Litigation always factors into the pharmaceutical world, but the US Supreme Court commanded a special place in recent days. The high court figured in no fewer than four contentious issues that, not surprisingly, play a vital role in how drug makers can and will operate.

Let’s start with a case that is not yet before the court, but many predict will be headed there thanks to one of its earlier rulings. Earlier this month, a three-judge panel of the US Court of Appeals for the Second Circuit overturned the conviction of a former sales representative, who argued that prosecuting him for remarks made about off-label use violated his free speech rights.

In their decision, the 2-to-1 majority cited a US Supreme Court ruling early last year that struck down a highly controversial Vermont law, which restricted the sale of prescription drug data identifying prescribers and patients for commercial marketing purposes. Specifically, the court ruled that “speech in aid of pharmaceutical marketing… is a form of expression protected by… the First Amendment.”

Last week I published part 1 of my conversation with Manus Cooney, who is one of the preeminent intellectual property lobbyists in Washington, D.C. Cooney, a former Chief Counsel to the Senate Judiciary Committee, is currently a partner with American Continental Group and was intimately involved in lobbying Congress relative to the America Invents Act (AIA), primarily on behalf of his client Tessera Technologies, who aligned themselves with the Innovation Alliance.

In part 1 we discussed lobbying in general, shining some light on the process as a whole and explaining why it is unrealistic to expect you can enter the debate near the end and have any hope of affecting change. In part 2, which is reproduced below, we discuss the specifics of lobbying the AIA, as well as the fight against further erosion of patent rights. And you thought that patent reform was over. Sadly, the fight continues.

COONEY: Going back to the AIA, when it comes to passing legislation, it’s important to know how each of the Congressional bodies work. It may be an oversimplification but it is usually the case that whatever the House Majority Leadership wants to pass, it usually gets done. In the Senate, however, it’s different because of its rules. There, whatever the Majority wants to pass has a shot at getting done. In other words, if the House Leadership, the Republicans in this case today, and the Chairman of the Committee want to see a particular measure passed, more often than not, particularly on an issue as esoteric and complex as patent law, the party members of the majority party are going to adhere or defer to the wishes of Leadership, And as a result, you’re trying to either create a situation in advance of the House measure coming to the floor where you have the support of the Leadership or you have created an environment where it’s less certain to the House Leadership and the Chairman that they will in fact be able to prevail, and thereby create an environment where they have to negotiate. Oftentimes in the House, your laying the foundation for a fight in the Senate where there is less deference to the Leadership. The rules are such that, in theory, any Senator can offer an amendment to any bill at any time, and you have a better shot at winning on the merits, so to speak. That has a way of forcing consensus. So realizing that those tend to be the ground rules, the landscape you’re dealing with, you develop a strategy for your clients.

Manus Cooney is a formidable figure.  He stands 6’3”, is the consummate professional, highly intelligent and very personable.  He is the type of person you notice when he walks into a room.

Who is Manus Cooney?  Those in Washington, DC, know the name well, but many practitioners in the intellectual property space are probably not well acquainted with Cooney, but Manus Cooney is a name you should know if you are at all involved in the world of intellectual property.

Cooney is a prominent behind the scenes player in Washington, DC.  He is a partner in the American Continental Group, a D.C. based consulting and lobbying firm that boasts one of the most prominent IP practice groups in town.  His partners include Marla Grossman, who was an IP counsel for Senate Judiciary Committee Chairman Senator Patrick Leahy (D-VT), and Chris Israel, who was the nation’s first U.S. Coordinator for International IP Enforcement — the first IP Czar.  Philosophically, ACG tends toward the pro-IP side, so it is not surprising that many of the clients they represent are interested in securing and promoting a strong IP regime both in the U.S. and abroad.  In short, Cooney and others at ACG fight the good fight, helping content creators and innovators convey their message in the halls of Congress.

Washington, D.C. (May 24, 2012) – BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).

In particular, we appreciate the leadership shown by Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) to craft a bipartisan measure which will continue to ensure patient safety, access to the newest cures and therapies, and job growth in America. FDASIA reflects the enhancements to PDUFA agreed upon by industry and the U.S. Food and Drug Administration (FDA). 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.

News broke several days ago that Senator Jon Kyl (R-AZ) has raised the issue of funding for the United States Patent and Trademark Office in his role as a member of the so-called Super Committee, which is charged with finding $1.2 trillion in budget cuts over the next 10 years. See Super Committee Considering an End to USPTO Fee Diversion.  This means the patent community has another chance to urge Congress to do the right thing and adequately fund the USPTO.  Everyone in the patent community can and should get involved and be heard — patent attorneys, patent agents, patent bar groups, patent bloggers, corporations, inventor groups, inventors and industry organizations such as the ABA IP Section, the AIPLA and IPO. It is time to get involved!

Many will recall that recently we came up to the doorstep of putting an end to fee diversion through the creation of a revolving fund for the USPTO.  The revolving fund proposed by Senator Tom Coburn (R-OK), would have tied a revolving fund together with taking the USPTO out of the appropriations process.  This would have meant that the USPTO would be guaranteed to keep 100% of the user fees collected without Congress being able to divert fees over and above what they specifically appropriated.  The revolving fund made it into the enacted America Invents Act, but not the part about taking the USPTO out of the regular appropriations process, which essentially just kept the status quo.

Today the U.S. patent community sits perilously in the path of an oncoming train. The Leahy-Smith America Invents Act (AIA) Act mandates – but fails to fund – a wholesale conversion of the USPTO from an expert examining agency to one that not only examines patents but also adjudicates patent disputes in ways that promise to be faster and cheaper than patent litigation in our courts.

Without predictable funding, the Congressionally mandated reforms of the AIA will likely turn out like the agency’s “fast track” and Detroit office initiatives: announced, planned, but then delayed by the lack of one essential element – money. Indeed, without predictable funding, the reforms mandated by the AIA will likely result in a greater patent backlog, significant additional delay in finalizing the value of disputed patents, and a confused and discouraged agency workforce, all of which will significantly delay the recovery of our national innovation-based economy.

The coming train wreck would have been avoided if the 95 Senators who voted for ending fee diversion (with the support of every significant stakeholder in the otherwise-divided patent community) had had their way. It can still be avoided at no cost to taxpayers. And it can be avoided quickly, before Thanksgiving’s leftovers are gone, via the Super Committee. Let me explain.

On Friday, September 16, 2011, President Obama signed into law “The America Invents Act” (“AIA”) which passed the Senate on September 8, 2011, by a vote of 89-9. The AIA passed the House of Representatives on June 23rd by a vote of 304-117. The measure, which is the product of a seven-years-long legislative battle among patent policy stakeholders, changes how patents are obtained and enforced in the United States. Important reforms to patent law are incorporated into the AIA and, just as significantly, several controversial proposed changes were deleted from the AIA before final passage.

Starting with President Obama’s State of the Union Address in January, where he made innovation and job creation key elements of his speech and specifically embraced passage of patent reform as a means of addressing both issues, patent reform was well positioned to be enacted in 2011. Moreover, Congress was desperate for legislative accomplishments in an environment where partisan differences, a weak economy, and government fiscal concerns dominated. Longstanding pro-reform coalitions and associations continued to expend considerable resources on the bill. Passage was deemed virtually assured when the Chairmen of the Judiciary Committees – Sen. Patrick Leahy (D-VT) and Rep. Lamar Smith (R-TX) – essentially agreed this summer on a common piece of legislation. But, as explained below, nothing’s ever as simple as it seems in Washington.

The United States Senate voted 93 to 5 earlier this evening to end debate on patent reform, which should set up a vote on H.R. 1249 in the coming days.

The United States Senate first passed its own version of patent reform, dubbed the America Invents Act – S. 23, in February 2011. The House of Representatives took up patent reform in the Spring, ultimately passing H.R. 1249, also dubbed the America Invents Act. Because the House version of patent reform was not identical to the Senate version of patent reform the legislation pinged back to the Senate. Immediately before the Senate went out on its annual August recess Senate Majority Leader Harry Reid (D-NV) filed for cloture on H.R. 1249, scheduling the Senate’s first day back after the August recess as the day for the cloture vote. That cloture vote is what passed by a vote of 93-5.

Once upon a time I used to not get worked up at all about proposals for patent reform, because after all they almost always didn’t seem to go through, or even if they did what was passed was hardly what was suggested.  Then, my good friend John White told me about six years ago that this time patent reform was going to happen, it was just a matter of time.  Since then I have written numerous articles on proposed patent legislation, followed the issue, reviewed transcripts from Congressional hearings and have watched multiple Congressional hearings streaming online, even while on vacation one year.  The end result is that not much has changed… at least not yet.

We have heard this all before, and to some extent it does sound a little like a “chicken little mentality” has captured the imagination of policy wonks and patent attorneys alike, but it is hard to deny the fact that there is growing momentum for real reform at the United States Patent Office.  Sadly, what the United States Senate will vote on Tuesday, September 6, 2011, does not represent that real reform that so many are hoping for.

It has now been several weeks since the U.S. House of Representatives passed H.R. 1249, dubbed the America Invents Act, which is commonly referred to as patent reform.  In February 2011, the U.S. Senate passed S. 23, their version of patent reform.  In their infinite wisdom, or lack thereof depending upon your perspective, the House did not pass a bill that was identical to S. 23, which means that before patent reform will become a reality it needs to once again be taken up by the Senate.  But what are the odds of that happening any time soon?

Even the most casual observer likely knows that the United States is in the middle of a debt crisis.  According to Treasury Secretary Timothy Geithner we have until August 2, 2011, within which to raise the debt limit and allow for more borrowing.  Apparently the failure to raise the debt ceiling will trigger calamitous events that will cascade into an economic catastrophe.  Yes, pretty big stuff seems to be at issue over the debt limit, which is consuming all of the oxygen in the room.

At approximately 5:50pm the United States House of Representatives passed H.R. 1249, which is known as the America Invents Act, by a vote of 304-117.  This bill differs from the Senate version of patent reform, S. 23, so there will be no bill going to the desk of President Obama just yet.  There are important differences between the two bills, chief among them is funding for the United States Patent and Trademark Office.  The bill passed by the Senate put an end to the practice of fee diversion, which occurs when the Congress appropriates the USPTO less than they collect in fees.  The excess in the fees collected from users of the USPTO then go to the federal government as general revenues and are used for purposes other than the operation of the United States Patent and Trademark Office.

The one thing in the Senate version of patent reform that everyone agreed on was the end to fee diversion.  The House of Representatives, however, has decided that an end to fee diversion should not be included in patent reform, which is causing a great unease within the industry.

The Senate had struggled with patent reform for years, and in February 2011 they broke through with a carefully crafted balance.  The Senate version of patent reform is light on “reform” in any real sense, except for one.  The Senate voted to end the practice of diverting fees collected by the Patent and Trademark Office to other, completely unrelated purposes.  The House of Representatives, lead by Congressman Hal Rogers (R-KY) who is Chair of the Appropriations Committee, demanded that the USPTO do with the amount of funds appropriators want to give the Office, not the amount of funds collected from users who pay for the Office.  This is causing many industry groups to openly withdraw support and fight against patent reform; a remarkable turn of events.