, which he asserted was too high and should instead be "very low." A copy of Mr. Isaacson's presentation can be obtained here.

Ms. Gaudry and Ms. Lezak presented data collected from business method art units, and concluded that the data indicated that following the Alice decision, the pendulum had swung too far towards rejection of applications directed to business methods.

They also noted that in the span of ten months, the allowance rate for business method art units had dipped from 24% in January to 5% in July to 3% in October. A copy of Ms. Gaudry's and Ms. Lezak's presentation can be obtained here.

The next presenter, Mr. Sachs, confessed to being "a critic of the Office," and expressed surprise that the Office had agreed to let him present. He explained that he had reviewed all of the Alice-related comments and had found that eighteen of the comments suggested that the Office require examiners to provide factual evidence and reasoning on the record in order to support a § 101 rejection. He noted that this is precisely what had been done in Bilski and Alice, and argued that examiners should not be permitted to make unsupported conclusory statements when finding a claim to be patent ineligible.

Mr. Sachs also noted that the Alice-related comments were in agreement that the focus of an eligibility analysis should be preemption, i.e., that preemption was the core of § 101. While pointing out that the Alice-related comments had all asked for more examples, what was also needed was more explanations. With respect to the Office's analysis of the cases, he argued that "the cases are inconsistent," which is "why we are here." A copy of Mr. Sachs' presentation can be obtained here.

The penultimate presenter in the second group, Dr. Schindler, warned the Office that they had "no chance" of settling the subject matter eligibility issue, and contended that the Supreme Court Justices were "excellent" and "brilliant" and had issued decisions in Alice and Myriad that were simply not understood. He also argued that while the Supreme Court was "absolutely on the right track," the Federal Circuit had "screwed it up" and would "sooner or later understand that they're dead wrong" on subject matter eligibility. A copy of Dr. Schindler's presentation can be obtained here.

For additional information regarding this topic, please see:

• "USPTO Holds Forum on Interim Guidance — Part II," February 18, 2015
• "USPTO Holds Forum on Interim Guidance — Part I," February 2, 2015
• "USPTO Issues Post-Alice Abstract Idea Examples," January 28, 2015
• "Impact of Interim Guidance on Business Method and Software Claims," December 17, 2014
• "USPTO Issues Interim Guidance on Subject Matter Eligibility," December 16, 2014
• "USPTO to Release Revised Subject Matter Eligibility Guidance," December 15, 2015