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MedNess: At the Frontier of Healthcare Business/ March For Science- Special Report

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Cover Design: Ipsa Jain

Hello everyone and welcome to MedNess: At the frontier of healthcare news. The month of April was pretty crucial for Gilead Sciences and Novartis. Read below to find out more.

Also, this issue of MedNess is special as we are covering a report on March for Science from Club SciWri’s “Reporting from the lab” led by Radhika Raheja, Ph.D. Why are we covering March for Science on MedNess? Science affects us; the scientists, science affects our decisions and perspectives..still need more reasons? Check out our section on March for Science.

To stay on top of major scientific advancements, subscribe to ClubSciWri (www.sciwri.club)

Gilead’s NASH candidate clears early proof concept study

Gilead Sciences presented the first clinical trial data for GS-0976, an acetyl–CoA carboxylase inhibitor in patients with non-alcoholic steatohepatitis (NASH) at the 2017 International Liver Congress. The results are very preliminary but hopeful.

Gilead acquired GS-0976 from Nimbus Therapeutics in a billion-dollar deal last year.

This chronic liver disease affects around 15 million Americans. It is manifested by fat deposition in the liver and can cause scarring and liver fibrosis leading to liver failure (FierceBiotech, SeekingAlpha).

The clinical trial consisted of only 10 patients treated with 20mg dose OD for 12-weeks. GS-0976 blocked the formation of new fat in the liver by 29% and reduced liver fat by 43%. There was also a statistically significant decline in liver stiffness, marker for liver fibrosis, from 3.4 to 3.1kPa.

MedNess: Although on Friday, April 21, 2017, we did not see Gilead stocks soaring after the news, based on 19 analysts polled by TipRanks, majority approve buying Gilead stock while 7 maintain a hold and 0 recommend selling (SmarterAnalyst).

 FDA issues new warnings against the use of opioids in kids and nursing mothers

The Food and Drug Administration (FDA) issued a consumer safety alert on April 20, 2017, ordering major label changes on prescription drugs containing codeine and tramadol. Codeine is found in some prescription pain, and cough medicines and some over-the-counter cough medicines and tramadol is found in some prescription pain medicines. The opioid drugs are metabolized rapidly by children which can lead to breathing problems.

The FDA listed 15 medications and their generics that will be affected by this warning ranging from J&J’s Tylenol with codeine and Ultracet with tramadol, Vertical’s ConZip with tramadol, and Allergan’s migraine medication Fiorinol with codeine (FDA.gov)

FDA approves Roche’s Tecentriq as first line treatment for certain patients with advanced bladder cancer treatment

Roche’s Tecentriq gained accelerated approval from the FDA as a first-line treatment in patients with advanced bladder cancer who are ineligible for cisplatin chemotherapy. Tecentriq was earlier approved for treatment in patients with advanced or metastatic bladder cancer whose disease worsened within one year of standard chemotherapy.

MedNess: This immunotherapy was approved earlier for the treatment of non-small cell lung cancer (Roche.com). The current approval enables label expansion of this immunotherapy. As per Zacks ranking list, Roche stocks are strongly recommended for buying (Zack.com)

Novartis’ CAR-T CTL019 receives FDA “Breakthrough” Tag for the treatment of most common form of lymphoma

Novartis received the US Food and Drug Administration (FDA) Breakthrough Therapy designation for CTL019, an investigational chimeric antigen receptor T-cell (CAR-T) therapy. Last month, CTL109 received the breakthrough designation for the treatment of r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients.

This is the second indication for which CTL019 has received this designation for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) for the treatment of adults who have failed two or more prior therapies.

The Breakthrough Therapy designation is based on data from the multi-center Phase II JULIET study. The results from JULIET study are expected to be presented soon (Novartis.com).

MedNess: Novartis is competing with Kite Pharma over CAR-T therapy. Kite already has breakthrough designations for DLBCL, transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma. After the announcement, Kites shares dropped by 1% and Novartis’s by 0.3% (FierceBiotech)

MedNess # March for Science by Radhika Raheja Ph.D

While we look at FDA approvals and how they affect pharmaceutical companies, it is important to acknowledge the science coming out of academic institutions that steers translational discoveries. Here is a brief report on how science impacts lives and why it is necessary to support scientific research.

Reporting from outside the lab – #marchforscience #Boston

This week we are not ‘Reporting from the lab” but from outside the lab where most of the excitement was happening. Thousands of scientists all over the world took to the streets to “March for Science” on April 22, usually observed as Earth Day.

Why do we march for science? We march for science because “ Science is real, denial is deadly”, “ No science, no beer”, “ Progress in science = progress in humanity”, “Climate change is real” and several other reasons. Here in Boston, the research community in the Longwood medical area marched under the motto “ Science is good for your health“. Our rally kick-started with a lineup of extremely eloquent speakers, faculty, students, patients and the Dean of Harvard Medical School (HMS) who spoke about the impact of science on our lives and the ramifications that reckless changes in science policy can have on all of us.

Why do we march for science? Science gives us the opportunity to give back to the community. The Dean for Students at HMS, Fidencio Saldana, emphasized that science affects all of us. “Science is for people who want to invest in the future of our children” he said, as science education creates awareness, teaches our children to think critically, ask questions and creates opportunities for them in the future. Fidencio Saldana ended by saying that there is, “too much at stake for us to remain silent anymore”. On a similar note, Senan Ebrahim, an MD-PhD student at the HMS reminded us, “to raise our voices and speak the truth, because we are blessed with knowledge and it is our responsibility to act on it and share it.” It is our duty to leave behind a legacy of advanced engineering, improved medical care and to safeguard the future for young and bright scientists.

Why do we march for science? Science gives us hope when we are afflicted with disease. This was further exemplified by the stories of patients and doctors on the innovative cures for various diseases including sickle cell anemia, acute lymphoblastic leukemia, neuroblastoma, lymphangioleiomyomatosis that have saved lives, thanks to fundamental scientific research conducted in laboratories within Boston and the nation. In order to continue fostering the promise of scientific discoveries, it is important to ensure our voices are heard. “Scientific research is one of the fundamental pillars of our society, … this is not a fight for our livelihoods, this is a fight for human lives “ said Elorm Avakame, an MD/MPH student at Kennedy School of Public Health.

Why do we march for science? “We march because we are facing a threat to humanity “. The proposed budget cuts within federal agencies like the National Institute of health itself will be dramatic as it has an annual budget of $32billion and propels scientific progress not only in the United states but in the world. “Such budget cuts, if applied, will have tragic consequences that will haunt us for generations, destabilize our economy and pose an existential threat to America’s preeminence as a world leader in biomedicine”, said George Daley, Dean of HMS. He also added that NIH funding supports over 380,000 jobs nationwide and over 31,000 jobs in the state of Massachusetts alone. Research funded by the NIH drives an economic activity of over $65 billion a year. “Scientific progress, scientific discovery is an enduring symbol of what is best and what is most noble about this great nation. Cutting biomedical research funding will eviscerate our ability to relieve suffering here and around the world. It threatens the very core of our mission”.

Boston plays a historic role in creating and nurturing some of the best scientists and physicians trained to alleviate human suffering caused by disease. Nearly half of new cancer drugs in the last 5 years emerged from the hard work and curiosity of scientists in the laboratories at Harvard University funded by grants from the National Institute of Health. In this era of phenomenal advancements in science, it is terrifying to envision the therapeutic landscape for various diseases without support for scientific research.

It was a cold, rainy day in Boston, with temperatures as low as 3oC (37oF) , yet this did not deter the spirit of the students, scientists, physicians, patients and people whose lives have been positively impacted by science to get out and stand up for science. We marched to reaffirm the importance of science and how it benefits our lives, our country, and our planet. We marched because science truly matters!

About the Authors:

Imit Kaur is a freelance medical writer, editor and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.

 

Radhika completed her PhD from Cornell University and is currently a Postdoctoral fellow at the Brigham and Women’s Hospital. Her research interests have centered around oncology and neuroimmunology. Among other things, she is striving to effectively communicate scientific discoveries to the community.

 

 

MedNess: FDA approvals,rejections, M&A and more…

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Illustration: Ipsa Jain

Hello and welcome to MedNess where we bring you the news from healthcare market. We are excited to announce the brand new section known as MedNess Focus, led by Abhinav Dey, Ph.D. that will be published every alternate week. Stay tuned for that next week where he will “Focus” on Novartis’ CAR-T therapy BLA! We are also excited to introduce MedEurope this week, led by Czuee Morey, Ph.D. For other in-depth coverage, please subscribe to @Club SciWri (www.sciwri.club)

FDA grants approval to Gilead Hep C drugs for pediatric patients
The U.S. Food and Drug Administration granted approval to supplemental applications for two Hep C drugs; Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for use in pediatric population ages 12 to 17 or weighing at least 35 kg. The drugs are approved to treat hepatitis C in adolescents without cirrhosis or with compensated cirrhosis. Harvoni gained approval for treating pediatric patients with genotype 1, 4, 5 or 6 hepatitis C virus (HCV), while Sovaldi was approved for treating pediatric patients with genotype 2 or 3, in combination with ribavirin. Both of these drugs were previously approved to treat hepatitis C virus (HCV) in adults. The supplemental approval came in as a win for both the medical field and business investment field. These two drugs are the direct-acting antiviral agents approved for the pediatric patients. Direct acting antivirals are efficient in curing HCV in most cases. These agents prevent the virus from multiplying thus reducing the amount of HCV in the body. Alternatively, the supplemental approval of Sovaldi  and Harvoni  also came in as a relief to the slumping Gilead sales (Fierce Pharma)

MedNess: Gilead Sciences tops HCV and HIV treatment market. However; recently, the patent battles and competition from the rivals has given tough time to Gilead’s stocks. While investors have been worried about Gilead’s cranking cash flow, the expanded label approval of Gilead Sciences star HCV drugs; Sovaldi and Harvoni should provide a sigh of relief. There was a slight increase in the stock price after the expanded drug approval use (seeking alpha and The Motley Fool).

FDA rejects Merck’s plea to drop cardiovascular risks from sitagliptin label
The FDA sent a complete response letter to Merck rejecting the drug maker’s appeal to include outcomes from its TECOS trial. This heart study showed that Merck’s drugs used for the treatment of diabetes; Januvia and its related combos Janumet and Janumet XR had “no signal” of heart failure (FiercePharma).

MedNess: Merck has been facing competition with Eli Lilly’s and Boehringer Ingelheim’s SGL2 medicine Jardiance and Novo Nordisk’s GLP-1 Victoza which have shown to reduce the combined risks of heart attack, stroke, and death from the cardiovascular disease. Amongst these rivals, Merck wanted to follow suit. The stock prices of Merck fell after the letter on Friday (Investor’s.com).

FDA authorizes 23andMe Personal Genome Service Genetic Health Risk tests
The FDA approved the marketing of genetic health risk analysis. The results of these tests will provide information directly to customers without requiring physician’s prescription.
The genetic health risk tests can detect a genetic predisposition to 10 diseases including Parkinson’s disease, late-onset Alzheimer’s disease, and Gaucher disease. But there are certainly gray areas with the testing system. The tests are designed to provide information on genetic predisposition that can help make lifestyle changes, but the results are not expected to be entirely valid or “fully penetrant.” This implies, even if a person is shown to be at higher risk genetically, he or she might never develop a disease in their lifetime and vice versa. In addition, the reports provided by these test results will be independent of the family history. This is particularly concerning as for some diseases; family predisposition might increase the risk in general. Therefore, customers are advised beforehand to not to rely on the test results completely and not to get emotionally upset with the unfavorable test results (STAT).

NIH’s Zika vaccine enters Phase 2 trial amongst budget cut frenzy
The Phase 2 trial testing a Zika vaccine, developed by scientists at the National Institute for Allergy and Infectious Diseases (NIAID), began at Baylor College of Medicine in Houston. The phase 2 study results are expected by the end of this year.
The clinical trial involves a DNA-based vaccine, lacking a live Zika virus, but from which proteins are placed into small pieces of DNA. NIAID is a part of the NIH and is obviously affected by President Trump’s recent budget proposal cut. However, given the importance of this study, the institute has dedicated $100 million funding for the Phase 2 work. If the Phase 2 study is successful, NIAID will partner with commercial sources to bear the costs of larger Phase 3 trials (STAT)

Novartis CAR-T therapy BLA granted FDA priority review
Novartis announced that the US Food and Drug Administration has accepted the company’s first Biologics License Application (BLA) filing and granted the priority review for CTL019 (tisagenlecleucel-T) in relapsed and in relapsed and refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). CTL019 is an investigational chimeric antigen receptor T-cell (CAR-T) therapy.  The priority review designation is expected to shorten the anticipated review time to six months.

In the Phase II ELIANA study, 82% (41 of 50) of patients infused with CAR-T cells achieved either complete remission or complete remission with incomplete blood count recovery after three months. The study enrolled patients globally across the US, EU, Canada, Australia, and Japan.

CAR-T therapy, one of the most controversial treatments involving gene therapy, utilizes reengineered patient’s T cells. These T cells (immune system’s killer cells) are filtered from patients blood and altered in the lab and injected back intravenously making it a “living drug.”(Novartis.com)

MedNess: After the announcement, Novartis shares were little changed but the shares of the company making CTL019 raw materials, Oxford BioMedica, rose by more than 4.5 percent. Alternatively, Kite Pharma, Novartis’ rival in CAR-T race, also submitted a rolling application for their chimeric antigen receptor T cell candidate. Rolling applications are allowed for promising new drugs. Kite’s application could be accepted early putting behind Novartis’. Therefore, the winner of the CAR-T race will set the price of the therapy and subsequently the stocks (Reuters and Nasdaq).

MedEurope by Czuee Morey, Ph.D.

Astellas Pharma expands its portfolio to women’s health by acquiring Belgian biotech Ogeda
Japanese Astellas Pharma announced its plans to acquire privately owned, clinical-stage drug discovery company Ogeda. The acquisition comes three months after Ogeda achieved positive results from a Phase IIa study of fezolinetant (ESN364), its lead drug candidate. Fezolinetant is a potential non-hormonal treatment for menopause-related vasomotor symptoms (MR-VMS) such as hot flushes and night sweats and is an antagonist of the GPCR known as tachykinin receptor neurokinin3 (NK3). The phase II data showed statistically significant reduction in both frequency and severity of menopausal hot flushes versus placebo in 80 women.
Astellas’ offer consists of €500 million ($530 million) upfront followed by an additional €300 million ($318 million) if Ogeda meets its development and regulatory milestones. Astellas will also benefit from a few pre-clinical assets under investigation for autoimmune diseases and ulcerative colitis. The companies expect the deal to close in the second quarter, at which point Ogeda will serve as an Astellas subsidiary. This acquisition will help to expand Astellas’ pipeline that is primarily focused on oncology.

MedNess: The global MR-VMS market was valued at US$3.77 bn in 2014 and is projected to grow at a CAGR of 3.7% from 2015 to 2023 to reach US$5.28 bn by 2023. Ogeda is also running Phase II trials with the lead candidate to treat polycystic ovary syndrome (PCOS) and uterine fibroids. Other companies developing neurokinin antagonists are UK based NeRRe Therapeutics for a range of conditions from sex hormone imbalances to opiate use and US-based Millendo Therapeutics for polycystic ovarian syndrome, both in Phase II.
Astellas stock, which trades on the Tokyo Stock Exchange, was up about 2% to ¥1,492 ($13.39) on Monday morning after the announcement.
(PRNewsWire, Labiotech.eu, Seeking Alpha)

About the author:

Imit Kaur is a freelance medical writer, editor and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.

 

MedNess- Immuno Oncology, Precision Medicine and more….

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Picture Illustration: Ipsa Jain

CAR-T therapy- a step closer to precision medicine?

Kite Pharma’s CAR-T candidate axicabtagene ciloleucel (previously referred to as KTE-C19) might be the first gene therapy to gain approval from FDA. The candidate therapy attained primary endpoints in a major study. The study encompassed patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma. The study showed that out of 101 patients enrolled in ZUMA-1 trial, 82% had their cancer shrunk at least by half after six months. In addition, 41% had partial response while 36% of patients went on complete remission. The therapy comes with its own share of risks. 3 patients in the study died and 2 of the deaths were attributed to the treatment.

CAR-T therapy, one of the most controversial treatments involving gene therapy, utilizes reengineered patient’s T cells. These T cells (immune system’s killer cells) are filtered from patients blood and altered in the lab and injected back intravenously making it a “living drug”.

Novartis and Juno Therapeutics are also in the race for CAR-T therapy. However, Juno Therapeutics announced the discontinuation of their experimental product early this month. This is because thirteen percent of patient deaths were reported, majorly due to cerebral edema and brain swelling. Kite Pharma’s CART-T cell product is safer in this regard. Kite Pharma’s axicabtagene ciloleucel was granted Breakthrough Therapy Designation status for diffuse large B cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma by the FDA and by the Food Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

MedNess: Although Kite Pharma has not presented formal results of the trial and is expected to present their report at the annual conference of American Association of Cancer Research in April this year, the reports of axicabtegene ciloleucel meeting primary endpoints raised the stock prices by 13% of this California-based biopharmaceutical company. Kite Pharma’s CAR-T product might be first in line to gain approval from FDA by the end of this year leaving behind the products from its competitors. Therefore, stocks of Kite Pharma hold a lucrative future. However, a lot can change in further studies and it all comes down to safety and efficacy of the final product (FiercePharma, STAT).

Barclays analyst’s stern advice to Gilead Sciences

Geoff Meacham, Barclays senior analyst apparently lost patience with Gilead Sciences, urging it to “do something”. He sent an open letter to the management prompting the company to either make an acquisition or take strict measures to improve sales and profit growth. Meacham suggested measures including Gilead’s orphan drugs diversification, cost cutting in Hep-C business due to declining market, HIV franchise clarification and/ or in-licensing deals in order to gain trust of its investors (Seekingalpha)

MedNess: Gilead Sciences sales and profit growth have eroded as its hepatitis C franchise has declined, the shares have slipped by 1% and profits have declined in each of the past five quarters.

Scott Gottlieb to lead FDA under Trump administration

Scott Gottlieb who has served as a practicing physician, clinical assistant professor at New York University and health information technology adviser for the department of Health and Human Services, has been selected as Trump’s nominee to lead FDA. The president’s selection is expected to yield support from biopharma industry. Gottlieb, if confirmed, is likely to hasten the drug approval process that might have earned him Trump’s support. He was a former deputy commissioner for medical and scientific affairs at the FDA under George W. Bush (FiercePharma).

Earlier this month, Club SciWri initiated a new section on Science and Policy, emphasizing on the involvement of scientists in the healthcare policy decisions. Gottlieb’s nomination to lead FDA will serve as a perfect example, underscoring the relevance of this sensitive subject.

BMS appoints Thomas Lynch as its new Chief Scientific Officer

BMS has been in news for quite a while now and that too for all the wrong reasons. Amongst the turmoil and speculations of its buyout, BMS appointed Thomas Lynch as its new Chief Scientific Officer (CSO) while the former CSO Francis Cuff made the exit this Wednesday. Thomas Lynch, an oncologist, was a former board member of BMS. With the new appointment, hopes are high on the Opdivo front as well. Recently, Opdivo fell short in a major clinical trial when tested on previously untreated lung cancer patients. Opdivo is PD-L1 checkpoint inhibitor and therefore its efficacy is expected to be better in patients with higher levels of this biomarker. However, BMS lost its non-small cell lung cancer lead to rival Merck’s Keytruda that succeeded in patients with a PD-L1 score of 50% or more. Also, earlier this year, BMS decided to not to seek accelerated approval for their Opdivo-plus-Yervoy combination in lung cancer. These two events combined with new checkpoint inhibitors expected from Roche, AstraZeneca, Merck and Pfizer have put BMS’s shares down. However, analysts suggest, BMS share might still be a great bargain if the drug succeeds in other arms of the trial, testing Opdivo as a monotherapy in first-line lung cancer. The company also awaits readouts from Phase 2 and Phase 3 studies evaluating Opdivo and Yervoy in other types of cancer (FiercePharma, The Motley Fool).

 

MedNess-Pill for Alzheimer’s?

in ClubSciWri/SciBiz/Uncategorized by

Hello and welcome to yet another exciting week of MedNess. We bring the news from medicine and healthcare with greatest impact. It seems like; year 2017 will be the year of neurology! It is just the second month of the year and treatment strategies for various neurological disorders are making headlines.

Merck halts Phase 3 study on Alzheimer’s drug- another setback for amyloid theory

Clinical trials on Verubecestat- a small molecule BACE 1 and BACE2 inhibitor were called off after an interim analysis on Phase 2/3 studies did not show promising results. The analysis team concluded that there was “virtually no chance of finding a positive clinical effect”. However, another trial on patients with early symptoms of Alzheimer’s will continue. It has been speculated that the drug was too weak, or was dosed inadequately or the disease had progressed too far in patients for the drug to show concrete effect. The failure of this trial is another blow to the famous “amyloid theory”. According to this theory, the amyloid plaques are believed to be cause of the disease. Verubecestat is a beta secretase inhibitor. This disappointing cessation of clinical trial came months after Eli Lilly’s Alzheimer’s drug; Solanezumab failed in Phase 3 clinical trials in November last year. Unlike Verubecestat, Solanezumab targets plaque rather than beta secretase enzyme. This brings in disappointment not only for the patients but also for the researchers. The evidence suggests that once the disease has advanced and patients have established dementia, the removal of amyloid plaque might not yield effective outcome.

                              Do we have a pill to cure Alzheimer’s? Some quick facts:

  • Alzheimer’s is an irreversible brain disorder causing cognitive impairment
  • More than 5 million Americans are expected to suffer from Alzheimer’s
  • Sixth leading cause of death in the USA
  • No new drug has been introduced to provide symptomatic relief or to halt its progression since last decade

Picture source: https://unsplash.com/search/brain?photo=rmWtVQN5RzU

There are couple of drugs at various stages of trial that are being tested under the amyloid plaque hypothesis. These drugs either act on the plaque or beta secretase enzyme (BACE inhibitor) or available as amyloid immunotherapy. These candidate drugs are from Biogen, AstraZeneca, Eli Lilly, Amgen and Novartis. Apart from BACE inhibitors, hopes are also high for Axovant’s intepirdine. Intepirdine is believed to improve cognitive symptoms by targeting receptor 5-HT6 that stimulates the release of a neurotransmitter. Interestingly, intepirdine was abandoned by GSK in 2010. The drug failed when compared to placebo. However, one study showed tangible effect on cognitive symptom when intepirdine was paired with the approved Alzheimer’s drug Aricept.

MedNess: Merck’s stock suffered severe blow after the announcement of cessation of clinical trial. On the contrary, shares of Eli Lilly, AstraZeneca, Biogen and Roche, the fellow Alzheimer’s drug makers, increased. (Fierce Biotech, Business Insider, STAT news, The Boston Globe)

Axovant’s nelotanserin passes phase 2 study for Lewy body dementia

Axovant Sciences declared successful completion of phase 2 study of nelotanserin. The company is now setting its foot forward for phase 3 study that is expected to initiate later this year. Axovant Sciences reported preliminary results from the first small group of 11 patients.

Lewy body dementia or LBD is the second most common form of dementia. The hallmark characteristic of this form of dementia is the build up of abnormal proteins i.e. Lewy bodies thus affecting cognition, movement, behavior and alertness.

The study included patients with either LBD or Parkinson’s disease dementia. These patients experienced frequent hallucinations as assessed by mini mental state examination (Pharmaceutical Business Review)

CRISPR battle of patents: The Broad institute and MIT wins!

The scientists who first demonstrated the use of most powerful gene editing technology in biotech suffered a major blow on Wednesday, February 15, 2017, in their fight to gain exclusive rights on their invention. CRISPR gene editing system has revolutionized the field of biotechnology enabling scientists to make changes in DNA. Jennifer Doudna, a UC Berkely biochemist and her European collaborator Emmanuelle Charpentier first published this gene editing technology in prokaryotic system (type of bacterial system) in 2012 in Science. UC Berkely and University of Vienna filed for U.S. patent in March 2013. There were 155 broad claims to the CRISPR-Cas9 technology. Feng Zhang, a biologist at the Broad Institute, demonstrated the use of this technology in eukaryotic cells (type of plant cells, animal cells and human cells). The Broad Institute filed their patent in 2013; months after Berkeley group filed their patent. Since the patent claims by Broad Institute were fewer than Berkeley’s, the Broad Institute’s patent was issued on April 15 2014 through accelerated approval while Berkeley group is still awaiting their approval. After the Broad Institute was granted their patent, UC Berkeley filed an interference claiming that the Broad Institute should not have been granted the patent since Doudna’s and Charpentier’s CRISPR research outlined in 2012 paved the way for Zhang’s research in eukaryotic system. The Broad Institute argued that the research was not obvious and the patent claims from both the institutes were different. The federal Patent Trial and Appeal Board ruled out UC Berkeley’s claims and sided with the Broad Institute. With this decision, UC Berkeley plans to move forward with their patent application, which if approved, will provide them right on the use of CRISPR on all cells. This would also mean that if the technology will be employed commercially, the companies would have to get licenses from both the Broad and the Berkeley group.

MedNess: The patent decision in the favor of the Broad institute increased the stocks of Editas Medicine by 30%. Editas Medicine licenses Broad’s patents for human genetic disorders. (Fierce Biotech, STAT News, The LA Times, NPR, Wired)

Are pharmaceutical industries in favor of Trump’s FDA pick? The story so far….

Donald Trump is pushing deregulation of FDA in order to accelerate the drug approval process. His ideology: drug costs are higher, drug approval process through FDA takes forever, drug companies are involved in “unfair foreign trade”, drugs should be manufactured in the USA and finally, drug companies should add the innovation factor for the better cure of the diseases. This recipe will work in favor of patients to bring the overall drug costs down and patients can have quicker access to the newer agents. Not to forget, drug manufacturing in the USA brings back jobs and the “fair trade” promotes revenue generation. This all sounds good, except, the pharmaceutical industries have opposing views. The most common complaint of every patient and every healthcare researcher is the never-ending drug approval process by the FDA. So suddenly, when we might be able to overcome this hurdle, why is everyone (read the researchers, pharmaceutical companies and informed patients) so anxious? The truth is bitter sweet. Even though we rant over the FDA, we still knew, the FDA has best interests at heart and such a tight screen is probably important for the safety of the patients. In addition, a 2011, study found that the FDA usually approves cancer drugs before Europe does. Moreover, the researchers at Yale found the FDA’s drug review is at least a month faster than Europe’s or Canada’s.

The pharmaceutical industries on the other hand are concerned about the high drug costs. In addition to the limited patient safety, deregulation in the FDA might not provide enough time for pharmaceutical companies to justify high costs of the drugs to patients and to insurance companies. The pharmaceutical companies will not be able to account for high costs of the drugs owing the limited safety and efficacy analysis that ultimately affects both the patients and the companies. President Trump said last month he has a “fantastic person” lined up for the role of the FDA commissioner. A survey conducted by Mizuho Securities of drug company executives indicated that 72 percent agreed Scot Gottlieb should be Trump’s pick to head the FDA. Until then, we all wait! (Reuters, The New York Times, Forbes)

 

              

MedNess- At the frontier of Medicine, Pharmaceutical and Healthcare Business

in Poli-Scie/SciBiz/Uncategorized by

Hello and welcome to the biweekly roundup of Healthcare business top stories. Please follow us on Twitter and LinkedIn

MedNess 

BMS’s injectable Opdivo approved by FDA for bladder cancer

FDA approved intravenous use of Opdivo (nivolumab), a PD-1 checkpoint inhibitor for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have not benefitted from platinum-containing chemotherapy or in cases where the disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. Last year, FDA approved Roche’s Tecentriq, a checkpoint inhibitor, for the treatement of bladder cancer.

From the business standpoint, this was much awaited good news for BMS as the Opdivo did not make the cut as first line monotherapy study in non small cell lung cancer (NSCLC) in 2016. However, Merck’s Keytruda gained FDA approval soon after Opdivo failed in NSCLC study (Fierce Pharma).

 

The battle of patents: bad news for Teva Pharmaceuticals

Genric drug maker giant: Teva Pharmaceuticals lost the patent challenge in U.S. District Court, safeguarding their star drug Copaxone against generic competition. Copaxone, approved in 1996, became the most prescribed drug for the treatment of multiple sclerosis. The patents protecting Copaxone against generic competition expired two years ago for 20mg dose. Novartis and Momenta launched their 20 mg alternative (Glatopa) in 2015. To recuperate, Teva launched a 40 mg formulation of Copaxone. However, this week, U.S. District Court invalidated Teva’s last and fourth key patent protecting 40 mg Copaxone from generic drug competition. Teva lost other 3 patents last year (Madison.com).

Trump pledges to bring drug costs down

Pharmaceutical industries were told by Trump that the drugs should be manufactured in the USA and the foreign countries buying US manufactured drugs should pay “fair share”. These changes in addition to “better innovation” will help bringing prices down for the US patients (CNBC).

MedNess from MedPol: Amgen CEO Robert Bradway announced that soon nearly 1600 jobs will be added. Bank of America Merrill Lynch predicted that Trump’s policies could help Amgen recover their stocks by 23% in the next 12 months (CNBC)

MedPol

US President’s executive order on immigration: the aftermaths

This is not a political blog, but the executive order has a very significant impact on the scientific, medical and healthcare community. In the following paragraphs, I will brief you with the sectors that have been affected.

  • NRMP issues the statement for the upcoming Match

Nearly 260 people from seven nations affected by travel ban, applied through National Resident Matching Program (NRMP) for medical residency in the USA (Association of American Medical Colleges, AAMC). Both the applicants and the hospital programs are concerned and affected by the travel ban. However, NRMP has urged the programs and the applicants to be discrete in their decisions that are in the interest of healthcare. The official statement issued by NRMP on their website states, “The medical education community must support all international medical graduates and their families during these difficult times. As for the current Match cycle, NRMP encourages applicants and programs to make the best decisions they can under current circumstances. For its part, NRMP will be liberal in granting waivers to applicants and programs if they cannot meet their respective Match obligations because of the effects of the Executive Order” (NRMP.org).

  • Dark times for the US hospitals and patients from seven nations affected by travel ban

Ill patients scheduled for treatment at the USA’s premier healthcare centers, John Hopkins Medicine and Cleveland Clinic are uncertain of their treatment options. Hopkins is taking a step ahead by either urging the patients to postpone their travel or sending their staff abroad for their treatment (STAT News)

We wrap up our biweekly MedNess and MedPol news section. Have a great weekend!

Image source: https://unsplash.com/search/medicine?photo=nss2eRzQwgw

Battle of Wisdom: CRISPR-CAS9

in Sci-IP/SciBiz/SciWorld by
Editor’s Note: Gene editing for a better (or worse) is coming to a store near you. Some of you may have followed the ongoing patent war on the ownership of CRISPR-Cas9 technology between University of California (Berkeley) and Broad Institute (MIT-Harvard). But there could be many who are wondering what is the fuss all about? At the Career Support Group (CSG) for STEM PhDs we might still continue the debate about CSG’s usefulness to biologists vs non-biologists, but as inventors we are always in unison about perfecting the art of claiming ownership. #ClubSciWri is always attempting to listen and respond to your expectations and we are pleased to present the “Battle of Wisdom:CRISPR-Cas9” from Dileep Vengasseri. Dileep has nicely deciphered the meshwork underlying this matrix of claims to the CRISPR invention. We hope this story helps make sure that the next big thing from your gray matter secures your rightful ownership to the intellectual property.- Abhinav Dey

My dear friend, this 60 minutes of my time and 1597 words are for you! As you rightly said, maybe we should discuss our opinion(s) in public at least for educating others on what we have learned during the due course of our time.

Disclaimer: All what is written/expressed here are my personal opinions, and are not to be construed in any manner as a reflection/opinion of the firm that I am associated with. My words are solely my words! I will try to be as generic as possible to ensure there is absolutely no conflicts of any interest. This is purely a personal blog, written within the constitutional freedom that my Country has offered me when I was born here.

Many great battles are won not in the battle fileds, but in the minds of the battle leaders. What we read, saw, and talked about were the after-effects of those battles won or lost inside those great minds. In the great epic Mahabharata, Arjuna was about to lose Kurukshetra battle even before it was fought. But, there was a Krishna to save him from that humiliation. Many may not be as lucky as Arjuna was.

Before I begin, with all due respect, let me remind all of us one trivia very clear. US is not the “World” … it is just one of the many countries [a privileged one, indeed] of this world.  A larger population residing outside that privileged country, do not play a “World Cup” between their states or clubs. They don’t re-spell a word to make it look like they have invented it. For them, the metal “Al” is still aluminium and not aluminum.

We, living at the periphery of the world of modern(?) science, have got enough fuel from CRISPR-Cas, the game-changing method of gene editing, to satisfy our ego of being a part of a ‘privileged community’ who understands (?) the words like ‘gene editing’ and ‘CRISPR-Cas’.  For all such ‘privileged souls’, the “IP Battle of CRISPR-Cas” is more than just another battle. Let me call it a “Battle of Wisdom”.

But, was this battle worth fighting?

Let me begin with disecting this IP battle to four main sections: (1) Technology (2) The Battle Field (3) The Win and (4) The Strategy. May be, in future, I can complete this article with “Lessons Learnt”.

  1. Technology: At least from what is publically available, we know that Doudna/Charpentier’s team made that beautiful gene editng system work in-vitro in prokaryotic cells, in a neater, simpler manner than what it was in the nature itself. Instead of using a 3-component system including tracrRNA, crRNA and Cas9, her team beautifully designed a 2-component system, including a key synthetic, single guided RNA (sgRNA), that effectively performed site specific genome editing along with Cas9 (It is interesting to note that in-vitro 3-component system is also IP protected!). What was the big deal? The big deal was its simplicity, efficiency, and marketability. It was not that gene editing methodologies never existed before… however, now the World has access to an elegant gene editing system that is much more easy to perform (no more protein engineering!) & predictable. We also know that Feng Zhang (don’t forget George Church’s back-to-back publication in Science along with Feng Zhang) made it work in the eukaryotic system.
  2. The Battle Field: No one (at least the majority of money makers) wants a gene editing system that works only in prokaryotic systems. So, the “Battle of Wisdom” eventually boiled down to the IP on gene editing in eukaryotic system with CRISPR-Cas. Duodna filed a US patent application (remember, US is not the World, more so when it comes to IP protection) first and Feng Zhang got the first granted patent in US (note that the USPTO could have  provoked an interference at that time itself, but they didn’t!). Feng Zhang’s patent ‘claims’ to ‘cover’ eukaryotic CRISPR/Cas gene editing system (no comments on its “claims” and/or its “coverage” as the battle is still on…at least let the battle be fought under the belief that the land that is going to be conquered is still fertile!).  Duodna had anyway made it easier for Feng Zhang to get his patent granted by ‘boasting about’ her team’s achievement in multiple forums and explaning ‘how difficult it is/was to make it work in a eukaryotic system’.   Alas! enough of such wisdom on eukaryotic system was passed on to that Patent Attorney who filed her provisional applications, at least before the one on 19th October 2012 that is prior to the Feng Zhang’s priority date of 12th December 2012. Now, the battle of wisdom (what we call as “Interference Proceedings”) is to establish who invented (i.e., conceived and/or reduced-to-practice) the “eukaryotic CRISPR-Cas” first. Duodna will be fighting to make a point that porting CRISPR to  eukaryotic system is just a non-inventive aspect. Feng Zhang is going to fight back at least on the ground that if it is that obvious why did it then take Doudna a good 6-9 months to achieve the same.   I refrain from making any comments on how long or short is 6-9 months in a field like Molecular Biology. I know that my dear friend, who forced me (as usual) to write this long article, has wandered in the wilderness of IISc campus behind an elusive protein for a good 6 years :-)). And, I must admit that I have made the entire story of this Battle of Wisdom to a deeply  abridged version as the facts of this case are much more than what this layman article can handle. But, I believe that this much background is good enough to make my “teaching moments” convincing.
  3. The Win: Does it matter who wins this battle? Of course, YES! All battles are known after the leader who has won it (Aravind Kejriwal and Hilary Clinton are no where near their counterparts, as of today). Generally, the winner get the privilege to write the history that we all can read and study. But, is this Battle of Wisdom the same as any other great battles fought, lost and won? No. What is required to win this battle? It is required to show that who has invented the “eukaryotic CRISPR-Cas” first; it is required to show what is inventive/not inventive in this field; and it is required to show what constitutes an adequate written description/enablement in this field so that the “public disclosure function” (spirit and letter of any patenting system in the world) of the patenting sytsem is intact.  But, as with any other battle, only one person can be the winner. But, what will they both win or lose? The loser will any way have a deep wound in ego that may take years to heal. But, will he/she lose everything? Need not be. It depends on what other IP portfolio or picket-fencing that he/she has done around this gene editing tool. For example, a good claim on the synthetic guide RNA, a good IP portoflio on a better Cas9 proteins,  a better method for transfecting the cell, or an alternative to Cas9 itself… all these can make or break a commercial deal.  Is the winner going to get everything? Need not be.  During this entire process, it might open a pandora box and a myriad of avenues to potentially invalidate the patent claims that the winner can take home, to limit its claim scope, to limit its application coverage etc.
  4. Strategy: Isn’t it important for everyone in the field of IP to realize that most often a “hand shake” may do more good than “a fight”.  Before taking the army to a battle, it is important to know if raisng a white flag will be more beneficial than a gruelling battle. It is important to understand for what one is fighting a battle.   Does anyone fight for satisfying an ego or to make a point?  It is imporant to  understand that in a patent battle field, a wiser does not fight from their heart, but from their mind!. It is  important for each of the fighting members to know “What will happen if we do not fight, but rather collaborate?”.  Both Doudna/Charpentier and Feng Zhang could have been still partners in Editas, and they could have ruled the field.  When you fight in public, you expose yourself…you expose more than what you wanted to. And, what you have exposed can kill you even if you win YOUR fight.

Three more points to ponder:

  1. IP protection of PCR technology made Roche the king of DNA amplificaiton for quite sometime. Why? It is true that PCR was a technology that literally transformed the world of Biotechnology. But, was the IP protection on PCR probes for important pathogens less important? Were Taqman probes for real time PCR less important? Were the chips that made thermal cycling easier less important? No. All of them “together” made PCR a “cult” technology. That’s what a strategy means.
  2. IP protection in the field of ESC took Thompson and Wisconsin Alumni Research Foundation (WARF) to the center of the scientific world. Many IP/Tech Transfer cells in the Universities across the world wanted to be like WARF. As far I know, WARF gave its rights for free to any academic instituties, but made any industry pay for the same. Great! What were the other things that were needed to sustain and progress that technology ? An environment that morally support ESC research, a completely synthetic media to grow ESC, a culture that is devoid of mouse fibroblasts … all these were essential for taking ESC to reach its maximum potential. In modern day science, it is unlikely that we will see a winner of a single battle emerging as the “real winner”. A real winner is going to be the one who knows the game and strategize accordingly.
  3. US is not the “World”, and IP rights are jurisdictional. So, make yourself open to strategize for the real world!

Another Disclaimer: While starting my blog in WordPress, I had promised that I will not proof-read what I have written. In the past, many times, I had become a victim of my perfectionism and my writings had never seen the light. So, please pardon any typographical, grammatical, or otherwise errors. I hope factual errors are not there. Please let me know if you find any errors so that I can correct the same.

Authored by

 

Dr Dileep Vangasseri, PhD (Indian Institute of Science, IISc); Post-Doctoral research, University of Pittsburgh; Senior IP Professional, John F. Welch Technology Center, GE India Technology Center Pvt. Ltd., GE Global Research, Bangalore, India). Dileep has over ten years of in-house IP experience in Life Sciences, Healthcare and Medical Diagnostics industry after eight years of academic research experience in Bio-Organic Chemistry, Gene Therapy and Cancer Immunotherapy. He is well versed in all facets of patent analytics, techno-competitive intelligence, technology forecasting and business development.

This blog was originally posted here on December 7 (2016).

Featured image source: Pixabay

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Med-Ness-JPM meeting, Epipen and more…..

in SciBiz by

Hi all, its our second week and co-incidentally this week SciWri turned one. Happy Birthday SciWri and may the members continue to spread the light of wisdom through their blog sections!

MedRecap

35th Annual JP Morgan Healthcare Conference (JPMHC17)

The annual JPMHC17 took place in San Francisco from Jan9-13. This conference boasts to be one of the largest healthcare conference wherein pharmaceutical companies and small-scale biotech companies present their most recent innovation technology and share their future goals. The major highlights of this year’s conference are as follows:

  • Major focus on Oncology as leading pharmaceutical companies presented their innovative ideas at the pipeline stage or approval stage. CAR-T therapy presentations stole the show.
  • Genomics was another hot topic that was discussed and new therapies and technological advancements were presented. Illumina’s $100 genome was one of the most successful presentations. Illumina’s latest baby NovaSeq was unveiled at JPMHC17. This new machine (available as 5000 or 6000 system) is expected to expedite the experimental plan while reducing the over all cost, although, the real “$100 genome” deal is still far. The introduction of NovaSeq is definitely good for the company’s rising stock.

Head turning business deal: $5.2 billion bid by Takeda Pharmaceutical Co Ltd for Ariad Pharmaceuticals Inc. Ariad Pharmaceuticals, specializing in oncology drugs, developed drugs like Iclusig (Ponatinib for chronic myeloid leukemia); AP32788- kinase inhibitor for NSCLC and now Brigatinib for Alk positive NSCLC patients resistant to or who experienced drug progression on Pfizer Inc’s Xalcori (Crizotinib). The deal is expected to close by end of February.

 MedNess

Do we have an alternative to Mylan’s EpiPen?

2016’s most controversial product, EpiPen’s alternative is expected to hit the market with a list price of $4500. Kaleo’s Auvi-Q allergic device will be available for as low as $360 in cash for uninsured patients. However, the company has agreed to cover the full cost for those with a high deductible insurance plan or with household income less than $100,000.

MedPharm

Biosimilar for AbbVie’s Humira accepted for Review

Abbvie’s Humira (adalimumab), indicated for multiple inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, adult and pediatric Crohn’s disease, ulcerative colitis, pulls in annual sales of nearly $15 billion. This drug was approved in US and EU. Boehringer Ingelheim introduced their biosimilar to Humira and has been accepted for review by both FDA and EMA.

In September last year, FDA also approved Humira’s first biosimilar version- Amgen’s Amjevita.

MedPol

Joe Biden’s Cancer Moonshot Future

Cancer Moonshot- an initiative by Joe Biden was a ray of hope for the scientists focusing on cancer research. However, researchers all over the US have feared the thwarting of research after the successful fulfillment of Barak Obama’s presidential term. In one of the last initiative, National Cancer Institute (NCI) is designing a new plan wherein the scientists can pursue new combination therapies. NCI will act as a mediator between the drug makers and the outside researcher’s thus enabling scientists to access new drugs for research.

At the present, six companies including Bristol-Myers Squibb, Eli Lilly, Genentech, Kyowa Kirin, Loxo Oncology and Xcovery have participated in the program.

Francis Collins to stay as NIH Director under Trump’s administration

Francis Collins has been asked by the president-elect Donald Trump to stay on his position as National Institute of Health Director. The duration of his stay is still unknown. He has been serving at NIH since last eight years under Obama’s administration.

 

This was the succinct version of MedRecap, MedNess, MedPol and MedPharm..more to follow next week. Have a great weekend.

Med-Ness: At the Frontier of Medicine, Healthcare and Pharma Business

in SciBiz by

This weekly blog will bring the major pharmaceutical and healthcare highlights. We all hate to move from blog to blog, post-to-post and website-to-website. Here, at Med-Ness we understand and value our reader’s time. Along with the major highlights, I will give you my opinion and my take for the week. 

     Med-Ness is for you if you are:

  • An inquisitive scientist and want to stay abreast in all the fields
  • Money minded and want to know business aspect
  • Medical Writer
  • Healthcare consultant

We will also focus on different sections each week. For example, next week will be the post-dated (or should I say, post-week?) section discussing the most coveted healthcare conference- JP Morgan 2017 (#JPM17)! Seriously, what is the fuss about this year’s conference? Never have I ever seen such hysteria about any conference! I hope one day my blog creates such a frenzy in the pharmaceutical field.

I will also brief you about the changing healthcare stocks and other market trends.

And how can I forget about political aspects? Did anybody say Trump’s take on Pharma industry? Where there is money, there is a political agenda. That is completely my take. Finally, I will bring in forefront any new policies or regulatory aspects that might or can affect the pharmaceutical business.

 

CNNMoney ranked healthcare stocks on number 2 position on their list, “5 stocks to buy in 2017”

So lets start with the simple and most commonly seen noun, “stock”. The dictionary spells out a very straightforward definition except; there is nothing simple about stocks. Moving on, stock is the capital that can be raised by any business firm when they issue and provide subscriptions for their shares. It basically defines and provides ownership rights to a company. So let’s say, you decide to buy stocks of a pharmaceutical company. With this stock you bought or rather own that part or percentage of the company. If the company makes profit or its net worth increases, so does the value of the stock increases. A Stock market aka equity market or share market enables such buying or selling of stocks.

  • Have you ever wondered about stocks, investments and equity research?
  • Have you ever thought of investing in healthcare market shares?
  • Have you ever felt speechless in the presence of colleagues talking about market forecast?

The most important question to ask is what determines the trends in stock market? Why should or why shouldn’t you buy a particular stock. The key to this question lies in research known as “equity research”. Equity Research involves analysis and forecast of company’s financials. The whole agenda behind such an exploration is to recommend a particular stock to buy or sell.

“Money has transformed every watchdog, every independent authority. Medical doctors are increasingly gulled by the lobbying of pharmaceutical salesmen”

– Thomas Frank

If you want to follow a particular stock market yourself, you will have to observe and understand the stocks in order to predict their future worth. This might take weeks or even months. All you need to keep is patience! In addition, if you are an amateur in healthcare stocks, you might have to consider previous historical trends to determine the worth of a particular stock. To learn more about stock market, I recommend you all two insightful articles published Forbes.

www.forbes.com/sites/…/01/…/10-things-you-absolutely-need-to-know-about-stocks

www.forbes.com/…/how-to-spot-the-stock-markets-trend-before-it-is-obvious-to-all/

The variability in the stock market due to drug introduction or rejection.

A pharmaceutical company invests in the drug much before it is available to the patients. The drug stays in the pipeline stage for years. The reason- it has to pass all the safety tests before it reaches the patient. Now, the success or failure of the drug’s safety or its use will determine the worth of its stock. Sometimes, small biotech start-ups or pharmaceutical giants announce the research of a particular drug against a disease or condition. The requirement and the need for that research will determine its initial stock worth and successful launch of the drug and Phase IV post-marketing analysis will determine the rise or fall of the stock. According to “Investopedia”, orphan drugs (drugs for the treatment of rare diseases or conditions) are most expensive drugs in the USA. Such drugs will often bring more revenue and hence increased stock value.

The information on new drug launches could be obtained from company’s website or from The Wall Street Journal or from Businessweek. You can also keep a check on the drugs entering clinical trials (clinicaltrials.gov) to follow drugs from the company.

With this, we wrap up our very first post on Med-Ness. Let the medicine and business madness continue. Have a great weekend!

 

 

 

 

 

 

 

Imit pursued her Ph.D. from the University of Utah, and is currently pursuing her Postdoctoral fellowship at the Albert Einstein Medical College in Bronx, NY. She has an expertise in preclinical drug development and regulatory protocol development and analytical chemistry focussed on Oncology. Her current work explores the signaling pathways involved in hematopoiesis and leukemia stem cells. She is passionate about medical and science communication.

NASDAQ Image Source:

https://secure.flickr.com/photos/bfishadow/3100369536/

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Entrepreneurship and IP Part III: Trade secrets

in Sci-IP/SciBiz by

Tradesecret blog_final_Lipika

Trade secret can be of any commercially valuable information that gives your business a competitive advantage as it is not known to your competitor or public. It could be a formula, physical device, survey method, idea, recipe (e.g., recipe for Coca-Cola), business plan, pattern, advertising or sales strategy, distribution method, document tracking process, consumer profile, manufacturing process or a little tweak involved in the process, computer algorithm (e.g. Google’s search engine), compilation of information (customer list, suppliers list etc.), financial information, that helps the owner gain a competitive advantage in market place.

Trade secret may have a combination of information available in public domain and information unique to the company. And compilation of such information provides a significant advantage to the owner.

How to protect trade secret?

Typically speaking, for trade secret protection, no registration or no government grant is required. You simply need to maintain secrecy of the information. However, few countries (e.g., US & EU) have formal legislation for trade secret registration. World Trade Organization (WTO) recognizes protection of trade secrets. Member states of WTO and counties that are party to the Agreement on Trade Related Aspects of Intellectual-Property Rights (TRIPS) are obliged to provide trade secret protection. Protection lasts as long as the information is kept confidential. Simply saying information as trade secret will not help, you need to take substantial and reasonable measure to keep the information confidential. Once the information is made available to public or if someone discovers from an independent source, the trade secret protection ends.

Challenges of start-ups:

Trade secret policies differ greatly in an established company and in early stage start-ups. Many start- ups and SMEs (Small and Medium-sized Enterprises) exclusively use trade secret to protect their Intellectual Property (IP). Start-ups have challenges in terms of space – many of them operate from incubation centre, accelerator, shared office space etc. However, they should have some policy documents for trade secret identification and protection. Start-ups should at least address the following:

1) Identifying your Trade secret

Every business has some set of information that can be categorized as trade secret.  First, you should identify such information. Take a through look of your company’s asset. It would be very difficult to prove later that a particular category of information is trade secret if you do not have a hard copy document or electronic format stating the same.

2) Maintenance of Trade secret

Once you have identified your trade secrets, you need to set up policies and procedures to protect them. Trade secrets are considered as the most valuable asset for start-ups. You can consider the following measures to protect your trade secret:

  • Signing non-disclosure agreements (NDA) with your third party development partners and manufacturers. NDA is a contractual agreement between you and the recipient of the information.
  • Signing trade secret assignment with employees, independent contractors and consultants. Writing them down makes it clear to the employee and others that these set of information are trade secrets & they should take effort to keep confidential.
  • Marking documents as confidential, password protection, limiting distribution of password & access to priority documents.
  • Locking important folders and listing who can access the information.
  • Reporting periodic status of the trade secret information. During the process of growth & operation some information might lose the status of trade secret e.g., product launch, patent filing etc. Regular auditing of information is required for appropriate maintenance of trade secrets.
  • Marking emails, attachments etc. as trade secret/private/confidential, specific guidelines for document sharing provision and email usage.
  • Having physical security, locks and limited access to the area/systems having confidential information.
  • You must have clear policies as how you handle visitors coming into your space. Your employees should know what information can/cannot be shared, and also not accessing confidential documents/ keeping off desk in the vicinity when the visitors are around. As the company grows, the policies and procedures expand and will become more robust.

3) Patents or trade secret

For start- ups, filing patents may be too expensive but the technology may be entitled for patent protection. In some cases, you can choose ‘trade secret’ as an alternate mode of protection. Furthermore, patent law requires complete disclosure of your invention in patent application in return for obtaining a 20 year monopoly. Some information/technology that you have developed might be of high value but not appropriate for patent protection. And you may also lose trade secret rights for such information by public disclosure in the process of patent filing. In addition, it might just be a gift to your competitor, as the information could easily be available to them.

If the trade secret is about an innovative product, others may reverse engineer and then entitled to manufacture and use the product. You need to know that, unlike patent law, trade secret does not protect against independent discovery of the information. The decision of keeping information as trade secret or filing a patent depends on technology, valuation, business consideration and evaluation of relative benefits of patent and trade secret.

4)  Employee awareness about trade secrets

Notify your employees about the category of information that are trade secret and routinely remind them.

Your trade secret policy should start to roll on immediately, when an employee comes on board and remain until she/he leaves the company. Employees coming on board can also ‘contaminate’ trade secret information from earlier employer(s), that should not happen. When employees leave, remind them about the non-disclosure documents they had signed and ensure that critical information do not leave with them. It is their duty to maintain the confidentiality of trade secret information of the employer for specified period of time (as mentioned in the trade secret agreement) even after their employment.

5) Trade secrets and misappropriation

When a trade secret is leaked out, unauthorized use of such information by persons/competitors/third parties other than the owner is regarded as an unfair practice and violation of the trade secret. In case of misappropriation, you need to show by record to substantiate, that the said piece of information is trade secret and you took adequate measure to protect the information.

The court will look into following while establishing misappropriation of trade secrets,

  • The information was confidential to company.
  • The information was of commercial value, and use of such information in an improper way results in financial damage to the company.
  • Company took reasonable efforts to keep the information as secret through agreements, trade secret policy and procedures.

Conclusion:

Trade secret is considered as one of the important form of Intellectual Property rights protection for start-ups. Value lies in information what works for your company, as well as what did not work and not spending resource what did not work. Documentation of such wealth of information (not known to your competitor) over time adds tremendous value to your company.

In case of industries, where employee attrition is very high, special measure should be taken. You should maintain record that you developed specific technologies or strategies independently of your competitor.   It will create a good defence in the long term protection of your company’s IP assets.

Finally,  do not loose valuable intellectual property  rights, just because you did not consider entering into a non-disclosure agreement, data encryption, training employees, marking documents as confidential, password protection of accounts, documenting trade secret policies due to lack of time or so.  Trade secrets are extremely valuable, but that value can instantly vanish, if not maintained adequately.

References: 1, 2, 3, 4

Image source: Author

This post is the third in the series of articles on “Entrepreneurship and IP”.

Link to the First part of the series: “Entrepreneurship and IP Part-I: Starting up right”http://www.sciwri.club/?p=871

Link to the Second part of the series: “Entrepreneurship and IP Part II: Patent strategy and business value” http://www.sciwri.club/?p=1174

 

Disclaimer: The materials in the blog are solely for the purposes of informing, assisting and educating the readers and are not in any way a substitute for professional opinion or advice. They do not constitute legal advice or legal opinion or solicitation.

Dr. Lipika Sahoo, Founder & CEO of Lifeintelect Consultancy Pvt. Ltd., a registered Indian Patent and Trademark Agent having 16 years of experience in academia and industry. She holds a PhD from Indian Institute of Science (IISc). She holds triple masters; MSc from Sambalpur University; PGDIPR from National Law School of India University (NLSIU); PGCBM from Xavier Institute of management (XIMB); and advanced certifications from World Intellectual Property Organization (WIPO) in Patents and Patent Drafting.

lipika@lifeintelect.com| https://in.linkedin.com/in/lipikasahoo|

News: The Author will be  conducting a workshop in IIM, Bangalore on IP & Entrepreneurship for start-ups & entrepreneurs associated with IIM ecosystem.

IP_DrLipika_24thAug_emailer

Link to Poster: IP_DrLipika_Poster_24thAug

 

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Entrepreneurship and IP Part II: Patent strategy and business value

in Sci-IP/SciBiz by

Lipika 2

Innovation is the central issue in economic prosperity” -Michael Porter

There are several challenges for a start-up company, including developing a viable product or service, business development, employee recruitment, business value creation, tackling competition from bigger companies and new entrants, technological advancement and also managing legal and regulatory compliances. Typically start-ups are flooded with recommendations and advice from friends, peers, mentors and investors about business challenges and patent strategy they should follow.

One of the expensive mistakes a start-up entrepreneur can make is messing up their intellectual property right policies.  Irrespective of size of the company, effective and diligent IP portfolio management is vital for any emerging company. Bigger companies have the resources to address IP issues with relative ease, but what about start-up company? Are the filing strategies for start-ups different from that of established enterprises? Should start-ups wait for venture capitalists to fund their patent filings? Should they focus on business development or prioritize patent protection? Should they wait for patent protection till they have conducted enough customer discoveries?

Patent rights are important because they create a legal barrier to competition, important drivers of risk reduction, adding value to business and for raising seed or venture funding by licensing or transferring IP rights. A start-up needs to manage its own IP rights while avoiding the IP rights of others.

According to WIPO, “A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.”

First thing we need to understand start-ups usually have a tighter budget to address IP issues. In addition, filing strategies differ for start-ups and bigger companies. The key difference is that, the latter have a validated business model, products in the market, qualified customers and established new product development channels. Whereas, the former should validate the actual paying customers who will buy the product or technology within start-up’s business framework. If the start-up cannot validate the actual paying customers for the innovation, then protecting such innovation is expensive waste of time and resource unless there is an actual customer demand for the start-up’s product or technology. The business value from patents should be measured for it to be managed well. Patenting decision should be backed by data. Once they have established that a strong demand exists they must move quickly and ensure a strong IP protection to restrict competitors.

The second most important point for start-ups is to remember that patenting decisions must go hand in hand with business processes, as opposed to being an event or an output of product development process. Patenting decisions should be integrated into business strategy on an ongoing basis. We always let our clients know the viable option to integrate IP strategy in innovation process. Proactive IP strategies can help overcome patenting mistakes.

There are few important things you need to know as a start-up to address patenting issues efficiently and in cost effective manner.

1. Specifying protective IP provisions in employees, contractors, partners and suppliers agreements/contracts:

Start-ups usually start their business with consultants, suppliers, partners, contractors and employees. If these stake holders develop an invention during their working time with the start-ups, the invention will belong to the start-up if IP ownership clause is covered in the agreement/contract. However, the stakeholder will always retain her/his right to be mentioned as inventor. All stakeholders including owner and executive board members should sign agreement and assign all IP rights to the start-up if generated using start-up’s resources.

2. Accountability for IP process

Large companies have an in house IP counsel who has the knowledge of company’s ongoing innovation process and are often in charge of IP protection. However, for start-ups with limited budget, it does not make any sense to hire full time IP counsel. Start-ups could look for training one of company’s managers in IP processes who could be accountable for IP protection. Another viable option for start-ups could have an external IP strategist who could be part of the innovation team and has access to product development pipeline on a part-time basis.

Accountability of IP process ensures that the IP created are adequately protected and unrecoverable errors that open unwelcome competition are minimized. Furthermore, it reinforces that IP creation and protection are aligned with company’s business processes

3. Protecting valuable innovations with patents

It is true that not all companies create patentable invention, and it is also true that patents can be obtained for simple safety pins to complex automobiles.

Sometimes companies decide not to protect innovations with patent filings for various reasons like; cost factors, strength of protection, time factor or wrongly informed etc. At times these are business decisions.

If you don’t protect your invention, and the product becomes successful, competitors may copy your product. Smaller competitor may sell at lower price as they would not have incurred research and development expenditure. Also, larger organization has the advantage of volume and scale; they can compete for a reasonable market price.

Also, chances are there that someone else may patent same or equivalent invention and could legitimately exclude you from manufacturing or may ask you to pay a licensing fee for the use of invention.

However, you may also consider disclosing your invention to the public without patenting it. Then it becomes prior art for all future applications. This is commonly known as defensive publication. In such scenario, no one (including yourself) can file patent for the same invention due to lack of novelty.

4. Patents are territorial

Patents are territorial rights, granted and enforced by national patent office as per the law of that country. At present, there is no “Universal patent” or “World patent”. However, there are few regional patent offices like, “European Patent Office (EPO)” and the “African Regional Intellectual Property Organization (ARIPO)” that accept regional patent application and grant patent for that region.

Again, if you are seeking patent protection in multiple countries, you may consider filing an international application under ‘Patent Cooperation Treaty (PCT)’. PCT has 148 participating nations; any resident of these nations can initiate a single international patent filing process through PCT. However, the grant and enforcement of patent will be done by national patent office that you will choose.

5. Invention has to be unique universally

Though patents are territorial rights, but the invention has to be unique world wide, in order to be patentable. Before incurring the expense for patent filing, it is highly recommended to conduct a worldwide patent search to identify similar patents, to understand the novelty and inventiveness of the invention.

6. Have cost effective strategies for patent filings

Patent application drafting, filing, prosecution and maintenance can be expensive when you have too many international filings. So it is important to develop good strategies to minimise cost on managing IP assets. Start-ups should work closely with a patent attorney or patent agent and should do some initial work by themselves to save money. They should be actively involved in patenting process and understanding the patent procedures.

7. Patent claim coverage

Patent should provide long term business value and competitive advantage to company. Patent claims should cover more than just the product. It should cover the reason why the customer will buy your product. Patent claims should capture the value of the product. It should cover functional benefits of the product and claims should have sufficient scope to prevent your competition from providing the same value to your customer.

Conclusion

Intellectual property rights, especially patents, help in safeguarding a start-up’s innovation, serve as an indicator for potential VC funding and a guide to discover potential alliance partners.

Innovation to a large extent happens in start-ups, smaller companies, research labs and universities. As company becomes too large, decision-making process becomes slower. Large companies usually do not stay responsive to support a vibrant innovation ecosystem. Most of the times they prefer to buy smaller start-up companies with a thriving innovation process and good IP assets. Without legal ownership of technology, both sides may find it difficult to disclose the invention for the fear of idea or concept being stolen. Therefore, start-ups should have a good patent portfolio to trade with. Patents are tools that can help facilitate a deal with other company that may want part of your right though license or technology transfer. How will you trade the interesting things the other company has to offer if you don’t have anything to trade for?

References: 1, 2, 3

This post is the second in the series of articles on “Entrepreneurship and IP”.

Disclaimer: The materials in the blog are solely for the purposes of informing, assisting and educating the readers and are not in anyway a substitute for professional opinion or advice. They do not constitute legal advice or legal opinion or solicitation.

Dr. Lipika Sahoo, Founder & CEO of Lifeintelect Consultancy Pvt. Ltd., a registered Indian Patent Agent having 16 years of experience in academia and industry. She holds a Ph.D from Indian Institute of Science (IISc). She holds triple masters; MSc from Sambalpur University; PGDIPR from National Law School of India University (NLSIU); PGCBM from Xavier Institute of management (XIMB); and advanced certifications from World Intellectual Property Organization (WIPO) in Patents and Patent Drafting. Dr. Lipika is also an inventor and passionate about technology & innovation; likes music, history & architecture.

lipika@lifeintelect.com | https://in.linkedin.com/in/lipikasahoo |

 

Image source: Google http://bit.ly/1WR16gz

 

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