Double Jeopardy at the PTO Threatens Healthcare Innovation

There has been no shortage of commentary related to the efforts of Allergan to shield itself from the un-American threat of double jeopardy they have repeatedly faced through gamesmanship of the PTO’s Inter Partes Review (IPR) process.

An op-ed by Allergan CEO Brent Saunders today in The Wall Street Journal demonstrates the unconventional steps the company has taken to protect itself from the flaws of IPR that are being “exploited by generic manufacturers and a new breed of reverse trolls.”

Generic pharmaceutical manufacturers, who already have full opportunities to challenge innovator patents in federal court, are using these flaws within IPR to initiate duplicative patent reviews until a sympathetic panel of PTO Administrative Patent Judges renders a decision to invalidate. In the process, they – not Allergan – are undermining the carefully balanced, Congressionally-mandated system that has successfully spurred both innovation and generic drug entry for decades.

IPR undermines the long-established, bi-partisan Hatch-Waxman framework that allows for legitimate patent questions to be litigated in the open in federal court.

To remedy the abuses of IPR, BIO has been calling on Congress for several years to harmonize the legal standards used in IPR and in the federal courts, and provide assurance that patent owners will be free of repeated threats to their intellectual property following a court ruling.

Group of Inventors Burn Their Patents in Protest

As reported last week by IP Watchdog, the United States Patent and Trademark Office (PTO) refused to approve a permit requested by US Inventor for booth or table space within the Agency’s office building  in Alexandra, VA. The group’s objective was to  protest and raise awareness of the ongoing high rates of patent invalidation resulting from decisions made by the Patent Trial and Appeal Board (PTAB).

Despite two denied appeals, US Inventor, a nonprofit organization devoted to improving the U.S. patent system, was undeterred. They opted to set up on the sidewalk outside the PTO. Some of the protestors went so far as to burn their actual patents, citing PTO policies had rendered them worthless.

The PTO’s interim director Joe Matal came out to speak with and listen to members of the group as they expressed their concerns with the PTAB.

Patents burn at US Inventor PTAB protest at the USPTO, Friday, August 11, 2017. Photo taken by @TheRealMattDowd.

The unintended consequences of the PTAB’s administrative patent challenge system known as Inter Partes Review, or IPR, have caused much concern among innovative, intellectual property-reliant companies that are helping to drive this nation’s economic growth. Rather than being a cheaper substitute for expensive district court litigation, these proceedings have produced more litigation, not less, and have perpetuated disputes rather than resolving them sooner.

BIO stands ready to work with Congress and the PTO on efforts to reform the patent system, to ensure better support for inventors, investors, and the people waiting for new biotech innovations treatments to improve their lives and their environment.

Weak Patent Law Endangers Healthcare Innovation

Last week The Wall Street Journal published a fascinating expose that pulled back the curtain on some of the self-serving and well-financed efforts of big high-tech companies (in this case Google) to  influence academic scholarship, and ultimately public policy, in their favor. Such strategies have long been used to undermine the U.S. patent system. As part of their ongoing campaign to weaken existing patent protections, big high tech interest groups have funded troves of exaggerated studies on the pervasiveness of “bad patents” and their abuse by “patent trolls” and “rogue judges.” They do this while ignoring the critical and historic importance of strong and predictable patent rights to economic growth and innovation outside of their particular sector of the economy.

Strong patents are the lifeblood of America’s innovation economy including the biotechnology industry. They are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines, alternative energy sources, and insect and drought resistant crops – capital that has now begun to flow to other countries with stronger patent protections like the European Union and China.   In a recent review of global patent protections, the U.S. Chamber of Commerce reported that the United States dropped from its #1 position to #10, tying with Hungary and falling behind most EU nations, Japan, and Singapore. Read the full report here.

It can take a decade or more of privately funded research and development before a biotech company can bring its product to market.  Only one in ten candidate drugs that make it as far as clinical trials will actually get licensed.  Despite the risks of biotech investment, the industry attracts billions of dollars in new investments each year based on the promise of its innovative and patented discoveries, which will only be translated into actual commercial products providing a return on investment after years, sometimes decades, of capital-intensive investment and research efforts.

Without strong and predictable protections for validly patented innovations, investors will shy away from investing in biotech innovation, degrading the ability to provide solutions to the most pressing medical, agricultural, industrial, and environmental challenges facing our nation and the world.  A short-sighted approach to patent reform will undermine the promise of these initiatives.

Biotechnology is one of the fields where the U.S. remains an undisputed world leader – both in terms of conceptualizing new products and bringing them to market.  Our Congress should be working to preserve and nurture the sectors where the U.S. remains head and shoulders above the rest of the world, where continued advancements hold the greatest societal and economic promise.

Make no mistake: the impact of weakening patent protection would be severe, and the aftershock could be devastating.

BIO Statement on SCOTUS Biosimilar Products Ruling

On Monday the United States Supreme Court issued a decision in Sandoz, Inc. v. Amgen, Inc., relating to the Biologics Price Competition and Innovation Act of 2009. BIO issued the following statement regarding the outcome:

“BIO is disappointed with the Supreme Court’s decision today regarding Sandoz v. Amgen, which has effectively gutted a statute that had been carefully designed to facilitate timely resolution of patent disputes in order to avoid delaying market entry of biosimilar products. Importantly, it will do nothing to expedite the delivery of biosimilars to market. To the contrary, it is likely to delay patient access to biosimilars.

“As stated in our legal brief, this outcome will only encourage more confusion, more litigation, and more gamesmanship by biosimilar applicants, negatively impacting patients and the innovators who invested billions of dollars to develop innovative medical breakthroughs.

“The Biologics Price Competition and Innovation Act of 2009 (BPCIA) properly reflects the delicate balance of interests between promoting innovation and lower-cost generic entry. Unlike the BPCIA, today’s Sandoz v. Amgen is a disservice to patients awaiting lower-cost medical therapies.”

#BIO2017: What’s Happening in the World of IP?

Who’s ready to hit the beach?

Wait, did I say beach? I meant the San Diego Convention Center.

….But the beach will be waiting for you once you wrap up two and a half days of IP educational programming!

Let’s take a look at what will be on the agenda for BIO’s Intellectual Property Track next week at our International Convention (not registered yet? We can solve that, just go here!)

Monday, June 19, 2017

Of Rats and Men: The Success Story of Human Therapeutic Antibodies Produced in the Omnirat
Time: 4:00 PM–5:00 PM    Date: Jun 19, 2017
Location: Room 7B, Upper Level

 

Tuesday, June 20, 2017

 

 

 

Wednesday, June 21, 2017

 

**Continuing Legal Education

Some of our Intellectual Property sessions at BIO will offer attorneys an opportunity to obtain Continuing Legal Education (CLE) credits in select states. Application for CLE credit will be submitted in California and Virginia, and attorneys will be notified if BIO receives credit approval. Attorneys needing CLE credit from other states are welcome to sign in, pick up the CLE forms and apply to their jurisdictions on their own. BIO will provide you with documentation when applying for CLE credit.

USTR’s Report Targets Trade Barriers to Biotech

The Office of the United States Trade Representative’s (USTR) annual Special 301 Report identifies trade barriers to U.S. companies and products due to the intellectual property (IP) laws. Each year the USTR identifies countries which do not appropriately administer intellectual property rights.

This year’s report addresses many of the key IP-related challenges that BIO members face globally, including inadequate legal protections, enforcement issues, restrictive patentability criteria, lengthy patent backlogs, and the threat of outright expropriation of U.S. intellectual property rights through compulsory licensing.

Read BIO’s full statement on the USTR’s 2017 “Special 301 Report”

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.

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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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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