Posts Tagged: "biotech"

BIO also is concerned about the inclusion of broader prior user rights in the House bill, and believes that this issue, coupled with the harmful inter partes review changes, could set back efforts to pass meaningful patent reform this year by undermining the broad coalition of American innovators currently supporting patent reform.

Carrier goes on to detail the comprehensive research of Professor John Walsh who in 2007 surveyed 1125 biomedical researchers in universities, government labs and nonprofit institutions. Walsh received 414 responses and the responses were overwhelmingly clear. Carrier explains that only 3% of respondents indicated that they stopped pursuit of a research agenda based on an excess of patents present in the space. Furthermore, Carrier explained that a mere 5% of respondents even regularly checked for patents related to their research and “no respondents reported that they had abandoned a line of research because of a patent.”

While New Mexico is not the only institution fostering growth, they do on average participate in the start up of 5 to 8 new companies a year. Kuutilla said that STC.UNM has participated in licensing technology to start-up companies that have created multiple hundreds of jobs at an average annual salary of $80,000 per job, which is $30,000 higher than the average private sector salary in the United States. There is no doubt that jobs in the innovation economy are high paying and exactly the type of jobs we need to be fostering.

At this time of the year all typically sit back and reflect on the year that has been, spend time with family and friends, watch some football and set a course to follow into the new year. So here are the top 10 events that shaped the patent, innovation and intellectual property industry during 2010 — at least according to me, and with a heavy patent emphasis. What did you expect?

Betsy de Parry spoke of how the Bayh-Dole act affected her personally by lending time and resources to university discoveries that created the life saving treatment that has led her to 8 years of being cancer free. de Parry brought an emotional and very human element to the celebration because she is living proof of what this piece of legislation has meant to so many — it fostered discoveries and drugs that literally saved her life. Her story was quite moving and admittedly brought me to tears. For those of us who have loved ones afflicted by cancer, it gives me great hope that eventually a cure will be found.

On Monday evening, November 1, 2010, David Kappos, Undersecretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, told the Dow Jones news service: “The USPTO at the present time is maintaining the status quo. We’re continuing with current procedures as they are.” This could set up a contentious and public policy battle between the United States Department of Commerce and the United States Department of Justice. This battle of agency titans — DOJ v. DOC — comes as a result of the Department of Justice filing an amicus brief in The Association of Molecular Pathology v. The United States Patent and Trademark Office, which actually does not take the side of the USPTO, but rather says that what the USPTO is doing is wrong. Thus, in an extremely odd twist the DOJ is supporting the plaintiffs’ against the United States Patent Office.

On Friday, October 29, 2010, practically on the eve of a national election that will in all certainty be an enormous rebuke of the Obama Administration and the Democrats’ agenda in general, the Department of Justice filed an amicus brief at the United States Court of Appeals for the Federal Circuit that would destroy the U.S. biotechnology sector. In an astonishing and irresponsible policy shift that directly contradicts the long-standing policy of the United States federal government and a variety of agencies, the Department of Justice is promoting the dialing back of what is considered patentable subject matter and is urging the Federal Circuit to rule that “isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.”

Biotechnology industry leaders announced today a major new program to improve the quality of U.S. life science education. The Biotechnology Institute’s new “Scientists in the Classroom” initiative is the life science industry’s response to President Obama’s “Educate to Innovate” campaign to improve the performance of America’s students in science, technology, engineering, and mathematics (STEM) education. The announcement came as life science industry executives participated in a White House event announcing the creation of the new broad education coalition called “Change the Equation” comprised of CEOs from across a broad spectrum of industries.

While success in Phase I is critical, there are substantial hurdles to overcome yet before this vaccine could reach the market. Nevertheless, such a promising cancer vaccine ought to be heralded by everyone, right? Think again! Inovio actually has the audacity to have patents on its ground breaking innovation, which will lead the anti-patent non-thinkers to be more concerned with blowing up the patent system than rooting on Inovio and others as they attempt to eradicate cancer. Absolutely ridiculous if you ask me!

I am skeptical about the prospects for invalidating patents on drugs, particularly important or blockbuster drugs. I also question whether anti-patent do-gooders in the biotech and pharma space are really causing more harm than good through attempts to bust patents on blockbuster drugs. According to their own press release, PUBPAT acknowledges that the tablet is heat stable and does not need to be refrigerated like prior versions of the drug. They seemingly make the argument, although not directly, that because this makes it much more convenient for patients it is unfair to charge prices sufficient to recoup R&D and a premium to make the speculative R&D reasonably profitable for investors. Of course, the fact that the drug in question is extremely convenient for patients is not a reason to invalid the claims, and in fact is likely a compelling reason why in this instance the patent claims cover a truly novel and nonobvious innovation.

Summer is almost over, but the Practising Law Institute still has some great Intellectual Property courses that all come with CLE credits. So whether you are looking for an excuse to take a trip to beautiful San Francisco, California, or the City that never sleeps, or you are looking for some great information and CLE credits via webcast, PLI has you covered. The remaining IP courses for Summer 2010 are all new and completely revised, with the exception of the extremely popular Claim Drafting & Amendment Writing workshop, which will still integrate recent changes and provide tons of practical learning.

One reason I was quite interested in Bilski was because the Supreme Court (not surprisingly) ruled that the Federal Circuit’s “machine or transformation” test was too inflexible, much like the “teaching, suggestion and motivation” (TSM) test in KSR International v. Teleflex. So why my intense interest in the Supreme Court (aka the Judicial Mount Olympus) relegating the “machine or transformation” (aka MoT) test to “second class status” in Bilski? Besides the inanity of MoT as the sole test for patent-eligibility, I am interested because of Judge Sweet’s ill-advised reliance on MoT (now smitten by the thunderbolts from our Judicial Mount Olympus in Bilski) for invalidating Myriad’s method claims using its BRCA1 and BRCA2 gene sequence technology.

“In our amicus brief, BIO urged the Supreme Court to overturn the lower court’s rigid new test for determining whether a method or process is eligible for patenting. We are pleased that the Justices crafted a narrow opinion that does just that. The Court was clearly conscious of the potential negative and unforeseeable consequences of a broad and sweeping decision,” stated BIO President and CEO Jim Greenwood. “This ruling specifically states that the ‘machine-or-transformation test is not the sole test for patent eligibility’ and recognized that the lower court’s ruling could have created uncertainty in fields such as advanced diagnostic medicine techniques.”

There is some irony that on the day we mark the 30th anniversary of the decision that launched the modern biotechnology industry we are still awaiting a decision on a patentable subject matter case — Bilski v. Kappos. Bilski has the potential to not only kill business methods, but also the software industry, the biotechnology industry and much of the medical innovation we see growing by leaps and bounds. So for today I toast the Supreme Court decision that launched the biotech industry, created millions of jobs and has lead to innumerable cures and treatments. I just hope that tomorrow (or whenever the Supreme Court issues its Bilski decision) it is not all for naught.

At these types of ceremonies everyone says such nice things, but what Judges Newman, Linn and Lourie said about Judge Michel seemed particularly heartfelt, and they seemed almost saddened to see their friend choose to leave and set out to make a difference advocating rather than opining. The video also included flattering comments from Chief Judge Anthony Joseph Scirica of the Third Circuit, one of Judge Michel’s former clerks and executives of the IPO. It was extremely tasteful, gave an appropriate but not lingering recap of his career and did not linger or go on at an uncomfortable length as these things sometimes can do. Extremely well done and kuddos to the IPO.