If biopharma companies heed the advice of their patent attorneys, there will be a mad dash to the Patent and Trademark Office (PTO) over the next few weeks as firms rush to file new patents before the reforms of the America Invents Act (AIA) take effect March 16.
The PTO has rolled out a slew of new regulations and guidances to implement the switch from first-to-invent to first-to-file, as well as the other changes in the sweeping reform, but "we don't know what these new laws mean exactly," Morrison & Foerster patent attorney Otis Littlefield told BioWorld Today. (See BioWorld Today, July 20, 2012.)
And until the Federal Circuit and the Supreme Court start interpreting the new law, which will be at least five to six years down the road, he said, there will be a lot of uncertainty in the U.S. patent world.
That's why patent experts are advising biotechs to file their patents under the old rules if they want to know what to expect.
There are other reasons to get in under the calendar. A big one is the expanded definition of prior art, which could render a claim unpatentable. The AIA includes a new catch-all bucket for prior art, Littlefield said. For instance, the new definition could include public presentations at a drug conference, even if there are no printed handouts. In the past, such presentations were only considered prior art if they included printed materials, he noted.
The definition broadens prior art to include disclosures made by anyone, even the applicant, prior to the filing of a patent application. However, disclosures made by the patent applicant within a year of the filing date would be excluded. (See BioWorld Today, Aug. 27, 2012.)
Going forward, companies will have to put practices in place to protect their claims from new prior art challenges. But since they were developed under the old rules, products that are in the lab now could be vulnerable if their patent applications are filed after March 15. If they beat the deadline, they won't be subject to the new, broader definition, Littlefield said.
They also couldn't be challenged in the PTO's new post-grant review process created by the AIA. Through post-grant review, the AIA expanded the types of third-party challenges that can be brought before the PTO, so long as they're filed within nine months of the grant of the patent.
Under the current scheme, third parties can only launch PTO challenges of patents based on prior art. All other issues have to be taken to court, where there is a much higher standard of evidence, Littlefield said. And a lawsuit can cost from $5 million to $10 million, compared with about $1 million for a challenge before the PTO.
Given the lower costs and standard of evidence of going before the PTO, post-grant review is likely to increase the number of third-party challenges.
In the long run, though, a post-grant review could prove more meaningful than a jury trial in district court. Since juries are generally made up of people with no background in the sciences or patent law, it's difficult to convince them of the finer technical points of a case, Littlefield said. But in a post-grant review, PTO officials with some expertise in the area will likely be assigned to hear a challenge.
As time and case law bring more certainty to the AIA, some of the reforms, at least, are expected to prove beneficial to patentholders, because the U.S. patent system will be in step with that of the rest of the world. No longer will one company have patent rights to a new drug in the U.S. while someone else holds the rights in Europe and elsewhere, Littlefield said.
Under the Paris Convention, which is ascribed to by most countries, a patentholder has one year after filing a priority application in a member country to file in other countries. But since the U.S. was on the first-to-invent system, a company that was the first to file a patent in another country wasn't always eligible for the patent in the U.S.
Fed Circuit Gives Enablement Guidance
While Cephalon Inc. is likely getting small comfort from a Federal Circuit ruling last week that partially reversed a lower court's decision on its Fentora patents, the appellate court's opinion offers some guidance to other companies on enablement, which refers to a specification in the patent that enables others, with ordinary skill in the art, to practice the invention without "undue experimentation."
The U.S. Court of Appeals for the Federal Circuit agreed with a federal district court that Teva Pharmaceutical Industries Ltd.'s generic Fentora (fentanyl buccal tablet) doesn't infringe two Cephalon patents, but it took issue with the district court's decision that the patents were invalid because of a lack of enablement.
The lower court erred when it accepted unsubstantiated statements from Teva's lone expert indicating that experimentation would be "difficult" and "complicated," the Federal Circuit said, reminding the district court that the challenger bears the burden "of proving lack of enablement by clear and convincing evidence."
While the district court seemed to get stuck on the fact that considerable experimentation was necessary, the appellate court differentiated between "unduly extensive" experimentation and the repetition of routine experimentation, noting that the focus isn't merely quantitative.
"A considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance," the appeals court said in its precedent-setting opinion.
Groups Push for Price Negotiations
Negotiating Medicare drug prices could save the federal government $230 billion to $541 billion by 2022, according to a report released last week by an economics research group.
Additionally, having Medicare negotiate the Part D prices could result in $31 billion to $72 billion in state government savings and $48 billion to $112 billion in savings to consumers, the Center for Economic and Policy Research said in its report, "Reducing Waste with an Efficient Medicare Prescription Drug Benefit."
The findings echo a refrain from President Barack Obama's State of the Union address last week and are part of a national campaign aimed at getting Congress to grant Medicare the authority to negotiate prescription prices with drugmakers and suppliers.
The push has started already in the Senate, with Sen. Al Franken (D-Minn.) reintroducing the Prescription Drug and Health Improvement Act last month. Noting that Medicare spent $67 billion in 2011 on the Part D drug program, Franken estimated that negotiated prices could save up to $24 billion annually for a maximum 10-year savings of $240 billion.
Meanwhile, the biopharma industry is telling Congress to stop trying to fix what isn't broken. "Part D is now 45 percent below the cost originally expected, and . . . while reducing Part D's 10-year projected cost by over $100 billion for the third consecutive year, the nonpartisan Congressional Budget Office pointed out that Part D is the single biggest factor responsible for lower Medicare spending projections," said Matthew Bennett, senior vice president at Pharmaceutical Research and Manufacturers of America.