June 30, 2014 – "Drafting Patent Claims After In re Packard: Navigating the New PTO Regime for Evaluating Indefiniteness" (Strafford) – 1:00 to 2:30 pm (EDT)

July 9, 2014 – "Nautilus and Limelight: The Supreme Court Keeps Chipping Away at Patentees" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

July 9-11, 2014 – Fundamentals of Patent Prosecution 2014: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

July 20-22, 2014 – 2014 Annual Meeting & Conference (National Association of Patent Practitioners) – Alexandria, Virginia.

August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

***Patent Docs is a media partner of this conference or CLE

By Andrew Williams —

Earlier today, BIO 2014 presented a session entitled "Navigating Patent Challenges Under the America Invents Act" during which the presenters analyzed the differences between patent challenges in Federal District Court and before the Patent Trial and Appeals Board ("PTAB").  The panelists that discussed this issue were Judge Dana Sabraw of the U.S. District Court for the Southern District of California; Lead Administrative Patent Judge Michael Tierney of the PTAB, Trial Section; and Cliff Ford, Executive Director and Senior Patent Counsel at Isis Pharmaceuticals, Inc.  Meaghan Kent of Venable LLP moderated the event.

Ms. Kent began by providing some interesting statistics.  As of June 18, 2014, there have been 1,542 Inter Partes Review ("IPR") petitions filed, and of those, 87 related to biotechnology and pharmaceutical patents.  Even though this only represents 6% of the total, it is much more than anyone expected when the America Invents Act ("AIA") was passed.  In addition, the statistics suggest that IPRs are becoming more popular every month.  IPR petitions make up about 88% of all post-grant patent challenges, while the Transitional Program for Covered Business Method Patents ("CBM") constitutes about 12%.  There have been no Post-Grant Review ("PGR") petitions to date, most likely due to the fact that they are only available to patents issuing from applications filed since March 16, 2013.

Judge Tierney then provided an overview of the IPR and PGR proceedings.  As readers of this blog are likely aware, IPR petitions can only include challenges under 35 U.S.C. §§ 102 and 103, and be based only on patents, published applications, and printed publications.  The legal standard for institution is a "reasonable likelihood" that the petitioner would prevail with respect to at least one of the claims.  As Judge Tierney explained, if the decision maker is on the fence (50%), the case should be instituted.  This is in contrast to the standard for PGR, which is "more likely than not" that at least one claim is unpatentable.  This is a higher threshold, because if the decision maker is on the fence (50%), the proceeding should not be instituted.  Instead, it is a greater than 50% standard.  In addition, unlike IPRs, PGR challenges can be based on 35 U.S.C. §§ 101, 102, 103, and 112 (except for best mode), and the 102 and 103 references are not as limited as for IPRs.  Judge Tierney noted that PGR might prove valuable for challenging biotechnology patents because of the section 112 issues that they can present.

Judge Tierney than answered a series of questions from the audience.  One participant inquired whether the denial of a PGR petition would estop a challenger from filing an IPR.  The simple answer was that if the review was not instituted, there would be no final written decision, and therefore estoppel would not apply.  The next question dealt with whether the PTAB has ever proceeded to a hearing despite a settlement agreement by the parties.  Judge Tierney explained that such a circumstance is rare, but it has happened in at least one CBM review in which the parties settled on the eve of the hearing.  Interestingly, because of the settlement agreement, when the case went forward, the petitioner did not participate.  Therefore, only the patent holder was present at the hearing.  There was question whether the Board has every handled section 112 issues in IPR proceedings.  Even though it is very rare, it has come up in the context of claim construction.  For example, Judge Tierney described a case in which a district court had already determined that the claims did not satisfy 35 U.S.C. § 112, ¶ 6 because of a lack of structure in the specification.  Even though that court's determination was not binding on the PTAB because of the different standards used by the two institutions, the PTAB also found it could not construe the claims, and therefore could not apply it to the prior art.  Finally, someone asked if the Myriad guidelines would be controlling on the PTAB.  Judge Tierney explained that the guidelines were just interpretations of case law, so they might be persuasive, but they would not be binding.  Whereas those in attendance appeared to approve of this answer, it is unclear if it will be any solution to the problem.  After all, eligibility challenges are not permitted in IPRs.

Judge Tierney next outlined the IPR proceeding.  With regard to whether a patent owner should file a response before institution, he explained that there were reasons for either strategy.  For example, if the patent owner didn't want to tip his hand, he might not want to file a response.  On the other hand, if there were serious holes in a petitioners challenge, it might be beneficial to point this out to the Board.  Judge Tierney also explained that the institution was on a claim by claim basis and that the PTAB was not required to institute the proceedings based on all ground found in the petition.  Part of the reason is because of the short timeframe to resolution – one year.  Someone in the audience asked whether there would be estoppel to the grounds not instituted.  Judge Tierney admitted that this has not come up yet, but that it would probably be dealt with on a case-by-case basis.  Judge Sabraw, however, indicated that district courts would probably apply the estoppel because the entire point of the IPRs is to streamline litigation, and therefore estoppel will likely be liberally applied.  A discussion about whether the PTAB was a "death squad" followed.  Judge Tierney stated that he believed that, even though initially the PTAB appeared pro-petitioner, things were getting better for the patent owner.  For example, IPRs are being instituted less, and the patent owners are winning more often – 8 final written decisions have now left the patent unscathed.

The topic then switched to pending legislation.  Judge Sabraw was asked about the 60-70% pass rate to grant motions to stay.  He pointed out that in his approximately 10 years on the bench, these new proceedings are a "game changer."  In determining whether the institute a stay, Judge Sabraw explained that district courts previously looked to three factors; whether it will streamline the issues in the case, the status of the case, and the prejudice to the parties.  In the case of IPRs, he indicated that the streamlining factor was neutral, and required a prediction of whether the PTAB would alter the patent.  As for the status of the case, Judge Sabraw pointed out that it was important to bring the petition early.  If there has been no claim construction and minimal discovery, the chance of a stay would be significantly higher.  With regard to the impact on the non-moving party, he pointed out that in the case of non-practicing entities ("NPEs"), there would generally be no real prejudice.  Finally, Judge Sabraw explained that the AIA required a fourth factor when considering a stay – whether the stay will reduce the burden of litigation.  This is always "yes," according to the judge, because the litigants will not need to proceed in two forums, and it will decrease the resources required by the district courts.  On the subject of stays, Mr. Ford explained that defendants will almost always want a stay, because all of the focus for the next year will be on the validity of the patent, and not on infringement.  He did, however, admit that there were cases in which the defendant might not want a stay, such as when inventorship was an issue, so that the notebooks of the patent owner might be desired, or when the accused infringer has deep pockets and wants to keep the pressure on the patent owner.

When asked which forum is better, Judge Sabraw acknowledged that the courts could improve, but that there were already signs that they were.  For example, his court in San Diego strives to complete trial in 18 months.  This includes streamlining discovery to avoid the proverbial "David and Goliath" effect.  Also, the introduction of the patent pilot program and the proliferation of local patent rules were cited as a positive step by the judge.  In response to the same question, Judge Tierney explained that the PTAB was meant to be an alternative to litigation.  Even though the reports are currently only anecdotal, he believes that IPRs must be cheaper than litigation, and they certainly are timelier.  Mr. Ford hypothesized that the accused infringer would almost always prefer the PTAB.  This is because the preponderance standard is much easier to meet, and the use of the broadest reasonable interpretation for claim construction is advantageous.  However, there are times where presenting the issues to a jury might be advantageous over the patent judges.  The only real concern is the estoppel concern, but as Mr. Ford pointed out, it a petitioner loses at the PTAB, they were likely going to have lost at the district court also.

In making the case for who is better suited to review the validity of a patent, Judge Tierney pointed to the patent judges years of experience reviewing patents, which makes them well suited to make these determinations.  Judge Sabraw acknowledged that district court judges were not specialists, but that they bring their own skills to bear on the issue.  For example, even though trials may be longer and more expensive, both sides have an adequate opportunity to make their case.  Also, federal judges are able to use the skills that they have obtained hearing the various cases that they do.  Finally, when asked whether these new post-grant review proceedings were good for patents, Mr. Ford pointed out that they were meant to troll-busting provisions, and so they have been successful.  However, it was the high tech sector that wanted these procedures, but the problem is that the biotech and pharmaceutical community is stuck with them now also.

Post-Grant Patent Challenges and Biosimilar Regulatory Pathways

By Andrew Williams —

The 2014 BIO International Convention has already begun in San Diego, but most of the sessions and forums get underway beginning on Tuesday, June 24, 2014.  Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention.  For example, today, we focus on issues surrounding post-grant challenges of patents, both in the U.S. and Europe, and on the issues surrounding the regulatory approval of biosimilars.  Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth to discuss these sessions (or whatever other topic is of interest to you) (#1337).

Today we highlight two distinct topics that may be of interest to readers of this blog.  The first involves the ability to challenge issued patents at the U.S. Patent Office or EPO instead of in the court system.  Many detractors of the U.S. patent system have blamed the Patent Office for issuing too many vague or allegedly invalid patents.  The AIA set up new and improved mechanisms allowing potential or alleged infringers to request another look by the Office.  Of course, EPO has already had a lot of experience with opposition proceedings.  A couple of panels will look at the challenges and considerations involving these mechanisms.  The second topic does not necessarily implicate intellectual property, but patent attorneys are certainly paying close attention to regulatory approval pathways for biosimilars.  All eyes have been focused on the FDA, but so far the mechanisms established for the approval of biosimiars have not been sufficiently utilized.  It is therefore useful to look at the scientific and regulatory issues faced by countries outside the U.S.

With regard to post-grant challenges, we first note that Donald Zuhn of Patent Docs fame will be moderating a panel on opposition proceedings at the European Patent Office on Wednesday, June 25, at 4:15 PM to 5:15 PM.  The title of this session is "'Chairman, That Patent Should be Revoked!' — Join the EPO Opposition Mock Workshop and Help Argue the Case."  As the name suggests, representatives of the EPO are scheduled to conduct a realistic opposition proceeding to decide the fate of a contested illustrative patent.  Both the proprietor and defendant will be represented by European patent attorneys, but attendees are invited to join either party and help debate the case.  The session promises to elucidate how opposition proceedings are conducted within the EPO, explore how the validity of patents are determined, and compare the differences with comparable proceedings in the U.S.  The speakers for this session are Siobhán Yeats, Director of Biotechnology at the European Patent Office; Reuben Jacob, partner at RGC Jenkins & Co.; and Aylsa Williams, Partner at D Young & Co LLP.

In addition to hearing the comparisons between the EPO and US systems in the previous session, attendees will also be able to hear an in-depth presentation on post-issuance challenges at the United States Patent Office.  On Wednesday, June 25, at 10:15 AM to 11:30 AM, the Intellectual Property track will be feature "Navigating Patent Challenges Under the America Invents Act."  Biotechnology and pharmaceutical companies are not immune to such challenges, so it is important to understand the intricacies of these relevantly new procedures.  Moreover, the Federal Circuit's Fresenius v. Baxter International decision has made the timing of such a challenge an important consideration.  Of course, which process is used and how it is defended can affect not only whether suitable patent protection can be maintained, but can limit or expand defenses available either in court or at the Office.  This session will assess the risks and benefits associated with the available actions for challenging patent validity at the Office, in the courts, and at the International Trade Commission.  The speakers for this session will be Lead Administrative Patent Judge Michael Tierney, Patent Trial and Appeal Board; Judge Dana Sabraw, U.S. District Court for the Southern District of California; and Cliff Ford, Executive Director and Senior Patent Counsel at Isis Pharmaceuticals, Inc.  The session will be moderated by Meaghan Kent from Venable LLP.

With regard to the two sessions we are highlighting with regard to the regulation of biosimilars, unfortunately their times overlap (likely because they are in different tracks/forums).  First, the Regulatory Review & Approval track will present "Ensuring the Safety and Commercial Success of Biosimilars in the United States" on Tuesday at 1:45 PM to 2:45 PM.  The description of the session notes that there is a debate over what approach the FDA and the industry should take to ensure patient safety on one hand, and promoting market competition and continued biomedical innovation on the other.  The session promises to explore several critical issues related to safety, naming and traceability, substitution, product drift, and comparability and similarity.  There will be a focus on the lessons learned from Europe in the launch of the new class of biosimilar monoclonal antibodies.  With regard to issues of naming products, the "unknown" differences between an approved treatment with known process histories and a new product being studied for biosimilarity will be discussed.  The speakers for the session are Marcia Horn, President and CEO of ICAN (the International Cancer Advocacy Network), Phillip Schneider, Associate Dean and Professor at the University of Arizona College of Pharmacy; and Robert Yapundich, Board Certified Neurologist with the Neurology Associates, P.A.

At about the same (1:30 PM to 3:30 PM on June 24), the Emerging Opportunities in Global Markets Forum will present "Biosimilars Regulations: A Perspective from Influential Global Regulators."  This session will feature regulatory agency officials from around the globe to discuss both scientific and regulatory issues for biosimilars, especially with regard to the WHO draft guidelines.  For example, the discussion of approval requirements will address clinical trials, extrapolation of data, and immunogenicity, among other topics.  The session promises to also address issues surrounding naming, labeling, and pharmacovigilance.  The panel will include Lic. Mikel Arriola, Commissioner at COFEPRIS; and Dirceu Barbano, President of ANVISA; and will be moderated by Christian Lopez-Silva, Partner with Baker & McKenzie, S.C. in Mexico.

We look forward to seeing you at BIO 2014!

BIO and Leaders in the IP Community

By Andrew Williams —

The 2014 BIO International Convention begins this week in San Diego.  If you are planning on attending, you probably already know that the amount of information and opportunities available at BIO can be daunting.  Therefore, Patent Docs has been highlighting a few sessions or other opportunities, in thematic fashion, to help you navigate your way through the convention.  For example, today, we focus on presentations by influential leaders in the Intellectual Property Community.  Of course, Patent Docs authors and contributors will be present at BIO as part of the MBHB contingent, and Patent Docs readers are encouraged to stop by the MBHB booth to discuss these sessions (or whatever other topic is of interest to you) (#1337).

In the United States, two of the entities that have the most impact on U.S. patent practice are the United States Patent and Trademark Office and the United States Court of Appeals for the Federal Circuit.  And, on the global scale, it can be argued that no organization has more impact on international patent practice than the World Intellectual Property Organization ("WIPO").  Impressively, BIO will feature at least three current or recent leaders of these three organizations.  Therefore, attendees will be able to gain insight from the individuals that play (or have played) a major role in each of these three organizations.

First on our list, Judge Randall R. Rader of the Federal Circuit will be providing his view from the bench on recent developments in biotech patent law in the courts and in Congress.  This session will be on Wednesday, June 25, from 8:30 AM to 9:00 AM for the Intellectual Property track.  Judge Rader recently stepped down from his position as Chief Judge, and was succeeded by now Chief Judge Sharon Prost.  Moreover, five days after his presentation at BIO, on June 30, Judge Rader will be retiring from the court.  The title of his presentation is aptly named "Welcome and Farewell — Judge Randall R. Rader."  Judge Rader has also been outspoken on the issue of using § 285 fee-shifting as a mechanism for federal courts to combat patent trolls.  It will be interesting to see what he has to say on the recent legislative efforts aimed at the same goal.  Along those lines, there will be a separate session later that day at 1:45 PM to 2:45 PM on these Congressional efforts.  The title of that session will be "As if AIA Hasn't Brought Enough Change — Patent Litigation Reform is Looming in the US."

Next up, literally, Acting Director Michelle Lee will participate in a session immediately following Judge Rader, from 9:00 AM to 10:00 AM, June 25, entitled "View from the USPTO — Address by Acting Director Michelle Lee and Discussion of the Myriad-Mayo Guidelines."  Anyone following this blog knows how controversial those guidelines have been, so it will be interesting to hear the perspective of the acting director herself on the issue.  With her will be two additional representatives from the patent office, June Cohan, Legal Advisor, and Andrew Hirshfeld, Deputy Commissioner for Patent Examination Policy.  They promise to provide the latest thinking on the examination guidelines, and take questions and feedback from the audience.  The period for submitting comments to the Office on these guidelines is still open, and in fact has been extended to July 31, 2014.  Those attendees interested in this topic might also be interested in the session "Patent Eligibility from the Trenches: Practical Implications of the Supreme Court's Mayo and Myriad Decisions" on June 25, from 3:00 PM to 4:00 PM.  The panel for this session includes former Acting Director of the USPTO Teresa Stanek Rea.

Finally (or should we say initially?), Director General Francis Gurry of WIPO will be kicking off the Intellectual Property track on Tuesday, June 24, from 2:15 PM to 2:45 PM.  The Director General will be discussing WIPO activities and their impact on the biotechnology sector.  Just last month, the member states of WIPO appointed Director General Gurry by consensus to a second six-year term of office.  Immediately preceding this presentation, there will be an Intellectual Property Meetup in the "IP Social Spot" from 1:30 PM to 2:15 PM.  This Meetup will provide intellectual property professionals to mingle and kick-off the track.

Be on the look-out for the next installment of BIO 2014 previews in the next few days.

The Biotechnology Industry Organization (BIO) is holding its annual BIO International Convention this week in San Diego, CA.  Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.

As part of the Convention, more than 1,700 biotech companies, organizations, and institutions are expected to participate in the BIO Exhibition.  Patent Docs Donald Zuhn, Kevin Noonan, Andrew Williams, Sherri Oslick, Michael Greenfield, Josh Bosman, Josh Rich, James DeGiulio, and Nate Chongsiriwatana will also be attending BIO as part of the MBHB contingent, and will be participating in BIO's blogger network throughout the week.  Patent Docs readers who may be attending BIO this week are encouraged to stop by booth #1337 to meet the Docs, at the times indicated below, and talk a little biotech patent law.

Tuesday, June 24

9:30 am – 12:00 pm — Andrew Williams, Josh Rich, James DeGiulio, and Nate Chongsiriwatana
12:00 – 2:30 pm — Donald Zuhn, Sherri Oslick, and Michael Greenfield
2:30 – 5:30 pm — Sherri Oslick, James DeGiulio, and Nate Chongsiriwatana

Wednesday, June 25

9:30 am – 12:00 pm — Michael Greenfield, Josh Bosman, and Josh Rich
12:00 – 2:30 pm — Sherri Oslick, James DeGiulio, and Nate Chongsiriwatana
2:30 – 5:30 pm — Josh Bosman and James DeGiulio

Thursday, June 26

9:30 am – 12:00 pm — Donald Zuhn, Andrew Williams, Michael Greenfield, and Josh Bosman
12:00 – 2:30 pm — James DeGiulio

In addition, most of the Docs will be attending the MBHB reception at Dublin Square Irish Pub & Grill in San Diego's downtown Gaslamp Quarter on Tuesday, June 24 from 8:00 pm to 1:00 am.  Additional information about the reception, including invitations for the event, can be picked up at the MBHB booth on Tuesday.