Posts Tagged: "biotech"

Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. State law claims are preempted by the BPCIA on both field and conflict grounds, which means only remedy available against biosimilar applicants refusing to engage in the patent dance is filing for a declaration of infringement, validity, or enforceability of a patent that claims the biological product or its use. Notably, this must be done before receiving manufacturing information from the biosimilar company. Patent lawsuits are notoriously costly so, in the short term, the decision will have the greatest impact on innovator start-ups with limited financial resources. In the long term, relying on costly litigations to keep biosimilar drugs off the market will likely increase the consumer price for any biologic drug.

In what appears to be a clear departure from the past, in Amgen, the Federal Circuit has rejected the test, basing its rejection on the ground that it effectively eliminates the written description requirement.  Amgen at 15, 16.  According to the Court, where a functional genus claim to antibodies to a newly characterized antigen is concerned, the underlying science is not so advanced as to establish that “make and use” is equivalent to the required description of the claimed antibodies.  Id. at 16.  Drawing such equivalence, the Court said would amount to declaring a contested scientific proposition to be so settled as to be entitled to judicial notice, which the Court was not prepared to do.  Id.

The dangers of killer germs and superbugs are not limited to bird flu in China, Ebola in West Africa, Zika in South America and MERS in the Middle East… If we are to have a fighting chance against superbugs and pandemics, we must invest in innovation and safeguard the property rights that incentivize these discoveries. Short-sighted efforts to enervate existing intellectual property rights laws and policies will not only damage incentives to innovate, they may hand a victory to the superbugs.

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.

The alliance is composed of firms that have a vested interest in the outcomes of a CRISPR patent interference case currently in front of the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB). The interference proceeding specifically involves patents covering CRISPR/Cas9 gene editing technologies. The companies joining the alliance include Ireland-based ERS Genomics and Switzerland’s CRISPR Therapeutics (NASDAQ:CRSP) along with American biotech firms Caribou Biosciences and Intellia Therapeutics (NASDAQ:NTLA). These companies have all licensed CRIPSR/Cas9 technologies

Artificial pancreas systems can provide dramatic improvements to the quality of life of diabetes patients and Kowalski should know, as he himself has had type 1 diabetes for 30 years. “I certainly think that the overnight control is going to be a huge, huge benefit,” he said. “I was fortunate enough to participate in a trial for five days and I was amazed that every single morning my blood sugar was perfect.” Data collected from artificial pancreas device users also shows better outcomes on A1C tests which indicate the risk that a diabetes patient has for developing blindness, kidney failure or other problems associated with diabetes. Kowalski added how his work had put him into contact with diabetes patients who were very frustrated by the variability of the disease despite strict adherence to diet and physical activity.

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.

At the time of an NIH study in 2011, algae-based biofuel production costs using conventional technologies were anywhere from $300 USD to $2,600 USD per barrel, much higher than the production costs of petroleum, which have since dropped dramatically in recent years. The economic disincentive associated with algae exploration when compared to petroleum is very real, but not the only challenge. Challenges preventing increased biofuel production from algae resources include the need to find more efficient algae harvesting techniques, more cost-effective oil extraction and effective use of land and water. Conquering these challenges should reduce the cost per barrel, but much research is still to be done. Despite the challenges that lie ahead, scientists and innovators remain optimistic.

Superbugs have powerful friends in high places. SCOTUS’s patent eligibility criteria emanating from Mayo/Alice’s mysterious “laws of nature” and credible reports of unremitting turndowns by USPTO applicants portend hard times commercializing much of this research, which means its development and testing may never make it to licensed distribution. In Congress, deficit scolds roll back much needed NIH funding while solons clamor for more military weapons that have long outlived their usefulness. Even sexy pandemics like Ebola, Pan Asian Flu, and Zika and competing with Biden moonshots and precision medicine initiatives are forced to forage for the fiscal nourishment they need to compete and commercialize their critical research.

Earlier today the United States Supreme Court denied certiorari to Sequenom, Inc., which will let stand a decision of the United States Court of Appeals for the Federal Circuit that ruled a truly revolutionary medical test to be patent ineligible. If the Supreme Court were to have taken the case they would have been required to reconsider the overwhelming breadth and scope of their prior ruling in Mayo Collaborative Servs. v. Prometheus Labs. Obviously, the Supreme Court is not ready to reconsider Mayo.

The pending report of the UN Secretary General’s High Level Panel on Access to Medicines not only attacks the patent system as predicted, but proposes giving the organization oversight of drug development. If you think United Nation functionaries would be more effective than entrepreneurs, you’ll be delighted. If you live in the real world where bureaucracy is the enemy of innovation, you don’t know whether to laugh or cry.

Right now, behind the walls of the USPTO, there is a fiery interference battle occurring between two scientific teams over who created a groundbreaking, DNA altering technique first. The victor stands to receive incredible gains. In one corner is a team of scientists from UC Berkeley headed by biologist Jennifer Doudna from the University of California, Berkeley and microbiologist Emmanuelle Charpentier from Umeå University in Sweden and the Max Planck Institute for Infection Biology in Berlin. In the other, a group led by synthetic biologist Feng Zhang of the Broad Institute of the Massachusetts Institute of Technology and Harvard in Cambridge, Massachusetts.

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated that a mere one in eight (11.8%) of all drugs that enter clinical trials are ultimately approved by the U.S. Food and Drug Administration. The drug development gamble appears to be getting riskier. A report released on May 25th by the Biotechnology Innovation Organization (BIO), the biotechnology industry’s national trade group, finds that fewer than one in ten (9.6%) of drugs that enter clinical trials will gain approval by the U.S. Food and Drug Administration.

On its face, the new guidance seems to urge examiners to develop well-reasoned, substantive rejections rather than conclusory rejections which provide little basis for applicants to advance applications toward allowance, particularly in the complex areas of vaccines, diagnostics, methods of treatment, and screening for genetic alterations, where the new examples are focused. Furthermore, compared with prior guidance, the new examples include more claims that are considered patent eligible subject matter. Some observers believe this may be an effort by the patent office to dispel hesitation that examiners have apparently had in drawing conclusions of patent eligibility when examining claims.