Posts Tagged: "drugs"

Drug manufactures spend billions of dollars in R&D and it takes years to get FDA approvals and patent protection. It is vital that these companies keep a vibrant and thriving product pipeline to offset costs of failed drugs, which do not work as intended or do not get FDA approval. Yet, all the money spent can yield tremendous dividends when a drug reaches “blockbuster” status. To attain this label, a drug must be so popular that it generates at least $1 billion in annual sales. Often treating the most common chronic and long-term ailments such as diabetes, high cholesterol and blood pressure, for example… In 2015, Pfizer spent $7.7 billion on R&D costs and Eli Lilly spent $4.5 billion. The forecast for Pfizer and Lilly in 2022 is expected to grow to $7.8 billion and $5 billion respectively. This is on trend with the worldwide pharmaceutical numbers at an expected growth of 2.8% to $182 billion in 2022. Both companies are targeting the largest therapy areas with sales which include oncology leading the group followed by anti-diabetics and anti-rheumatics.

The WHO is gathering governments, academics and activists in Amsterdam next month to discuss price setting options for medicines. But the so-called Fair Pricing Forum ignores the main driver of higher healthcare spending and will do more harm than good. While there is a pressing need to balance access to affordable medicines and the incentives to innovate, a reactionary focus on prices is misdirected and could have dire consequences for pharmaceutical innovation… The WHO’s exclusive focus on price setting also misses the mark on another issue – medicines are working to extend lives and even to lower overall healthcare spending by eliminating the need for more expensive interventions, such as surgery and hospitalization.

Although Dupixent hasn’t been granted FDA approval as of yet, the drug has made it further than Amgen’s AMG-317, the code name for Amgen’s own IL-4 inhibitor developed during the 2000s, which failed in phase 2 clinical trials… The major impetus behind this suit was Sanofi-Aventis and Regeneron’s discovery that Amgen hired litigation counsel to assert the ‘487 patent and is also working on retaining experts. The plaintiffs believe that the only likely target for any potential Amgen infringement suit asserting the ‘487 patent would target Dupixent, “the only IL-4 inhibitor expected to come to market in the near future.”

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and “exclusivity” separately. “Exclusivity” refers to exclusive marketing rights granted by the FDA upon approval and was designed to promote a balance between new drug innovation and generic drug competition. Some differences are that patents can be issued or expire at any time – before, during or after FDA approval– while exclusivity attaches upon approval of a drug product. Further, some drugs have both patent and exclusivity protection while others have just one or neither… Make no mistake, it would be tremendously unwise to proceed sans patents. No patent means the generic can enter the market as soon as the FDA exclusivity period expires, and having a patent can extend the exclusivity period to the end of the patent term, often years later.

The savings impact of directly negotiated drug costs is considered negligible, but intrusion into biomedical pricing will destabilize life science commercialization… Any way you slice it, added commercialization uncertainty resulting from even negligible savings will be seen by the private sector as a foot-in-the-door for more government price controlling… Participants in early stage life science development including research universities and medical centers must watch this issue closely and be ready to join MMA’ s more conspicuous defenders if and when MMA’s ban on Medicare direct negotiations suddenly appears.

On January 5, 2017, the District of Delaware issued its long-awaited decision in the patent dispute pending between Amgen and Regeneron wherein the Court granted Amgen’s request for a permanent injunction against Regeneron’s new PCSK9-inhibitor cholesterol drug. Both Amgen and Regeneron each independently spent billions of dollars over the past decade-plus developing a new class of cholesterol drug. The drug itself comprises an antibody that binds to PCSK9 proteins… Whereas Regeneron managed to be the first to market, Amgen succeeded in getting to the Patent Office first. Amgen originally sued Regeneron, along with Sanofi, its European partner, in October 2014. Amgen asserted three patents directed to antibodies that bind to PCSK9. Over the next month, Amgen commenced additional lawsuits as new patents issued from the Patent Office. The cases were eventually consolidated, but Amgen eventually went to trial against Regeneron on only two of the originally asserted patents.

Respiratory syncytial virus, commonly referred to simply as RSV, is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. Up to 2.5 million infections occur in the U.S. each year. It is also the leading cause of childhood hospitalization globally. Nearly all children are infected with the virus at least once by the age of two to three years, and many develop pulmonary disease and/or asthma that persists throughout adult life, making them susceptible to re-infection. RSV particularly dangerous for premature babies, children with preexisting health conditions and the elderly, and is responsible for 16,000 deaths each year in adults over 65.

With the Cures Act now signed into law, the incoming Trump administration has an opportunity to advance the broad-spectrum medical countermeasure goal set forth by the U.S. Department of Health and Human Services (HHS) 2015 Public Health Emergency Medical Countermeasure Enterprise, otherwise known as PHEMCE. If achieved, the PHEMCE broad-spectrum goal would spur the advancement of innovative therapeutics to defend against the many pathogens that are not addressed with traditional disease-specific drugs or vaccines approved by the FDA.

What started as a curiosity in Colorado and Washington state in 2012 could have gained the momentum of a juggernaut: marijuana legalization. Now with California and other states passing initiatives to fully legalize recreational marijuana use in November 2016, a new multi-billion-dollar industry could be in the offing. Inventors are already at work on new methods of delivering THC in stronger and safer doses… But with cannabis still on the federal DEA Schedule I of controlled substances what can these idea people do to protect their intellectual property?… Ironically, the USTPO has granted a patent on certain cannabis strains to a California biotech institute even as it has disallowed marijuana-related trademarks.

We create two new companies around academic inventions every day of the year. The critical role such companies play in drug development is clear. The successful integration of public research institutions into the economy is based on the Bayh-Dole Act, which inserted the incentives of patent ownership into the government R&D system. Not a single new drug had been developed from NIH funded research under the patent destroying policies preceding Bayh-Dole. No one is going to spend billions of dollars and more than a decade of effort turning early stage inventions into new drugs or fund a life science startup company without strong patent protection. Yet the patent system and Bayh-Dole are precisely what the critics seek to undermine.

The vast majority of medicines found on WHO’s model list of essential medicines are off-patent according to information published by the World International Property Organization (WIPO). As of 2013, 95 percent of the 375 pharmaceutical compounds on that year’s MLEM were off-patent, indicating a high likelihood that generic equivalents of treatments are available. Going back to the early 2000s, the percentage of essential medicine on WHO’s MLEM which are off-patent has consistently been between 90 to 95 percent. Thus, it seems clear that the patent system has served its intended purpose: To incentivize the creation of important, innovative, even live saving products that society can reap the benefits from long after the exclusivity of the patent has expired.

EpiPen’s eruptive timing was important. Had Congress been in town, lawmakers would have filled the front pages with populist blather. Had Mylan been less forthcoming about the retail drug supply chain, the press would have been less likely to look into its composition. Had Mylan’s CEO not been a sitting Senator’s daughter, gossipy Hill reporters would have been bored. If health insurer withdrawals from ACA exchanges had not led to higher consumer costs and rates to match, and most important, if anaphylaxis did not simultaneously threaten the lives so many children and bust the back-to-school budgets of more than 15 million middle American families, the multi component drug pricing issues might have been buried on news papers’ back pages. EpiPen pulled these issues out of hiding into the light of public concern where oversimplified self-serving solutions tend to wilt. The fact is we have been treated to a highly publicized health pricing tutorial using a live case study to learn about the many drivers of retail drug pricing.

The problem is that the government is standing in the way of these competitive autoinjectors getting into the hands of the patients who need them. For example, Teva Pharmaceutical Industries has a competitive autoinjector. However, in March, the U.S. Food and Drug Administration (FDA) rejected Teva’s application to bring its competitive autoinjector to patients… While Mylan, like most large pharmaceutical manufacturers, has spent millions of dollars on lobbyists and political campaign contributions, there is no evidence of any illegal quid pro quo. Mylan is simply acting in the interests of its shareholders. It is the system itself, not Mylan, that is corrupt.

A consistent charge against the patent system is that it denies the poor access to critical medicines. This belief led the UN Secretary General to launch his High Level Panel on Access to Medicines that is supported by groups like Universities Allied for Essential Medicines (UAEM)… As to UN Secretary General’s claim of a “policy incoherence” between IP rights and access to medicines, without the patent system there will be a lot fewer drugs to access here or abroad. That’s a thought he might ponder.

How will our patent system treat this wonderful new discovery? How long will it take before its curative benefits can be deployed ? We can only hope that DC’s meddlers in our innovation ecosystem read the Ms. Sun’s article. Because however fervently the medical and scientific communities respond to this growing superbug crisis, IP’s DC government legal eagles are either unaware or unconcerned. The USPTO is regularly rejecting microbial patent applications in blind servitude to Alice-Mayo’s confusing eligibility formula. We can hope, but cannot be assured, the Federal Circuit will make sense some day of Alice-Mayo’s two-step test. But when? Worse, it appears that SCOTUS is infected by the anti-patent poison infesting our Capitol. How refreshing it would be to have our Congress and the nation’s highest Court be as concerned with superbugs as they seem to be with PR-created patent trolls.