Articles by Stephen Albainy-Jenei

If separate entities each perform separate steps of a method claim, under what circumstances would that claim be directly infringed, and to what extent would each of the parties be liable?

The new legislation is intended to accomplish three primary goals: transition to a first-to-file system; improve patent quality; and provide more certainty in litigation.

The Federal Circuit recently affirmed that an admission that an accused infringing device practicing an industry standard may, without more, be the basis for a finding of infringement.

Eli Lilly & Co. recently lost an appeal from a final judgment of the U.S. District Court for the Eastern District of Michigan, finding claims 2, 6, and 7 of U.S. Patent No. 5,464,826 invalid for obviousness-type double patenting over its earlier U.S. Patent No. 4,808,614. (See, Sun Pharmaceutical Industries v. Lilly, U.S. Court of Appeals for the Federal Circuit, 2010-1105).

The U.S. Court of Appeals for the Federal Circuit recently rendered a decision in Ortho-McNeil Pharmaceutical Inc. v. Lupin Pharmaceuticals Inc. on the question of whether separate enantiomers can have “first commercial marketing or use” status for purposes of patent term extension under 35 U.S.C. § 156.

Here comes the Patent Reform Act of 2010 in the form of an amendment to S. 515.

Pfizer is continuing its fight with generic drug manufacturer United Laboratories =in the Philippines over the issue of the validity of the patent on Lipitor as Unilab tries to have the patent canceled.

Is Bilski important? Some estimates say as many as 200,000 patents could be invalidated if Bilski is held to strictly apply to all method patents. For the biotech industry, the decision has significant ramifications for the patentability of many inventions, particularly diagnostics and personalized medicine.

How do you know the government is upset about spending all its money on healthcare? When you’re required to pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions.

The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted last month in favor of a proposal by Sens. Kay Hagan (D-N.C.), Michael Enzi (R-WY) and Orrin Hatch (R-UT) to create a follow-on biologics (FOB) pathway that provides 12 years of data exclusivity for brand-name biologic drugs.

The fight over the patentability of isolated genes is misplaced since patents are usually obtained not just for the isolated gene, but also for methods of use and as part of more complex assays or kits.

You’re not alone in your financial suffering. The recession has even hit the U.S. Patent and Trademark Office, which is funded by fees paid by applicants for patent applications and other services.

Last month, Abbott Laboratories was sued by Bayer AG’s HealthCare unit, alleging that Abbott's best-selling drug Humira infringes on a Bayer patent. In one new twist, Abbott has sued Bayer AG’s HealthCare unit, claiming the Bayer patent is invalid, not infringed or unenforceable.

As Congress is considering possible legislation to create an abbreviated pathway for the FDA to approve generic biologic therapies, differences in the R&D expense and product cost, and the potential for both new therapies post-approval and second-generation innovations, have raised questions about how to achieve the proper balance between innovation and competition.

In a spate of recent articles, it would seem that the world has come to an end in terms of high-tech IPOs—not to mention venture backing of early-stage start-ups.