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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.

Please contact meetings@ipo.org if you have difficulty finding a recording.

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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  • What does it mean for claims in a new application to be “consonant” with those withdrawn from the earlier case?;
  • The new amendment to the Manual of Patent Examining Procedure that describes when a terminal disclaimer can be withdrawn; and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.

Speakers:

  • 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? 

 Speakers: 

  • 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. 

Speakers: 

  • 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. 

Speakers: 

  • 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.

Speakers:

  • 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.

Speakers:

  • 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.

Speakers:

  • 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.

Speakers:

  • 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.

Speakers:

  • 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.

Speakers:

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.

Speakers:

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?

Speakers:

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.

Speakers:
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.

Speakers:

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.

 

Speakers:

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




USPTO's After Final Consideration Pilot: Tips to Reach Allowance

Webinar Date: 11/19/2015

The USPTO recently announced that it is extending the After Final Consideration Pilot (AFCP), a compact prosecution initiative that authorizes additional time for examiners to search and to consider responses from a patent applicant after final rejection. Many applicants remain leery of this program that dates in its current form to 2013. But that skepticism may be misplaced. According to the USPTO, about 27% of the 122,882 AFCP requests since then have directly resulted in allowances, a result made possible by the fact that an applicant must file a non-broadening amendment to at least one independent claim to be eligible for the program. More than 60% of applicants in a recent USPTO survey said that using the AFCP reduced the likelihood a Request for Continued Examination (RCE) being filed. The applicants who fail to get an application allowed during AFCP are less likely to appeal. Appeal briefs are only submitted in 2.4% of AFCP applications, compared to 6% of cases with traditional after-final submissions.

Our panel features the group director of a USPTO Technology Center who practices in and helped develop the program, and two law-firm patent prosecutors, one specializing in electronics and the other in the life sciences. They will discuss which cases are best suited to the AFCP and which are not, giving real-life examples of successful cases that passed through the program and others that failed. They will also discuss another recently-extended USPTO program aimed at the later stages of prosecution, the Quick Path Information Disclosure Statement (QPIDS) program, which can let an applicant file an IDS after the issue fee is paid without paying for reopening prosecution through an RCE.

Speakers:

Tariq Hafiz, USPTO
David Longo, Oblon, McClelland, Maier & Neustadt, L.L.P.
Eli Loots, Knobbe, Martens, Olson & Bear, LLP




Definite Change: Nautilus Gets Some Traction

Webinar Date: 10/07/2015

Our panel — a pharmaceutical industry IP lawyer and two high-tech patent litigators — will analyze several recent Federal Circuit opinions with the aim of pinpointing the court’s newly-evolving rules regarding the definiteness of terms and measures and allegedly “subjective” claims in patent litigation. At first little seemed to change after last year’s U.S. Supreme Court’s Nautilus decision made it easier for defendants to prove a plaintiff’s patent to be indefinite. But the August decision in Dow Chemical v. Nova Chemical might have been something of a watershed, giving the Federal Circuit the opportunity to rule on the definiteness of the very same plastics patents both before and after Nautilus. Those patents describe a “slope of strain hardening” but do not describe which of several methods for measuring slope should be used. “Under Nautilus this is no longer sufficient,” the court said, since the patent does not provide a skilled artisan with “reasonable certainty.” Our panel will discuss several recent Federal Circuit opinions that cite Nautilus with different results – eg, Teva v. Sandoz, Ethicon v. Covidien, Interval Licensing v. AOL — and give tips for patent prosecutors as well as patent holders and defendants involved in disputes over definiteness.

Speakers:

Robert Kramer, Dentons US LLP
Chris Mammen, Hogan Lovells
Bryan Zielinski, Pfizer Inc.




New Litigation Scenarios after Akamai: Fact Pattern Hypotheticals

Webinar Date: 09/17/2015

Trying once again to meet the challenge posed by situations in which multiple parties work together and infringe a patent, in August the en banc Federal Circuit expanded the scope of a key aspect of patent law: the definition of direct infringement under Section 271(a) of the Patent Act. In the new Akamai opinion, the Federal Circuit adds to its own earlier precedent an additional category of direct infringement that falls within the scope of “control or direction”: “… Liability under § 271(a) can also be found when an alleged infringer 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.

Our panel of litigators will consider several different fact patterns to discern and discuss, at the margin, where the boundary will fall between infringement and non-infringement under this new scope. Some of these facts will be drawn from earlier Federal Circuit cases on joint infringement involving the Internet and software, such as McKesson v. Epic Systems and Golden Hour v. emsCharts; others will be hypotheticals to analyze joint infringement in personalized medicine and diagnostics.

Paul Berghoff, McDonnell Boehnen Hulbert & Berghoff LLP
Andrei Iancu, Irell & Manella LLP
Steve Moore, Kilpatrick Townsend & Stockton LLP




Amgen v. Sandoz: What Now?

Webinar Date: 09/02/2015

Now that the “patent dance” spelled out in the 2010 Biologics Price Competition and Innovation Act (BPCIA) has been declared by the Federal Circuit to be just one option open to biosimilar market aspirants, the expectations of many industry participants have been upended. Our panel includes two patent litigators, one who counsels on biosimilar launches and one who counsels on branded strategy, as well as an FDA regulatory attorney who represented biotech innovators in the lengthy legislative negotiations leading to the BPCIA. They will discuss:

  • Branded company strategy now that an innovator may have only six months notice before a biosimilar launch; the implications of having no information about the biosimilar maker’s patent strategy or manufacturing process; the new importance of competitive intelligence;
  • Biosimilar launch strategy, including the pros & cons of the BPCIA pathway – will any biosimilar aspirants still choose to go the BPCIA route?; the importance of due diligence and assessing at-risk launches;
  • New litigation dynamics outside the BPCIA, including crucial preliminary injunction battles, discovery, licensing, damages and willfulness; and
  • The next front and the end game: en banc at the Federal Circuit? How will this all end up?

Krista Carver, Covington & Burling
Kevin Nelson, Duane Morris
Elizabeth Weiswasser, Weil, Gotshal & Manges LLP




Elusive Global Patent Claims - Life Sciences

Webinar Date: 08/11/2015

Economic globalization continues, but patent owners still must reckon with differences among national and regional patent regimes that make it challenging to protect innovation across borders. Speakers will highlight key differences among law and practice that matter in their industry, and give examples when and how it is possible to tweak claims to meet foreign standards and when it is not.

  • Methods of treatment (MOT) claims, including combination claims and dosage regimes; MOT v. “medical uses” in Europe, dealing with statutory ban on MOT claims in China
  • Methods of diagnosis claims
  • Personalized medicine and biomarkers
  • Need for more data support in China and Europe
  • Composition of matter claims and Section 101 concerns, including pursuing protection outside the U.S. for inventions that are not patent-eligible here

Speakers:

Michael Lin, Marks & Clerk
James Mullen, Morrison & Foerster, LLP
Edward Oates, Carpmaels & Ransford LLP




Lessons from Proxyconn: Federal Circuit's First Reversal of an IPR

Webinar Date: 07/07/2015

In mid-June, for the first time, the Federal Circuit reversed and remanded the claim construction in an inter partes review back to the PTAB, breaking an almost unbroken string of Rule 36 summary affirmances. The appellate move offers encouragement to patent owners by illustrating circumstances where the Federal Circuit is willing to point out the flaws in a PTAB decision invalidating a patent.

Our panel, which includes a Federal Circuit specialist and two experienced PTAB litigators, will examine the lessons to be learned from Microsoft v. Proxyconn regarding both claim construction and amending claims, where the appeals court gave some reason for optimism to patent owners who want to appeal the PTAB’s denial of a motion to amend a patent. The panelists will also discuss procedural questions regarding the PTAB’s handling of remands and give their views on how the relationship between the Federal Circuit and the PTAB will evolve.

Speakers:

Gregory Castanias, Jones Day
Gerald Flattmann Jr., Paul Hastings LLP
David O’Brien, Haynes and Boone, LLP




Hatch-Waxman and Biologic Strategies at the PTAB

Webinar Date: 03/03/2015

This month was a watershed for biopharmaceutical patents in post-grant proceedings. The PTAB invalidated claims for three patents on Genzyme’s treatment for Pompe disease in an inter partes review brought by a would-be competitor, a first for a biologic. And an IPR attack even came from outside the pharma industry: a hedge fund manager linked up with a well-known non-practicing entity to target Acorda Therapeutics’ patent on a multiple sclerosis drug. Some fear threats of an IPR to win a settlement from a company even before a petition is filed.

These patents are among the growing number of biopharmaceutical patents that have been targeted recently at the PTAB. This webinar will analyze how inter partes review and other post-grant proceedings should influence Hatch-Waxman/small molecule and biologic litigation strategies. Compliance with multiple tricky timelines is involved. Our panelists include a litigator who succeeded in the first-ever defense of a drug patent on a granted petition for IPR; a Hatch-Waxman litigator who represents generic companies; and a life science lawyer who has experience in biologics and leadership experience at the USPTO.

Speakers:

Cynthia Hardman, Goodwin Procter, LLP
Gerald Flattmann Jr., Paul Hastings
Teresa Stanek Rea, Crowell & Moring, LLP




The USPTO Revised Patent Eligibility Guidance: Life Science

Webinar Date: 01/14/2015

On December 15 the USPTO issued new “Interim Guidance” for determining whether claims are eligible for patenting under 35 USC § 101. Each of these webinar panels will bring together a senior counsel from the USPTO’s Office of Legal Administration with an in-house patent counsel at a major corporation and a law firm attorney who is an expert in that industry. The discussion will clarify the meaning of the new guidance, discuss which inventions are now more likely to be found patent eligible and how to write patent applications that clear current hurdles. The panelists will also consider the impact of subsequent appellate decisions such as the invalidation of Myriad patents in University of Utah Research Foundation et al. v. Ambry Genetics Corp.

Speakers:

Life Science Speakers (Jan. 14):
Raul Tamayo, USPTO
Deborah Martin, Pfizer, Inc.
Kevin Noonan, McDonnell Boehnen Hulbert & Berghoff LLP




Biosimilars: The Action Finally Starts

Webinar Date: 01/08/2015

The Biologics Price Competition and Innovation Act became law four-and-a-half years ago and for a long time not much happened to clarify how the high-stakes new regulatory pathway for biosimilars would work. Now finally the action is starting. In December the U.S. Court of Appeals for the Federal Circuit issued its first decision regarding a legal conflict over a biosimilar, while other pending lawsuits promise to show the life science industry how the law will be interpreted. Our panel of bioscience IP litigators will discuss the impact of these cases and other BPCIA developments:

  • The Federal Circuit opinion, Sandoz v. Amgen, which involves the blockbuster drug Enbrel and addressed whether a biosimilar developer can seek an early adjudication of questions of validity and infringement of patents before it files a biosimilar application and
  • Efforts by Celltrion and Hospira to get declaratory judgment on the invalidity of other biological drug patents and
  • Amgen’s complaint, filed in October in the Northern District of California, alleging that Sandoz unlawfully refused to follow BPCIA patent resolution procedures (colloquially known as the “patent dance”) regarding its application to the Food and Drug Administration for approval of a biosimilar to Neupogen. Amgen’s complaint asserts unfair competition under California law, conversion, and patent infringement.

Speakers:

Kevin Nelson, Duane Morris LLP
Brian Slater, Fitzpatrick, Cella, Harper & Scinto
Elizabeth Weiswasser, Weil, Gotshal & Manges, LLP