Licensing of Academic Patents Has Contributed Up to $1.3 Trillion to US Economy

The licensing of university research has made a significant contribution to US gross domestic product (GDP), industry gross output, and jobs over the last two decades, according to an independent study commissioned by the Biotechnology Innovation Organization (BIO) and the Association of University Technology Managers (AUTM).

The report, “The Economic Contribution of University/Nonprofit Inventions in the United States: 1996- 2015,” documents the sizable return that US taxpayers receive on their investment in federally-funded research. It shows that, during a 20-year period, academic patents and the subsequent licensing to industry bolstered US industry gross output by up to $1.33 trillion, US GDP by up to $591 billion, and supported up to 4,272,000 person years of employment.

“Thanks to the enduring effectiveness of the Bayh-Dole Act, American research universities, along with industry partners, are turning federally-funded basic research into new and valuable products that save and improve lives. The commercialization of university-based research to create new companies and good, high-paying jobs is a key driver of America’s innovation economy,” said BIO President & CEO Jim Greenwood. “This updated study demonstrates that fact.”

DOWNLOAD BIO’S POLICY BRIEF

 

The study, which was conducted by technology transfer experts and former senior economic consultants, is based on data gathered by the Association of University Technology Managers (AUTM) in its annual Licensing Activity Survey. The most recent 2015 survey showed:

  • 1,012 startup companies were formed, averaging 2.75 new companies created every day of the year– up 11.3% from FY 14;
  • 879 new products based on academic inventions were introduced to the marketplace, averaging 2.4 new products introduced every day of the year;
  • Products based on academic patent licenses generated more than $28.7 billion in net product sales; and
  • 7,942 new licenses and options were executed, up 15% from FY 14. More than 70% of academic patent licenses go to small companies.

 

DOWNLOAD THE REPORT

 

BIO Reacts to Supreme Court opinion in Impression Products, Inc. v. Lexmark International, Inc.

On Tuesday, May 30, 2017, the U.S. Supreme Court issued an opinion in  Impression Products, Inc. v. Lexmark International, Inc.

As mentioned in our previous post on this case, the issue before the court was whether or not 1) international sales exhausted patent rights, and 2) if conditional restrictions on the sale of the patent by the patentee exhausted patent rights.

BIO and Croplife International submitted an amicus brief supporting Lexmark International, Inc. in February.

In a 7-1 ruling authored by Chief Justice Roberts, the Court determined that Lexmark had exhausted its patents rights, and could not sue Impression Products for patent infringement with respect to its toner cartridges sold abroad, “because an authorized sale outside the United States, just as one within the United States, exhausts all rights under the Patent Act.”

Justice Ginsburg filed an opinion concurring in part and dissenting in part. Justice Gorsuch took no part in the consideration or decision of the case.

In a post for IP Watchdog, Melissa Brand, BIO’s Associate Counsel and Director, Intellectual Property Policy provided this reaction:

“The Court’s decision will change decades of established commercial practice essential to the U.S. economy.  The Court provided no analysis of whether such sweeping changes are necessary or even beneficial.  Instead, relying on theories of property rights articulated in the 17th Century—a time at which our country was burning people for witchcraft—and a superficial similarity to copyright law, the Court upends established practices, opening the floodgates of grey marketed products to the detriment of consumers in less affluent markets.

With respect to the domestic component, the Court’s decision greatly reduces the incentive for patentees to utilize conditional sales.  This penalizes manufacturers who sell products at preferential prices to special users who could not otherwise afford the product.  For example, manufacturers will have to rethink whether sales for “research use only” to universities at lower cost will continue to be commercially viable.  This could make it more difficult for the end products of such research endeavors to be made available to the public.

The consequences of the Court’s ruling on international exhaustion run counter to decades of U.S. trade negotiations and will have countless unintended and unforeseen consequences.  By extending U.S. patent law to foreign transactions that have nothing to do with the United States, the Court has called into question thousands of existing contracts between patentees and foreign distributors, many of which will now need to be renegotiated.  Further, because regional pricing will now be virtually eliminated, consumers in less affluent markets will be disadvantaged.  This will inevitably lead to an increase in grey marketed goods in the U.S.  FDA regulations and emphasis on drug safety will currently mitigate the potential harm in the pharmaceutical sector, but other industries with less regulation will be immediately impacted.  And it should be noted that, despite the Court’s suggestion to the contrary, this case itself illustrates that contract law will not be an effective alternative: Lexmark was not in privity with Impression Products, and therefore Lexmark could not have sued Impression Products for breach of contract.  Lexmark’s recourse would have been to sue the individual consumers who entered into the Return Program contracts with Lexmark.  Not only would suing individual consumers be unrealistic and expensive, but the remedies available to Lexmark and the ability of the individual consumers to satisfy judgments against them are unclear.”

In a press release, BIO CEO Jim Greenwood issued the following statement:

“BIO is concerned that today’s U.S. Supreme Court ruling in the case of Impression Products  v. Lexmark International could make it more difficult for patients across the world to gain access to critical therapies. The biotechnology industry is overwhelmingly comprised of small companies that rely on the stability and dependability of the patent system to bring innovative technologies to market. We fear this ruling will undermine that stability. The decision systematically undercuts innovative companies willing to sell their products at discounted prices for special uses, such as furthering scientific research and helping underserved populations. By extending the reach of U.S. patent law to foreign transactions that have nothing to do with domestic markets, the Court’s decision creates counterproductive uncertainty for U.S. innovators and their customers.

“BIO will work with our member companies to help them understand and comply with this ruling and adjust their intellectual property strategies accordingly.”

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BIO Chimes In: TC Heartland LLC v. Kraft Food Brands Group LLC (Supreme Court)

This is part two of a three part series on BIO’s recently submitted amicus briefs in cases before the Supreme Court as well as the U.S. Court of Appeals for the Federal Circuit.

Spring kicked off yesterday, and with it was the beginning of the confirmation process for U.S. Supreme Court nominee Judge Neil M. Gorsuch. Empty seat or not, SCOTUS has a full plate of decisions to reach this term, patent cases among them.

We’ve already talked about BIO’s position on Impression Products v. Lexmark International (oral arguments begin today), so let’s take a look at another important patent case headed to the Supreme Court next week.

At issue in this case is the determination of venue for patentees and the interpretation of Congress’s venue statute. The court is being asked “whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) limits the venue of patent cases to 1) the judicial district where he defendant resides, or 2) where the defendant has committed acts of infringement and has a regular and established place of business.

28 U.S.C. § 1391(c) broadens the definition of residence for venue to be any judicial district where the defendant is subject to the court’s personal jurisdiction. Since patent defendants are generally subject to nationwide personal jurisdiction, venue would be in any jurisdiction.

Given the broad interpretation of 28 U.S.C. § 1391(c), there has been a significant concentration of patent-infringement suits in the Eastern District of Texas, where more than 40% of patent cases are litigated.

BIO and the Association of University Technology Managers (AUTM) submitted an amicus brief supporting Kraft Food Group (the respondent).

In the brief, BIO argues that while it is not good for the patent system to have a concentration of patent cases come up through a single district, “attempting to resolve [these] issues through this case would do significantly more harm than good.”

If the Supreme Court decides in favor of TC Heartland, the venue regime that prevailed prior to 1988 would return, severely inconveniencing patent owners (particularly small businesses) and increase the amount of patent litigation, “forcing patent holders to brin related claims in multiple separate actions, and would skew litigation in favor of accused infringers.”

BIO’s brief further argues that Congressional reform efforts have “recognized the importance of including venue options tied to locations where the patent owner is or was engaged in activities related to the patent.”

BIO and AUTM argue that reform efforts to combat issues with patent venue should be left to Congress, “rather than legislating an obsolete approach to venue that Congress has not endorsed.”

Oral arguments in this case will take place next Monday, March 27, 2017.

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , , , ,

BIO Chimes In: TC Heartland LLC v. Kraft Food Brands Group LLC (Supreme Court)

This is part two of a three part series on BIO’s recently submitted amicus briefs in cases before the Supreme Court as well as the U.S. Court of Appeals for the Federal Circuit.

Spring kicked off yesterday, and with it was the beginning of the confirmation process for U.S. Supreme Court nominee Judge Neil M. Gorsuch. Empty seat or not, SCOTUS has a full plate of decisions to reach this term, patent cases among them.

We’ve already talked about BIO’s position on Impression Products v. Lexmark International (oral arguments begin today), so let’s take a look at another important patent case headed to the Supreme Court next week.

At issue in this case is the determination of venue for patentees and the interpretation of Congress’s venue statute. The court is being asked “whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) limits the venue of patent cases to 1) the judicial district where he defendant resides, or 2) where the defendant has committed acts of infringement and has a regular and established place of business.

28 U.S.C. § 1391(c) broadens the definition of residence for venue to be any judicial district where the defendant is subject to the court’s personal jurisdiction. Since patent defendants are generally subject to nationwide personal jurisdiction, venue would be in any jurisdiction.

Given the broad interpretation of 28 U.S.C. § 1391(c), there has been a significant concentration of patent-infringement suits in the Eastern District of Texas, where more than 40% of patent cases are litigated.

BIO and the Association of University Technology Managers (AUTM) submitted an amicus brief supporting Kraft Food Group (the respondent).

In the brief, BIO argues that while it is not good for the patent system to have a concentration of patent cases come up through a single district, “attempting to resolve [these] issues through this case would do significantly more harm than good.”

If the Supreme Court decides in favor of TC Heartland, the venue regime that prevailed prior to 1988 would return, severely inconveniencing patent owners (particularly small businesses) and increase the amount of patent litigation, “forcing patent holders to brin related claims in multiple separate actions, and would skew litigation in favor of accused infringers.”

BIO’s brief further argues that Congressional reform efforts have “recognized the importance of including venue options tied to locations where the patent owner is or was engaged in activities related to the patent.”

BIO and AUTM argue that reform efforts to combat issues with patent venue should be left to Congress, “rather than legislating an obsolete approach to venue that Congress has not endorsed.”

Oral arguments in this case will take place next Monday, March 27, 2017.

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , , , ,

BIO Spring IPCC Meeting: Special Offer for First Time In-House Attendees!

Are you a patent practitioner at a biotech company?

Is your in-house IP group small, or are you perhaps the only “IP person” in your company?

Would you like more opportunities to connect with similarly-situated in-house colleagues, get updates and analysis on patent law developments, share best practices, and participate in policy discussions that affect our industry?

Have you never attended the BIO IP Counsels Committee Conference, but always wanted to?

BIO wants you, and can make it easier to attend.

The BIO IPCC Conference is organized biannually by the IP Counsels Committee of the Biotechnology Innovation Organization. It is organized by in-house practitioners for in-house practitioners, and over the past decade has become the premiere event for corporate biotech patent counsels and agents, providing valuable opportunities for education, practice pointers, policy discussions, and for meeting similarly-situated colleagues in the industry. Registration policies and programming are designed to ensure that the event first and foremost benefits the in-house community.

Our spring conference will take place March 27-29, 2017 in Newport Beach, California.

We are continually seeking out ways to enhance its value to our core audience, especially practitioners at smaller companies whose budgets are tight and responsibilities are spread. BIO will waive registration and reimburse $500 in hotel and airline for up to 10 biotech in-house IP counsel first-time attendees. Recipients must have never attended a BIO IPCC Conference before.

Please contact adonohue@bio.org if you believe you qualify.

BIO Chimes In: Impression Products v. Lexmark International (Supreme Court)

This is a three part series on BIO’s recently submitted amicus briefs in cases before the Supreme Court as well as the U.S. Court of Appeals for the Federal Circuit.

Included in our cases to watch post were some upcoming IP cases on the agenda this term for the Supreme Court.  BIO, with Croplife International, has subsequently submitted an amicus brief in one of those cases. Let’s take a look:

BIO and Croplife’s brief addressed two questions facing the Supreme Court directed at patent exhaustion: the territoriality principle of U.S. patent law and the question of conditional sales.

International sales, they argued, should not exhaust patent rights. The Supreme Court has held since the 1857 decision in Brown v. Duchesne that “no infringement occurs when a patented product is made and sold in another country.” The Federal Circuit’s en banc opinion rested on this precedent, supported for over 150 years in other cases including Boesch v. Graff (1890) in which the Court held that a sale authorized by another international law did not permit “defiance of the rights of patentees under a United States patent.”

The Federal Circuit’s decision had affirmed prior holding in previous cases including Jazz Photo Corp. v. International Trade Commission and supported the Supreme Court’s existing precedent “confirming the territoriality of the U.S. patent system and furthering important public policy.”

For BIO and Croplife, who support holders of U.S. patents, “the territorial limitation on patent exhaustion advances public policy and economic efficiency…[and] permits innovators to sell patented products internationally at locally-driven market prices.”

Addressing the question of conditional sales, the brief supports the Federal Circuit’s decision affirming prior holding in Mallinckrodt, Inc. v. Medipart, Inc., which held that conditional sales of patented products do not exhaust patent rights:

“Mallinckrodt rests on longstanding precedent recognizing the right of a patent owner to convey only a portion of the patent right without giving away the rest. The Court should reaffirm this precedent, on which industry members have relied for decades to structure their businesses and to establish the value of rights and products they convey through licenses and sales contracts.”

The Supreme Court has reaffirmed this foundational principle of patent law and consistently recognized that “a patent owner may grant a license for restricted use.”

“The Federal Circuit’s decision in Mallinckrodt built on fundamental principles spanning over a hundred years of Supreme Court precedent and held that unless a conditional sale ‘violate[d] some other law or policy … private parties retain the freedom to contract concerning conditions of sale.’976 F.2d 700, 708 (Fed. Cir. 1992).”

In the closing paragraph of their brief, BIO and Croplife affirmed the following:

“The current legal regime has long ensured certainty and efficiency in the market. Petitioner’s request to overrule Mallinckrodt and disrupt the way patented products have been and continue to be sold should be rejected. To do otherwise would fundamentally alter the market for many patented products: disrupting pricing strategies, restricting access to innovative products, 37 and creating obstacles to further innovation as well as the country’s economic growth.”

Oral arguments will be held March 21, 2017.

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , ,

Coming Down the Pipeline: Patent Cases to Watch in 2017

The Supreme Court returns from recess on February 17, and alongside the likely confirmation of Neil Gorsuch to the bench, a plethora of IP cases are on their agenda.

Let’s take a look at some of the cases that SCOTUS  will hear in the spring that may have significant impact on biotech IP:

The Supreme Court granted certiorari last month to hear arguments for dual petitions involving the Federal Circuit’s 2015 interpretation of the Biologics Price Competition and Innovation Act (BPCIA).

The Federal Circuit had previously ruled in a split panel decision (1) that the disclosures set forth in subsection (l)(2)(A) of the BPCIA are not mandatory and that the statute allows a biosimilar applicant to choose between either disclosing its subsection (k) application and manufacturing information, or not disclosing such information and instead facing an immediate infringement action from the reference product sponsor and (2) that a notice of commercial marketing pursuant to subsection (l)(9)(A) of the BPCIA can be given only after FDA approval of the biosimilar product.

The briefing schedule has been set and can be found on SCOTUS Blog.

The Supreme Court granted certiorari to decide: “Whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) states that “any civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.”

28 U.S.C. § 1391(c) states that “For all venue purposes—

  1. A natural person, including an alien lawfully admitted for permanent residence in the United States, shall be deemed to reside in the judicial district in which that person is domiciled;
  2. An entity with the capacity to sue and be sued in its common name under applicable law, whether or not incorporated, shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction with respect to the civil action in question and, if a plaintiff, only in the judicial district in which it maintains its principal place of business; and
  3. A defendant not resident in the United States may be sued in any judicial district, and the joinder of such a defendant shall be disregarded in determining where the action may be brought with respect to other defendants.

The Supreme Court’s decision may limit the districts in which patentees can bring infringement lawsuits and return to a narrower venue rule as outlined in 28 U.S.C. § 1400(b).

Oral arguments are set for March 27, 2017.

This case involves the scope of patent exhaustion.

The first question before the Supreme Court is whether a “conditional sale” that transfers title to a patented item, but also restricts the article’s use or resale post-sale, avoids the patent exhaustion doctrine.  The second question is whether a sale of a patented article (i) occurring outside the United States but (ii) with the U.S. patentee’s authorization exhausts the U.S. patent rights in that article.

“The Federal Circuit ruled en banc that the sale of a product abroad by a U.S. patent holder (or others) does not exhaust the patent owner’s U.S. patent rights, such as the right to exclude sale or importation of that product within the United States.  The Federal Circuit also ruled that, when a U.S. patent holder sells a product with expressed restrictions on resale or reuse of that product, the patent exhaustion doctrine does not preclude the patent owner from exercising its rights to exclude resale or reuse of that product.”

Oral arguments are set for March 21, 2017.

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Registration for BIO’s Spring IP Counsels Committee Conference is now OPEN!

Tired of those pea-coats and earmuffs? Wish you were lying on a beach right now, potentially with some interesting literature on developments in the biotech patent space?

Do we have good news for YOU.

This spring’s BIO IPCC Conference will take place March 27-29, 2017 in Newport Beach, California!

BIO’s IP Counsels Committee Conference offers timely, relevant educational sessions on the latest issues in the biotech IP sector, informal networking events designed to promote discussion and foster relationships among industry colleagues, and practical tips for attendees to use the next day. Over 100 attendees representing biotech and pharma companies, law firms, academia and government come together from the U.S. and abroad to attend this one of a kind event.

And guess what? Registration is now open!

So remember to pack that sunscreen and surfboard, and we’ll see you in Orange County!

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Will the PTAB Be A Roadblock for Biotech? Stories from Sessions at BIO 2016

We’re at the beginning of day 3 here at BIO 2016, and that means we’ve already had a full day of high quality programming for our Intellectual Property track! Let’s take a look at one of yesterday’s most popular sessions.

Will the PTAB be a Road Block for Biotech? Lessons Learned from the First Three Years of Inter-Partes Review and Future Prospects

Moderated by William Kubetin, Managing Editor at Bloomberg BNA

Panelists:

  • Kevin Noonan, Partner at McDonnell, Boehnen, Hulbert & Berghoff LLP
  • Teresa Stanek Rea, Partner at Crowell & Moring LLP
  • Michael Tierney, Lead Administrative Patent Judge at U.S. Patent and Trademark Office (USPTO)

The USPTO’s inter partes review (IPR)  has emerged as one of the most concerning elements of the 2011 America Invents Act. An administrative trial method for challenging patents, it has generated criticism that legitimate biopharma patent claims are being invalidated.

Yesterday’s panel walked through a case study of the procedures of IPR, examining the processes both petitioner and patent holder would use within the USPTO system.

Panelists introduced arguments for the petitioner’s claim and Judge Tierney offered insights on how PTAB judges would evaluate and likely rule through each part of the process.

Topics of discussion ranged from USPTO’s evaluation of priority determination, prior art, obviousness, and claim construction.

Judge Tierney closed with practice tips for both petitioner and patent holders when subject to the IPR process. Some key takeaways included:

  • The petitioner must demonstrate that there is a reasonable likelihood that he/she would prevail as to at least one of the claims challenged.  In instituting a review, the Board may take into account whether, and reject the petition or request because, the same or substantially same prior art or arguments previously were presented to the Office.
  • Include intrinsic reference in claim construction
  • Expert testimony must have underlying facts or data of record
  • Petitioners should address specific teachings that disclose claim elements, and support reasoning why claimed elements were known in prior art, used for a known purpose, and yielded predictable results.

In the question and answer session, BIO’s Deputy General Counsel for IP, Hans Sauer expressed skepticism about recent assertions that IPR petitions against biopharma patents were declining.

When panelists pointed out to Dr. Sauer that petitions to challenge biotech pharma patents had decreased by 25% for the first four months of 2016 compared to those filed for the same period in 2015, he was quick to point out that seven to 15 biotech pharma IPR petitions is still significant. The drop off could likely be due to a decrease in filings from Kyle Bass and hedge fund entities, who filed over 33 challenges against drug related patent claims in 2015.

As Jacob Sherkow, associate professor at NYU’s Innovation for Law and Technology said in Bloomberg BNA’s  2016 Life Sciences Law & Industry Report:

“If there’s seven to 15 challenges a month, and one out of 15 wins, that’s one patent invalidated by a generic drug maker each month.”

Check out more of our IP Coverage later this week here in San Francisco!

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IP Sessions at BIO 2016–Come Join us in San Francisco!

That’s right, we’re back at it again! This year’s BIO International Convention will host several innovative educational sessions on the state of intellectual property in the biotech sector.   BIO‘s top-notch education program covers the biotechnology and pharma industry’s most relevant and timely topics in intellectual property.  In each session, top thought leaders will offer insights on issues essential to the industry and provide a wealth of information of strategic relevance to the IP biotech sector. 

Well, what are you waiting for? Check out our IP sessions below, and don’t forget to register!

Rise of the Biosimilars: Recent Developments and Strategies for Innovators and Biosimilar Applicants for Resolving Patent Disputes Under the BPCIA

1:00 PM–2:00 PM Jun 7, 2016

The Biologics Price Competition and Innovation Act (BPCIA) defines a process for resolving patent disputes before the launch of a biosimilar product. Although the purpose is similar to the process under the Hatch-Waxman Act, the process is substantially different and biosimilar applicants have pursued varied approaches to date. The session will explore recent legal developments in the field of biosimilars, including the patent dance and litigation under the BPCIA. Additionally, the panel, comprised of IP experts, will discuss strategies for both innovators and biosimilar applicants.

Room West 3008

Will the PTAB be a Road Block for Biotech? Lessons Learned from the First Three Years of Inter-Partes Review and Future Prospects

2:15 PM–3:15 PM Jun 7, 2016

Inter-partes review proceedings before the Patent Trial and Appeal Board (PTAB) have transformed patent practice and unsettled expectations for patent holders while empowering patent challengers. In the first three years of this practice, the Board has invalidated patent claims and entire patents with such frequency that some see the proceedings as a road block for patents. Most of the affected patents have been outside the biotech and pharma area but recently patents on these technologies have also been subject to IPR with greater frequency. As the PTAB has developed procedures for instituting and holding IPR proceedings there has developed a belief that some of those practices be modified, including the standard used for claim construction and the ability of a patent holder to amend claims during proceedings. This panel will explore these issues and proposals for change in the context of using IPRs as an adjunct to biosimilars litigation under the Biologics Price Competition and Innovation Act.

Room West 3008

Piecing Together the Hatch-Waxman, BPCIA and PTAB Puzzle: Revealing the Big Picture in Patent Challenges Brought in Multiple Fora

3:30 PM–4:30 PM Jun 7, 2016

In the United States, drug and biologic drug patents are subject to special rules and standards when litigated in court. The same patents can also be challenged in new administrative proceedings in the US Patent and Trademark Office, under different rules and standards, giving rise to perplexing questions and unexpected developments. In 2015, by all accounts, there was a sizeable increase in the number of inter parties review (IPRs) filed at the Patent Trial and Appeal Board (PTAB) which challenged pharmaceutical and biotechnology patents. Some sources show that the majority of all IPRs in the biomedical space are now being brought by generic drug companies. The approach to IPRs seem to stem from filings by generic drug companies to interfere with the market prospects of other generic companies, filings resulting in parallel proceedings with litigation under the Hatch-Waxman Act, and filings in anticipation of the BPCIA “patent dance.” Designed for corporate decision makers and practicing IP professionals, this panel will address the interplay between these two systems – the Hatch-Waxman Act and BPCIA patent litigation pathways – and the inter parties review proceedings at the Patent Trial and Appeal Board.

Room West 3008

US Patents and Global Business: Clear Borders or Blurred Lines?

10:45 AM–11:45 AM Jun 8, 2016

Biotechnology companies are operating in a global environment at every turn with strategic supply-chain decisions, complex licensing agreements and regional pricing decisions. At the same time, the extraterritorial effect of US patent rights is in flux with decisions including Suprema v. ITC, Lexmark v. Impression Products and Promega v. Life Technologies. This session will flag some of the hot topics involving the extraterritorial reach of US patents including patent infringement and inducement under sections 102(f) and 102(g), the jurisdictional scope of the International Trade Commission, international patent exhaustion and the implications of off-shore activity in patent damages. The panel will address hypothetical scenarios to delineate best practices for IP counsel and business decision-makers, including supply chain managers, to manage patent rights and patent risks in this evolving landscape.

Room West 3008

Successful Pharmaceutical Branding: Key Insights from the Business, Legal and Creative Perspectives

1:00 PM–2:00 PM Jun 8, 2016

Pharmaceutical brands can rise to be among the most valuable brands in the world, often symbolizing enormous goodwill and customer loyalty. A brand may therefore be a valuable company asset driving increased profitability and mitigating competitive erosion of marketshare, even from generic competition. Creating these brands is challenging due to the need to meet the requirements of both the trademark (U.S. Patent & Trademark Office) and drug regulatory (Food & Drug Administration) regimes. This panel will provide a broad overview of the role brands play in the increasingly competitive pharmaceutical marketplace, review the pharmaceutical branding process from creative naming inception to approval and registration with the FDA and U.S. trademark office and offer insights on issues which arise post introduction into the marketplace. Panelists, including representatives from premier pharmaceutical companies, a branding agency and a law firm, will provide diverse perspectives and considerations on the issues arising in the business, creative and legal contexts.

Room West 3008

Protecting Biomedical Innovation in a Shifting Patent-Eligibility Landscape

2:15 PM–3:15 PM Jun 8, 2016

Patenting in the biotechnology space has been beset by a new uncertainty in recent years. Irrespective of other requirements for patenting such as whether an invention is new, not obvious over existing technology or sufficiently described, the requirement of patent eligibility excludes from patent protection inventions whose subject matter is deemed directed to judicially created subject matter exceptions: abstract ideas, laws of nature and natural phenomena. The patent eligibility doctrine is not new, but courts and the USPTO have followed the US Supreme Court’s recent lead in invoking it to deny patent protection, particularly in the biomedical and biotechnological fields, even for admittedly “breakthrough” inventions. The panel, with representatives from the judiciary, USPTO and industry, will discuss how stakeholders can maneuver the still-changing landscape in this challenging area and where it may be heading moving forward.

Room West 3008

No Patent, No Cure

3:30 PM–4:30 PM Jun 8, 2016

The EU has specific legislation on the legal protection of biotechnological inventions (IP) known as Directive 98/44/EC (July 6, 1998).Different stakeholders have argued of a review of this legislation in order to reduce or modify the scope of IP in the field of biotechnology and more recently the discussion has been raised at the level of European Councils of Ministers. On the other side of the Atlantic, the 2013 Supreme Court “gene patenting” case and the USPTO Interim guidance on patent subject matter have led to increased uncertainty for biotech companies in the area of IP. Against this backdrop, the aim of this session is to understand the effects that such changes or proposed changes could and do have on the business model of biotech companies on both sides of the Atlantic, and help companies successfully navigate these uncertain waters.

Room West 3008

Intellectual Property Track Reception

4:30 PM–5:30 PM Jun 8, 2016

Room West Third Floor Lobby Intellectual Property Reception

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