Intellectual Property Owners Association

Serving the Global Intellectual Property Community


IP Chat Channel – Biotech/Pharmaceutical

Webinars are listed in chronological order with the most recent at the top of the page.
In order to view past webinars click on the register button below.  Then click on “View Event Recordings” in the upper right hand corner.  All recordings are in chronological order, and can be searched by title using the find feature in your browser.

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Avoiding and Utilizing Prosecution History Traps: Litigation, Prosecution and Due Diligence

Webinar Date: 10/09/2018

Prosecution history is sometimes overlooked when valuing a patent, but some commentators would say it’s nearly impossible to overestimate the role it can play in litigation.

This summer the Federal Circuit issued a precedential decision in Blackbird Tech v. ELB Electronics, which vacated an earlier judgment of non-infringement of a lighting technology patent asserted by Blackbird. The Federal Circuit determined that the district court had erred in construing the claim term “attachment surface” in finding non-infringement. A claim amendment made during patent prosecution played a prominent part in the appellate court’s decision.

Further, life science litigation involving broad patents can often find a patent owner boxed in by the need to meet Section 112 requirements in prosecution. The scope of disclaimers can also be dispositive in high-tech litigation such as Avid Tech., Inc. v. Harmonic, Inc., which centered on digital data storage.

This webinar will look at the nature of legal traps that can lurk in prosecution history, caused both by disclaimers and amendments, and how they can snare defendants or plaintiffs in infringement litigation. It features attorneys with a wide array of experience related to these issues, including panelists who recently won cases for their clients by exploiting prosecution history. They will provide tips for patent prosecutors on how to try to avoid leaving damaging history — and for transactional lawyers on how to spot problems during due diligence that could turn the patent into a lemon for a purchaser.


  • Brian Diner, Finnegan, Henderson, Farabow, Garrrett & Dunner, LLP
  • Brian Nolan, Mayer Brown, LLP
  • James Trainor, Fenwick & West, LLP

Biosimilars in the Antitrust Spotlight: Patent, Litigation and Settlement

Webinar Date: 10/04/2018

It’s been a little over five years since the U.S. Supreme Court issued its landmark decision in FTC v. Actavis, finding that payments made by brand­name drug companies to generic manufacturers in patent settlements can raise antitrust concerns. The prolific and ongoing litigation stemming from that decision is limited to the small-molecule drugs governed by the Hatch-Waxman regulatory scheme. Now some commentators believe that the FDA has set down a pro-competition gauntlet regarding large molecule biologic drugs governed by the BPCIA — and that the FTC is not far behind.

Up until now the economic arguments associated with pharmaceutical IP and antitrust litigation were based on the pattern of small molecule drugs, where generics usually achieve a substantial share of the market quickly with large price discounts. But the complexity and costs of developing biosimilar drugs, along with substantially different regulatory and market conditions, has already shaped a different pattern for biosimilar competition, raising new issues of which practitioners need to be aware.

Our panel – a veteran pharma litigator, an antitrust lawyer who formerly worked at the FTC and who was involved in FTC v. Actavis, and a healthcare economist and expert witness – will address these issues and look ahead and discuss:

-The likely shape of settlements in patent litigation between innovator biologic companies and biosimilar aspirants
-In light of FTC challenges to a series of contemporaneous business deals including patent settlements, the future of non-cash forms of compensation
-As multiple patents in biosimilar infringement litigation can be asserted in staggered waves over time, whether “at-risk” entry is more or less likely than for traditional generic drugs



  • Nicholas Mitrokostas, Goodwin Procter, LLP
  • Richard Mortimer, Analysis Group
  • Michael Perry, Baker Botts LLP

An Update on the On-Sale Bar: Helsinn at the Supreme Court

Webinar Date: 07/19/2018

The U.S. Supreme Court granted certiorari in Helsinn v. Teva in late June, teeing up an important question about the on- sale bar under the AIA. In this particular case, which the Federal Circuit declined to rehear en banc, a patent was invalidated after the sale was partially made public: the details of the invention, an anti-nausea drug, were kept secret, but the existence of the sale was publicly disclosed.

Our panel of experts, including a top Supreme Court advocate, in-house counsel, and a patent litigator, will review the current status quo after two significant Federal Circuit decisions in recent years on the on-sale and public use bars, Merck & CIE v. Watson Labs and The Medicines Co. v. Hospira. These decisions raised in-house concerns about patent prosecution practices, confidentiality, and guidance to commercial teams. The panelists will also consider what questions may remain unanswered after Helsinn, such as (1) does a fully-secret sales offer count to bar a patent under section 102? and
(2) even if it serves as a bar to patentability under section 102, to what extent does a secret sale count as “prior art” for obviousness purposes? They will also consider the Justices’ options in this case.



  • John Duffy, University of Virginia
  • Jennifer Johnson,DuPont
  • Christopher Loh, Fitzpatrick, Cella, Harper & Scinto

Patent Eligibility in the Life Sciences: Exergen and Praxair- and USPTO Memos on Vanda and Berkheimer

Webinar Date: 06/14/2018

Pity the life sciences patent prosecutor who tries to find a path through recent appellate court decisions regarding patent eligibility.  A recent concurrence in a divided Federal Circuit decision indicated that U.S. Supreme Court decisions like Mayo have left too much uncertainty about what is and is not patent eligible under section 101.  Like others in the IP community, the concurrence indicated that perhaps Congress should act.  But few experts expect a legislative fix to come quickly.  That leaves both patent owners and applicants with a pressing need to assess the impact of recent significant Federal Circuit opinions, such as ExergenVanda and Praxair.

Exergen and Vanda have been the cause for cautious optimism for some life science companies.

Exergen’s invention, a diagnostic patent, was upheld under section 101 by the Federal Circuit, which was considered an important event post-Mayo.  This decision is referenced in the USPTO’s Berkheimer memo of 19 April, which takes the agency into the uncharted territory of trying to decide how much and what kind of evidence it takes to show that an invention is not “well understood, routine and conventional.”

Vanda affirmed a district court’s finding that claims to a personalized method of treatment are patent eligible.  In early June, the USPTO issued a new memo to examiners on Vanda.  The Federal Circuit decision didn’t address a number of relevant issues, however, such as whether a doctor could be a direct infringer through divided infringement.

The most recent of the three decisions is far more ominous for life science inventions.  Praxair, a recent appeal of an IPR decision, could result in many section 101 challenges being made in IPRs in the form of a printed matter/obviousness challenge.

Our panel includes a life sciences expert at the USPTO, a top patent lawyer at a major pharmaceutical company, and a founding shareholder of an IP law firm who specializes in biotech.  They will assess the cumulative impact of recent changes and delineate prosecution strategies to address them.


  • Paul Golian, Bristol-Myers Squibb Company
  • Ali Salimi, S. Patent & Trademark Office
  • Warren Woessner, Schwegman, Lundberg & Woessner, P.A.

Biosimilar and Hatch-Waxman Litigation: Jurisdiction and Venue Issues

Webinar Date: 04/25/2018

Infringement litigation over biosimilars and pharmaceuticals poses its own knotty jurisdictional and venue issues due to the unique frameworks of the BPCIA and Hatch-Waxman.

These issues are particularly hot right now, with several disputes pending that could have a wide impact going forward, such as Momenta Pharmaceuticals v. Bristol-Myers Squibb. Further, after the Supreme Court’s TC Heartland decision, judges must decide where the artificial act of infringement occurs —and district courts are already split.

To help you navigate these complex issues, our panel includes the head of U.S. patent litigation for a major international pharma and biologic company that is active both as an innovator and in biosimilars, as well as two veteran litigators (one who typically represents innovators and the other who represents biosimilar applicants and generic drug companies). They will discuss what you need to know, and will make predictions, regarding:

  • Whether a biosimilar applicant will be able to bring BPCIA litigation before the brand sponsor brings its own suit.
  • Will a biosimilar maker who has not yet filed its marketing application with the FDA be able to appeal an unsuccessful inter partes review? Or does it need Article III standing to seek an appeal?
  • The complicated calculus regarding venue in both Hatch-Waxman litigation and BPCIA litigation.
  • Issues when there are multiple defendants in different jurisdictions.
  • How to deal with foreign defendants.


  • Cynthia Lamber Hardman, Procter Goodwin
  • Christopher Loh, Fitzpatrick, Cella, Harper & Scinto
  • Peter Waibel, Novartis

Divided Infringement after Tropp

Webinar Date: 02/15/2018

The 2015 en banc Federal Circuit opinion in Akamai V refined divided infringement, but left room for further judicial fine tuning. One such shift took place last December, in a Federal Circuit panel decision, Tropp v. Travel Sentry. That opinion considered when multiple parties can be found to have infringed a patent together —- and it could lead to greater liability for joint infringement. It also likely means such decisions will have to be made by jurors, not judges. Another 2017 earlier Federal Circuit opinion, Lilly v. Teva, addressed divided infringement in the context of the pharmaceutical industry for the first time.

Our panel includes the winning appellate attorney for the inventor/plaintiff in Tropp, who will discuss how the new opinion fits into the framework created by Akamai V., an attorney who manages litigation for a high tech company, and a litigator who won summary judgment for a defendant in an Eastern District of Texas case involving divided infringement . They will consider recent federal district court decisions involving divided infringement, including Sonrai Sys. v. AMCS Group., PersonalWeb Techs v. IBM, and Progme Corp. v. Comcast Cable, and discuss how the outcomes for similar fact patterns might be different in light of Tropp.


  • John Carlin, Fitzpatrick, Cella, Harper & Scinto
  • Paul Hughes, Mayer Brown LLP
  • Frank Nuzzi, Siemens Corp.

Exhaustion Tamed? Early Reports and New Ideas on After Lexmark

Webinar Date: 02/08/2018

Last year’s Supreme Court Lexmark decision poses a major problem for patent owners across many industries by dramatically broadening the scope of patent exhaustion. Apple’s pending litigation against Qualcomm underlines Lexmark’s impact because it challenges the chip maker’s business model for allegedly requiring customers to both purchase chips and take a patent license.

The IP world still awaits a significant Federal Circuit decision on exhaustion in the eight months since Lexmark. But many cases have been bubbling up from district courts, and companies would do well to examine these decisions and other fresh ideas that have been proposed to ameliorate Lexmark’s impact.

Our panel includes the Chief IP Counsel of a major drug company, an attorney with vast experience in licensing matters, and a litigator who won an exhaustion case for his defendant on summary judgment. They will discuss strategies and recent court cases that involve:

  • Staking out the claim that a sale is not an “authorized sale” — Chrimar v. Alcatel Lucent and Sunoco v. U.S. Venture;
  • Using claims of tortious interference under state law against competitors if they interfere with the patent owner’s contracts with purchasers;
  • Obtaining patent protection on each component of a system, as well as on the system as a whole; and
  • Obtaining separate patents on an inventions’ different methods of use.


  • Jorge Goldstein, Sterne, Kessler, Goldstein & Fox PLLC
  • Brian Kacedon, Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • William Krovatin, Merck & Co., Inc.

Written Description in the Life Sciences after Amgen v. Sanofi

Webinar Date: 12/12/2017

Hatch-Waxman litigation with generic manufacturers has long been the focus of competition involving traditional small molecule drugs.  The litigation between Amgen and Sanofi regarding large molecule next-generation cholesterol drugs, however, illustrates the new prominence of innovator vs. innovator litigation in the pharmaceutical industry.  In these types of cases, the law of written description looms large because innovators might try to cover all possible drugs that focus on a biologic target while disclosing only a few examples of a possibly large genus.

The recent Federal Circuit opinion in Amgen v. Sanofi, reversing Amgen’s district court win, will have a significant impact from R&D labs to court rooms.  The Federal Circuit vacated a district court’s finding that Amgen’s claims for a genus of monoclonal antibodies were not invalid and a permanent injunction enjoining sales of Sanofi’s Praluent®- and remanded for a new trial.

The Federal Circuit also made new law that will influence pharma litigation outside of antibodies. The district court had excluded evidence about Sanofi and co-defendant Regeneron’s own products. The district court excluded the post-priority evidence because it “did not illuminate the state of the art at the time of filing.” The Federal Circuit, by contrast, explained that evidence showing that species disclosed in a patent are not representative of a claimed genus is in fact likely to postdate the priority date, and is able to prove inadequate written description.

Our panel includes the biotech counsel of a multinational innovator company, and two top litigators. They will discuss:

  • What is now needed by way of written description to create a valid patent on an antibody? The entire DNA sequence? Just the CDRs? The entire 3D structure?
  • How does Amgen v. Sanofi clarify the law beyond earlier cases such as Abbvie v. Janssen and Ariad v. Lilly?

How will pharma litigation change after the case, and how will it affect specific pending cases including challenges on Amgen’s Embrel®?


  • Jane Love, Gibson, Dunn & Crutcher LLP
  • Duane Marks, Eli, Lilly & Company
  • Irena Royzman, Patterson Belknap Webb & Tyler LLP

USPTO on Restriction Practice, Terminal Disclaimers, and Patent Term Adjustment

Webinar Date: 09/26/2017

Restriction requirement practice has assumed a new importance since the Federal Circuit decision in Gilead v. Natco three years ago, which found that a later-issuing but earlier-expiring patent could serve as an obviousness-type double patenting (OTDP) reference. A restriction requirement lets a patent examiner categorize a patent application as containing multiple inventions and then restrict examination to just a “single” invention. Our panelists — an expert from the USPTO’s Office of Patent Legal Administration and two veteran and savvy patent prosecutors — will analyze the opportunities and pitfalls for patent prosecutors raised by restriction requirements, discussing such topics as:

  • After a restriction requirement, how can a patent applicant make sure that the subsequent application falls into the section 121 “safe harbor,” while also garnering the longest protection through patent term adjustment?;
  • What does it mean for claims in a new application to be “consonant” with those withdrawn from the earlier case?;
  • The new amendment to the Manual of Patent Examining Procedure that describes when a terminal disclaimer can be withdrawn; and
  • Lessons learned from cases such as Hagenbuch v. Sonrai (E.D. Ill. 2016) on the potential danger of filing an ill-worded terminal disclaimer, and Janssen v. Celltrion (D. Mass. 2016) on serious consequences from filing a continuation instead of a divisional.


  • Kathleen Fonda, USPTO
  • Jeffrey Hohenshell, Medtronic, Inc.
  • Kevin Noonan, McDonnell Hulbert Berghoff & Boehnen LLP

Who Will "Dance" Now? Biosimilars After Amgen v. Sandoz 

Webinar Date: 07/12/2017

Developers for biosimilars face not only stiff technical and manufacturing challenges, but also legal uncertainty regarding the enabling legal framework, the Biologics Price Competition and Innovation Act (BPCIA) of 2010. Two of those questions — regarding the availability of a federal injunction to compel information disclosure and the timing of the biosimilar maker’s notice of marketing — were answered in last month’s U.S. Supreme Court opinion on two cases between Amgen and Sandoz. 

But much remains uncertain. Our panel of top drug industry litigators will give their views on what lies ahead regarding such questions as: 

  • Will the “patent dance” be essentially mandatory under state law? Will availability of an injunction vary by state, perhaps triggering important venue issues? 
  • When would a biosimilar maker choose the patent dance even if it is not mandatory? 
  • How soon can a biosimilar manufacturer give notice of commercial marketing? Can it be done before filing for FDA approval? 


  • Elaine Blais, Goodwin Procter LLP 
  • Brian Slater, Kramer Levin Naftalis & Frankel LLP 
  • Bruce Wexler, Paul Hastings LLP 

Exhaustion Unleashed: Licensing, Patenting Strategy, and Litigation After Lexmark 

Webinar Date: 06/28/2017

This webinar will explore the significant ramifications of the recent U.S. Supreme Court decision in Impression Products v. Lexmark. Exhaustion of patent rights is a very simple matter, the Court said, and the Federal Circuit has been wrong both to allow domestic post-sale restrictions under patent law and to allow U.S. patent owners to sue for infringement of products imported into the U.S. that the patentee first sold abroad. The opinion notes, “We conclude that a patentee’s decision to sell a product exhausts all of its patent rights in that item, regardless of any restrictions the patentee purports to impose or the location of the sale.” 

Our panelists include the top IP lawyer at a multinational pharmaceutical company, a law firm attorney who was formerly the head of IP litigation at GE, and a licensing expert. They will discuss how companies will need to react to the newly-fortified power of exhaustion, including: 

  • Structuring licenses as a way around exhaustion; 
  • Antitrust concerns about enforcing post-sale restrictions through contracts after Lexmark; 
  • Structuring patent ownership, supply chain management, and inventory management to reduce exhaustion, and important tax implications. 


  • Paul Jahn, Morrison & Foerster LLP 
  • William Krovatin, Merck & Co., Inc. 
  • Richard Rainey, Covington & Burling LLP

Pharma Lessons from the PTAB: Litigation and Prosecution 

Webinar Date: 06/08/2017

After a slow start, AIA challenges are now a frequent life-or-death risk for biopharmaceutical patents, totaling 212 in 2016, more than twice the number two years earlier. Exemplifying the PTAB’s power was the Federal Circuit’s April decision in Novartis v. Noven that upheld the invalidation by the PTAB of claims covering Novartis’ dementia patch Exelon, even though both the Federal Circuit and Delaware’s federal court had earlier ruled otherwise. Our panelists, all litigators with extensive pharma patent PTAB experience, will spell out winning strategies specific to the industry for both patent owners and challengers, and also will highlight lessons for patent prosecutors that emerge from PTAB practice. Topics to be discussed include: 

  • The role of objective indicia of nonobviousness. Pharma patents do put up a better fight at the PTAB than other technologies: last year, a third of biotech/pharma claims survived PTAB trials, almost three times the survival rate of electrical/computer claims; 
  • The surge in PGRs challenges to pharma patents on Section 112 grounds of indefiniteness and enablement; 
  • The relationship between district court Hatch-Waxman litigation and PTAB challenges; 
  • How to inoculate continuations or divisionals of challenged patents to relevant prior art. 


  • Eldora Ellison, Sterne Kessler Goldstein & Fox, PLLC 
  • Cynthia Lambert Hardman, Goodwin Procter LLP 
  • Kerry Taylor, Knobbe, Martens, Olson & Bear LLP 

On-Sale Bar After Helsinn: What is the Scope? 

Webinar Date: 06/01/2017

How can a recent Federal Circuit opinion on the on-sale bar, that appears to maintain the status quo, all the same be causing anxiety in the minds of some in-house counsel? This webinar will explore the ramifications of the April decision Helsinn v. Teva, that reversed a lower court by holding that the 2011 America Invents Act on-sale bar provision renders patents invalid if the invention was sold prior to patenting, even if the sale did not publicly disclose the invention.

Helsinn appears to be consistent with a long line of cases about secret sales, including Metallizing. But some in-house counsel, particularly in pharma and other regulated industries, are concerned about the facts of the case, in which the public disclosure of a private purchase-and-supply agreement between Helsinn and a third-party distributor was found invalidating. They worry that many contracts regularly inked by their in-house clients prior to filing a patent application will now need the added scrutiny of IP counsel. And if such transactions are known by the prosecuting patent attorney, will they have to be disclosed to the USPTO?

Our panel includes an in-house counsel at a global chemical company, a pharmaceutical industry litigator, and a professor of patent law.


  • Prof. Dennis Crouch, University of Missouri School of Law
  • Deborah Fishman, Arnold & Porter Kaye Scholer LLP
  • Jennifer Johnson, DuPont

Divided Infringement in the Life Sciences: Patent Prosecution Perspective

Webinar Date: 03/16/2017

With the Federal Circuit decision earlier this year in Eli Lilly v. Teva Parenteral, the reach of divided infringement into the life sciences left the realm of the hypothetical. Akamai v. Limelight and other prior cases about divided infringement involved software and the Internet, but the Lilly case involved a medical method of treatment. The case is also the first Federal Circuit decision to affirm a finding of divided infringement using the new standard for “direct or control” established by the en banc Federal Circuit in August 2015. Under that standard, an infringer can be found guilty of infringement, even if one did not perform all steps of a patented method. In addition to exerting control through traditional means, an infringer can now be held liable when one “conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.” The relationship between doctor and patient is discussed in this context in the Lilly opinion.

Our panel, which includes an in-house patent counsel at a drug company and two patent prosecutors, will analyze Lilly, and extract principles that can be used to guide patent claim drafting in such fields as personalized medicine and companion diagnostics, measuring the efficacy of treatment through biomarkers, and methods involving pretreatment. The panelists will also consider the interplay of factors unique to the drug industry, such as the role of the FDA label.

Divided Infringement Since Akamai En Banc: Development of the Law

Webinar Date: 03/14/2017

Following a lengthy trip to the U.S. Supreme Court and back, in August 2015, the Akamai v. Limelight case resulted in the en banc Federal Circuit establishing a new standard for finding an infringer guilty of direct infringement even if one did not perform all steps of a patented method. The infringer can now be held liable when one “conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance,” in addition to exerting control through traditional means

Companies in many industries are acutely interested in how the new legal standard is developing, and there are now signposts. Earlier this year, the Federal Circuit affirmed a finding of divided infringement in Eli Lilly v. Teva Parenteral. Underlining the broad impact of Akamai, a case that involved software and the Internet, this case involved a method of medical treatment. The Federal Circuit has also ruled for the defendant in two other cases, refusing to remand a case back to the district court because the new standard would not change the outcome and find the pleading of divided infringement too vague. Several district courts have also recently rendered decisions on divided infringement.

Our panel will describe and analyze how courts are applying Akamai.


  • John Carlin, Fitzpatrick, Cella, Harper & Scinto
  • Michael Joffre, Sterne, Kessler, Goldstein & Fox PLLC
  • Frank Nuzzi, Siemens Corp.

After Life Tech v. Promega: Litigation and Business Strategies for Patent Owners and Defendants

Webinar Date: 03/09/2017

This webinar will consider what new legal battles are likely to follow from last month’s U.S. Supreme Court decision in Life Tech v. Promega. The decision reversed the Federal Circuit by finding that Thermo Fisher Scientific’s Life Technologies unit did not infringe by shipping a single component of Promega’s patented invention overseas, in a case involving Section 271(f)(1) of the Patent Act.

In parsing that statute, the Justices declined to rule on how close to “all” of an invention’s components must be exported in order to be the “substantial portion” that is needed to infringe. Presumably, that determination will be argued in front of a jury. It is also not clear whether it will be a judge or the jury who will answer the question of exactly how many “components” are defined within a patent. Patent owners will want to argue that there are multiple components in the part of an invention shipped overseas, while alleged infringers will want to include many parts of a patent in one component.

Our panel, which includes the head of IP for a large technology company and two litigators, each of whom was involved in an amicus brief in the case, will also discuss strategies for patent prosecution and global supply chain management going forward. For instance, inventors may want to look harder at procuring foreign patents in countries where competitors are likely to repackage or use components of an invention that now is patented only in the U.S.


  • Paul Berghoff, McDonnell Boehnen Hulbert & Berghoff LLP
  • Irena Royzman, Patterson Belknap Webb & Tyler LLP
  • Bradford Schmidt, Agilent Technologies

Evidence of Prior Art at the PTAB: Rigorous Proof -- or Else

Webinar Date: 01/19/2017

Several interesting recent decisions at the PTAB exhibit a “man bites dog” pattern in which the patent owner has succeeded in disqualifying the petitioner’s evidence of prior art, and saved patent claims as a result. These decisions reflect the limited discovery allowed by the PTAB to meet its tight deadlines. Although ambiguity about prior art might be resolved in discovery at district court, the PTAB generally requires evidence of prior art to be meticulously substantiated in the petition for an AIA review.

These cases, including Blue Calypso v. Groupon and GoPro v. Contour IP, expand the edges of existing case law on the use of Internet-based and printed prior art regarding public accessibility to those skilled in the art. Moreover, in a recent post-grant review (PGR) Altaire Pharmaceuticals v.  Paragon Bioteck, the first time the PTAB upheld a patent in a PGR, the patent survived because the petitioner failed to prove that the claims were invalid due to public use or on-sale activity. Altaire asserted that earlier sales of its own eye solution product had made Paragon’s invention obvious, but failed to conform to PTAB rules about experimental testing.


  • David Conrad, Fish & Richardson PC
  • Brian Mudge, Andrews Kurth Kenyon LLP
  • Michael Rosato, Wilson Sonsini Goodrich & Rosati

Obviousness After Apple v. Samsung

Webinar Date: 11/02/2016

The early October en banc decision in a smartphone patent dispute between Apple and Samsung has revealed a startling disagreement on the Federal Circuit about obviousness – a concept viewed by many experts as the central issue in patent law. Judge Dyk, a member of the original three-judge panel that was overruled by the eight-judges majority, said in a dissent that the majority opinion created “profound changes in the law of obviousness” by turning the legal question into a factual one, contrary to KSR. The majority, in contrast, insisted their opinion involved simply “apply[ing] the existing obviousness to the facts of this case.” The majority and the original panel disagree in this case about what weight to give the jury verdict of non-obviousness. While the original panel found little to support the jury’s finding, the majority found that there was the “substantial evidence” required by law, and that the appellate court needed to show the appropriate deference.

Our panel will discuss the likely impact of this case, as well as of the recent Federal Circuit opinion in Arendi v. Apple, where the court overruled the PTAB invalidation of of Arendi’s patents, stressing that “common sense” critiques of an invention must be supported by substantial evidence and explained with sufficient reasoning. Lessons will also be drawn from the recent PTAB decision Innopharma v. Senju Pharmceutical, where after institution the patentee was able to prove to the PTAB both unexpected technical effects and the nexus between those technical effects and commercial success.


  • Robert Asher, Sunstein Kann Murphy & Timbers
  • Kenneth Corsello, IBM Corp.
  • Justin Hasford, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Life Sciences & Section 101: The Way Ahead

Webinar Date: 08/11/2016

The U.S. Supreme Court’s recent decision not to grant certiorari in Ariosa v. Sequenom was a sharp disappointment to many inventors and patent owners who had hoped the Court would revisit and clarify its views on patent eligibility after its decisions in Mayo and Alice. But that was not to be. As a result, the two industries most wounded by Mayo and Alice — life sciences and computer software — must look for paths ahead without any reprieve from the Justices. Recent Section 101 cases from the U.S. Federal Circuit and ex parte PTAB decisions can serve as signposts for both the life sciences and software industries. Our industry-specific panel is made up of a technically-savvy in-house counsel and two top law firm patent prosecutors. They will discuss cases such as:

  • Rapid Litigation v. CellzDirect, where in early July, the U.S. Federal Circuit panel reversed a district court’s holding that claims to a method of isolating and preserving liver cells were patent-ineligible. The appellate court held that the claims did not encompass a judicial exception (step one of the Mayo/Alice analysis). The same kind of analysis helped save patents involving self-referential software databases in Enfish v. Microsoft this spring.
  • Bascom v. AT&T, where in June the U.S. Federal Circuit reversed a district court’s finding that Bascom’s patent for filtering internet content failed step two of the Mayo/Alice The U.S. Federal Circuit stated that “the inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . an inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.” Life science experts believe this finding can also help life science patents.

Our panelists will give specific tips for drafting and prosecuting patents in their industries to avoid Section 101 rejections, resulting in patents that will withstand patent-eligibility attacks in litigation. The life science webinar will include discussion of both therapeutics and diagnostics, and the software webinar will include discussion of several recent useful ex parte PTAB decisions that overturned examiners Section 101 rejections.


Deborah Martin, Pfizer Inc.
Christopher Jeffers, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Warren Woessner, Schwegman, Lundberg & Woessner, P.A.

Life Science and Section 101: USPTO New Examiner Guideline

Webinar Date: 05/25/2016

A senior lawyer at the USPTO and two experienced life science patent prosecutors will use this webinar to probe deeply into the new examples published this month that show how claims for life science inventions should be examined by the agency for subject-matter patent eligibility. They will look in detail at the first four examples, two centering on diagnostics and two on inventions that involve a product of nature. Attendees will benefit most if they are already familiar with the examples and have a printed copy of the examples available to refer to during the webinar. The examples are available on the USPTO website.

The panelists will crystallize the examples into “dos and don’t” for patent prosecutors in life science matters relating to Subject 101. They will also discuss pending litigation and how the guidelines will have to change if the U.S. Supreme Court denies certiorari in the Sequenom case. The two diagnostic examples do not apply the 2015 Federal Circuit decision in Sequenom.


Raul Tamayo, USPTO
Courtenay Brinckerhoff, Foley & Lardner
Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP

USPTO and Section 101: New Examiner Guidelines

Webinar Date: 05/18/2016

The USPTO is trying to put an end to the “I know it when I see it” era of subject-matter ineligibility decisions by patent examiners. This month the agency published a new package of guidance to examiners that includes, among other things, instructions on formulating detailed subject-matter eligibility rejections and responses to applicant’s replies, and a new set of life science examples.

Our webinar on Wednesday, May 18 will focus on the patent prosecution process and Section 101 rejections in light of the new guidance. The panel features the USPTO’s Deputy Commissioner of Patent Examination Policy. In discussion with two law firm patent prosecutors, he will explain the agency’s new policies and how the agency will encourage examiners to follow them. The panel will also review the recent Federal Circuit decision in Enfish v. Microsoft and other pending decisions that may cause the USPTO to further adjust its policies.

Another upcoming webinar (date to be announced shortly) will feature a USPTO life sciences expert who will hone in on the new life science examples in discussion with two life science patent prosecutors. Despite the welcome new insights provided to patent applicants by the latest USPTO examples, some experts point out that hard questions remain. For example, what is the likely eligibility of a claim directed to a mixture of an efficacious amount of a naturally-occurring product?


Robert Bahr, USPTO
Bart Eppenauer, Shook, Hardy & Bacon L.L.P.
Michelle Holoubek, Sterne Kessler Goldstein and Fox

Settling ANDA Litigation: Options and Risks

Webinar Date: 03/23/2016

The recent First Circuit opinion in the In Re Loestrin reverse-payment litigation appears to have clarified that non-cash payments to a generic company from a branded pharmaceutical company can be targeted as anti-competitive under the U.S. Supreme Court 2013 decision in FTC v. Actavis. But many other antitrust-related issues about settling Hatch-Waxman litigation remain open, such as:

  • How big must a reverse payment be to count as a “large and unjustified” under Actavis?
  • Does the promise of “no authorized generic” amount to an unlawful reverse payment?
  • May side deals that are profitable for the generic manufacturer and reflect commercially reasonable arm’s-length terms be freely entered into by settling parties
  • What role will arguments about patent strength play if a reverse-payments antitrust case goes to trial?

Our panel, which will discuss these and other issues, features an attorney at the Federal Trade Commission, and two law firm litigators, one from each side of the innovator/generic divide.

Daniel Butrymowicz, Federal Trade Commission
Kevin Nelson, Duane Morris
Bruce Wexler, Paul Hastings

Double-Patenting: Tech Patents, Double Patenting, and Ex Parte Reexam

Webinar Date: 01/08/2016

This panel will examine how double patenting arises in tech company patent portfolios, how ex parte reexam differs from other post-grant proceedings vis a vis double patenting, and how it can be used to invalidate vulnerable patents. Our panel includes both an in-house tech company lawyer and a law firm lawyer with relevant first-hand experience, and a law firm attorney who was former head of the USPTO’s Central Reexamination Unit.

The Federal Circuit decision twenty months ago in Gilead v. Natco arose out of ANDA litigation over patents on anti-viral drugs, and tremors from that decision – which expanded the universe of patents vulnerable to charges of double patenting — are being widely felt in the pharma and biotech industry. But life sciences companies are not the only ones to find themselves with Gilead’s problem: after asserting a patent in litigation, some high-tech companies have discovered that the defendant can use one of the plaintiff’s later issued but earlier expiring patents to knock out a patent that was issued earlier but expires later. Like drugmakers, some tech companies may come to regret relying heavily on continuations in their patent prosecution, using a “more is more” strategy to grow large patent families. Ex parte reexamination has emerged as the proceeding of choice for tech patent challengers with at least a dozen patents invalidated by the USPTO’s Central Reexamination Unit for double patenting since Gilead.


Barry Bretschneider , BakerHostetler
Jeffrey Hohenshell , Medtronic
Lissi Mojica, Dentons US LLP

Double-Patenting: Impact of Gilead on Bio and Pharma

Webinar Date: 01/07/2016

The Federal Circuit decision twenty months ago in Gilead v. Natco arose out of ANDA litigation over patents on anti-viral drugs, and it is widely seen as expanding the universe of patents vulnerable to charges of double patenting in the pharma and biotech industry. However, life sciences companies are not the only ones to find themselves with Gilead’s problem. After asserting a patent in litigation, some high-tech companies have discovered that the defendant can use one of the plaintiff’s later issued, but earlier expiring patents, to knock out a patent that was issued earlier but expires later.

Like drugmakers, some tech companies may come to regret relying heavily on continuations in their patent prosecution, using a “more is more” strategy to grow large patent families. Ex parte reexamination has emerged as the proceeding of choice for tech patent challengers, with at least a dozen patents invalidated by the USPTO’s Central Reexamination Unit for double patenting since Gilead.

This panel will focus on tips for patent prosecution after Gilead, as well as the litigation outlook with a particular focus on biosimilars. Because many branded pharma companies are entering the biosimilar market, they are finding themselves combing the portfolios of competitors for double patenting weakness, much as generic companies are doing. Our panel features the lawyer who argued for Natco at the Federal Circuit, a law firm biotech lawyer who is an expert on patent term adjustment, and the vice president of IP at a drug development company.



Tim Babcock, Akros Pharma Inc.
Jack Brennan, Fish & Richardson
Jeremy Lowe, Axinn Veltrop