Wednesday 26 August 2020

Diversity in Startups and Inventing Patented Developments

The Creator Fund has released a report titled, “State of Student Startups,” concerning university student involvement at around 545 startups in the UK.  Notably, the report states that Covid-19 has not slowed down student engagement in startups.  Moreover, some interesting statistics are that around 57% of students involved in university startups are foreign born, and pretty close to half of students involved in university startups are BAME (Black, Asian, Minority Ethnic) and are women.  Over 60% of the startups at Oxford and Cambridge “have at least one BAME founder.”  These data are very heartening given some of the other statistics about the lack of some racial and ethnic minorities and female involvement in inventing.  Indeed, in the United States, the United States Patent and Trademark Office relatively recently released a report stating that women are still not represented similarly to their percentage of the overall population in inventing demonstrated by patents (around 20%); although, the percentage of women participating as inventors is increasing.  Here are the USPTO’s report’s major findings:

  • More women are entering and staying active in the patent system than ever before.
  • The number of patents with at least one woman inventor increased from 20.7% in 2016 to 21.9% by the end of 2019.
  • The “Women Inventor Rate” (WIR) – the share of U.S. inventors receiving patents who are women – increased from 12.1% in 2016 to 12.8% in 2019.
  • The share of women among new inventors on issued patents increased from 16.6% in 2016 to 17.3% by 2019.
  • The gender gap in the number of women inventors who remain active by patenting again within five years is decreasing. For new inventors in 2014, 46% of women patented again in the next five years versus 52% of men (by 2019). In 1980, the gap was 28% for women versus 38% for men. 
  • Among the leading patent filers, the 3M Company showed the largest improvement in the participation of women inventor-patentees: Their average WIR increased from 15.2% over 2007-2016 to 16.6% for 2007-2019. 

President Trump's Executive Orders to Address Drug Pricing

In July, President Trump issued three Executive Orders designed to decrease the cost of prescription drugs.  The executive orders are part of a fulfillment of his campaign promise to address the high cost of healthcare and specifically the high cost of pharmaceuticals.  The first is directed at importation of safe drugs from other countries.  The second is directed to reducing the price of insulin and epinephrine.  The third executive order concern rebates and middleman, such as pharmacy benefit managers.  The third order states in relevant part:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1.  Purpose.  One of the reasons pharmaceutical drug prices in the United States are so high is because of the complex mix of payers and negotiators that often separates the consumer from the manufacturer in the drug-purchasing process.  The result is that the prices patients see at the point-of-sale do not reflect the prices that the patient’s insurance companies, and middlemen hired by the insurance companies, actually pay for drugs.  Instead, these middlemen — health plan sponsors and pharmacy benefit managers (PBMs) — negotiate significant discounts off of the list prices, sometimes up to 50 percent of the cost of the drug.  Medicare patients, whose cost sharing is typically based on list prices, pay more than they should for drugs while the middlemen collect large “rebate” checks.  These rebates are the functional equivalent of kickbacks, and erode savings that could otherwise go to the Medicare patients taking those drugs.  Yet currently, Federal regulations create a safe harbor for such discounts and preclude treating them as kickbacks under the law.
Fixing this problem could save Medicare patients billions of dollars.  The Office of the Inspector General at the Department of Health and Human Services has found that patients in the catastrophic phase of the Medicare Part D program saw their out-of-pocket costs for high-price drugs increase by 47 percent from 2010 to 2015, from $175 per month to $257 per month.  Narrowing the safe harbor for these discounts under the anti-kickback statute will allow tens of billions in dollars of rebates on prescription drugs in the Medicare Part D program to go directly to patients, saving many patients hundreds or thousands of dollars per year at the pharmacy counter.
Sec2.  Policy.  It is the policy of the United States that discounts offered on prescription drugs should be passed on to patients.
Sec3.  Directing Drug Rebates to Patients Instead of Middlemen.  The Secretary of Health and Human Services shall complete the rulemaking process he commenced seeking to:
(a)  exclude from safe harbor protections under the anti-kickback statute, section 1128B(b) of the Social Security Act, 42 U.S.C. 1320a–7b, certain retrospective reductions in price that are not applied at the point-of-sale or other remuneration that drug manufacturers provide to health plan sponsors, pharmacies, or PBMs in operating the Medicare Part D program; and
(b)  establish new safe harbors that would permit health plan sponsors, pharmacies, and PBMs to apply discounts at the patient’s point-of-sale in order to lower the patient’s out-of-pocket costs, and that would permit the use of certain bona fide PBM service fees.
Sec4.  Protecting Low Premiums.  Prior to taking action under section 3 of this order, the Secretary of Health and Human Services shall confirm — and make public such confirmation — that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.
July 24, 2020.

Friday 7 August 2020

President Trump Moves on Ensuring Essential Medicines Produced in United States

President Trump issued an Executive Order which helps ensure that essential medicines are produced in the United States, including critical inputs, among other things.  The Executive Order provides, in part: 

“Section 1.  Policy.  The United States must protect our citizens, critical infrastructure, military forces, and economy against outbreaks of emerging infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats.  To achieve this, the United States must have a strong Public Health Industrial Base with resilient domestic supply chains for Essential Medicines, Medical Countermeasures, and Critical Inputs deemed necessary for the United States.  These domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN threats and public health emergencies, including emerging infectious diseases such as COVID-19.  It is critical that we reduce our dependence on foreign manufacturers for Essential Medicines, Medical Countermeasures, and Critical Inputs to ensure sufficient and reliable long-term domestic production of these products, to minimize potential shortages, and to mobilize our Nation’s Public Health Industrial Base to respond to these threats.  
It is therefore the policy of the United States to:(a)  accelerate the development of cost-effective and efficient domestic production of Essential Medicines and Medical Countermeasures and have adequate redundancy built into the domestic supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs;(b)  ensure long-term demand for Essential Medicines, Medical Countermeasures, and Critical Inputs that are produced in the United States;(c)  create, maintain, and maximize domestic production capabilities for Critical Inputs, Finished Drug Products, and Finished Devices that are essential to protect public safety and human health and to provide for the national defense; and(d)  combat the trafficking of counterfeit Essential Medicines, Medical Countermeasures, and Critical Inputs over e commerce platforms and from third-party online sellers involved in the government procurement process.
I am therefore directing each executive department and agency involved in the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs (agency) to consider a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, and to identify vulnerabilities in our Nation’s supply chains for these products.  Under this order, agencies will have the necessary flexibility to increase their domestic procurement in appropriate and responsible ways, while protecting our Nation’s service members, veterans, and their families from increases in drug prices and without interfering with our Nation’s ability to respond to the spread of COVID-19.” 

Saturday 1 August 2020

Will Trump Win the Presidential Election in November?

A common general inquiry I get from friends who are not Americans is “what is going on in the United States with respect to Trump—will he be reelected?”.  My answer is, “I don’t know.”  This may surprise some because they see Biden as the obvious winner.  Here are my imperfect and half-baked thoughts on the subject: 

1)      My guess is that we’ll get good news about a vaccine before the election.  It may even be distributed before the election to some in the United States.  My guess is that Trump’s biggest concern with mail in voting is that it’ll occur before the “best” news possible about a vaccine to COVID-19. 

2)     What about Trump’s handling of COVID-19?  This seems to look bad, but see above on point 1.  Also, Trump put the lock-down decisions in the hands of state and local government.  Could Trump have done more earlier?  Yes, I think he could of done more.  The Chinese apparently knew that masks were effective in slowing the spread.  Why didn’t we move faster on that?  But, see state and local government.  And, please don’t forget that many are suffering badly economically because of lock-downs. 

3)     What about Trump’s handling of race-related issues, including the George Floyd horror and BLM?  I think Trump’s botched this badly.  However, please remember that before the last election we had serious BLM protests.  I am concerned that Trump voters have become even more concerned about so-called “law and order issues.”  This means that turn-out amongst the concerned may be strong.  Hopefully, turn-out amongst BLM supporters will be strong.  Please remember one of President Obama’s relatively quick responses to the protests: Be sure to get out and vote in local elections. 

4)     What about the polls?  I haven’t looked closely at this, but my understanding is that the polls are not that far off from where Hilary Clinton was in the last election in battleground states—she had quite a nice lead.  I think Biden has a better lead now.  We’ll see if it holds up.  Also, please don’t forget one of the supposed reasons the last election defied the polls—people didn’t want to admit they were voting for Trump.  That effect may be even stronger now. 

5)     What about the debates?  I am quite worried about this.  I think Trump is going to blast Biden on any supposed mistakes concerning the Obama/Biden administration.  This time Biden is fully on the hook as VP: 1) Opioid Crisis; 2) Crappy Economy in Some Battleground States (goodness, AOC actually is attacking Opportunity Zones); 3) Bad Trade Deals; 4) Skyrocketing Health Care Costs; and 4) the China Relationship.  Finally, Trump doesn’t have to worry about how he looks debating a woman.  He is going to fully unload on Biden.  Biden also does not always present well in debates.  He sometimes looks befuddled.  If Trump is sharp, he may come out as the winner.  Biden needs to hammer Trump on his immigration disasters.  

6)      More stimulus is on the way.  More money directly into the pockets of Americans.  If the Senate Republicans were thinking, they’d continue the $600 unemployment benefit and push up the stimulus.  People are suffering economically.  When was the last time the economy was very good--when Trump was president.  Also, Trump just issued executive orders on pharmaceutical pricing and access--he's fulfilling campaign promises (see debates). 

7)      The most important issue concerning American politics is likely turnout.  If your people don’t turnout, then you’ve got a serious problem.  Will the lack of big-time rallies hurt Trump?  Maybe.  However, I fear the continuing protests in Portland and elsewhere are going to push some Trump protesters to vote.  What about young people?  Are they going to be pissed about Tik Tok?  Well, they need to register to vote.  Guess who won’t be on campus where a lot of voter registration efforts happen?  Young people.  What about Biden’s VP choice?  That may help with turnout for him, but may help the other side as well.  And, don’t forget, the possibility of a Supreme Court vacancy(ies) soon should be a good motivator to turnout.  That’s going to seriously be on the minds of members of both parties—it really should for Dems especially given the age and health of Dem Supreme Court Justices.  

What’s the answer?  I don’t know, but this election cycle is fascinating and the result is going to be devastating to one side.  What impact on IP and Innovation?  Whoever wins the impact will be huge--from USPTO appointments and policy to FTC/DOJ appointments and policy to court appointments to trade.