Posts Tagged: "biotech"

Patents for Humanity in the news was also the perfect excuse to chat with Erik. I always enjoy our conversations. We touch base regularly and talk about industry matters, and I always leave those conversations wanting to write about something. Unfortunately, I have had the hardest time getting my head around what seems to be very counterintuitive — namely the use of patented technology for humanitarian purposes. I can confidently now say that I get it. I am happy to share this interview and hope that it can shed light on what might seem like an otherwise purely altruistic endeavor without much likelihood of success. There is great work being done in this space and it is indeed a “win-win” for everyone.

So maybe the Federal Circuit won’t find “preemption” to be useful in deciding this appeal; we’ll know soon enough. I, for one, can’t make sense of the DOJ’s fixation on “tying up.” In Flook, the Supreme Court made clear that a claim’s patent-eligibility does not turn on the range of uses that are preempted versus those that remain in the public domain. Even in Mayo, the Supreme Court discussed preemption explicitly only as an underlying policy concern, as a justification for an outcome that, to the Court, seemed right and just – not as a test that distinguishes a “law of nature” from a man-made process. By elevating “tying up” to the status of an actual analytical tool, DOJ proposes an unworkable test that fails to distinguish “products of nature” from man-made inventions and leads to absurd outcomes. It asks the Federal Circuit to rely on asserted facts and unstated claim constructions. It requires strained interpretations of leading precedent. It is evasive and avoids the hard work of construing the claims and applying them to the activities believed to be “tied up” – lawyer work that, if undertaken, may or may not show that the preemptive scope of these claims isn’t all it’s trumped up to be.

It will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase FDA’s access to external expertise to improve the drug review process. FDASIA will foster timely interactive communication with sponsors during the drug development phase as a core Agency activity to facilitate the conduct of efficient and effective drug development programs and help make safe and effective drugs available to the American public in a timely manner.

Earlier in the week BIO also unveiled another report it commissioned and which was authored by Lori Pressman, David Roessner, Jennifer Bond, Sumiye Okubo, and Mark Planting. This report, titled Taking Stock: How Global Biotechnology Benefits from Intellectual Property Rights, discusses the role of intellectual property rights in encouraging upstream research and development as well as downstream commercialization of biotechnology. More specifically, the report outlines how intellectual property rights and technology transfer mechanisms encourage collaboration and lead to the research and development of new biotechnologies, particularly in emerging and developing economies.

The inclusion of an enhanced Accelerated Approval pathway, crafted by Senator Kay Hagan (D-NC), will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA’s robust standards for safety and effectiveness. Senator Hagan is to be congratulated for her hard work and leadership on this very important provision.

Just over three weeks ago the United States Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, which sent much of the patent world into a whirlwind. In that decision the Supreme Court unanimously found that the claims at issue did not exhibit patent eligible subject matter because the additional steps that were added to the underlying law of nature were well known in the industry. A curious ruling for many reasons, and one that will have to be digested over many years as the United States Patent and Trademark Office and the Federal Circuit struggle to figure out how Diamond v. Diehr remains good law (it was not overruled) and remains consistent with a ruling that seems completely inapposite. To continue to provide a variety of perspectives on this landmark ruling what follows is the reactions of those in the industry.

I like writing about esoteric patent law topics and the question of “intervening rights” in reexaminations/reissues is one of the more esoteric. See my 1998 JPTOS article entitledIntervening Rights: A Potential Hidden Trap for Reexamined Patent. The case of Marine Polymer Technologies, Inc. v. HemCon, Inc. is one of those rare instances in this esoteric area of patent law where the Federal Circuit announced a new “wrinkle” on when “intervening rights” apply in reexamination. Unfortunately, the rule announced by the majority in Marine Polymer Technologies (“intervening rights” apply to unamended claims based on statements made during reexamination) is squarely in conflict with the express language of 35 U.S.C. § 307(b), as Judge Lourie’s dissent vigorously (and more importantly, correctly) points out.

The basic argument in Myriad is whether DNA that is isolated from the chromosomes is statutory subject matter, or whether it is a product of nature. The stakes are high in the Myriad case, since the isolated DNA claimed by Myriad encodes mutated BRCA1 and BRCA2 proteins that can be used to detect breast cancer. Myriad has the only test offered in the United States because of its aggressive enforcement of its several patents. The numerous plaintiffs in the case speak to the core of the patent versus non-patent debate: whether patents actually “promote the progress of science and useful arts” as required in the U.S. Constitution. Myriad and other companies heavily reliant on biotechnology patents, would support the argument that strong patent enforcement allows companies which have invested millions or billions in assay or drug development for clinical use to recoup their investment and provide a return for investors. The plaintiffs would argue that such patents not only hinder the useful arts, but also endanger lives and/or drives up the cost of providing potentially life-saving testing and treatment.

After much anticipation, the United States Court of Appeals for the Federal Circuit earlier today issued a decision in Association for Molecular Pathology v. Myriad Genetics. The decision on first glance will seem to be a split decision, particularly by Federal Circuit standards. The majority opinion was written by Judge Lourie, Judge Moore wrote a concurring opinion and Judge Bryson concurred in part and dissented in part. Having said that, the outcome largely seems to be what was predicted by the patent community. On the major substantive issue — are isolated DNA molecules patent eligible subject matter — the Federal Circuit reversed the decision of the district court and ruled that isolated DNA molecules do constituted patent eligible subject matter. The Federal Circuit also ruled that methods relating to the screening for potential cancer therapeutics are, likewise, patent eligible subject matter. All three Judges also found the “comparing” and “analyzing” claims to be ineligible for patent protection because they were not transformative, and thus were merely abstract mental steps.

While many people believe that alternative energy is at least several decades away, what is clear is that if we do not set out about making that future a reality it will never been the future we realize. There is tremendous research ongoing relative to battery technologies, solar energy, biofuels, geothermal energy, wind energy, hydroelectric energy and much more. In all likelihood no one, single solution will replace our dependence on fossil fuels, at least not in the foreseeable future, but there does seem to be a light at the end of the tunnel. We only need to choose the path to obtain that reality.

BIO has consistently praised House Judiciary Committee Chairman Lamar Smith (R-TX) for his introduction of a comprehensive patent reform bill similar to the bill adopted by the U.S. Senate earlier this month by a nearly unanimous vote. Unfortunately, given the addition of the Goodlatte supplemental examination amendment, added to the bill during Committee consideration, we have no choice but to oppose floor consideration of the bill until this issue is repaired.

In the situation where there is a joint research collaboration everything is fine, people are happy and hope springs eternal right up until that moment when everything falls apart. Then you have issues associated with a law firm representing inventors of a joint collaboration might be conflicted out of the representation altogether because downstream patent applications filed by one or more of the collaborators creates a situation where the collaborators no longer have jointly aligned interests, perhaps as the result of double patenting issues. Ware explained several cases arising out of a common set of facts whereby multiple joint collaborators were not consulted on the filing of a joint application (or at least not enough to their liking), which created a double patenting issue for an after filed application. The law firm representing the collective was sued for malpractice and breach of fiduciary duty; the case settled.

Richard M. Marsh, Executive Vice President and General Counsel for Myriad Genetics is on the panel. He started off his presentation explaining that he really wants to talk about the case and the issues, but given that the case is ongoing and the future is uncertain regarding whether it will continue to be appealed, go back to trial or be dismissed altogether he might be unable to answer all questions. He did say clearly that the biotechnology industry “is under attack.” Marsh explained that the industry needs to be proactive because “if we sit back and idly do nothing there could be grave consequences.” Marsh explained that Myriad was able to do what it did thanks to the patents by giving it the time, money and incentive to innovate. I couldn’t agree with him more.

This morning the first panel discussion is focusing on Stanford v. Roche, titled Who’s Rights Are They Anyway? The first speaker, Maggie Shafmaster, Ph.D., Vice President and Chief Patent Counsel, Genzyme Corporation, lead off by pointing out something that everyone largely seems to agree with, namely that the facts of the case are still largely in dispute, which makes me wonder why would the Supreme Court take such a case. Be that as it may, Shafmaster went on to say that this case is one that makes in-house attorneys and those representing Universities lay awake at night. She characterized the case as “an academic/industry collaboration gone wrong.” And we are off to the races!

Both the House and Senate bills create the opportunity for continual and constant challenges, one right after another. For example, challengers could tie up issued patents in post-grant review, followed by inter partes review and subsequently, or simultaneously, by challenges in one of the Federal District Courts. Thus, the settling of patent rights seems a distant dream if a well funded challenger wants to tie up a patent. The only hope for the patent owner is that with every subsequent challenge it becomes more difficult to challenge. That is what S. 23 sets up by having a “substantial new question of patentability” standard to initiate a post-grant review and then a much heightened “likelihood of success” standard to institute inter partes review.