Sara Demy was recently interviewed by Janelle R. Anderson on the Human Proof of Concept podcast during Biotech Showcase.  Janelle is currently a Managing Partner at CTI Life Sciences Fund.

If Biotech Showcase is the farm team for JPM, then Sara Demy is the coach. She literally got high fives when her conference burst onto the scene in 2008.  Since then, it has busted out of its first two locations and now boasts over 3,000 attendees, with 400 presenting companies and 1,000 investors. Listen as Sara explains the launch of Biotech Showcase.

In the discussion at the Trans-Pacific Health Sciences Dialogue meeting led by Grace Pan, a partner at Holland and Knight we heard from Dr. Judy Jarecki-Black is Global Head of the Intellectual Property Department at Merial, Inc., the Animal Health subsidiary of Sanofi-Aventis. And Fang Xie, Ph.D. is Of Counsel at international law firm Greenberg Traurig, LLP where she co‐leads the firm’s Biotechnology and Pharmaceutical Group.

Dr. Fang Xie and Dr. Judy Jarecki-Black enlightened the participants about what it takes to obtain a patent in China and the different types of patents. During that same talk they explained the challenges of bringing new vaccines to China.

Obtaining patent protection and bringing new drugs and vaccines to China is not, unfortunately, a simple process. China’s patent process, especially relating to vaccines, is sophisticated and data-driven, and companies new to the experience are likely to encountered several hurdles.

Language Barriers: The first hurdle encountered is simply that any patent in China must be filed in Mandarin. That makes obtaining a skilled translator an essential part of the process. Finding an IP attorney who is fluent in both English and Chinese and familiar with the Chinese patent process can overcome this obstacle; if nothing else, opt for a reputable, reliable translator.  

The Patent Filing Process: Vaccines and other drugs must file for an invention patent, as opposed to a utility patent. The prosecution period for an invention can often last for years. However, at the same time, invention patents offer 20 years of protection.

Placing a Sample on File: In the patent filing process, you must place a sample of your vaccine on file. This can certainly be a cause for concern for companies who are used to working in other markets, but the policy is in place as a measure to track strains and mutations.

Obtaining Chinese Resources: Related to that matter is the fact that collaboration with Chinese scientists is often crucial to developing vaccines for the market. This is especially true in the veterinary industry, because many diseases have different strains from one region to the next and a vaccine that counters one may not work against another. Obtaining those samples is important for success; it is worth mentioning that the research happens at state-sponsored institutions.

Other Government Requirements: Any vaccines must be manufactured in China, which makes government assistance crucial to the process, and even makes it questionable whether you can truly establish a biotech company without the Chinese government’s assistance.

In addition, the process of clearing a vaccine for production in China is complicated by the government’s reluctance to accept the documentation provided for approval in Europe or the U.S. Obtaining a patent and regulatory approval will require reworking of your existing materials.

Multinational Development: Global companies that rely on development in several nations may find them wondering where to file first and what type of filing is required. For vaccines developed partially in China, the exact requirements will depend on a variety of circumstances; once again it is crucial to have an experienced IP attorney to guide you through the requirements.

All in all, filing for a vaccine patent in China could easily cost $20,000 just to obtain the patent, between translation fees and filing costs. And despite the challenges that companies will face, and complex legal environment, China remains a market poised for growth, making it an appealing nation to expand into.

On the second day of Biotech Showcase we examined what the biotech industry should expect from the Trump Administration with the help of our friends at Hogan Lovells. Over the course of the luncheon plenary and two afternoon workshops panelists discussed what lies ahead for the Affordable Care Act, the FDA and CMS.

Repeal or Replace?

When it comes to the fate of the signature program of the Obama Administration, the Affordable Care Act, our panelists were skeptical that the Trump team and the Republican Congress will be able to make good on their promise to repeal the Act and replace it with ‘something much better.’

Greg Simon, formerly Executive Director of the White House Cancer Moonshot Task Force, quipped, “You can’t replace reality with a bumper sticker,” underscoring the fact that the Republicans haven’t put forth any details on an alternative.

As Ken Choe, a partner at Hogan Lovells explained, “Lots of balancing of interests went into the ACA that will make it hard to unwind.” For example, as Liz Fowler, Vice President of Global Health Policy for Johnson & Johnson pointed out, ACA included a ‘drug company tax’ that was levied against biopharmaceutical firms in exchange for the promise that more patients would be brought into the health care system through greater access. If the ACA is repealed, those companies may, rightly, want a refund.

Another complicating factor is the fact that the biosimilars regulatory pathway is part of the ACA. If that law is repealed, new legislation will be required to restore the pathway.

As to what a replacement program might include, Dan Todd, Principal at Todd Strategy, said that while details are unclear, it is likely it will include high risk pools to cover patients with existing conditions and advanceable tax credits in place of subsidies.

Wither the FDA?

While many names have been mooted as potential FDA commissioners, (including Joseph Gulfo, Executive Director of the Lewis Center for Healthcare Policy and Technology, who moderated our FDA workshop), President Trump has not yet produced a nominee. As a result, it’s hard to speculate what direction the agency might take, however, our panelists did their best to comment on the rumors and speculation that have been making the rounds.

Jane Axelrad, Principal of Axelrad Solutions LLC, who previously served as Associate Director for Policy at the Center for Drug Evaluation, noted that there are fewer than five political appointees at the FDA. The majority of the agency staff are civilian employees who have been with the agency through several administrations. So a change in administration does not necessarily spell wholesale change at the FDA.

Jane and other panelists expressed more concern about the impact of the government hiring freeze on the agency which has been notoriously hard to staff – particularly in light of the fact that many agency staff may take this change in administrations as an opportunity to retire.

As Senator Norm Coleman, now Of Counsel at Hogan Lovells, pointed out, “It is likely the administration will push the agency farther than it wants to go.” Jane agreed, saying “Staff will resist any push to undermine the rigor of the drug approval process until they are overturned up the line.”

The panelists dismissed the idea that has been floated that the FDA should be reworked to focus reviews on safety and not efficacy. It was noted that payers would not be willing to reimburse drugs without proven efficacy making the idea a non-starter.

The Fate of Other HC Initiatives

As Jane pointed out, many of the health care reforms that are in process are already enshrined in the 21st Century Cures Act, signed into law in November by President Obama. Among other things, this sweeping legislation covers the adoption of Electronic Health Records (EHRs), patient-focused drug development, the use of Real World Evidence (RWE) and the Cancer Moonshot.

In fact, Greg Simon explained that the change of administrations is having virtually no effect on the Cancer Moonshot, explaining “It’s not important if the program is officed in the White House.”

Prognosis for the Next Four Years

Summing up the panelists prognosis for the next four years, Julie Gerberding, Executive Vice President and Chief Patient Officer for Merck, explained, “The government is designed for stability.” None of our panelists expect that the new administration will be able to accomplish the radical reforms proposed on the campaign trail.

The biopharmaceutical industry should, as Greg Simon advised, “Go about your business and continue to try to do the best you can” and hope the new administration chooses “neglect” when it comes to our industry. 

Chinese Patents

The 15th Annual Trans-Pacific Health Sciences Dialogue was a meeting for biopharmaceutical industry executives and business development executives who wanted to accelerate, explore and develop collaborations and partnerships with their counterparts in the most important Trans-Pacific health care markets including Japan, China, South Korea and North America.

In a discussion led by Grace Pan, a partner at Holland and Knight we heard from Dr. Judy Jarecki-Black, who is Global Head of the Intellectual Property Department at Merial, Inc., the Animal Health subsidiary of Sanofi-Aventis. Also part of the discussion was Fang Xie, Ph.D., Of Counsel at international law firm Greenberg Traurig, LLP, where she co‐leads the firm’s Biotechnology and Pharmaceutical Group.

Dr. Fang Xie and Dr. Judy Jarecki-Black enlightened the participants about what it takes to obtain a patent in China, and the different types of patents that are available.

Understanding the Types of Chinese Patents

China’s patent law allows inventors and companies to file for one of three types of patents: utility, invention, and design. The time it takes to file, the cost to file, and the duration of protection depend on which type of patent you choose to pursue. They bear similar names to US patents, but don’t correlate exactly.

Utility Patents

Chinese utility patents are granted to new solutions or improvements to items — such as a new shape or structural features added. They can only apply to physical products.. A Chinese utility patent has some similarity to Japanese or European utility model patents — but there is no direct US equivalent. Utility patents are not as innovative as invention patents; the degree of “inventiveness” is lower and there is far less scrutiny required.

Utility patents offer 10 years of protections as opposed to 20 years for invention patents. However, they can be obtained in less than one year because there is less scrutiny applied. This makes them attractive in industries where products become less valuable over time (electronics, for example).  

Invention Patents

The Chinese invention patent applies to both physical products as well as processes. It offers 20 years of protection to the patent holder, but compared to a utility patent, can take significantly longer to obtain — often several years. An invention patent is the appropriate choice for products with a long development time, or those that will remain valuable for a very long time.

It is possible to file for both utility and invention patents for a particular improvement, product or process— however, you cannot obtain both. During the prosecution (evaluation?) period, you will be asked to choose which one to pursue. If you opt for the invention patent, you must abandon the utility patent. Similarly, you may choose to keep the utility patent when it is granted and abandon the invention patent.

Design Patents

Chinese design patents relate specifically to the external features of a product, including any of the following:

  • Pattern
  • Shape
  • Pattern and shape
  • Shape and color
  • Pattern, shape and color

The only other requirement is that the patent be suitable for “industrial application” — that is, able to be mass produced. Like utility patents, design patents have a protection period of 10 years and can be obtained relatively quickly — within a year.

Additional Concerns for Chinese Patents

One common factor to all Chinese patents is that they must be filed in Mandarin, which means that translation is very important. In addition, patents are issued on a first-come, first-served basis, and cannot have been published or unveiled publicly before the patent application is approved. Demonstrating that a patented product was published or unveiled before the patent was issued could invalidate the patent.

Utility patents have a noteworthy feature in that patent holders have an option, in the case of infringement, to pursue action using the administrative branch of the patent office. This is far less costly and time consuming because there are no courts involved. The administrative branch will not assess any damages, either, but it will facilitate mediation so the affected parties can negotiate damages.

For those of us who have been making the rounds of the investor meetings in 2015, it’s not news to hear that biotech’s time has come – in fact it’s almost a cliché.

Are we in another biotech market bubble, or have things fundamentally changed? That’s been the lingering question. But now financial data is beginning to come to light that supports the position that we are in the midst of a sea change rather than a bubble.

Bruce Booth, one of our favorite VC’s and a thoughtful blogger on biotech finance, did an analysis of post IPO performance of the recent crop of newly public biopharma companies. He discerns that a degree of pricing discipline for biotech securities is emerging that is indicative of a maturing sector.

In a more obvious indicator of market maturity, in Fierce Pharma’s ranking of the top 15 pharmaceutical companies by sales for 2014, Gilead displaced Eli Lilly, becoming the first biotech company to make the list.

It is against this backdrop that Demy-Colton Life Sciences Advisors is launching the Biotech CEO Summit as a forum where key biotech leaders who are reshaping the biotech landscape can serve as a ‘brain trust’ for the industry as it grows to maturity and sustainability.

The private interactive forum will be held July 21 to 23, 2015 at the Carneros Inn in Napa, CA. Attendance will be limited to an invited group of 40- 60 CEOs who are thought leaders and influencers in the biotech industry.

We undertake this project with the goal of bringing together prominent thought leaders from industry or academia, leading investors and global key opinion leaders to examine and address the opportunities and challenges the biopharmaceutical industry faces as it forges a future where it will indeed deliver on the promise of transformational science.

In 2014 the biopharmaceutical industry has surpassed virtually every financial benchmark imaginable. As the industry gets ready to gather in San Francisco next month, the question on everyone’s mind is, how long will it last?

Analysts are predicting 2015 will be another strong year for the sector even if it doesn’t outperform 2014. The optimists argue that the current market upswing isn’t a bubble, but a reflection of a fundamental change in the business model. Credit Suisse calls it a transition from Biotech 1.0 based on hopes and dreams to a Biotech 2.0 model where next gen blockbusters deliver on the promise.

But while commercial success brings a new sense of stability to biotech financial markets, it also brings new risks.

A backlash over drug pricing and/or compassionate use tops most list of risks cited by cautious analysts. There is the unknown potential of biosimilars to challenge blockbuster biologics.

Changes in policy could impact the relationship between the industry and the FDA or other critical regulatory agencies. On the legislative side there is the risk that the JOBS Act that has played such an important role in kick starting the industry’s recovery or that attempts to repeal aspects of the Affordable Care Act could create market uncertainty regarding pricing and payment models.

The Tuesday plenary lunch panel at Biotech Showcase will explore these issues and provide some perspective on the state of the biotech industry as we start the year.

(First published on LinkedIn Pulse)

Polaris Partners joins the parade of new biotech funds launched in 2014 with a $450M fund which exceeds $400M number they filed with the SEC last summer. Polaris joins Arch, Venrock, Versant and Sofinnova, among others, who have launched funds of similar size in 2014.

These new funds will bring a welcome surge of new private capital to innovative biotechs. How will it be deployed and will it be enough to sustain early-stage development at a time when drug development costs are soaring? Our Wednesday plenary panel at Biotech Showcase will discuss these topics and others as they contemplate the next five years of private investment in the biopharmaceutical industry.

(First published on LinkedIn Pulse)

The Japanese biopharmaceutical industry emerged as a global player in the 1990s followed more recently by South Korea. As PharmAsia recently noted (subscription required) now China is emerging as a major source of both patients and innovation. Following Japan’s lead, East Asian biopharma companies are looking to partner with Western firms to increase their global reach. At the same time, US pharmaceutical companies want and need access to customers and technology in major Asian markets.

We created the Trans-Pacific Health Sciences Dialogue meeting to bring together dealmakers and senior executives from both sides of the Pacific to discuss how best to accelerate and develop collaborations. The invitation-only event has a well-earned reputation as the best place for biopharma companies seeking to forge Trans-Pacific ventures to begin exploring their options.

Our 2014 program features:

  • Peter B. Corr, Co-Founder and Managing General Partner, Auven Therapeutics
  • Robert DeBenedetto, President &CEO, SFJ Pharmaceuticals
  • Iain D. Dukes, D. Phil., Senior Vice President, MRL Licensing & External Scientific Affairs, Merck
  • Glen Giovannetti, Global Biotechnology Leader, EY, LLP
  • Kiyoshi Kurokawa, Professor, National Graduate Institute for Policy Studies & Science Advisor, National Diet, Japan

Our plenary sessions and workshops will explore key issues that are critical to a successful East Asian strategy such as:

  • Where are the best opportunities for growth and collaboration?
  • What are the drivers of biopharma innovation in East Asia and where is it going?
  • What does your management team need to know before expanding into East Asia?
  • How does Big Pharma view global collaboration and drug development?

If you are looking for the answers to these kinds of questions, please contact ljoseph(Replace this parenthesis with the @ sign) to request an invitation. More details are available at the conference website.

(First Published on LinkedIn Pulse)