Posts Tagged: "biotech"

What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of December 2013. Fitch Puts Negative Outlook on Bristol-Myers. AstraZeneca Loses at the Federal Circuit on Omeprazole. Merck and GlaxoSmithKline Collaborate on Regimen for Advanced Renal Cell Carcinoma. Teva and Pfizer Settle Viagra® Patent Dispute. FTC Settles with Mylan over Agila Acquisition. FDA Fast Tracks Savara Pharmaceuticals Antibiotic AeroVanc to treat MRSA. Fitch Gives Johnson & Johnson AAA Rating. Sales of Antiretroviral Drugs for HIV Predicted to Decrease.

On the method claims, the test, derived from Prometheus, is whether the claims add enough to a natural principle/law of nature/ natural phenomenon to make them go beyond claiming just the natural principle/law of natural/natural phenomenon alone and to ensure practical application. If they do and if that extra stuff isn’t just routine or conventional steps known in the field, the claims are patent eligible. So, are diagnostic method claims acceptable, or what about personalized medicine claims outlining which drugs work better for specific patient populations? How about a kit with instructions? We can look to the PTO Guidelines and to the case history after Prometheus to give us a some tips on what may not be eligible and how put our best foot forward when preparing biotech process patent applications.

Today, after several years of substantial turmoil, patent eligibility in a variety of economically significant technologies is extremely uncertain, including software, natural products, medical diagnostics and personalized medicine. It is with great irony that one of the few things we know with any degree of certainty is that business methods are patent eligible… If you haven’t noticed, overwhelming portions of the U.S. economy are tied to the biotechnology and software sectors. Are we about to throw away our economic leadership? There are already some lawyers talking openly with clients about whether they may be able to in some cases actually get broader, more certain protection outside the United States.

In order to fabricate a case or controversy where clearly none existed, the farmers — AFTER filing the declaratory judgment action — sent Monsanto a letter, which asked Monsanto to expressly waive any claim for patent infringement they may ever have against the farmers and memorialize that waiver by providing a written covenant not to sue. The farmers explained that without such a covenant, they would at risk. With such a disingenuous attempt to fabricate declaratory judgment jurisdiction you really need to ask yourself exactly who the evil party is here! To ask for such a ridiculously broad covenant not to sue was nothing more than grandstanding. Thus, Monsanto understandably refused to provide a blanket covenant not to sue for any and all actions both known and unknown that maybe undertaken by the farmers.

The Supreme Court quite directly contradicts the reasoning of Chakrabarty in Myriad. Thomas explains that it is a fact that isolated DNA is nonnaturally occurring, but still nevertheless not patent eligible. Whether we like it or not, the very foundation of the Supreme Court’s decision in Chakrabarty has been overruled, or at the very least significantly cut back. Arguments to the contrary are simply wishful thinking and ignore the explicit language of the Myriad decision.

You can expect a near complete cessation in many areas of personalized medicine. If creating something in a lab, such as a composite cDNA, does not make the underlying claims patent eligible because what results is indistinguishable from what appears in nature that means that the fledgling and potentially promising technologies to grow organs for transplantation will shrivel up and die. The whole point is to create an organ that is indistinguishable from what appears in nature so that it can be transplanted into a human body to prolong life. Given the breadth of this opinion and the uncertainty it will cause funding will dry up in the U.S.

Some had hoped that the Court would use Bowman as an opportunity to address the extent of a patent owner’s monopoly over other self-replicating technologies in the areas of biotechnology and information technology, such as human cell lines or computer programs. Certainly, the Court hinted at the possibility of situations where the patented article’s self-replication is truly outside the purchaser’s control, or where the self-replication is an essential step in using the patented article for another authorized purpose. The Court, however, cautiously declined to extend its holding in Bowman to those situations. The decision in Monsanto is intended to be fact-specific and carry slight ramification. Indeed, the Court’s unanimous decision ended with a significant caveat that the holding is limited, “addressing the situation before [the Court], rather than every one involving a self-replicating product.”

Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases. The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. Another argument before the Supreme Court was about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. The Court also heard arguments about a case that raises crucial questions about whether human genes can be patented. And the outcome may well reset the boundaries and direction of medical research in the US, which of course has tremendous implications for investments made by the biopharmaceutical industry and the battle against many diseases, notably cancer.

Social policy concerns have influenced the AMP v Myriad debate. The Supreme Court, to the extent it must make a ruling for our times, informed by societal context, should dispassionately consider all the available empirical evidence, from the academic work cited here, to the claim scope limits resulting from massive sequence publication projects and recent court cases, and the thriving innovation ecosystem in personalized medicine at and among for profit and not for profits, and render a clear forward compatible decision for us all.

As the patent community waits to see whether the United States Supreme Court will deal a significant, perhaps fatal blow, to the patenting of many genetic related innovations in Association of Molecular Pathology v. Myriad Genetics, announcement came this morning of a newly issued U.S. patent. This patent was issued to St. Jude Children’s Research Hospital. The invention relates to compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults.

From implementation of sections of the Leahy-Smith America Invents Act to anticipated decisions from the Supreme Court, we can expect changes to the patent system that will affect the high tech and biotechnology industries, start up companies and established businesses of all sizes. Just some of the developments we can expect to see include a determination of whether genes are patentable, proposed legislation addressing the litigation strategies of non practicing entities, and harmonization of the US with much of the world through the implementation of the first-to-file patent application system and the introduction of an international design patent application process.

The FDA decided not to pursue a re-hearing before a federal appeals court that recently ruled the federal government could not prosecute a sales rep who promoted off-label uses of a medicine because his speech was not false and misleading. Meanwhile, Congress delayed Medicare price restraints on a group of medications that will benefit Amgen while costing taxpayers up to $500 million over two years. Still further, after a federal court judge decided that the Bristol-Myers patent on the Baraclude hepatitis B treatment was invalid, some analysts are saying the ruling may prompt greater scrutiny of so-called composition of matter patents.

In its amicus brief, CLI responds by arguing that the term “makes,” as used in Section 271(a), has its plain and ordinary meaning, which embraces the concepts of “bringing about” or “causing.” CLI contends that Bowman, through his acts of planting and cultivating, brought about and caused the formation of a next-generation of herbicide-resistant soybeans. Alternatively, CLI argues that, even if the concept of a “making” only literally reaches the acts of the herbicide-resistant soybean plants Bowman cultivated, Bowman would still be liable for those acts under principles of agency-instrumentality law. Based on his acts of planting and cultivating, CLI asserts that Bowman exercised sufficient control over the herbicide-resistant soybean plants he raised that they should be treated as mere instrumentalities of his, the conduct of which can and should be attributed to him.

One side in the “gene patent war” has nevertheless convinced the Supreme Court to weigh in on the issue of whether DNA sequences derived from the human genome are patentable, in Association for Molecular Pathology (AMP) v. Myriad Genetics, while disingenuously labeling the patents at issue as “human gene patents.” Let’s set the record straight.

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.