Profession

Tinkering with patents: Decisions muddy the waters on legal rights

After years of broadening patent protection, the courts are pulling in the reins, with implications for medical research.

By Amy Lynn Sorrel — Posted May 26, 2008

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

A flurry of recent legal and legislative developments is shifting the boundaries in patent protection.

The forecast for medical advancements? Cloudy and uncertain, say various stakeholders -- from the medical community to patent lawyers to the biomedical industry -- who fear a potential threat to medical research.

For the first time in decades, the Supreme Court took up several cases testing the validity and force of patents and arguably raised the bar for getting and keeping a patent, experts say. Meanwhile, Congress is considering systemic reforms that could do the same, with a bill that cleared the House in September 2007 and a companion measure under consideration in a Senate committee. And the U.S. Patent and Trademark Office is looking to change its review process, though a recent court decision has stymied those efforts.

The impending changes are expected to impact patents in a wide range of industries. Experts say the judicial and congressional intervention comes after years of broadening patent protections by the PTO and U.S. Court of Appeals for the Federal Circuit, which has jurisdiction over patent appeals. A steady proliferation of patents across all sectors, including health care, also has contributed to a rise in litigation, analysts said.

Now the scale may be tipping the other way to rein in patent policy.

"There is a balance here: Patents obviously create an incentive system for innovation, but too many can stifle innovation," said David B. Fournier, a Chicago patent lawyer with Howrey LLP who specializes in biotechnology and medical devices. "Only time will tell whether [the courts and lawmakers] have struck an appropriate balance or gone too far."

In KSR v. Teleflex, the Supreme Court in April 2007 broadened the criteria for determining whether a proposed invention is considered obvious, or not distinct enough from elements already known in a particular field. That could make it more difficult for individual inventors or companies to prove many patents -- for example, those that combine known devices or chemicals in novel ways -- are valid, said Robert G. Krupka, a California-based patent attorney who has represented physician inventors.

The justices' decision in eBay v. MercExchange in May 2006 also will make it more difficult for patent holders to guard against infringement, said Krupka, a partner with Kirkland & Ellis. The Supreme Court ruled that patent holders who prove infringement may not automatically receive an injunction blocking the alleged violators from using the disputed rights, common practice among lower courts. Instead, judges first must consider certain factors to determine whether an order is warranted -- the same standard used in other types of cases.

Experts say it could take a few years to see how lower courts and the patent office apply the new standards.

Meanwhile, federal lawmakers are seeking changes, most recently through the Patent Reform Act of 2007. The legislation, proposed in the House and Senate, would:

  • Require patent applicants to submit additional documentation that distinguishes their discoveries from existing ones.
  • Broaden the standard of proof for awarding damages for infringement.
  • Permit third parties to challenge patent grants more quickly without going through the courts.
  • Allow increased damages for willful patent infringement.

Bill sponsors want to streamline the process to ensure high-quality patents while cutting down on litigation abuses by so-called "patent squatters" -- those who purchase patent rights and sue others with similar inventions to win awards. Fournier said the proposal could double or triple the cost of acquiring a patent while making it easier to contest a claim.

Patenting vs. sharing ideas

Some physicians and consumer advocates say patent standards have strayed from legal precedent and it's time for a re-examination of what medical discoveries deserve protection.

Patents can promote scientific progress, said Aaron S. Kesselheim, MD, a patent lawyer and clinical fellow at the Harvard School of Public Health. "But they also carry a lot of weight in the market, and when they are granted in cases where a product is not innovative, they can serve to increase costs and prevent access" to new therapies by thwarting competition, said Dr. Kesselheim, an internist at Brigham and Women's Hospital in Boston.

For example, pharmaceutical companies may focus on making incremental adjustments to existing drugs to extend exclusive rights, rather than searching for new products, he said. Physicians worry that overly broad patents on treatment methods could inhibit medical advancements and put patient care at risk.

Dr. Kesselheim said method patents are outlawed in most countries outside the U.S. When it comes to these discoveries, doctors, universities and companies "should be publishing and trying to share as much information as possible."

AMA ethical policy recognizes a doctor's right to patent a surgical or diagnostic instrument. The AMA also says use of patents to limit the availability of medical procedures restricts the dissemination of medical knowledge and is unethical.

A court case concerning a patent on a treatment method caught organized medicine's attention.

Without opinion, the Supreme Court in June 2006 let stand Metabolite Laboratories Inc.'s patent on a test for diagnosing a vitamin deficiency by measuring total homocysteine levels in blood. Metabolite sued Laboratory Corp. of America for violating the patent when it used a different testing method linking the two elements, but did not pay royalties.

The medical community claimed that the patent exceeded legal precedent and covered a basic scientific relationship. The AMA and others filed a friend-of-the-court brief in the case.

"Upholding a claimed patent on a scientific fact would directly undercut the goal of making diagnostic treatment advances widely accessible," the brief stated.

A 1996 federal law, which the AMA lobbied for, prevents doctors from being sued for infringing a patent on a medical or surgical procedure. Nevertheless, the LabCorp v. Metabolite ruling leaves open some concerns.

For example, universities, hospitals and medical education companies still might be at risk for infringement. Allowing such overreaching patents also could deter physicians or other entities from using certain treatments for fear of violation, organized medicine's brief argued.

Although doctors may not be sued, "they are more likely to have the chilling effect [of broad patents] passed down to them," said Daniel B. Ravicher, president and executive director of the Public Patent Foundation, a group advocating for stricter patent policy.

PUBPAT recently challenged embryonic stem cell patents held by the Wisconsin Alumni Research Foundation, an affiliate of the University of Wisconsin-Madison, saying they were obvious and impeding scientific progress. The PTO in February upheld some of WARF's claims, though PUBPAT plans to appeal, Ravicher said. He said the university restricted use of the patents by other academic researchers through prohibitive license agreements and fees.

"It's not just what patents cover, but also what is the patent owner doing with them that matters," Ravicher said.

Meanwhile, a dissenting opinion in LabCorp, though not binding, could cause lower courts to think twice about granting sweeping medical process patents. Three justices said such claims could impose "restrictions [that] may inhibit doctors from using their best medical judgment ... divert resources" and "raise the cost of health care while inhibiting its effective delivery."

A separate case pending in the federal circuit will address the question of whether business processes are patentable. Experts said the case, In re Bilski, likely will have implications for medical-related patents, too.

A system of incentives

If patent protection is inhibited, however, some researchers and biomedical companies fear that medical advancements will suffer. They say lawmakers should put wholesale reforms on hold until the recent high court rulings play out.

"We have a very delicate relationship between academic and clinical scientists and the companies involved in the translation of their discoveries and getting the investors needed to fund these types of activities," said John Maraganore, PhD, CEO of Alnylam Pharmaceuticals, a biopharmaceutical company in Cambridge, Mass.

That relationship depends on safeguards to attract the dollars needed to get new technologies on the market and in use, he said. Drugs, for example, can take 10 to 15 years of research and development at a cost of nearly $1 billion, according to the Pharmaceutical Research and Manufacturers of America, an industry trade group.

Many ideas published in journals -- stem cell research, for example -- are early-stage developments, said Andrew Cohn, government relations manager for WARF.

"There are very few that can roll into a doctor's office, and they need to be developed into a way to help how we practice medicine. And we need to have protection to develop it," he said.

Research investment helps encourage further developments and communication within the scientific and medical community, Cohn added. He said WARF shares its discoveries with researchers in 40 states and 26 countries.

Maraganore said if patents are weakened, the biotech industry will be more likely to protect breakthroughs as trade secrets.

Patent lawyers fear rules recently proposed by the Patent and Trademark Office could close the door on patents.

The regulations -- struck down in April by a federal court in Virginia -- would limit applications inventors can file and would require additional documentation. The PTO is considering an appeal and said the rules were aimed at ensuring a more careful examination of patent claims and avoiding unnecessary litigation.

PUBPAT's Ravicher agreed that a balanced patent system can be beneficial. "But what we have today is a system that rewards people who manipulate it. Hopefully, we can stem the tide."

Back to top


ADDITIONAL INFORMATION

Patent rulings

The U.S. Supreme Court recently decided a few patent cases that are likely to influence research and innovation in the medical field. Here's a look at what experts consider some notable opinions:

KSR v. Teleflex Outcome: The high court broadened the standard for what is considered an "obvious" invention or something that is not distinct enough from other known elements in the field.

eBay v. MercExchange Outcome: Justices ruled that patent holders who prove infringement may not automatically receive an injunction blocking alleged violators from using the disputed patent rights. Judges first must consider certain factors to determine whether an order is warranted.

LabCorp v. Metabolite Outcome: The Supreme Court, without opinion, affirmed a lower court decision validating a patent on a method for diagnosing a vitamin B deficiency in patients. Dissenting judges said they would have taken up the case because of potential restrictions such patents might impose on the practice of medicine.

Back to top


[download pdf]

Got an idea?

You've been mulling a problem for awhile. There's got to be a tool or device that would make your life so much easier. Then inspiration strikes. But before you even start looking into research and development, you want to protect your idea. Here's what you do:

Step 1: Idea!

Step 2: File an application with the U.S. Patent and Trademark Office.

Step 3: Patent undergoes examination by PTO.

Step 4: If the patent is not approved, go to Step 5. If the patent is approved, it is issued. Stop here. OR: Once issued, the patent can be challenged by a third party. Go to Step 7. OR: Once issued, the patent holder can contest any possible infringement in court. Go to Step 8.

Step 5: If the patent is not approved, the patent holder can appeal his or her claim to the Board of Patent Appeals and Interferences.

Step 6: If the board rejects the patent, the applicant can challenge the decision in federal court. Appeals go to the U.S. Court of Appeals for the Federal Circuit. Stop here.

Step 7: If a third party challenges a patent's validity, the challenger can either ask the PTO to re-examine the patent claim or take the action to federal court. Appeals go to the U.S. Court of Appeals for the Federal Circuit.

Step 8: A patent holder can contest any alleged infringement in federal court. Appeals go to the U.S. Court of Appeals for the Federal Circuit.

Source: U.S. Patent and Trademark Office

Back to top


ADVERTISEMENT

ADVERTISE HERE


Featured
Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story


Read story

Goodbye

American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story


Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story


Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story


Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story


Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story


Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story


Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn