BIO Fall 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.

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.

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 fall conference will take place November 13-15 in Annapolis, Maryland.

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.

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

Registration for BIO’s Fall IP Counsels Committee Conference is NOW OPEN!

Ah, Autumn. A time for pumpkin spice lattes, cozy sweaters, soup, and updates in the biotech patent space.

That’s right, registration for BIO’s Fall IP Counsels Committee Conference is NOW OPEN! Our Fall meeting will take place November 13-15 in Annapolis, Maryland.

Photo Credit to visitannapolis.org

BIO’s IP Counsels Committee Conference is THE place to get the most relevant information and updates on the latest issues in the biotech IP sector. Organized by in-house practitioners, it is the premiere event for corporate biotech patent counsels. We provide opportunities for education, policy discussions, networking, and offer the most up to date information in the field.

Our agenda, details for registration, and other info can be found here. 

Now grab your sailor suits and come join us!

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.”

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

She Blinded Me With Science: What We’re Reading, May 2017

Each month, GMO Answers compiles a few stories we think particularly noteworthy. Science is everywhere, and that was especially true in the stories that caught our eye this past April. So go with the flow, lose control, feel the power, fight your resistance, be a catalyst, start a reaction, keep an ion the ball, and join us in finding out the latest in the world of science and GMOs in this month’s What We’re Reading post:

To learn more about the science of GMOs, agriculture, and plants, please visit the GMO Answers website.

Filed under: Farmer Gene, Food And Agriculture, , , , , , , , , , ,

10 new crowdfunded health devices that will intrigue you

money conflict of interest patient advocacy organizations

[Image from Unsplash]

With crowdfunding websites like Kickstarter and Indiegogo, companies can obtain the funding for ideas they want to come to life (even potato salad parties), with the promise of something in return to the donors. And while crowdfunding presents challenges for regulated medical devices, it’s proven to be a boon for startups touting potentially innovative health and wellness devices to consumers.

Some of these devices raise eyebrows, of course. Do they actually work? Is there credible research to back up the technology? Are they going to run afoul of FDA? But they are nevertheless intriguing – and offer potential food for thought for medical device developers.

From devices that fix your posture to dissolvable strips meant to replace pills, here are 10 intriguing health and wellness campaigns seeking the funds to get their devices manufactured and delivered.

Next >>

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”

PeptiDream and J&J ink billion-dollar drug discovery deal

Japan’s PeptiDream has once again turned small molecules into big business, signing a drug discovery agreement with Johnson & Johnson that could be worth up to $1.15 billion.

FDA allows 23andMe to reintroduce 10 genetic health risk reports for Parkinson’s, Alzheimer’s, and more

Some 3 1/2 years after having its hand slapped, 23andMe has received a green light from the FDA to market 10 direct-to-consumer genetic health risk reports for conditions such as Parkinson’s, late-onset Alzheimer’s, and celiac disease.

The expanding ecosystem of microbiome startups

More funding and another powerful pharma backer have entered the microbiome space, showing that at least some investors and pharma execs believe the field can begin converting preclinical ideas into valid human therapies.

Finch Therapeutics

Somerville, Massachusetts-based Finch Therapeutics announced a new agreement with Takeda Pharmaceuticals on Wednesday, a solid endorsement of its sophisticated bioinformatics platform.

Along with oncology and central nervous system disorders, gastrointestinal diseases are one of Takeda’s three therapeutic pillars. As part of the deal, Takeda will pay an upfront $10 million for exclusive worldwide rights to FIN-524, an investigational drug for ulcerative colitis, and any follow-on products for irritable bowel diseases (IBDs). Ulcerative colitis is a form of IBD in which the immune system attacks the lining of the large intestine.

Finch’s science taps into the high-potential, highly-unpalatable concept of a fecal transplant. It involves transferring a microbiota rich stool sample from a healthy individual into someone with severe gut dysbiosis.

It’s a smart approach, given how little we know about the many thousands of microbial strains that occupy our guts. Instead of adding them to a therapy one-by-one, scientists can take a sample ecosystem that is already known to work. Finch then has a feedback loop in place to determine how patients responded to the different donor cultures.

“By working from clinically annotated datasets of donor and patient microbiota before and after fecal transplantation, we can look for the patterns in changes to the patients’ microbiota associated with targeted clinical outcomes,” said Finch CEO Mark Smith in an email forwarded by a company representative.

It underscores how variable our microbiomes are, whether we’re healthy, sick, or somewhere in between.

Smith cited a 70-patient randomized control trial of fecal transplants performed at McMaster University (Moayyedi et al, 2015). Five donors were used in the study, but just one, Donor B, had a demonstrably large therapeutic effect. Without Donor B, the study would have failed.

Just how much Kombucha was Donor B drinking? And how do we learn from the strength of that participant’s microbiota? Finch is working to answer the latter.

Azitra

While gut bacteria and the microbiome are often used interchangeably, our microscopic citizens really populate our entire body, including the skin. That’s the target for Farmington, Connecticut-based Azitra.

Azitra announced on Wednesday that it had closed a $2.9 million Series A venture round led by Bios Partners. With earlier seed funding, including from Peter Thiel’s Breakout Labs program, the startup has raised $3.75 million to date.

Rather than brewing a complex bacterial concoction, Azitra has identified one key bacteria strain for its lead candidate, AZT-01, to be applied as a cream to affected skin. In its cross-hairs for treatment are eczema, rare genetic skin diseases, and more everyday cosmetic applications such as dry skin.

In an email forwarded by a company representative, Azitra Cofounder and CSO Travis Whitfill said the microbial treatment isn’t just a band-aid — it could address an underlying cause.

“Studies have repeatedly shown that these patients have an imbalanced microbiome, and in the case of eczema, they often have an overgrowth of Staph aureus. There is also evidence that our strain of bacteria can kill some strains of Staph aureus, which is one of the reasons we chose it as a chassis,” Whitfill said.

Applied topically, the good bacteria can colonize the area and begin correcting the dysbiosis.

Photo: spawns, Getty Images

Five things we learned about FDA nominee Scott Gottlieb

There’s no shortage of areas to debate when it comes to FDA policies, the need for reform and the argument against the erosion of safety standards.

In fact, there were so many drug and device-related fields to cover, President Trump’s nominee for the top job at the Food and Drug Administration Scott Gottlieb didn’t get a chance to comment on food safety, supplements, and his other potential jurisdictions.

In Tuesday’s nomination hearing, broadcast live, the Senate Health, Education, Labor and Pensions Committee pushed other major areas to the fore.

They included Gottlieb’s “unprecedented” industry ties, drug and device approval speeds, science versus ideology, biosimilars and generics, and Gottlieb’s biggest concern of all: the opioid epidemic.

Handling the boss

Both sides of the aisle seemed concerned about President Trump’s hiring freeze in government departments, including FDA. Committee chair Sen. Lamar Alexander (R-TN) addressed it directly in his opening remarks, asking how Gottlieb would lead a strong agency incapable of hiring new talent.

According to Alexander, former commissioner Robert Califf’s top priority with the passing of the 21st Century Cures Act was to be able to hire and pay the necessary talent to review investigational drugs and devices.

Gottlieb reiterated the importance of FDA possessing a world-class workforce, armed with the resources and tools they need to do their job.

The most direct sentence he could summon, however, was to note that he has been vocal about the need to maintain a strong FDA workforce in the past.

“I will continue to make my opinions known on that issue,” he said.

Others questioned how he could maintain a science-first, objective approach while working beneath an ideological president.

“For those who have worked with me, I haven’t been shy about offering my unvarnished advice,” Gottlieb replied. “We mentioned 866 articles I’ve written where I’ve offered very clear thoughts. I’m going to continue to offer people my very clear thoughts on whatever issues I’m asked to opine on, including my boss’s.”

Industry interests

Unsurprisingly, the political parties returned to their respective corners when Gottlieb’s extensive industry ties were flagged. Democrat senators were concerned about his ability to remain impartial, while Republican’s viewed it as valuable experience in the field.

Sen. Patty Murray (D-WA) began her address by expressing disappointment in the limited amount of time the committee had to review Gottlieb’s application papers, which chronicle his many connections. The full package was received on Friday, Murray said.

“We’ve had just a handful of days to fully understand the extent of Dr. Gottlieb’s unprecedented financial entanglements with the industries he would regulate as FDA commissioner.”

Murray repeated the term “unprecedented” several times, as Senator Alexander reminded the audience that the most recent FDA commissioner, Robert Califf, had extensive industry ties too.

“I’m glad to know that you’ve got a background and experience in the issues before you,” Alexander told Gottlieb.

For his part, the nominee promised to work with ethical experts throughout his tenure. He has already withdrawn from multiple compromising positions and has met the minimum impartiality requirements for the position.

Part of the damage can’t be undone, however, in the eyes of the Democrats. It was pointed out that, if approved, he would likely oversee regulatory filings from some of the many companies that he has consulted for or financially invested in, including Cerecor and CRISPR Therapeutics.

Drug approvals

As a prolific writer and speaker, Gottlieb has an established track record indicating he would like to streamline the approval process. Some committee members, particularly Sen. Elizabeth Warren (D-MA) were particularly concerned about this pro-industry approach.

Gottlieb’s biggest message here was that it doesn’t need to be a trade-off.

“We should reject the false dichotomy that it all boils down to a choice between speed and safety,” he said.

The approval process can be improved from many angles, he argued, such as through adapted clinical trials that don’t infringe on the scientific rigor applied.

“We should be reminded always that we save lives by allowing good things to happen,” Gottlieb told the committee. “But we also save lives when we keep bad things from happening.”

Biosimilars and generics

Sen. Mike Enzi (R-WY) floated the issue of biosimilars in question session. Since 2012, four biologics have been approved, he said, but only two made it to the market. By 2021, some 70 more biologics patents will expire, creating a major opportunity for healthcare savings.

Since 2012, four biologics have been approved, he said, but only two made it to the market. By 2021, some 70 more biologic patents will expire, creating a major opportunity for healthcare savings.

“I think many of us have been disappointed by the economic savings we’ve seen from biosimilars so far,” Gottlieb said. 

His answer was concise but touched on one of the major issues; FDA giving guidelines to biologics manufacturers in a timely fashion. Uncertainty has clouded the field until now.

He also stated that the FDA needs to answer specific questions, such as whether or not biosimilars can be used interchangeably.

The discussion moved on, returning later to generic drugs with a question by Sen. Todd Young (R-IN) that played right into one of Gottlieb’s top priorities.

“There are literally billions of dollars worth of drugs each year that are sold as branded drugs at high prices but should be subject to generic competition,” the nominee said in agreement.

A huge part of the problem, Gottlieb said, was the inability of current FDA guidelines to handle new complex drugs. The standard measures for bioequivalence and bioavailability no longer suffice. That confusion prolongs the exclusivity period of the drug, as generics struggle to break into the market.

“This is an area I want to work on,” he said.

Opioids

The committee and Gottlieb all agreed on the urgency of the opioid epidemic.

“The opioid epidemic in this country is having staggering human consequences,” Gottlieb said in response to a question by Alexander. “I think this is the biggest crisis facing the agency.”

While he said an “all of the above” approach is needed, he singled out opioid alternatives as one of the greatest opportunities to turn the tide on the crisis.

That could include new pain relieving drugs and devices that can administer them in a more localized way. He also mentioned the need for medical options that help patients maintain sobriety.

Photo: VladimirSorokin, Getty Images