Patent Docs

Top Four Stories of 2020

By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 14th annual list of top patent stories.  For 2020, we identified eight stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  On Monday, we counted down stories #8 to #5, and today we count down the top four stories of 2020.  As with our other lists (2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2020" on January 20, 2020 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.

4.  Arthrex and Other PTAB Developments

In October, the Supreme Court granted petitions for a writ of certiorari to review the Federal Circuit's decision in Arthrex, Inc. v. Smith & Nephew, Inc., in which the Court of Appeals determined that the manner in which administrative patent judges were appointed to the Patent Trial and Appeal Board violated the Appointments Clause of the Constitution (Art. II, sec. 2, cl. 2).  A decision in the case is likely to be issued by the Supreme Court this June, so it is quite possible that Arthrex will make our 2021 list.

In addition to Arthrex, there were several other developments involving the PTAB that occurred in 2020.  In Facebook, Inc. v. Windy City Innovations, LLC, Facebook tried to join its own IPR to attack the claims asserted against it, which worked before the PTAB, but not before the Federal Circuit, which determined that joinder was only permitted for other parties who were seeking review of the same issues, and not for the same party seeking to change the scope of the review.  In Bozeman Financial LLC v. Federal Reserve Bank, the Federal Circuit held that the twelve regional Federal Reserve Banks, which sought to invalidate two Bozeman Financial patents in covered business method (CBM) review proceedings, are "persons" under the AIA, and therefore entitled to seek PTAB review.  In Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., Pfizer Inc. v. Chugai Pharmaceuticals Co., and Adidas AG v. Nike, Inc., the Federal Circuit continued its explication of the standing issue for unsuccessful petitioners in inter partes reviews.  In Amneal Pharmaceuticals LLC v. Almirall, LLC, the Federal Circuit determined that attorney's fees and an exceptional case determination were not available for fees and costs incurred when a patent owner defends an inter partes review challenge before the PTAB.  And in Uniloc 2017 LLC v. Hulu, LLC, the Federal Circuit found that the PTAB may consider patent eligibility under 35 U.S.C. § 101 for substitute claims.

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

• "Supreme Court to Consider Constitutional Propriety of Appointment of PTAB Judges," October 13, 2020
• "Snyders Heart Valve LLC v. St. Jude Medical, LLC (Fed. Cir. 2020)," September 9, 2020
• "USPTO Initiates Fast-Track Appeals Pilot Program," August 11, 2020
• "Uniloc 2017 LLC v. Hulu, LLC (Fed. Cir. 2020)," July 26, 2020
• "Arthrex Files Certiorari Petition in Arthrex Case, July 19, 2020
• "Arthrex Files Certiorari Petition in Arthrex Case," July 14, 2020
• "U.S. Government Petitions for Certiorari in Arthrex Case," July 13, 2020
• "Smith & Nephew File Certiorari Petition in Arthrex Case," July 12, 2020
• "In re Boloro Global Ltd. (Fed. Cir. 2020)," July 9, 2020
• "Adidas AG v. Nike, Inc. (Fed. Cir. 2020)," June 28, 2020
• "Supreme Court Takes Pass on Considering IPR Constitutionality," June 24, 2020
• "Amneal Pharmaceuticals LLC v. Almirall, LLC (Fed. Cir. 2020)," June 8, 2020
• "Pfizer Inc. v. Chugai Pharmaceuticals Co. (Fed. Cir. 2020)," May 5, 2020
• "Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020)," May 3, 2020
• "Thryv, Inc. v. Click-to-Call Technologies, LP (2020)," April 20, 2020
• "Bozeman Financial LLC v. Federal Reserve Bank (Fed. Cir. 2020)," April 15, 2020
• "Nike, Inc. v. Adidas AG (Fed. Cir. 2020)," April 13, 2020
• "Genentech, Inc. v. Iancu (Fed. Cir. 2020)," March 30, 2020
• "Facebook, Inc. v. Windy City Innovations, LLC (Fed. Cir. 2020)," March 22, 2020
• "Naples Roundtable Requests PTAB to Make Decisions Precedential," March 20, 2020

3.  But cf. American Axle & Mfg. v. Neapco Holdings LLC

In contrast with past years, there was some sense that fewer "major" developments occurred with respect to subject matter eligibility in 2020.  For example, stories involving subject matter eligibility took the #2 and #5 spots on our 2019 list; the #2 spot on our 2018 list; the #1, #2, and #4 spots on both our 2016 and 2015 lists; the #1 and #2 spots on our 2014 list; and the #1 spot on our 2013 list.  And yet, our #2 and #3 stories for 2020 involve subject matter eligibility.

Coming in at #3 is American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, where the Federal Circuit issued an interesting (and somewhat troubling) decision on the patent eligibility of claims directed to a method for manufacturing a shaft assembly of a driveline system.  In October 2019, a divided panel of the Federal Circuit affirmed a District Court finding of patent ineligibility.  The Court of Appeals then denied rehearing en banc.  And in August, the Federal Circuit withdrew its original opinion and handed down a substitute opinion in response to the petition for rehearing and rehearing en banc (as the Federal Circuit also did in IIllumina, Inc. v. Ariosa Diagnostics, Inc.).  The Federal Circuit followed this practice in what we wrote at the time was perhaps its most confusing and controversial application of the Supreme Court's subject matter eligibility jurisprudence under Alice Corp. Pty. Ltd. v. CLS Bank International.  Judge Moore, writing in dissent, expressed the view that the Federal Circuit had embarked on a course that resembles "enablement on steroids" and "turns the [Section 101] gatekeeper into a barricade.  In October, the Federal Circuit followed up its substitute opinion by denying American Axle's motion to stay issuance of the Court of Appeals' mandate while awaiting the Supreme Court's decision on American Axle's petition for certiorari.

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

• "American Axle & Manufacturing, Inc. v. Neapco Holdings LLC (Fed. Cir. 2020)," October 25, 2020
• "American Axle & Mfg. v. Neapco Holdings LLC (Fed. Cir. 2020)," August 9, 2020

2.  Nothing to See Here -- Congress and Courts "Move Along" on Patent Eligibility

Aside from American Axle & Manufacturing, Inc., however, Congress and the courts appeared to "move along" on subject matter eligibility.  In January, the Supreme Court entered orders denying certiorari in five cases having petitions on subject matter eligibility, including Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC; Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc.; and Berkheimer v. HP Inc.  One possible conclusion is that the Court is comfortable with the state of diagnostic method patenting (i.e., it no longer exists in the U.S.).  Or perhaps the Court believed that its decision not to decide would motivate Congress to change the law.  Or maybe the Court was facing up to the reality that it did not have a solution to the problem, in which case Congress would be the only answer.  That last hope appeared to have been dashed (or at least put on hold) in February when Senator Thom Tillis, Chair of the Senate's Subcommittee on Intellectual Property, in an interview with the Intellectual Property Owner's association, noted that Congress would not be completing its work on a legislative solution to the patent eligibility problem.  Sen. Tillis told the IPO that "[g]iven the reasonable concerns that have been expressed about the draft [legislation] as well as the practical realities of the difficulty of passing legislation, absent stakeholder consensus I don't see a path forward for producing a bill—much less steering it to passage—in this Congress."  Sen Tillis noted that "[i]f we're going to get anything done on this issue, everyone will have to compromise," adding that "[a]nything less than that is dead on arrival."  So, 2020 provided no judicial or legislative solutions to the patent eligibility problem, and yet this lack of solutions was still good enough for this story to take the #2 spot on our list (which somehow seems fitting for 2020).

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

• "Simio, LLC v. FlexSim Software Products, Inc. (Fed. Cir. 2020)," December 29, 2020
• "Adaptive Streaming Inc. v. Netflix, Inc. (Fed. Cir. 2020)," December 22, 2020
• "An Analytic Approach to Patent Eligibility," December 16, 2020
• "Gree, Inc. v. Supercell Oy (Fed. Cir. 2020)," December 3, 2020
• "C R Bard Inc. v. AngioDynamics, Inc. (Fed. Cir. 2020)," November 15, 2020
• "On the Patent Eligibility of Graphical User Interfaces: Part II," November 9, 2020
• "On the Patent Eligibility of Graphical User Interfaces: Part I," November 8, 2020
• "Stupid § 101 Tricks," November 1, 2020
• "Realtime Data LLC v. Reduxio Systems, Inc. (Fed. Cir. 2020)," October 26, 2020
• "Reconsidered: The Federal Circuit's Enfish Interpretation of Mayo-Alice," September 13, 2020
• "Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)," August 3, 2020
• "XY, LLC v. Trans Ova Genetics, LC (Fed. Cir. 2020)," August 2, 2020
• "The Three Properties of Patent-Eligibility: An Empirical Study," July 30, 2020
• "Federal Circuit Rules Public Key Cryptography Algorithm Invalid Under 35 U.S.C. § 101," July 22, 2020
• "Packet Intelligence LLC v. NetScout Systems, Inc. (Fed. Cir. 2020)," July 20, 2020
• "Electronic Communication Technologies, LLC v. ShoppersChoice.com, LLC (Fed. Cir. 2020)," July 16, 2020
• "In re Zunshine (Fed. Cir. 2020)," July 8, 2020
• "Barbaro Technologies, LLC v. Niantic, Inc. (N.D. Cal. 2020)," May 28, 2020
• "Uniloc USA, Inc. v. LG Electronics USA, Inc. (Fed. Cir. 2020)," May 6, 2020
• "USPTO Assesses the Impact of Patent Eligibility's Changing Landscape," April 27, 2020
• "Cardionet, LLC v. Infobionic, Inc. (Fed. Cir. 2020)," April 19, 2020
• "Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)," April 5, 2020
• "Mallinckrodt Files Certiorari Petition in iNO v. Praxair," March 19, 2020
• "Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)," March 17, 2020
• "What is an Abstract Idea, Anyway?" March 1, 2020
• "A Step-by-Step Approach to Patent Subject Matter Eligibility Reform," February 17, 2020
• "Pebble Tide LLC v. Arlo Technologies, Inc. (D. Del. 2020)," February 13, 2020
• "CareDX, Inc. v. Natera, Inc. (D. Del. 2020)," February 12, 2020
• "The Zombie Apocalypse of Patent Eligibility Reform and a Possible Escape Route," February 4, 2020
• "iLife Technologies, Inc. v. Nintendo of America, Inc. (N.D. Tex. 2020)," January 27, 2020
• "U.S. Supreme Court on Eligibility: Nothing to See Here, Move Along," January 13, 2020

1.  Pandemic Impacts Patent Practice

On March 11, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," cautioning that the WHO has "rung the alarm bell loud and clear."  At the time of the announcement, the WHO noted that there were 118,000 cases reported globally in 114 countries.  In its latest situation report, issued on January 12, 2021, the WHO indicates that there have been 88,387,352 cases globally.  The Director-General also stated in March that the pandemic was "not just a public health crisis, it is a crisis that will touch every sector -- so every sector and every individual must be involved in the fight."

As it has for nearly every single industry, the COVID-19 pandemic has had a profound impact on patent practice.  The pandemic has changed how most of us work, where most of us work, and what many of us work on.  In the early weeks and months of the pandemic, the U.S. Patent and Trademark Office, World Intellectual Property Organization, European Patent Office, IP Australia, Intellectual Property Office of New Zealand (IPONZ), Brazilian Patent and Trademark Office (INPI), Canadian Intellectual Property Office (CIPO), Mexican Institute of Industrial Property (IMPI), National Office of Intellectual Property (ONAPI) in the Dominican Republic, Intellectual Property India, National Intellectual Property Office (NIPO) in Sri Lanka, Israel Patent Office, Intellectual Property Office of Vietnam (NOIP), and Directorate General of Intellectual Property (DGIP) in Indonesia, among numerous other patent offices, modified deadlines and procedures to accommodate applicants and their representatives.

In addition to providing some deadline relief at the beginning of the pandemic, the USPTO implemented a COVID-19 prioritized examination pilot program, in which applicants that qualify for small or micro entity status can request prioritized examination without paying the fees typically associated with such prioritized examination.  In September, the USPTO also implemented a deferred-fee provisional patent application pilot program in order to promote the expedited exchange of information about inventions designed to combat COVID–19.  And in June, USPTO Director Andrei Iancu sent a letter to the Chairmen and Ranking Members of the Senate and House Committees on the Judiciary, Senate Subcommittee on Intellectual Property, and House Subcommittee on Courts, Intellectual Property, and the Internet, to provide information regarding the Office's transition to full time telework, the status of patent and trademark filings and fee collections, and cost saving measures that the Office had taken in response to the COVID-19 pandemic-related economic downturn.  In his letter, the Director stated that the trends through mid-May were "troubling and the current economic uncertainty could lead us to revise FY 2020 and FY 2021 revenue estimates further downward."  Even though the U.S., like many other countries, is currently confronting a third wave of the COVID-19 pandemic, the USPTO, like many other patent offices, has tried to return to something akin to "normal" operations (or at least what must pass for normal during a pandemic).  The hope is that the coming spring will see sufficient distribution and adoption of vaccines such that we can all return to something that is not merely akin to normal.

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

• "Inherited Neanderthal Gene Encodes Genetic Risk for COVID-19," November 4, 2020
• "USPTO Announces Deferred-Fee Provisional Application Pilot Program to Encourage COVID-19 Related Inventions," September 17, 2020
• "USPTO Announces Additional Extension of Certain Patent Deadlines for Small and Micro Entities," June 29, 2020
• "USPTO Director Updates Congress Regarding Impact of COVID-19 Pandemic on USPTO Operations," June 18, 2020
• "USPTO Announces Extension for Petitioning for Restoration of Right of Priority or Benefit," June 14, 2020
• "Impact of COVID-19 Pandemic on Patent Offices – June 10 Update," June 10, 2020
• "USPTO News Briefs," June 2, 2020
• "USPTO Announces Further Extension of Certain Patent Deadlines for Small and Micro Entities," May 27, 2020
• "USPTO Announces COVID-19 Prioritized Examination Pilot Program," May 18, 2020
• "Life Sciences Court Report & COVID-19 Impact on District Court Filings," May 17, 2020
• "USPTO Announces Further Extension of Certain Patent Deadlines," April 30, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – April 12 UPDATE," April 12, 2020
• "USPTO Answers FAQs on Extension of Patent Deadlines under CARES Act," April 6, 2020
• "USPTO Announces Extension of Certain Patent Deadlines," March 31, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 29 UPDATE," MARCH 29, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 26 UPDATE," March 26, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 19 UPDATE," March 19, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 18 UPDATE," March 18, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 17 UPDATE," March 17, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- UPDATED," March 16, 2020
• "Impact of COVID-19 Pandemic on Patent Offices and Federal Courts," March 15, 2020

WIPO Launches Coordinated Examination before Top Five Patent Offices

By Kevin E. Noonan --

The World Intellectual Property Organization (WIPO) launched a pilot program on July 1st termed Collaborative Search and Examination (CS&E) that will enable an applicant to have searching performed by all five of the major global patent offices (the USPTO, European Patent Office (EPO), Chinese Patent Office (SIPO), Japan Patent Office (JPO), and Korean Intellectual Property Office (KIPO)).

According to WIPO, the program has the following features:  it is "applicant driven," insofar as applicants must request searching under the pilot program.  It envisions a "balanced workload distribution," wherein each office will perform a search as a "main ISA" for 100 applications and perform "peer ISA" searches for another 400 applications for the two years of the pilot program.  Finally, each ISA will use a "common set of quality and operational standards" in performing the searches.  Initially, all applications accepted into the pilot program must be filed in the English language (although WIPO anticipates that it may accept applications in other languages later in the program).

The program is depicted schematically on the WIPO website as follows:

The request for participation in the pilot program should be included with the application as filed, using this form.  Anticipating future acceptance of applications in other languages, WIPO has made available versions of this form in the Chinese, French, and German languages.

RWS Inovia Releases 2017 Report on Global Patent Trends

By Donald Zuhn --

Patent services provider RWS inovia recently released its eighth annual report on global patent and IP trends.  In compiling "The 2017 U.S. Global Patent & IP Trends Indicator," RWS inovia, which produces products for PCT national phase entry and European patent validation, and provides IP translations and search services, surveyed more than 115 companies and universities in May 2017 to identify the trends having the greatest impact on the foreign filing strategies of patentees around the world.

In contrast with the first RWS Inovia report, which was based on surveys of U.S.-based companies and universities, the 2017 report has a more global focus, relying on surveys of patent applicants from six continents.  More specifically, 42.6% of survey respondents are based in the United States, 35.6% of respondents are based in Europe, and the remainder (21.8%) are based in Mexico, Canada, Brazil, Taiwan, Egypt, Turkey, India, China, Japan, South Africa, South Korea, and Australia.

The 2017 report also provides the following industry breakdown for survey respondents:  mechanical/engineering (17.8%), pharmaceuticals/biotech (15.8%), chemicals/materials (11.9%), university/association/non-profit (8.9%), IT/software/media (5.9%), and electrical/electronics (5.0%) (the remaining 34.7% of respondents were classified as "other," which in the 2016 report was described as encompassing manufacturing, telecommunications, teaching/research, consulting, pest control, and mining).  With regard to the size of respondents, the report notes that 41.6% of respondents had one to 100 employees, 18.8% had 101 to 1,000 employees, 22.8% had 1,001 to 10,000 employees, and 16.8% had more than 10,000 employees.  The report also indicates that 21.8% of survey respondents had no in-house patent attorneys or agents, 43.6% had one to four attorneys or agents, 16.8% had five to nine attorneys or agents, 8.9% had ten to 24 attorneys or agents, and 8.9% had 25 or more attorneys or agents.

The 2017 report points out that for U.S. applicants, the primary areas of concern include the overall low state of patent quality, effects of the America Invents Act (AIA) and post grant challenges with the change from first-to-invent to first-to-file, and the questionable patentability of certain subject matters with the fallout from the Alice Corp v. CLS Bank ruling (the latter being the primary concern of respondents last year).  For European applicants, the unitary patent was the main topic of concern (as it was last year) -- the 2017 report notes that 41.0% of respondents plan to use the system, 11.5% do not plan to use the system, and 47.5% are undecided.  For applicants outside the U.S. and Europe, topics of focus included the rapid development of China as a major patent hub, invalidity disputes, and lack of consistency between varying jurisdictions.

With respect to filing expectations, 56.8% of respondents said they filed as many patent applications as they expected to file in 2016 (down from 79.2% in last year's report), 10.2% filed more than they expected (up from 8.3%), and 32.9% filed less than they expected (up from 12.5%).  The 2017 report indicates that 36.8% of survey respondents filed between four and nineteen patents in 2016, 18.4% filed more than 100 patents, 16.1% filed 1-3 patents, 12.6% filed 20-49 patents, 10.3% filed no patents, and 5.8% filed 50-99 patents.  The report also notes that respondents filed more patents last year as compared with two years ago.

In addition, more than 41% respondents filed their patent families internationally in 2016, up from 34.3% last year, but still lower than the 49% and 52% of respondents that filed internationally in 2014 and 2013, respectively.  The report notes that 69.8% of those international filings were made using the PCT, 3.2% were made using the Paris Convention, and 27.0% were made using a combination of the PCT and Paris Convention (a similar breakdown was noted in the 2016 report).  For respondents using the PCT to file internationally, 77.4% respondents had used the European Patent Office as the International Searching Authority (up from 56% last year), 61.3% respondents used the U.S. Patent & Trademark Office (down from 64%), 22.6% used the Korean IP Office (down from 31%), 11.3% used the Japan Patent Office, 9.7% used the IP Australia, 3.2% used the Russian Patent Office, and 1.6% used the Brazilian National Institute of IP (the remaining 25.8% used another search authority, including the Nordic Patent Institute, Swedish Patent Office, Spanish Patent Office, and Austrian Patent Office, or the information was not available).  With regard to the countries in which respondents regularly filed, the top thirteen jurisdictions were (with last year's ranking indicated in parentheses):

1. United States (1)
2. Europe (2)
3. China (3)
4. Japan (4)
5. Canada (5)
6. South Korea (8)
7. Brazil (9)
8. Australia (7)
9. India (6)
10. Russia (10)
11. South Africa (12)
12. Singapore (11)
13. ARIPO (–)

With respect to IP budgets, 33.8% of survey respondents experienced IP budget cuts in 2016 (of which 19.1% of respondents were experiencing budget cuts for the first time in recent years), which compared with 41.4% of respondents who experienced budget cuts in last year's report.  For respondents who had reduced foreign patenting costs in 2016, cost savings were achieved by filing in fewer countries (43.6%), bringing steps in-house (33.9%), consolidating foreign counsel (29.0%), negotiating with foreign counsel (22.6%), reducing costs on patent translations (21.0%), negotiating with U.S. or European counsel (19.8%), consolidating foreign counsel (19.4%), using non-law firm providers (16.1%), and consolidating local counsel (14.5%).

RWS Inovia Releases 2016 Report on Global Patent Trends

By Donald Zuhn --

Patent services provider RWS inovia recently released its seventh annual report on global patent and IP trends.  In compiling "The 2016 U.S. Global Patent & IP Trends Indicator," RWS inovia, which produces products for PCT national phase entry and European patent validation, and provides IP translations and search services, surveyed more than 100 companies and universities in May 2016 to identify the trends having the greatest impact on the foreign filing strategies of patentees around the world.

The 2016 report notes that 68% of survey respondents are from the U.S. and 32% are from Europe.  In addition, the report provides the following industry breakdown for survey respondents:  mechanical/engineering (16.8%), university/association/non-profit (15.9%), pharmaceuticals or biotech industries (14.0%), electrical/electronics (10.3%), IT/software/media (8.4%), and chemicals/materials (6.5%) (the remaining 28% of respondents were classified as "other," which encompasses manufacturing, telecommunications, teaching/research, consulting, pest control, and mining).  With regard to the size of respondents, the report notes that 37.4% of respondents had one to 100 employees, 19.6% had 101 to 1,000 employees, 32.7% had 1,001 to 10,000 employees, and 10.3% had more than 10,000 employees.  The report also indicates that 37.4% of survey respondents had no in-house patent attorneys or agents, 48.6% had one to four attorneys or agents, 6.5% had five to nine attorneys or agents, 5.6% had ten to 24 attorneys or agents, and 1.9% had 25 or more attorneys or agents.

The 2016 report indicates that for U.S. applicants, fallout from the Alice Corp. v. CLS Bank ruling was the dominating issue in 2015, and for European applicants, the unitary patent was the main topic of concern.  With respect to filing expectations, 79.2% of respondents said they filed as many patent applications as they expected to file in 2015, 8.3% filed more than they expected, and 12.5% filed less than they expected.  The 2016 report indicates that 36.5% of survey respondents filed between four and nineteen patent families in 2015, 24% filed 1-3 patent families, 12.5% filed 20-49 patent families, 10.4% filed either no patent families or more than 100 patent families, and 6.3% filed 50-99 patent families.  The report noted that respondents have been filing fewer patent families as compared to three years ago.

In addition, respondents filed 34.3% of their patent families internationally in 2015, down from 49% in 2014 and 52% in 2013.  The report notes that 66.7% of those international filings were made using the PCT, 2.6% were made using the Paris Convention, and 30.6% were made using a combination of the PCT and Paris Convention.  For respondents using the PCT to file internationally, 64% respondents had used the USPTO as the International Searching Authority, 56% had used the EPO, 31% had used the Korean IP Office (KIPO), and 8% had used the Australian Patent Office.  With regard to the countries in which respondents regularly filed, the top twelve jurisdictions were:

1. United States
2. Europe
3. China
4. Japan
5. Canada
6. India
7. Australia
8. South Korea
9. Brazil
10. Russia
11. Singapore
12. South Africa

With respect to IP budgets, 41.4% of survey respondents experienced IP budget cuts in 2015 (of which 12.1% of respondents were experiencing budget cuts for the first time in recent years).  For respondents who had reduced foreign patenting costs in 2015, cost savings were achieved by filing in fewer countries (41.0%), bringing steps in-house (23.7%), negotiating with U.S. or European counsel (19.8%), consolidating foreign counsel (18.4%), negotiating with foreign counsel (17.1%), using non-law firm providers (14.5%), reducing costs on patent translations (11.8%), and consolidating local counsel (9.2%).  For survey respondents who brought steps in-house, those steps included annuities (29.0%), drafting specifications (17.1%), foreign patent filing (17.1%), patent translations (11.8%), U.S. or European prosecution (9.2%), filing U.S. or European patent applications (7.9%), and foreign patent prosecution (6.6%).

Inovia Releases 2014 Report on Global Patent Trends

By Donald Zuhn --

Patent services provider inovia has released its fifth annual report on global patent and IP trends.  In compiling "The 2014 U.S. Global Patent & IP Trends Indicator," inovia, which produces products for PCT national phase entry, European patent validation, and patent translations, surveyed more than 100 companies and universities in May 2014 to identify the trends having the greatest impact on the foreign filing strategies of U.S. patentees.

The 2014 report notes that 20.4% of survey respondents are involved in the pharmaceuticals or biotech industries.  Other sectors or groups represented in the survey include chemicals/materials (13.6%), electrical/electronics (7.8%), mechanical/engineering (12.6%), IT/software/media (1.9%), and university/association/non-profit (16.5%).  The report also indicates that 24.3% of survey respondents had no in-house patent attorneys or agents, 51.5% had one to four attorneys or agents, 11.7% had five to nine attorneys or agents, 4.9% had ten to 24 attorneys or agents, and 7.8% had 25 or more attorneys or agents.  With respect to the number of in-house patent attorneys or agents, the trend was towards increasing numbers of in-house practitioners (in last year's report, 33% of survey respondents had no in-house patent attorneys or agents and 47% had one to four attorneys or agents, and in the 2012 report 37% of respondents had no in-house patent attorneys or agents and 46% had one to four attorneys or agents).  Also, fewer respondents experienced IP budget cuts in 2013 than in 2012, and fewer respondents brought some prosecution activies in house in 2013 (dropping to 45% of respondents in 2013 from 57% of respondents in 2012).

Not surprisingly, the 2014 report indicates that for U.S. applicants, patent reform was the dominating issue in 2013.  With respect to filing expectations, 79% of respondents said they filed as many patent applications as they expected to file in 2013, 6% filed more than they expected, and 14% filed less than they expected.  In last year's survey, 73% of respondents said they filed as many applications as expected in 2012, 11% filed more, and 16% filed fewer, and in the 2012 survey, 67% of respondents said they filed as many applications as expected in 2011, while 18% filed more and 15% filed fewer.

The 2014 report indicates continued growth for international patent protection, as 52.6% of respondents filed more than half of their patent applications abroad (up from 50% in last year's report and 42% in the 2012 report).  Respondents were also less selective with their filings abroad in 2013, with 12.4% of respondents filing corresponding applications in only 1-3 foreign countries and another 30.9% filed internationally in 4-19 countries.  In last year's survey, 22% of respondents drew the line at 1-3 foreign filings and 32% filed in only 4-19 countries, and in the 2012 survey, 37% filed corresponding applications in only 1-3 foreign countries.

With regard to the countries in which respondents regularly filed, 20% added new countries to their list (down from from 23% in 2012), with China now considered a regular destination for many U.S. applicants.  A smaller percentage of respondents (15%) dropped countries from their lists (down from 19% in 2012), with respondents noting that market opportunity in Japan, Australia, and Canada was dwindling, prosecution was becoming more onerous in Saudi Arabia and too expensive in Japan.  As in last year's survey, respondents who dropped the European Patent Office believed that the high cost of pursuing such protection did not justify the value.  In ranking foreign jurisdictions, respondents placed Europe, China, and Japan first, second, and third, respectively, which was the same ranking respondents provided in the last two reports.  Finally, the report noted that a large majority of respondents (96%) rely on the PCT for foreign filing.  Of these respondents, 71% selected the EPO as an International Searching Authority (down from 75% in 2012), 45% selected the Korean IP Office (KIPO) (down from 50% in 2012), and 11% selected the Japan Patent Office (JPO) (no change from 2012).

Inovia Releases 2013 Report on Global Patent Trends

By Donald Zuhn --

Patent services provider inovia announced the release of its 2013 report on global patent and IP trends today.  In compiling the report, inovia, which produces products for PCT national phase entry, European patent validation, and patent translations, surveyed 125 U.S. companies and universities in January 2013 to identify the trends having the greatest impact on the foreign filing strategies of U.S. patentees.

The 2013 report notes that 23% of survey respondents are involved in the pharmaceuticals, biotech, or medical devices industries.  Other sectors or groups represented in the survey include chemicals/materials (13%), electrical/electronics (10%), mechanical/engineering (10%), IT/software/media (7%), and university/association/non-profit (18%).  The report also indicates that one-third of survey respondents (33%) had no in-house patent attorneys or agents, 47% had one to four in-house patent attorneys or agents, and the remainder (20%) had five or more attorneys or agents.  With respect to the number of in-house patent attorneys or agents, the trend was towards increasing numbers of in-house practitioners (the 2012 report indicated that 37% of survey respondents had no in-house patent attorneys or agents, 46% had one to four in-house patent attorneys or agents, and 17% had five or more attorneys or agents).

The report states that among survey respondents, "[t]he theme of 'cautious optimism' from previous surveys continues."  The report notes, however, that "respondents don't foresee too much growth in terms of the number of patent families expected to be filed in 2013."  Fewer respondents experienced IP budget cuts in 2012 than in 2011, and a greater percentage brought in in-house support or outsourced annuity payments.  Half of respondents cited final implementation of the Leahy-Smith America Invents Act as the most important issue/trend of 2013.  Other key trends for 2013 included cost containment, the rising cost to obtain patent protection, as well as enforcement and patent trolls.

With respect to application filings, 11% of survey respondents said they filed more patent applications in 2012 than they expected (down from 18% in 2011), 16% said they filed fewer patent applications (up from 15% in 2011), and 73% said they filed as many patent applications in 2012 as they expected (up from 67% in 2011).  The results of this year's survey, however, were a significant improvement over those from inovia's first survey (released in 2010), where 41% of respondents said they filed fewer applications than expected in 2009.

The 2013 report indicates continued growth for international patent protection, as 50% of respondents filed more than half of their patent applications abroad (up from 42% in last year's report).  Respondents, however, are even more selective with their filings abroad, with 22% of respondents filing corresponding applications in only 1-3 foreign countries and another 32% filed internationally in 4-19 countries (the 2012 report indicated that 37% of respondents filed corresponding applications in 1-3 foreign countries and another 42% filed internationally in 4-8 countries; this year's survey did not provide a breakdown of the percentage of respondents filing in 4-8 countries).

With regard to the countries in which respondents regularly filed, 23% added new countries to their list (up from 21% in 2011 and 17% in 2010), with 14% adding China and smaller percentages adding South American countries, India, South Africa, South Korea, and Japan.  Noting that 28% of respondents added China to their list in 2011, the report stated that the drop could be an indication that China is now a regular filing destination for many U.S. applicants.  A smaller percentage of respondents (19%) dropped countries from their lists (up from 17% in 2011), with the European Patent Office or individual European countries being dropped by 24% of respondents who pared down their lists, 10% dropping China, Japan, and Mexico, and 7% dropping Australia, Canada, South Korea, and Russia from their lists.  Respondents who dropped the European Patent Office or individual European countries believed that the high cost of pursuing such protection did not justify the value.  In ranking foreign jurisdictions, respondents placed Europe, China, and Japan first, second, and third, respectively, which was the same ranking respondents provided in last year's report.

Finally, the report noted that a large majority of respondents (99%) rely on the PCT for foreign filing.  Of these respondents, 75% selected the EPO as an International Searching Authority (up from 72% in 2011), 50% selected the Korean IP Office (KIPO) (up from 42% in 2011), and 11% selected the Japan Patent Office (JPO) (down from 12% in 2011).

Inovia Releases 2012 Report on Global Patent Trends

By Donald Zuhn --

Patent services provider inovia announced the release of its 2012 report on global patent and IP trends today.  In compiling the report, inovia, which produces products for PCT national phase entry, European patent validation, and patent translations, surveyed nearly 150 U.S. companies to identify the trends having the greatest impact on the foreign filing strategies of U.S. patentees.

The 2012 report notes that 22% of survey respondents are involved in the pharmaceuticals/biotech industry.  Other sectors or groups represented in the survey include chemicals/materials (16%), electrical/electronics (15%), mechanical/engineering (10%), IT/software/media (3%), and university/association/non-profit (22%).  The report also indicates that more than a third of survey respondents (37%) had no in-house patent attorneys or agents, 46% had one to four in-house patent attorneys or agents, and the remainder (17%) had five or more attorneys or agents.

The report states that among survey respondents, "the mood for 2011 was cautiously optimistic" (the 2011 report noted that the mood in 2010 was "mixed"), with fewer respondents experiencing IP budget cuts and a greater percentage bringing in in-house support or outsourcing IP tasks.  Nevertheless, respondents did not expect to increase the number of patent families filed in 2012.  A majority of respondents cited passage of the Leahy-Smith America Invents Act, and the upcoming move to a first-to-file system, as the most important trend of 2012.  Other key trends for 2012 included cost containment (a repeat trend from last year's survey) and the maximization of IP revenue potential.

Reflecting their cautious optimism, 18% of survey respondents said they filed more patent applications in 2011 than they expected (up from 9% in 2010) and 15% said they filed fewer patent applications (down from 19% in 2010) -- 67% of respondents said they filed as many patent applications in 2011 as they expected (down from 72% in 2010).  The 2012 results were a significant improvement over those from inovia's first survey (released in 2010), where 41% of respondents said they filed fewer applications than expected in 2009.

The 2012 report indicates a growing need for international patent protection, as 42% of respondents filed more than half of their patent applications abroad.  Respondents, however, continue to be selective with their filings abroad, with 37% of respondents filing corresponding applications in only 1-3 foreign countries and another 42% filed internationally in only 4-8 countries.  With regard to the countries in which respondents regularly filed, 21% added new countries to their list (up from 17% in 2010), with 28% adding China and smaller percentages adding India, Brazil, Russia, Taiwan, Chile, Korea, and South Africa (the latter four being new to the "newly added" list).  Only 17% of respondents dropped countries from their lists (down from 25% in 2010), with China and Europe each being dropped by 24% of respondents who pared down their lists, and a small percentage of respondents dropping Canada, Australia, India, and Italy from their lists.  Respondents who dropped China cited enforcement concerns as the primary reason, and those who dropped Europe cited the high cost of filing there.

Interest in a unified European patent system rose again, with 93% of respondents in favor of the concept (as opposed to 88% in 2010).  In addition, the report notes that a large majority of respondents (99%) continue to rely on the PCT for foreign filing.  Of these respondents, 72% selected the EPO as an International Searching Authority (down from 89% in 2010), 42% selected the Korean IP Office (KIPO) (down from 43% in 2010), and 12% selected the Japan Patent Office (JPO) (down from 17% in 2010).

With regard to IP budgets, fewer respondents reported budget cuts in the 2012 survey.  Only 20% of respondents said their IP budgets had been reduced in 2011, as opposed to 38% and 60% of respondents who noted that their budgets were cut in 2010 and 2009, respectively.  Respondents who experienced budget cuts, saw cuts that were less severe than in the past, with 15% losing more than 30% of their budget in 2011 as compared with the 18% who lost more than 30% of their IP budget in 2010.

The report concludes by predicting that "[t]he cautious optimism identified in last year’s survey seems likely to continue in 2012."

PCT and EP Filings on the Rise Again

By Donald Zuhn --

Last week, the World Intellectual Property Organization (WIPO) announced that International patent filings under the Patent Cooperation Treaty (PCT) rose from 155,398 in 2009 to 162,900 in 2010 -- an increase of 4.8%.  While the United States ranked first in filings with 44,855 applications, this still marked a 1.7% decline from the 45,618 applications that were filed in 2009.  China saw the strongest growth in PCT filings, with applications up 56.2% to 12,337 in 2010.  Japan, Germany, and South Korea rounded out the remainder of the top five with 32,156; 17,171; and 9,686 applications, respectively.

When 2010 filings were sorted into 35 technical fields by International Patent Classification (IPC), the top five fields were:

(1) Electrical machinery, apparatus, energy: 10,581 applications
(2) Medical technology: 10,465
(3) Computer technology: 9,540
(4) Electrical machinery, apparatus, energy: 9,143
(5) Pharmaceuticals: 7,843

While the fields of biotechnology and organic fine chemistry each had more than 5,000 filings (with 5,206 and 5,511, respectively), both fields saw filings drop in 2010 (down 1.5% and 2.9%, respectively).  However, only six of 35 technical fields saw filings rise in 2010 (digital communication; semiconductors; materials, metallurgy; electrical machinery, apparatus, energy; thermal processes and apparatus; and medical technology).

According to WIPO's figures, the top ten corporate PCT filers in 2010 were:

(1) Panasonic Corp. (Japan) - 2,154 applications
(2) ZTE Corp. (China): 1,863
(3) Qualcomm Inc. (U.S.): 1,677
(4) Huawei Technologies Co., Ltd. (China): 1,528
(5) Koninklijke Philips Electronics N.V. (Netherlands): 1,435
(6) Robert Bosch GmbH (Germany): 1,301
(7) LG Electronics Inc. (South Korea): 1,298
(8) Sharp Kabushiki Kaisha (Japan): 1,286
(9) Telefonaktiebolaget LM Ericsson (Sweden): 1,149
(10) NEC Corp. (Japan): 1,106

and the top five university filers in 2010 were:

(1) The Regents of the University of California (U.S.): 306 applications
(2) Massachusetts Institute of Technology (U.S.): 145
(3) Board of Regents, The University of Texas System (U.S.): 130
(4) University of Florida (U.S.): 107
(5) The University of Tokyo (Japan): 105

A list of the top corporate and university filers can be found here.

In January, the European Patent Office (EPO) announced that it had also seen a rise in application filings in 2010.  According to the EPO release, 232,000 European applications were filed in 2010, up 10% from the 211,000 filings in 2009.  The EPO noted that 39% of the applications originated from the 38 member states of the European Patent Organisation, 26% came from the U.S., 18% were from Japan, and 5% were from each of South Korea and China.  The EPO also noted that 58,100 European patents were granted in 2010, up 11% from the 52,400 patents granted in 2009.  More detailed statistics are expected to be released later this year.

USPTO Signs Memorandums of Understanding with Rospatent and SIPO

    By Sarah Fendrick --

On June 2, 2010, Sharon Barner, Deputy Director of the U.S. Patent and Trademark Office, and Boris Simonov, Director of the Russian Federal Service for Intellectual Property, Patents and Trademark (Rospatent), signed a Memorandum of Understanding (MOU) on comprehensive bilateral cooperation between the two Offices.  The MOU, which was announced in a June 7th press release, sets out the general framework required for bilateral cooperation between the USPTO and Rospatent, and will facilitate exchange of information between the Offices and overall effectiveness of the intellectual property systems in both Offices.

On May 19, 2010, the USPTO also entered into an MOU with China's State Intellectual Property Office (SIPO).  In a May 20th press release, USPTO Director David Kappos stated that the MOU "reconfirms and further strengthens our commitment to the growing cooperative relationship between our two offices," adding that he was "especially pleased that we have agreed to work toward constructing a Patent Prosecution Highway where both Offices can leverage each other's examination expertise to eliminate work redundancy, increase efficiency and increase patent quality."

USPTO and EPO Announce Extension of Trial Period for PPH Program

    By Christopher P. Singer --

In a notice dated September 23, 2009, the U.S. Patent and Trademark Office announced that it will extend for one year the trial period for its patent prosecution highway (PPH) program with the European Patent Office.  The extended trial period will expire on September 30, 2010.  As we have noted, the PPH programs are designed to expedite and leverage the examination process for applicants that have received favorable examination in one of the partner countries.

We reported last winter about the types of applications that are eligible for participation in the trial PPH, and the requirements for participation (see "Additional Application Types Eligible for Participation in PPH Between USPTO and EPO").  Updated requirements for participation in the USPTO will be available here, and requirements in the EPO will be posted here.

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

• "USPTO Initiates Patent Prosecution Highway Pilot Program with Finland Patent Office," June 29, 2009
• "USPTO Extends Patent Prosecution Highway Pilot Program with IP Australia; Begins Pilot Program with German Patent Office," April 15, 2009
• "USPTO Begins Pilot Program with the German Patent Office," May 7, 2009
• "Pilot PPH Program between Singapore and U.S.," February 1, 2009
• "Full Time Patent Prosecution Highway between Korea and US," January 28, 2009
• "Patent Prosecution Highway Pilot with CIPO Is Extended," December 23, 2008
• "Additional Application Types Eligible for Participation in PPH between USPTO and WPO," December 11, 2008
• "Patent Prosecution Highway Pilot Program between U.S. and Danish Patent Offices," October 29, 2008
• "Patent Prosecution Highway Expands to Europe," September 25, 2008
• "USPTO and UKIPO Extend Patent Prosecution Highway Pilot Program," September 3, 2008
• "USPTO and EPO to Implement Pilot Patent Prosecution Highway Program," April 29, 2008
• "Patent Prosecution Highway Extended to IP Australia," April 2, 2008
• "Patent Prosecution Highway Network Expands to Canada & Korea," January 29, 2008
• "USPTO Announces Two Additional Partners in the Patent Prosecution Highway Pilot Program," January 17, 2008
• "USPTO and JPO to Implement Patent Prosecution Highway on Full-Time Basis," December 27, 2007
• "USPTO and UK IPO to Collaborate on Patent Prosecution Highway," September 14, 2007

Top Stories of 2008: #13 to #10

    By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its second annual list of top biotech/pharma stories.  For 2008, we identified a baker's dozen of top stories covered on Patent Docs.  Today we will count down stories #13 to #10.  On Sunday, we will present stories #9 to #6, and on Monday, we will count down the top five stories.  As with last year's list, links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with our rankings, please let us know.

#13 -- Pharma Patent Injunctions in View of Amgen v. F. Hoffmann-La Roche

In the fall of 2007, a jury returned verdicts in Amgen Inc. v. F. Hoffmann-La Roche Ltd., finding five of Amgen's patents not invalid and three of these patents infringed by Roche's Mircera®, a form of recombinant EPO that has been covalently linked to polyethylene glycol.  The District Court for the District of Massachusetts entered a preliminary injunction in February preventing Roche from putting Mircera® on the market.  In granting the injunction, the Court found that Amgen had satisfied all but the public interest prong of the classic four-factor test discussed in eBay Inc. v. MercExchange, L.L.C.  The District Court struggled with the public interest prong of the test, in view of Roche's argument that the public interest was served, at least in part, by the presumed reduced price that would ensue from competition between Mircera® and Amgen's Epogen® and Aranesp® products.  The Court, expressly refraining from entering any findings on the fourth prong, left open the possibility that the injunction could be modified under a handful of conditions.  Roche agreed to the Court's conditions, but Amgen did not, and the Court subsequently appointed a special master to consider the question of how dosing and pricing of Amgen's and Roche's products should be compared.  Roche responded to the Court's appointment of the special master by filing a Notice of Appeal.  On October 2nd, the Court issued a 150-page opinion in the case, handing victory to Amgen, and eight days later, the Federal Circuit affirmed the preliminary injunction without opinion.

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

• "Amgen v. Hoffmann-LaRoche: Remaining Issues," October 13, 2008
• "Amgen v. Hoffmann-LaRoche: Back to the District Court," October 10, 2008
• "Victory for Amgen in District Court Decision - Part III," October 9, 2008
• "Victory for Amgen in District Court Decision - Part II," October 8, 2008
• "Victory for Amgen in District Court Decision - Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "How to Avoid a Permanent Injunction: The Lessons of Amgen v. Hoffmann-LaRoche," April 28, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008

#12 -- International Enforcement of Drug Patents

Last year, drug pricing and compulsory licensing in the developing world took the #10 spot on our list of top stories.  The fact that this story dropped two places on this year's list should not, however, be taken to mean that developing countries and the pharmaceutical industry have reached accord regarding this issue.  For example, in February, Novartis responded to Thailand's threats to issue a compulsory license by agreeing to supply its cancer drug Gleevac® (imatinib mesylate) at no cost to Thai patients -- provided that the Thai gvernment did not issue any compulsory licenses.  One month later, Thailand instead announced that it would maintain its compulsory licensing policy for Gleevac® as well as three other anti-cancer drugs (Novartis' Letrozole®, Sanofi-Aventis' Docetaxel®, and Roche's Erlotinib®).  The use by developing countries of tools provided in international agreements such as GATT, TRIPS, and the Doha Declaration (e.g., compulsory licensing and parallel importing) will no doubt continue to be a hotly debated in 2009.

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

• "Recent Developments in Pharmaceutical Patenting and Compulsory Licensing of Pharmaceutical Patents in Developing Countries," July 8, 2008
• "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
• "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008
• "Thailand Continues Its Compulsory Licensing Practices," March 11, 2008
• "Indian Generic Drug Maker Seeks to Invalidate Cancer Drug Patent," February 29, 2008
• "Novartis to Supply Cancer Drug to Thai Patients," February 5, 2008


#11 -- Greater Cooperation between Patent Offices

When your backlog of unexamined applications rises from 760,924 to 771,529, as it did for the USPTO in 2008, you should be searching for all reasonable ways to reduce that backlog.  Last year, the USPTO attempted to address its application backlog by focusing on the development of a number of worksharing programs with foreign patent offices.  In particular, the USPTO expanded its Patent Prosecution Highway (PPH) program to include pilots with the Canadian Intellectual Property Office (CIPO), Korean Intellectual Property Office (KIPO), IP Australia (IPAU), European Patent Office (EP), and Danish Patent and Trademark Office (DKPTO); extended its PPH pilot program with the CIPO; entered into an agreement with IPAU, in which the IPAU will act as an International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) for certain International applications filed with the USPTO Receiving Office; added the KIPO as a participating foreign patent office in the Priority Document Exchange (PDX) system; initiated the "Triway" worksharing program between the USPTO, EPO, and JPO; initiated the "New Route" worksharing program with the JPO; announced a new worksharing initiative with the KIPO, EPO, JPO, and State Intellectual Property Office of the People's Republic of China (SIPO); and released information about a Common Application Format (CAF) that arose out of an agreement between the USPTO, EPO, and JPO at the 25th Annual Trilateral Conference.

For information regarding this topic, please see:

• "Patent Prosecution Highway Pilot with CIPO Is Extended," December 23, 2008
• "Additional Application Types Eligible for Participation in PPH Between USPTO and EPO," December 11, 2008
• "'Blueprint' Announced for Work Sharing Initiative Between Five IP Offices," November 6, 2008
• "IP Australia Now Competent ISA for PCT Applications Received by USPTO," November 3, 2008
• "Patent Prosecution Highway Pilot Program Between U.S. and Danish Patent Offices," October 29, 2008
• "KIPO Becomes Participating Foreign Office in PDX Program," October 21, 2008
• "Online Priority Document Exchange Service Between USPTO and KIPO," October 9, 2008
• "USPTO and JPO Sign Statement of Enhanced Mutual Cooperation," September 29, 2008
• "IP Australia to Provide International Search and Examination Services for Certain PCT Applications," September 29, 2008
• "Patent Prosecution Highway Expands to Europe," September 25, 2008
• "USPTO and KIPO Sign Memoradum on Cooperative Patent Examination," September 24, 2008
• "USPTO and UKIPO Extend Patent Prosecution Highway Pilot Program," September 3, 2008
• "PTO Announces 'Triway' Pilot Program," July 15, 2008
• "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.," June 22, 2008
• "USPTO and EPO to Implement Pilot Patent Prosecution Highway Program," April 29, 2008
• "Patent Office Announces Common Application Format," April 28, 2008
• "Patent Prosecution Highway Extended to IP Australia," April 2, 2008
• "Patent Prosecution Highway Network Expands to Canada & Korea," January 29, 2008
• "'New Route' Created between USPTO and JPO," January 25, 2008
• "USPTO Announces Two Additional Partners in the Patent Prosecution Highway Pilot Program," January 17, 2008


#10 -- USPTO's PTA Calculations Called into Question

On September 30th, the District Court for the District of Columbia issued a decision in Wyeth v. Dudas that could eventually impact the manner in which Patent Term Adjustment (PTA) determinations are made.  In particular, the Court granted summary judgment in favor of Wyeth, determining that the USPTO had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a result, had denied Wyeth a portion of patent term to which it was entitled.  Less than a month later, USPTO Director Jon Dudas filed a Notice of Appeal in the District Court for the District of Columbia, appealing the Court's decision in Wyeth to the United States Court of Appeals for the District of Columbia Circuit, thus indicating how the Office would rule on requests for reconsideration being filed by patentees that had been similarly deprived of patent term.  Having no other recourse under 35 U.S.C. § 154(b)(4)(A), which requires patentees to file actions seeking corrected PTA determinations within 180 days of a patent's issuance, Napo Pharmaceuticals, Inc.; Ironwood Pharmaceuticals, Inc.; Solvay Pharmaceuticals GmbH; Biogen Idec Inc.; Purac Biochem B.V.; and Molecular Insight Pharmaceuticals, Inc. all followed Wyeth's lead by filing lawsuits against Director Dudas this fall.

For information regarding this topic, please see:

• "More Patentees Follow Wyeth's Lead in Seeking Additional PTA," December 3, 2008
• "USPTO to Appeal Wyeth v. Dudas," December 2, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008

USPTO News: New PCT Transmittal and Search Fees Effective in January

    By Christopher P. Singer --

In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Wednesday, November 12, 2008, the U.S. Patent and Trademark Office announced new fees for the transmittal and search for international applications filed under the Patent Cooperation Treaty (PCT).  The fees are designed to recover the estimated average cost to the Office of processing PCT international applications and preparing international search reports and written opinions for PCT international applications.  The new PCT transmittal fee will be $240 (adjusted from the current fee of $300), and the new search fee where the USPTO is acting as the International Searching Authority will be $2,080 (up from the current fee of  $1,800).  The supplemental search fee for each examined additional invention, which applicants have the option of requesting will also increase to $2,080, from the current fee of $1,800.  The fees will apply to international applications having a receipt date that is on or after January 12, 2009.

Washington Legal Foundation "Conversations With" Series Examines IP Issues

    By Donald Zuhn --

As part of its ongoing "Conversations With" series, the Washington Legal Foundation (WLF) recently made available its latest question-and-answer offering, which examines the ongoing evolution of intellectual property rights in the United States and internationally.  In the paper, entitled "The Changing Legal Landscape For Intellectual Property," former Attorney General and Pennsylvania Governor Dick Thornburgh (Of Counsel at K&L Gates LLP), moderates a discussion on the role that intellectual property protection plays in commerce and innovation with Robert Armitage, Senior Vice President and General Counsel of Eli Lilly and Company; Michael Fricklas, Executive Vice President, General Counsel, and Secretary of Viacom Inc.; and Brad Smith, Senior Vice President, General Counsel, Corporate Secretary, Legal & Corporate Affairs for Microsoft.  While the 18-page paper contains some interesting discussion by Mr. Fricklas and Mr. Smith on a number of copyright issues, we focus on the portion of the discussion (mostly by Mr. Armitage) that concerns patent issues.

With respect to whether U.S. patent law was in need of reform, Mr. Armitage (at left) stated that the 110th Congress had debated a number of "legislative proposals that could diminish our patent system in profound ways."  While noting that "it is undeniable that the U.S. patent system does need major reforms," Mr. Armitage argued that the needed reforms failed to address the "root-causes of well-understood problems."  Instead of a providing "more efficient ways in which to enforce valid patents and challenge questionable ones," Mr. Armitage contended that needed patent reform was being held hostage by "an anti-patent agenda."

Mr. Armitage also addressed the efforts by countries such as Brazil and Thailand to circumvent patent protection on therapeutics, stating that disrespecting patent rights on medicines available today "destroys any possible incentive" for addressing a country's need for new medicines in the future.  He added that the pharmaceutical industry "has been painted as the chief impediment to access to needed medicines," but that "making a solution-provider the problem-maker is morally and intellectually dishonest, not to mention unproductive."

When asked about "reverse payment" agreements, Mr. Armitage turned the discussion to the need to update the Hatch-Waxman regulatory scheme.  Noting that a nearly $1 billion investment was required to develop a new drug, and further, that the number of new drugs being approved by the FDA was "alarmingly low" (less than 30 in 2007), Mr. Armitage said that "it becomes clear that an industry that invests over $90 billion dollars in research and development cannot be sustained if the intellectual property protecting the few medicines that are discovered and approved are attacked after four years," (i.e., the amount of time Mr. Armitage says it generally takes for a generic company to challenge a brand company's patent).  Because the Hatch-Waxman scheme "no longer provides the right balance of exclusivity protection for innovators," he noted that "Lilly and others in the industry have opened the dialog to extend data package protection to 14 years."

On the topic of follow-on biologics, Mr. Armitage pointed out that "Lilly has been adamant that a period of data exclusivity of 15-20 years for innovative products would represent the best policy choice for overall patient welfare."  To those demanding shorter periods, he argued that a 5-year or 10-year period of data exclusivity did not "make sense" in view of the safety hurdles and small number of new medicines coming to market.

In closing, Mr. Armitage stated that the most important task for the Patent Office and the courts was to "apply all requirements for patent validity rigorously."  While he concedes that "[t]he problems with the patent system -- such as the backlog of patent applications and the rising cost of procuring and enforcing a patent -- are real," he also acknowledges that the increase in application filings and patent issuances "is a sign of success not failure of the system."

Patent Docs thanks WLF Chief Counsel Glenn Lammi for alerting us to the WLF's paper on IP issues.

USPTO News: "Blueprint" Announced for Work Sharing Initiative Between Five IP Offices

    By Christopher P. Singer --

In an October 31, 2008 press release, the U.S. Patent and Trademark Office announced the development of a work sharing plan between five major intellectual property offices.  The representatives of the five offices, including Dr. Jung-Sik Koh, Commissioner of the Korean Intellectual Property Office (KIPO); Alison Brimelow, President of the European Patent Office (EPO); Takashi Suzuki, Commissioner of the Japan Patent Office (JPO); Tian Lipu, Commissioner of the State Intellectual Property Office of the People's Republic of China (SIPO); and Jon Dudas, Director of the USPTO, adopted a unified vision statement for the initiative:  "The elimination of unnecessary duplication of work among the offices, enhancement of patent examination efficiency and quality, and guarantee of the stability of patent right."  The group also laid the framework for ten "Foundation Projects" that are designed to harmonize the search and examination environment in each office and to standardize the information sharing process.  Through these projects the offices hope to facilitate work sharing by building mutual trust in each office's work product, and enhancing search and examination quality.

According to the press release, each office will oversee the implementation of two Foundation Projects.  The offices agreed that as an initial step they would exchange detailed proposals regarding each of the ten Foundation Projects, and identify areas of agreement and discuss specific details of implementation no later than the end of April 2009.  The Foundation Projects split between the offices as follows:

EPO
• Common Documentation Database -- which has a goal of bringing together a common set of relevant patent and non-patent literature from around the world to assist patent examiners in their prior art searches.
• Common Approach for a Hybrid Classification -- which has a goal of enabling joint and efficient updating of patent classification and facilitate the reuse of work among the patent offices

JPO
• Common Application Format -- which has a goal of facilitating the filing procedure of each office by using a Common Application Format; and by using electronic or digitized patent application filing (in XML format) and subsequent processing and publication in XML format.
• Common Access to Search and Examination Results -- which has a goal of enabling examiners to find one-stop references in the dossier information of other offices, such as search and examination results.  Another goal of this project is to conduct the priority document exchange (PDX) to reduce the cost of ordering copies of priority documents for applicants and the administrative costs of electronic processing for offices.

KIPO
• Common Training Policy -- which has a goal of standardizing the training of patent examiners at each office, helping examiners to produce equivalent results of search and examination at the five offices.
• Mutual Machine Translation -- which has a goal of helping the offices overcome the language barrier of patent information and allow greater access to each office's patent information.

SIPO
• Common Rules for Examination Practice and Quality Control -- which has a goal of performing patent examinations at a similar standard and quality through common rules of examination practice and quality control.
• Common Statistical Parameter System for Examination -- which has a goal of establishing a system of common statistical parameters for all examinations at the five offices; and to conduct statistical tasks and exchange information on examination practices under common rules and parameters, building on the work of the Trilateral statistical working group.

USPTO
• Common Approach to Sharing and Documenting Search Strategies -- which has a goal of promoting repeated use of searches by enabling the patent examiners of each office to understand each other's search strategy.
• Common Search and Examination Support Tools -- which has a goal of establishing a system of common search and examination tools to facilitate work-sharing.