Turtle on a Fence Post

A  Saturday New York Times editorial called to our mind an old saying:  “If a turtle is perched on a fence post you know it didn’t get there by itself.”

With Congress now in recess and, when it returns, still entangled in health care, tax reform and Russia-gate, how is it that a high-priced, big tech PR firm would be trying to breathe life into patent litigation reform to justify its monthly retainer? No problem, just call in a favor and get a NYT editorial praising SCOTUS for its latest weakening of US patents. The editorial praised the recent SCOTUS decisions in TC Heartland v Kraft Foods and Impression Products v Lexmark under the headline, “Protecting Consumers in Patent Cases.” It was planted, we suspect, (like the turtle) on the Editorial Board’s patent troll narrative Kool-Aid cabinet shelf.

The Court in both decisions overturned years of patent law precedent on defendant venue in Heartland while in Lexmark it effectively held that any sale whatever or wherever of a patented product, including sales in other countries where our patent laws have no effect, cancels its US patent protection. One major problem is that when applied to existing arrangements such decisions have a retroactive impact. So if drug maker XYZ has made a discounted sale to the Gates Foundation of a patented anti-pandemic therapy for use in Africa, (even with a routine boilerplate restriction on further resales or other gray market activity) the US patent protecting the product is now automatically nullified. The Impression Products decision and the Court’s reasoning are explained in an IPWatchdog twin posts last week where experts comment on its “known unknowns.” As usual, however, the problem is the decision’s “unknown unknowns.” It appears to us that new uncertainties may further adversely affect investment in university life science research. It definitely will disrupt today’s biopharma innovation ecosystem.

Continue reading Turtle on a Fence Post

Canada’s “Promise Doctrine” to Continue Weakening Patent Reliability

Canada’s pernicious ” Promise Doctrine” has been upheld by a NAFTA tribunal in which Eli Lilly claimed that Canada’s unique judicially-created “promise doctrine” by which patented subject matter is strictly held to the application predicted specifics of its patent application claim even though new uses have emerged since its development and use. In contrast to SCOTUS “over-broad” concerns underlying continuing US patent eligibility, Canada’s unique requirement that the “promise” (i.e. its described future post development use) creates and absolute limitation on its enforceability for any other use. So, if a patent claim describes a process to prevent apples from quickly turning brown when cut can be similarly used for pears, its patent protection applies only to apples.

Driven by Canadian generic drug makers seeking to narrow patent protection, the doctrine is inconsistent with AIA mandated First to File patent prosecution requirements which compel early applications to assure patent protection for early stage innovation. But often during its development and use the method to accomplish A. is later found to accomplish B as well. In virtually all other patent venues the A. Patent would provide exclusivity protection to its applicability to B. Continue reading Canada’s “Promise Doctrine” to Continue Weakening Patent Reliability

Take Back the Rights

On March 9, 2017, I will be serving on a panel moderated by former Federal Circuit Court CJ Paul Michel and Robert Sterne Esq. at the USPTO. The UT Panel on the Global Patent Landscape is a well-attended, mixed assembly where patent jurists and practitioners gather to consider patent law developments and trends from a more detached and wider vantage point than daily contention with individual cases allows. Wearing my university hat, I will be joined by representative panelists Paul Evans, Paul Stone, Peter Detkin and Damon Matteo each of whom expertly exercises keystone roles in our innovation ecosystem. Sadly, although there are many pressing issues confronting the IP community our panel preparation calls have inevitably focused on one overriding issue.

Inadvertently or not, SCOTUS, Congress, CAFC and PTAB have combined to drape an iron curtain of enforcement cost and uncertainty over patent enforcement, weakening US patents to the point of risk-adjusted irrelevance. For under-resourced patent holders, a growing cohort growing larger with expanding litigation overuse of post grant process, patents’ statutory presumption of validity has become a presumption of non-enforceability. Biopharma interests may still count on patents, but incumbent ICT operating companies whose efficient infringement business model has substantially reduced patent values see their value now only as weapons to preserve global market share and/or as clubs to beat down component product pricing, daring their suppliers to assert.  In short U.S. Patents are rapidly losing their critical investment attracting role within our national innovation ecosystem. The question now is what we can do about it?   Continue reading Take Back the Rights

Trump Moves Towards Life Science Support

The pre-election clamor about prescription drug pricing took an interesting turn last week following President Trump’s meeting with prescription drug-makers at the White House. Earlier this year pricing abuse by rogue firms whose lack of competition in certain markets enabled upward price ratcheting attracted glaring press outrage leading to presidential campaign promises to curb prescription drug pricing if elected. Unfortunately, top down price controls cannot cure this market malady. Indeed, by choking-off investment in basic life science research to develop cures advancing competition they will only worsen it. Post-AIA uncertainty plaguing commercialization is shrinking independent private investment in the long and costly development of high-risk life science products, shielding sole suppliers to certain patient markets from competition. Continue reading Trump Moves Towards Life Science Support

Bayh-Dole Commercialization Under Attack

Because TT commercialization requires prudent private sector investment, increasing uncertainty regarding post-patent and post-development patent and pricing reliability threatens Bayh-Dole TT commercialization. Patent reliability and investor pricing aegis are critical prerequisites private sector entrance into commercialization partnerships. Both are now under attack. now it appears that R&D funding for disposition by federal grant agencies also is under concerted attack. When the NY Times and the Wall Street Journal publish op-eds attacking federal funding attacking NIH and research universities, the attack is confirmed and must be met head-on. Continue reading Bayh-Dole Commercialization Under Attack

Draining the Swamp Uncertainty

Congress returned this week with a carefully pre-planned 100-day House agenda focused on repealing ACA and certain regulatory reforms. Even before its members were sworn in however chaos erupted.

On Monday night over the objections of Speaker Ryan and House Majority Leader McCarthy, Rep. Goodlatte passed a Rules change in the Republican Conference renaming the Office of Congressional Ethics as the Office of Congressional Complaint Review, placing it back under the aegis of the House Ethics Committee. Tuesday AM President Elect Trump tweeted a rebuke to the House Republicans for action inconsistent with “draining the swamp” or as he puts it, “#DST” Later today chastened Republicans removed the changeContinue reading Draining the Swamp Uncertainty

Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits – The New York Times

This New York Times above-the-fold hit piece is designed to support price-based march-in and generally damage Bayh-Dole. It tells us that enemies of B-D obviously plan to engage again and to use drug pricing as their weapon of choice. Engineered by James Love of KEI, it attacks a seemingly successful CRADA partnership, refers to unrealized capital gains as “profit’ (which could be wiped out by a future adverse FDA ruling), misstates NIH’s repeated conclusions that price-based BD march-in is not authorized by BD, factually saying it is now available to curb drug pricing. Continue reading Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits – The New York Times

Conference on Sec 101 and Joe Allen on Bayh-Dole, Past and Present

We attended an excellent conference at Covington & Burling this AM sponsored by Inventing America and IPWatchdog. The panels and speakers are listed below. An all-star cast gave a great performance. The first panel was moderated by Qualcomm’s Lauri Self and the second by IPW’s Gene Quinn. The morning’s focus was on the real life impacts of recent SCOTUS decisions addressing patent eligibility. After the state of developing law was ably explained by Jeff Lefstin, the panelists talked about the harms the decisions have caused and what to do about the new uncertainties haunting patent eligibility under Sec 101. The new doctrines emerging from several SCOTUS decisions are commonly referred to as Alice-Mayo eligibility .We will explain the problems in detail later. Suffice it to say for now that because commercialization occurs so early in the development sequence, every problem discussed most adversely affects research university Bayh-Dole execution. Continue reading Conference on Sec 101 and Joe Allen on Bayh-Dole, Past and Present